Monday, August 6, 2012

Older Men's Sperm Raise Risk Of Genetic Problems In Offspring

Babies born to older men carry a higher risk of having genetic problems, says a study from the USA . A French study showed that male infertility shoots up after the age of 40. Not only does the lower quality of older men's sperm lower fertility, it also makes it more likely that babies with genetic abnormalities are born.

You can read about the American study in the Proceedings of the National Academy of Sciences under the title "Advancing age has differential effects on DNA damage, chromatin integrity, gene mutations, and aneuploidies (chromosome abnormalities) in sperm".

Andrew Wyrobek, Lawrence Livermore National Laboratory, and Brenda Eskenazi, University of California, Berkeley School of Public Health, study leaders, said that the their study demonstrated that men who wait till later in life to have children are not only risking infertility, but also having babies with such genetic disorders as achondroplasia and schizophrenia. The researchers found that the DNA in the sperm of older men do deteriorate. (Achondroplasia = Dwarfism)

Women of any age who become pregnant with older men also have a higher risk of miscarriage, the study found.

The US study analyzed the semen of 97 men, aged 22-80. All the men were non-smokers. The scientists tested for DNA damage, chromosomal abnormalities and gene mutations. They found that lower sperm motility correlated with DNA fragmentation.

The study showed that men, as well as women, have a biological fertility clock. The difference seems to be that for women the change occurs more abruptly.

Even though older men are more likely to produce babies with genetic problems, there is not a raised risk of having a child with Down syndrome, Klinefelter syndrome, Turner syndrome, triple X syndrome, and XYY - as is the case with older women. Some older men, a small fraction, have a higher risk of fathering offspring with multiple genetic and chromosomal defects.

The researchers found that older men recruited in the Baltimore inner city area had an increased risk of fathering children with Apert syndrome. However, this was not the case with the men recruited in California. Apert syndrome is a serious disfiguring birth defect. The report suggests that socioeconomic, ethnic and/or dietary factors may also influence how age affects human sperm quality.

A French study found that male fertility takes a nosedive when a man reaches the age of 40. The study was carried out at INSERM (Institut National de la Sant� et de la Recherche M�dicale). The study looked at the 2,000 couples in France who were having fertility treatment.

Since 1980, the USA has seen a 40% jump in 35-49 year-old men fathering children and a 20% fall in men under 30 fathering children.

Links:
INSERM
Proceedings of the National Academy of Sciences
Lawrence Livermore National Laboratory (LLNL)
Continue to Read more ...

Steroids For Treatment Of Sudden Hearing Loss

Sudden sensorineural hearing loss (SSNHL) can occur suddenly in one ear, and generally within three days, cause a 30+ decibel (dB) hearing loss at three consecutive frequencies. The cause for this disorder is unclear, but research has indicated that viral infection, vascular compromise, and immunologic diseases could be key reasons for this hearing disorder. A few celebrities have reported experiencing sudden hearing loss. In recent years, radio personality Rush Limbaugh and Rapper Foxy Brown both reported experiencing sudden hearing loss.

Treatment of SSNHL remains controversial. Different approaches such as steroids, vasodilator, antiviral agents, diuretics, and low-salt diets have been suggested. Nevertheless, spontaneous recovery rate without treatment ranges from 30 to 60 percent, most resolving within two weeks after onset.

As a result of its anti-inflammatory effect, high-dosage systemic steroid therapy is currently the mainstay of the treatment for SSNHL. Despite oral or intravenous steroid therapy for two weeks, approximately 30-50 percent of patients show no response. Animal studies have found that intratympanic steroid injections, introducing steroids through the tympanic membrane, results in reduced systemic steroid toxicity and higher perilymph steroid level selectively. Past research has focused on use of these injections as a secondary-line therapy in SSNHL refractory cases. Other clinicians promote its use as first-line therapy in all SSNHL cases. Nevertheless, few controlled studies have been published comparing the results between intratympanic steroid treatment and other approaches.

A New Study

A new study evaluates the effect of intratympanic steroid injections in patients with SSNHL after failure to respond to systemic steroid treatment. Patients who refused this regimen were used as controls in this research. The authors of "Intratympanic Steroids for Treatment of Sudden Hearing Loss After Failure of Intravenous Therapy," are Guillermo Plaza MD PhD, from the Otolaryngology Department, Hospital de Fuenlabrada, and Carlos Herr�iz MD PhD, with the Otolaryngology Department, Fundaci�n Hospital Alcorc�n, both in Madrid, Spain. Their findings are being presented at the 110th Annual Meeting & OTO EXPO of the American Academy of Otolaryngology-Head and Neck Surgery Foundation, being held September 17-20, 2006, at the Metro Toronto Convention Centre, Toronto, Canada.

Methodology

From January 2000 to December 2004, a non-randomized prospective clinical trial was conducted for 50 patients diagnosed with unilateral (affecting one ear) SSNHL due to unknown reasons. All patients underwent a complete clinical history, physical and audiologic examination, syphilis serology, autoimmune antibody test, and magnetic resonance imaging, producing negative results. Patients were excluded if SSNHL might be caused by trauma, Meniere's disease, tumors, or autoimmune diseases. Also, those cases that were treated later than 30 days after onset of SSNHL were also excluded.


All cases were intravenously treated, with 120 mg of methlyprednisolone per day, for five days. Rest, stop smoking, and low-salt diet were also advised. Although antiviral agents or diuretic were not included in the standard protocol, intravenous pentoxyphylline was sometimes used with the steroids. After five days of intravenous treatment, pure-tone audiometry and speech discrimination tests (SDT) were performed. Pure-tone average (PTA) was calculated as the average of the thresholds at 0.5, 1, 2 and 3 kHz.

After this period of intravenous therapy, failures (18 cases) were offered intratympanic steroid treatment. Nine patients refused, and were treated with oral steroid tapering during 15 days. They were considered as internal controls, whereas the other nine patients received three weekly intratympanic injections of methylprednisolone. Intratympanic steroid treatment was started 5-7 days after onset of conservative treatment.

Pure-tone audiometry and SDT were performed just before each injection, and one week, one month and six months after the last injection. In the control group that refused intratympanic treatment, pure-tone audiometry and SDT were performed one month and six months after onset. Recovery of hearing was defined as improvement of more than 15 dBs in PTA or an increase in speech discrimination score (SDS) of 15 percent or more. Threshold differences were also analyzed at each frequency in PTA. Side effects and subjective symptoms were also recorded.

Results

The average age of the study patients the patients was 52.0 � 15.8 years. Male to female ratio was 22:28. Time of onset to start of intravenous therapy averaged 5.6 � 7.7 days. Tinnitus was present in 58 percent of the cases, whereas vertigo presented in 24 percent. Thirty-two percent of cases had hypertension, and 14 percent had diabetes mellitus. Initial hearing impairment was average 76.5 � 21.2 dB PTA, and 38 � 12 percent.

After standard intravenous treatment, hearing improvement of 15 dB or more in PTA was noted in 32 cases (64 percent). In these responders, the mean improvement of the value of PTAs before and after intravenous treatment was 35.0 � 16.56 dB. For the 18 failures, nine patients accepted intratympanic treatment, and were enrolled in the treatment group, whereas the other nine served as internal controls. There were no statistical differences in age, sex ratio, time of onset to therapy, presence of vertigo and tinnitus, initial hearing level, and final hearing level after intravenous treatment between the two groups.

In the treatment group, hearing improvement of 15 dB or more in PTA was noted in five cases (55 percent). The mean value of PTA before and one month after intratympanic injections treatment were 73.3 � 20.8 dB and 40.2 � 17.3 dB, respectively, so that an improvement in mean PTA after intratympanic treatment was 33 � 12.55 dB.

Conclusions

This non-randomized prospective clinical trial shows that intratympanic methylprednisolone significantly improved the outcome of SSNHL after intravenous steroid treatment. As previously reported, intratympanic steroids actually are an effective and safe therapy in SSNHL cases that are refractory to standard treatment.

The researchers suggest that the number of injections, the type of steroid, and the most adequate doses must be defined in randomized prospective clinical trials. Also, these randomized studies will allow establishing an evidence-based treatment for idiopathic SSNHL. These trials should also evaluate outcomes after initial therapy for SSNHL comparing steroids that are administrated systemically or by intratympanic injections.

American Academy of Otolaryngology Head and Neck Surgery (AAOHNS)
Continue to Read more ...

Rage Disorder Affects 7.3 Per Cent Of US Adults

Rage disorder, or Intermittent Explosive Disorder (IED), affects 7.3% of US adults at some time during their lifetimes. The disorder comes with moments of unexpected anger in which the person may attack other people, other people's belongings and actually hurt them and damage their property.

The study was funded by the National Institute of Mental Health (NIMH). It found that up to 16 million Americans may experience IED during their lifetimes. Data comes from the National Comorbidity Survey Replication, involving 9,282 adults - a national face-to-face survey.

According to Ronald Kessler, Ph.D., Harvard Medical School, and team, people with IED generally start showing symptoms during their early teenage years. Nearly 82% of IED sufferers go on to experience depression, anxiety and substance abuse disorders. Unfortunately, only 28.8% are ever treated for their anger. Treatment may prevent later depression, anxiety and substance abuse disorders.

You can read about this report in the Archives of General Psychiatry, June 2006.

According to the standard psychiatric diagnostic manual, a diagnosis of IED includes:

-- The person had 3 episodes of impulsive aggressiveness 'grossly out of proportion to any precipitating psychosocial stressor' during his/her lifetime

-- The person suddenly lost control and smashed something worth more than a few dollars

-- The person hit or tried to hurt someone

-- The person threatened to hit or hurt someone

If a person has had three episodes within the last 12 months he/she is considered to have a more persistent and severe disorder - especially if the episodes included attacking people and property. People with persistent and severe IED tend to cause 3.5 times more damage than other people with IED.

People with severe IED have an average of 43 episodes with serious attacks during their lifetimes. It is estimated that between 5.9 - 8.5 million people in the United States are in this sub-group. The disorder brings with it considerable functional impairment.

The researchers suggest that due to the stressful lives IED sufferers have, which includes a high divorce rate and serious money problems, they are much more susceptible to having drug and alcohol abuse disorders, as well as experiencing depression and/or anxiety.

As the onset of IED tends to take place early in life, the researchers suggest more should be done to identify it in schools and provide early treatment. This may reduce the number of people who go on to experience the other co-occurring disorders.

Even though most IED sufferers had seen a professional for emotional problems, only 11.7% had been treated for anger during the previous year before being interviewed.

The number of sufferers is much higher than other studies on IED had indicated. The report says cases of anger outbursts are probably much higher than the numbers reported in this report, because it excluded outbursts from people with other disorders that may overlap with IED, such as bipolar disorder.

NIH - National Institute of Mental Health
http://www.nimh.nih.gov
Continue to Read more ...

How To Choose Petite Maternity Clothing That Will Fit You Just Right

If you are among those who have a petite frame, finding the right petite maternity clothes must be tough. To find appropriate clothes that minimize your growing waistline and bust line is necessary. This is where especially tailored maternity clothing comes as a blessing. Over the years, maternity clothes have diversified into a number of styles. These designs cater to every body type and size. Nowadays, you will find that tops, blouses, jeans, pants, skirts and evening dresses for pregnant women come in petite sizes.

What Types of Clothes to Wear and When - How to Select the Right Items

Wearing clothes with the right fit becomes even more important when you have a small frame. One has to keep in mind several points to dress smart. In the first trimester, you can wear most of your pre-pregnancy wear. Be careful not to wear form-fitting or tight jeans as this might harm the growing baby. Pants and skirts with elastic waists, dresses without a waistline, oversized clothing serves as wonderful maternity wear. This transitional clothing will come into use again after the baby is born and before you return to your pre-pregnancy size.

From the fifth month onwards, you will need to wear maternity clothes. We suggest you buy monochromatic tops and bottoms designed specially for petite women. The single color effect will make you appear taller and give you a slimmer look. Choose boat-neck or high-neck tops. This will emphasize your slim shoulders and give you a narrower effect. Avoid horizontal stripes especially in the later half of your pregnancy.

For a casual look, you could buy a good pair of black pants, a short or long black skirt, and a pair of twill or denim pants. Another good option you might want to try is a cotton/spandex jumpsuit that hugs your body and has a little extra room in the middle.

When choosing a maternity evening dress for a special occasion, buy a full-length one instead of a short or knee-length one. This will add to your height and frame your figure. Try not to go in for layered clothing when you are selecting petite size maternity clothes. Try out a slim silhouette instead. Many manufacturers are coming out with innovative designs of maternity clothes for the petite woman. A common choice for a special dress is the classic black number. This has been modified into a long sleeved, full-length, body-hugging style, which looks chic and glamorous.

How to Wear It Right!

Apart from buying petite size maternity clothes, one should remember a few things. Never buy clothes with big and heavy prints. Choose light and airy fabrics that will give you a fresh look. Wearing the right accessories is also crucial to looking great. A person who has a short frame should wear long necklaces and delicate jewelry. Never use over size bags as these can make you look bulky. Loosely knotted scarves are a good idea to give a dramatic effect. With the right planning and eye towards colors, patterns and comfort - you will find the right fashionable maternity clothing for you!
Continue to Read more ...

Life Expectancy Of 14 Nations In Europe

Setting World Cup considerations - or grievances - to one side, the 14-nation study found that in 2003 Portugal had the lowest life expectancy at birth for men - almost 4 years less than the highest (Sweden).

Italy and France were the top two nations for life expectancy among women. Italy narrowly beat France as far as life-expectancy for men was concerned.

Between 1995 and 2003 life expectancy at birth rose in all 14 European countries by on average 3 months each year for men and 2 months for women, claims the report from the first year's work of the European Health Expectancy Monitoring Unit* (EHEMU).

In 2003 Portugal had the lowest life expectancy at birth for men, almost 4 years less than the highest (Sweden). Women's life expectancy was lowest in Denmark and highest in France.

Life Expectancy (LE) Men and Women 2003

Austria
Men 76.4 --- Annual increase in LE at birth (months) 4
Women 82.5 --- Annual increase in LE at birth (months) 4

Belgium
Men 75.4 --- Annual increase in LE at birth (months) 3
Women 81.3 --- Annual increase in LE at birth (months) 1

Denmark
Men 75.8 --- Annual increase in LE at birth (months) 4
Women 80.1 --- Annual increase in LE at birth (months) 3

Finland
Men 75.1 --- Annual increase in LE at birth (months) 3
Women 81.8 --- Annual increase in LE at birth (months) 2

France
Men 76.1 --- Annual increase in LE at birth (months) 3
Women 83.2 --- Annual increase in LE at birth (months) 2

GB
Men 76.1 --- Annual increase in LE at birth (months) 3
Women 80.5 --- Annual increase in LE at birth (months) 2

Germany
Men 76.3 --- Annual increase in LE at birth (months) 4
Women 81.8 --- Annual increase in LE at birth (months) 3

Greece
Men 75.7 --- Annual increase in LE at birth (months) 1
Women 80.7 --- Annual increase in LE at birth (months) <1 month

Ireland
Men 74.9 --- Annual increase in LE at birth (months) 3
Women 80.7 --- Annual increase in LE at birth (months) 2

Italy
Men 77.3 --- Annual increase in LE at birth (months) 3
Women 83.1 --- Annual increase in LE at birth (months) 2

Netherlands
Men 76.2 --- Annual increase in LE at birth (months) 2
Women 80.7 --- Annual increase in LE at birth (months) 1

Portugal
Men 74.2 --- Annual increase in LE at birth (months) 3
Women 80.8 --- Annual increase in LE at birth (months) 3

Spain
Men 76.2 --- Annual increase in LE at birth (months) 3
Women 83 --- Annual increase in LE at birth (months) 2

Sweden
Men 78 --- Annual increase in LE at birth (months) 2
Women 82.2 --- Annual increase in LE at birth (months) 1

"Whether the extra years of life gained were spent in good or bad health remains a crucial question," said Professor Carol Jagger from the University of Leicester who co-leads the EHEMU project.

"Compared to life expectancy, disability-free life expectancy varied more widely across the EU countries but this may be due to cultural differences in how people report disability. So at present ranking countries by the years people live without disability is not recommended. However the trends between 1995 and 2001 will be less sensitive to such differences so we can compare how disability-free life expectancy is tracking life expectancy between countries".

The report found that between 1995 and 2001 Belgium, Italy and Spain appeared to be the healthiest countries as both men and women's disability-free life expectancy at birth was increasing faster than life expectancy. In Denmark, Great Britain and Portugal disability-free life expectancy was increasing at the same rate as life expectancy. Other countries showed differences between men and women: in the Netherlands men's disability-free life expectancy increased faster than life expectancy but women's disability-free life expectancy declined over the period so Dutch women were living longer but the extra years were spent with disability.

"We now have to explore the reasons for these differences through in-depth analyses" said Professor Jagger. "EU countries vary widely on a number of factors that could be responsible such as smoking and diet as well as the prevalence of diseases that commonly result in disability such as stroke and coronary heart disease. The new EU structural indicator Healthy Life Years which will be based on more comparable data, is an important step forward in monitoring the health of our ageing European populations for future planning.

The EHEMU project is funded by the EU Public Health Programme from 2004-2007 and is a collaboration between four teams based in: CRLC and the University of Montpellier in France (Jean-Marie Robine); the University of Leicester, UK (Carol Jagger); the Scientific Institute of Public Health, Belgium (Herman van Oyen); and the French National Institute of Demography, INED (Emmanuelle Cambois). The main aim of EHEMU is to provide a central facility for the co-ordinated analysis and synthesis of life and health expectancies.

The full report can be accessed at: Click here to see the FULL REPORT (PDF).
Continue to Read more ...

How To Sleep Comfortably During Pregnancy - Maternity Pillows!

Difficulty sleeping during pregnancy is a common occurrence among women. Many factors contribute to the sleeplessness and discomfort at bedtime. Histamines in the body are much higher for pregnant women. This is a result of a rise in hormones such as estrogen and prolactin in the body.

Some women complain of being extremely itchy at night and the stretching of the skin around the ever-growing belly may contribute to the discomfort. Lotions such as coco butter and creams enriched in vitamin E may help remedy the itchy skin but it does not really take care of all the sleeping issues.

Because of the weight gain, which can be anywhere from 25 to 55 pounds, many women experience moderate to severe back pain. Stomach lying and back lying are out of the question and the only other position would be side lying. This can be painful on the pelvic bones, as well as the hips. Support under the belly and back by way of a maternity pillow is definitely needed to alleviate much of the problem.

Traditional body pillows are soft and usually long like the letter 'I'. Pregnancy is a unique time during which the belly and back both need supporting. Many of these pillows feature adjustable straps and other amenities that appeal to pregnant women. They may be scented with lavender or other herbs to help the mother-to-be relax. They also come in a wide variety of colors and fabrics.

There are plenty of different styles of body pillows specifically designed for pregnancy. There are U shaped pillows, designed to support belly, back and knees. Without the unique shape of the U pillow, another pillow can be placed between the knees to mimic the support of the U. Some pregnant women feel that this particular pillow can be too large and prefer a smaller, yet supportive one.

If cost is an issue, there are styles that range from as low as thirty dollars and others that may cost upwards of $150. The Snoozer, for example, costs $154 and boasts it has down filling and total body support. The product also tells of its patented design, which aligns the spine and hips for ultimate comfort. The more affordable Maternity Pillow priced at around $48.89, is filled with premium hypoallergenic polyfill. It has a 100% cotton cover and the entire pillow is machine washable for easy care.

The median pillow, which is priced at $75.50, is called the Sleeping Bean Natural Kapok Body Pillow. This pillow extends to an extra long five and a half feet! This pillow is filled with a material called Kapok, which is found in the rainforest and can hold its shape better than most pillow fillings. The kapok is harvested from pods by indigenous peoples and proves to be a source of employment for them. Maternity pillows with a conscience! For the frugal and crafty expectant mother, there are even sewing patterns that can be purchased to create her very own unique looking maternity pillow out of whichever fabrics of her choosing.

Whatever sleeping aids an expectant mother chooses, there is no question that sound sleep is a necessity to keep her energy up! Pregnancy pillows were created to meet just this need, and, with so many options on the market, there is surely a pillow to meet any body size or shape.
Continue to Read more ...

Zimbabwe Life Expectancy Lowest In The World

In Zimbabwe, female life expectancy stands at 34 years, while for males it is 37 years. According to a report issued by the United Nations, Zimbabwe has the lowest life expectancy in the world.

Over the last two years, according to the World Health Organization (WHO), life expectancy for women has dropped by two years.

Experts believe this is due to two main factors (among others):

1. The country's economy has been deteriorating without any sign of any improvement.

2. AIDS/HIV (even though there has been a recent drop in numbers)

Women are much more likely to be infected with HIV than men (in Zimbabwe).

Compared with Japan, where average life-expectancy now stands at 82, the situation in Zimbabwe is tragic.

It is a very sad state of affairs. Zimbabwe used to be one of the richest countries in Africa.

A decade ago Zimbabwe's economy was almost twice as big as it is now.

A lady who lives in Zimbabwe wrote this email to us (she wished to remain anonymous):
'Zimbabwe used to be a place with so much hope, its future looked wonderful. As a black woman I really felt we were going somewhere. A man took over and gradually turned into a monster. He has torn the place to pieces - like a cat playing with a squeaking mouse. It is a tragedy.'
Continue to Read more ...

Sleep More Important Than Diet For Weight Control

If you manage to get a good night's sleep on a regular basis your chances of staying slim or becoming slimmer are significantly higher, say researchers from Care Western University, Ohio, USA, after monitoring nearly 70,000 women for over a decade and-a-half. This is the largest study ever to examine the effects of sleep on weight over the long-term.

What constitutes a good night's sleep? For this study, the researchers observed the effect sleeping five or fewer hours regularly has on a woman's weight over the medium and long term. They compared them to women who managed to regularly get 7 hours' sleep each night.

The findings were presented at the American Thoracic Society International Conference, San Diego, California.

Women who don't get much sleep, up to five hours each night, are much more likely to have put on 33lbs (15 kilos) over a 16 year period - 30% more likely when compared to the women who managed to get 7 hours sleep each night. Light sleepers also have a significantly higher risk of becoming obese.

What surprised the researchers was that sleeping patterns had a much greater influence on women's long term weight than eating habits or physical activity.

At the start of the study, the women who slept up to five hours a night weighed 5.4 pounds more than those who got 7 hours or more. They also put on 1.6 pounds more each year than the good sleepers.

The researchers stressed that the 1.6 pounds extra per year may not sound like much, but this was an average. Multiply this number by ten and you are beginning to have a sizeable weight gap. Imagine what the difference would be over 20 or 30 years.

Dr. S Patel, lead researcher, said that hormones which regulate appetite are affected after just a few nights of sleep restriction. What surprised the researchers was that those who sleep less actually eat less than those who get adequate sleep. This shows that sleep is a much greater contributor to your long term weight than diet.

Dr Patel said he believes that people who sleep well fidget more during their waking hours - this helps them consume more calories. It is also most likely that hormones are tweaked in such a way as a result of how much we sleep - and this has a bearing on how many calories we burn off each day.

In order to stay/get slim, people have to focus on three factors:

  • -- Adequate sleep
  • -- Nutrition
  • -- Physical activity

Ask any professional sportsperson what the secret of top fitness is, and they will all say it is a combination of good training, eating the right foods and sleeping well - get one of those three factors wrong and you seriously undermine your chances of winning a race.
Continue to Read more ...

What Causes Men Pain In Prostate Biopsy And Best Method To Alleviate It

Researchers at Mayo Clinic have evaluated the major sources of pain for some men during in-office prostate biopsy and an anesthetic method that can best lessen it. Findings will be presented in two abstracts Thursday at the annual meeting of the North Central Section of the American Urological Association in San Diego.

Most prostate biopsies are performed on men who have abnormal digital rectal exams or abnormally elevated prostate-specific antigen (PSA) tests to evaluate the potential presence of cancer.

"Prostate biopsy evokes significant anxiety for some men due to anticipated pain associated with the procedure," says Richard Ashley, M.D., Mayo Clinic urology resident and lead study investigator. "We also noted that it seemed more men had pain with their prostate biopsies than we would have liked, and we wanted to make this procedure as comfortable as possible."

The researchers found about 16 percent of men who undergo prostate biopsy experienced a moderate or higher level of pain -- pain scores of 5 or more on a scale from 1 to 10. The injection of lidocaine to dull pain during the biopsy caused more pain than the insertion of the transrectal ultrasound probe, a small probe about the size of a cigar inserted into the rectum to produce images of the prostate gland during the biopsy. They also discovered that taking tissue samples in certain locations tested in a prostate biopsy were more likely to cause pain. Specifically, biopsy of the part of the prostate closest to the urethra, the prostate apex, was more painful than biopsy of the part closest to the bladder, the prostate base.

"We found we cannot predict who will have higher levels of pain at the time of a prostate biopsy simply based on the patient's history and features," says Dr. Ashley. "We discovered the location of biopsy was the most predictive of higher pain scores -- not age, body mass index, family history, presence of cancer, inflammation, whether a lump was palpable, or whether the prostate was large or small."

The investigators also found that anesthesia administered by direct infiltration of the prostate apex and the surrounding rectal tissues may provide better pain control during a prostate biopsy than other anesthetic methods.

"The prostate biopsy likely will never be a completely painless procedure, but it should be tolerable," says Dr. Ashley. "Patients should request that anesthetic be used at the time of a biopsy, and pain control should be the standard of care in a urologist's office. It does not take much time, and patients do benefit from this simple procedure to make the biopsy more tolerable. Patients should also be aware that different prostate locations biopsied are associated with more pain, and this may never be completely overcome by anesthetic. However, a complete and thorough sampling of the prostate gland is necessary to give the most accurate diagnosis to the patient."

In the study, Dr. Ashley and colleagues recruited 243 men scheduled to undergo in-office prostate biopsy in the Department of Urology at Mayo Clinic. The researchers randomly assigned the men to three different types of anesthetic: injection between the prostate base and seminal vesicle where the neurovascular bundle lies; intraprostatic injection into the substance of the gland, from the base to the apex; and injection at the prostate apex and surrounding rectal wall tissue. The biopsies were performed using a side-fire ultrasound probe and a biopsy gun. Six biopsies were performed on the right and left side of the prostate of each patient, focusing on the peripheral zone where most cancers occur.

The findings in this study need to be verified by other researchers in a larger study, according to Dr. Ashley.

Other study investigators include: Jonathan Routh, M.D.; Amy Krambeck, M.D.; Sameer Siddiqui, M.D.; Jeffrey Slezak; Lance Mynderse, M.D.; Michael Blute, M.D.; and Matthew Gettman, M.D.

Mayo Clinic

200 First St. SW
Rochester, MN 55902
United States
Mayo Clinic
Continue to Read more ...

FDA Approves New, Once-A-Day COREG CR For The Treatment Of Three Key Cardiovascular Conditions

GlaxoSmithKline (NYSE: GSK) and Flamel Technologies (NASDAQ:FLML) today announced FDA approval of once-a-day Coreg CR (carvedilol phosphate) extended-release capsules, for the treatment of three cardiovascular conditions:

  • -- High blood pressure, also known as hypertension.
  • -- A heart attack that has reduced how well the heart pumps (known medically as post-myocardial infarction left ventricular dysfunction).
  • -- Mild to severe heart failure.

COREG CR will utilize Flamel's proprietary Micropump technology, which controls the delivery of carvedilol helping to maintain appropriate amounts of medicine in the body over a 24-hour span. This technology allows COREG CR to be dosed once daily, in contrast to immediate-release COREG (carvedilol) tablets, which patients must take twice daily. GlaxoSmithKline plans to begin shipping COREG CR in the first quarter of 2007.

"Once-a-day COREG CR will simplify the treatment regimen and offer the potential for improved compliance for patients with heart disease," said Michael A. Weber, M.D., professor of medicine, at the SUNY Downstate Medical College of Medicine, Brooklyn, New York. "The combination of this benefit with the proven effectiveness of COREG offers a treatment advantage for the growing number of heart patients who take multiple medications every day."

COREG CR is a third generation "beta blocker," which is a class of medicines that work by slowing heart rate and lowering the force with which it pumps. Studies of COREG CR indicate it is generally well tolerated with a low incidence of adverse events. COREG CR, a once-a-day medicine, is approved to treat the same conditions as twice-a-day COREG, which has established a significant role in the treatment of heart disease.

Evidence of the treatment benefits of COREG has come from multiple clinical studies. These COREG studies include COMET, published in 2003. This trial of more than 3,000 heart failure patients demonstrated that patients receiving COREG lived 1.4 years longer compared to patients taking the beta blocker metoprolol tartrate.

Important insights into the effect of COREG following a heart attack came from the CAPRICORN trial, published in 2001. This study showed that when COREG was maintained long term in patients following a heart attack that reduced how well the heart pumps, the risk of dying was reduced by 23 percent. In addition, patients taking COREG had a significantly reduced risk of having another heart attack.

Another study, GEMINI, in 2004, evaluated patients with hypertension and underlying diabetes. Older beta blockers have generally been regarded as having a negative impact on key metabolic parameters. In contrast, the GEMINI study results showed that COREG effectively lowered blood pressure while having a neutral impact on blood-sugar levels, lipids and weight gain.

Heart Disease and the Role of Beta Blockers

Heart disease is the leading cause of death in the United States. The American Heart Association estimates that 71.3 million people in America have heart disease. Beta blockers are a critical component of the treatment regimen for many patients with high blood pressure, those who have had heart attacks and those with heart failure.

The use of newer beta-blockers like COREG is supported by current evidence-based guidelines, such as the AmericanCollegeof Cardiology and American Heart Association (ACC/AHA) Heart Failure Guidelines and the American Association of Clinical Endocrinologists (AACE) Hypertension Task Force's Medical Guidelines for Clinical Practice for the Diagnosis and Treatment of Hypertension.

COREG CR Dose Strengths

COREG CR will be available in four dosage strengths: 10 mg, 20 mg, 40 mg and 80 mg.

Important COREG CR Safety Information

It is important for patients to take their medicine every day as directed by their doctors or health care providers. Patients taking COREG CR should avoid stopping therapy abruptly. With certain beta-blocking agents, stopping therapy abruptly has led to chest pain and, in some cases, heart attack. If their doctor decides that they should stop taking COREG CR, their doctor or health care provider may slowly reduce their doses over a period of time before stopping it completely.

Some common side effects associated with COREG CR include shortness of breath, a slow heartbeat, weight gain, fatigue, hypotension, dizziness or faintness. People taking COREG CR who have any of these symptoms should call their doctor. Additionally, if patients experience fatigue or dizziness, they should sit or lie down and avoid driving or hazardous tasks. Beta-blockers may mask the symptoms of low blood sugar or alter blood sugar levels. People with diabetes should report any changes in blood sugar levels to their physician. Contact lens wearers may produce fewer tears or have dry eyes. As with any medicine, patients taking COREG CR should first tell their doctor what other medications they are taking.

As with any medicine, there are some people who should not take COREG CR. The people who should not take COREG CR include those with severe heart failure who are hospitalized in the intensive care unit. Also, people who require certain intravenous medications that help support their circulation (inotropic medications) should not receive COREG CR. Other people who should not take COREG CR are those who are prone to asthma or other breathing problems, those with a very slow heartbeat or heart that skips a beat (irregular heartbeat) and those with liver problems.

About Flamel Technologies

Flamel Technologies, S.A.is a biopharmaceutical company principally engaged in the development of two unique polymer-based delivery technologies for medical applications. Flamel's Medusa technology is designed to deliver controlled-release formulations of therapeutic proteins and peptides. Micropump is a controlled release and taste-masking technology for the oral administration of small molecule drugs.

About GlaxoSmithKline

GlaxoSmithKline, one of the world's leading research-based pharmaceutical and health care companies, is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
Continue to Read more ...

Super Antibiotic For Hospital Superbug MRSA

Merck scientists have discovered an antibiotic that is effective in destroying MRSA, otherwise known as the hospital superbug. This antibiotic, unlike others, blocks the enzymes that produce fatty acids - essential for the construction of the membranes of bacteria. The compound binds to FabF.

If the drug successfully passes clinical trials, it will be only the third new antibiotic type in the last four decades. Most modern antibiotics still work on variations of compounds discovered in the late 1940s to 1950s. Current antibiotics either inhibit a bacterium's ability to build a membrane or prevent it from creating proteins or DNA.

This fact, that most antibiotics are basically quite similar, may be one of the main reasons for the increasing incidence of antibiotic resistance. Antibiotic resistance is also the result of overuse of antibiotics.

Any completely new type of antibiotic is viewed with enthusiasm by doctors because it may smash resistance on the head and give us a headstart of many decades.

The researchers were looking through more than one quarter of a million natural products when they came across 'platensimycin' found in a soil sample from South Africa. Platensimycin is produced by Streptomyces platensis, an actinomycete bacteria. Platensimycin was found to be a powerful inhibitor of many Gram-positive bacteria, including many Staphylococcus strains.

Initially, researchers found that platensimycin eliminated S. aureus bacteria, related to MRSA, from infected mice. According to their preliminary investigations, there were no toxic side-effects. After further tests, they found platensimycin to be very effective against MRSA and many other types of bacteria.

This could be welcome news for doctors who are concerned at the rising numbers MRSA infection cases in hospitals throughout most of the world. The majority of pharmaceutical companies have moved away from antibiotic research. Over the last ten years the number of new antibiotics coming onto the market has gone down, while the number of MRSA cases has been steadily rising. MRSA is resistant to most antibiotics.

The scientists said that this potential breakthrough is in its birth and we could be looking at several years before a new, effective and safe product is on the market.
Continue to Read more ...

Cymbalta(R) Safely And Effectively Treats Core Anxiety Symptoms Of Generalized Anxiety Disorder - Study

A new study of approximately 500 patients evaluated the safety and efficacy of the antidepressant Cymbalta(R) (duloxetine HCl) on the core anxiety symptoms in patients with generalized anxiety disorder. Cymbalta significantly reduced core anxiety symptoms and associated painful physical symptoms and improved functional impairment associated with the illness. Results will be announced on Saturday, March 25, in two separate presentations[i],[ii] at the Anxiety Disorders Association of America (ADAA) Annual Conference.

In this nine-week study, Cymbalta significantly improved core anxiety symptoms such as anxious mood, fears and tension by 51 percent in patients taking 60mg/day and by 50 percent in patients taking 120mg/day compared to an improvement of 32 percent in patients taking sugar pill. Patients taking both 60mg/day and 120 mg/day had significantly greater response and remission rates compared to patients taking sugar pill. In addition, Cymbalta significantly reduced overall pain by 41 percent and 37 percent respectively, compared to 16 percent in patients taking sugar pill. Cymbalta patients also reported greater improvement in quality of life as measured by the Sheehan Disability Scale, Quality of Life Enjoyment and Satisfaction Questionnaire and European Quality of Life 5 Dimensions, including improved ability to perform everyday activities at work, home, and in social situations compared to sugar pill.

"While it is important to evaluate anxiety symptoms such as excessive worry and irritability, it is also important to evaluate associated painful physical symptoms and functioning because many patients also report these symptoms," said Christer Allgulander, MD, associate professor, senior lecturer, Karolinska Institutet, and lead author on the study. "These data suggest that not only was Cymbalta able to significantly improve the core anxiety symptoms, but it also reduced painful physical symptoms associated with the disorder and improved functioning resulting in improved quality of life."

"We are encouraged by these results that suggest Cymbalta may address a broad range of core anxiety symptoms and the associated physical symptoms that are often reported in patients with generalized anxiety disorder," said James Russell, MD, Medical Advisor, Eli Lilly and Company.

Study Highlights

------- Compared to sugar pill, patients receiving Cymbalta 60mg/day and 120mg/day experienced significant improvement in symptom severity and disability associated with generalized anxiety disorder, including:
* Significantly greater improvement in the severity of anxiety symptoms, such as anxious mood, fears, and tension, as measured by the Hamilton Anxiety Scale. (average improvement 60mg = 51%, 120mg = 50%, sugar pill = 32%)
* Greater response rates (58%, 56%, 31%, respectively)
* Greater sustained improvement rates (64%, 67%, 43%, respectively)


------- Patients receiving Cymbalta 60mg/day and 120mg/day experienced greater remission rates compared to those receiving sugar pill (31%, 38% and 19%, respectively).

------- Compared to sugar pill, patients receiving Cymbalta 60mg/day and 120mg/day reported significant improvement in ratings on the Visual Analogue Scale for Pain for each of the following pain items:
* Overall pain (average improvement 60mg = 41%, 120mg = 37%, sugar pill = 16%)
* Headaches (34%, 38%, 13%, respectively)
* Back pain (44%, 46%, 14%, respectively)
* Shoulder pain (47%, 43%, 19%, respectively)
* Interference due to pain (39%, 41%, 10%, respectively)
* Pain during waking hours (42%, 43%, 12%, respectively)

------- In this study, the most common adverse events (occurred at a rate of >=5 percent and at least twice the rate of placebo) were nausea, dizziness, dry mouth, fatigue, hyperhidrosis, insomnia, constipation, diarrhea, decreased libido, anorexia, somnolence, vomiting and sedation.

Methods

In this study of patients with generalized anxiety disorder, 168 patients were randomly assigned to receive 60mg of Cymbalta a day, 170 patients received 120mg of Cymbalta a day and 175 patients received a sugar pill. Patients with a recent diagnosis (within six months) of major depression were excluded from this study. The primary endpoint of the study was effect on anxiety symptoms as measured by the Hamilton Anxiety Scale (HAMA). Changes from baseline to endpoint were analyzed using ANCOVA. Secondary measures included effects on associated pain and functioning. Pain was assessed using a Visual Analogue Scale. Functional outcomes, such as the ability to complete everyday activities at work, home, and in social situations, were measured using the Sheehan Disability Scale (SDS), the Quality of Life Enjoyment and Satisfaction Questionnaire short form (Q-LES-Q-SF) and the European Quality of Life 5 Dimensions (EQ-5D).

About Generalized Anxiety Disorder

Approximately four million Americans are diagnosed with generalized anxiety disorder each year.[iii] Symptoms persist for at least six months and can include exaggerated worry or chronic anxiety and irritability, which can lead to poor concentration, and procrastination, as well as physical symptoms like muscle tension, fatigue and nausea.[iv] Episodes of generalized anxiety disorder may be brought on, or worsened by, stressful life events. The illness also tends to be chronic with periods of exacerbation and remission.[v]

About Cymbalta

Serotonin and norepinephrine in the brain and spinal cord are believed to both mediate core depression symptoms and help regulate the perception of pain. It is common for anxiety disorders to be associated with other disorders, such as depression.vi

Disturbances of serotonin and/or norepinephrine may explain the presence of both the emotional and physical symptoms of depression. Based on pre-clinical studies, duloxetine is a balanced and potent reuptake inhibitor of serotonin and norepinephrine. While the mechanism of action of duloxetine is not fully known, scientists believe its effect on both emotional symptoms and pain perception is due to increasing the activity of serotonin and norepinephrine in the central nervous system.

Cymbalta is approved in the United States for the treatment of major depressive disorder and the management of diabetic peripheral neuropathic pain, both in adults. Cymbalta is not approved for use in pediatric patients.

Important Safety Information

In clinical studies, antidepressants increased the risk of suicidal thinking and behavior in children and adolescents with depression and other psychiatric disorders. Anyone considering the use of Cymbalta or any other antidepressant in a child or adolescent must balance the risk with the clinical need. Patients who are starting therapy should be observed closely for worsening depression symptoms, suicidal thoughts or behavior, or unusual changes in behavior. Cymbalta is not approved for use in patients under the age of 18.

Patients on antidepressants and their families or caregivers should watch for worsening depression symptoms, unusual changes in behavior and thoughts of suicide, as well as for anxiety, agitation, panic attacks, difficulty sleeping, irritability, hostility, aggressiveness, impulsivity, restlessness, or extreme hyperactivity. Call the doctor if you have thoughts of suicide or if any of these symptoms are severe or occur suddenly. Be especially observant at the beginning of antidepressive treatment or whenever there is a change in dose.

Prescription Cymbalta is not for everyone. People who are allergic to Cymbalta or the other ingredients in Cymbalta should not take it. If you have recently taken a type of antidepressant called a monoamine oxidase inhibitor (MAOI), are taking Mellaril(R) (thioridazine) or have uncontrolled narrow-angle glaucoma, you should not take Cymbalta. Talk with your doctor before taking Cymbalta if you have liver or kidney problems, glaucoma or consume large quantities of alcohol. Women who are pregnant should talk with their doctor before taking Cymbalta. Nursing while taking Cymbalta is not recommended. Tell your doctor if you are taking other prescription or nonprescription medications.

In clinical studies of Cymbalta for depression, the most common side effects were nausea, dry mouth, constipation, decreased appetite, fatigue, sleepiness, and increased sweating. Nausea was the most common side effect. For most people, the nausea was mild to moderate, and usually subsided within one-to-two weeks. Cymbalta is also approved for the management of neuro-pathic pain associated with diabetic peripheral neuropathy. In clinical studies of Cymbalta in these patients, the most common side effects were nausea, sleepiness, dizziness, constipation, dry mouth, increased sweating, decreased appetite, and loss of strength or energy. In all clinical trials, most people were not bothered enough by side effects to stop taking Cymbalta. Your doctor may periodically check your blood pressure. Don't stop taking Cymbalta without talking to your doctor.

For full Patient Information, visit http://www.Cymbalta.com.

For full Prescribing Information, including Boxed Warning, visit http://www.Cymbalta.com

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs. Additional information about Lilly is available at http://www.lilly.com.
Continue to Read more ...

Pfizer's Anti-Smoking Pill Champix(R) Approved In Europe

Pfizer Inc said today that the European Commission has approved Champix(R) (varenicline), a novel pill for smoking cessation in adults. In addition, because smokers often need considerable support to quit successfully, Champix will be available with a patient support plan which smokers can customize to address their individual behavioral triggers as they try to quit smoking.

Smoking is a chronic relapsing medical condition that typically involves a physical and psychological addiction to nicotine. In Europe alone, more than 1.2 million people die each year from smoking-related diseases. In addition to the human toll, there is a significant social and economic cost associated with smoking. By 2010, the World Health Organization predicts the annual global cost of tobacco-related illness will be approximately $500 billion, with Europe accounting for up to $165 billion of this sum. While most smokers recognize the significant health risks associated with smoking, research shows that without adequate behavioral therapy and environmental support, most smokers relapse within a few days of trying to quit and few are able to remain quit.

"Champix provides a unique and new treatment that was specifically designed to help people stop smoking," said Dr. Michael Berelowitz, Pfizer Worldwide Medical. "Most smokers do not continue to smoke out of choice, but because they are addicted to nicotine in tobacco. Prior research has shown that the combination of behavior counseling and drug therapy is often more effective and cost-effective as health interventions than attempting to quit unaided. To meet these needs Pfizer will go beyond offering a new treatment by also providing customized behavioral support through a program designed to help smokers in the quit process."

Discovered and developed by Pfizer, Champix is specifically designed as an aid to smoking cessation. It is believed to work by reducing the severity of the smoker's urge to smoke and alleviating many withdrawal symptoms from nicotine. Moreover, if a person smokes a cigarette while receiving treatment, the medicine has the potential to diminish the sense of satisfaction associated with smoking.

Many European governments have instituted tobacco control policy changes that help create a more supportive environment for smokers who want to quit. These policies include bans on tobacco advertising and sponsorship, stronger public health warning labels, and smoking bans in all workplaces, including restaurants, bars and pubs. Comprehensive workplace smoking bans have already been approved in Ireland, Italy, Malta, Norway, England, Scotland, Belgium and Lithuania. Similar policies are being considered in France, Germany and other countries.

"Public health campaigns have increased people's understanding of the harmful health effects of smoking so that smokers are educated and more motivated to quit. In addition, more smokers are trying to quit today as a result of smoke-free policies in Europe and they need our support," said Professor Bertrand Dautzenberg, Service of Pneumology and Intensive Care, Hospital Pitie-Salpetriere, Paris. "With Champix's approval, healthcare professionals and smokers have a new treatment advance to help address this challenging addiction."

The approval of Champix(R) (varenicline) was based on a comprehensive clinical trial program including four pivotal trials involving approximately 4,000 cigarette smokers. Subjects on average had smoked about 21 cigarettes per day for an average of approximately 25 years. In two identically designed studies, patients receiving a 12-week course of varenicline therapy (1 mg twice daily) had nearly four times the odds of quitting versus those taking placebo and had nearly twice the odds of quitting versus those patients taking bupropion SR (150 mg twice daily), at the end of the 12-week course of therapy. Patients in these studies were also provided with educational materials and received brief smoking-cessation counseling at each clinic visit. Patients were followed for an additional 40 weeks without treatment. After one year, approximately one-in-five patients who received the 12-week course of varenicline remained smoke-free. For those patients who quit at the end of 12 weeks with varenicline, a separate study showed that an additional course of 12 weeks treatment with varenicline resulted in a greater likelihood of long-term success in quitting smoking.

In trials, varenicline was generally well tolerated, with overall discontinuation rates similar to placebo (11.4% for varenicline vs. 9.7% for placebo). The most common side effects included nausea, abnormal dreams, headache, insomnia, constipation, gas and vomiting.

This medication, varenicline, received U.S. Food and Drug Administration approval as an aid to smoking cessation treatment in May 2006 (with tradename Chantix(TM) (varenicline) in the United States).

Pfizer Inc
http://www.pfizer.com
Continue to Read more ...

Having An Older Brother Raises A Male's Chances Of Being Gay

A male is more likely to be gay if he has an older brother, the likelihood grows the more older brothers he has. The percentage of gay males is estimated to be around 3%, this probability can go up to 5% for males with several older brothers, say researchers from Brock University, St. Catharines, Canada.

The researchers are certain there is a biological basis for sexual orientation - in other words, there is a prenatal effect. It is not a case of older brothers having a psychological effect on the male baby after it is born. Males with older stepbrothers, or adopted brothers, are not more likely to be gay, only males with blood brothers. The scientists say the effect has to be through the mother, the only link between them.

You can read about this study in the Proceedings of the National Academy of Sciences.

Previous studies have shown a link between male homosexuality and the number of older brothers. This study is the first one to factor out social and environmental effects.

Study leader, Anthony Bogaert, and team examined four groups of men - 944 males. They looked at how many male and female siblings they had, whether they were blood related and lived in the same house when they grew up. The also looked at whether the men had been adopted.

They found that males with one older blood brother were more likely to be gay than males with no older brother(s). The more older brothers a male had the higher his chances of being gay. They said the likelihood had the same increase when blood brothers were raised in different households.

The team stressed that even with several older brothers, the chances of a male being heterosexual is 95%. 97% of all males are heterosexual.

Only males who had an older brother from the same mother had a higher chance of being gay, said the researchers.

The researchers said the environment the male was brought up in makes no difference at all. The only link is that the older brother(s) shared the same womb.

Proceedings of the National Academy of Sciences
http://www.pnas.org

The Social Sciences and Humanities Research Council of Canada funded the research
http://www.sshrc.ca/web/home_e.asp
Continue to Read more ...

Predicting Penile Length After Penile Prosthesis Implantation

UroToday.com - Dissatisfaction with penile prosthesis implantation is multifactorial. Patients commonly report penile shortening as a major issue; it may be perceived or real. Candidates for penile prosthesis commonly have chronic and advanced ED and therefore are predisposed or already have penile shortening. To reduce dissatisfaction with the procedure and medical/legal liability, proper preoperative counseling is invaluable.

Drs. Montague and Angermeier recently studied the utility of preoperative stretched penile length (SPL) as a predictor of post-implant functional length. Forty-nine patients received either an AMS 700 CX or CXM, or AMS 700 Ultrex depending on the presence or absence of fibrosis (tunica or corporal smooth muscle), respectively. Preoperative stretch, post-operative inflated and deflated lengths were compared.

In the fibrosis patients who received the AMS 700 CX/M, preoperative SPL was predictive in 38% and within 1-cm in 88%. In the non-fibrotic group who received the girth and length expanders (AMS Ultrex), preoperative SPL was predictive in 27% and within 1-cm in 70%. Moreover, with the expanders inflated, the Ultrex group reported penile lengthening of at least 1-cm and up to 3-cm in 15% of patients.

The authors concluded that preoperative SPL was useful for counseling patients on expected penile lengths post-implant. Those patients without fibrosis who undergo the AMS Ultrex implant should expect to gain anywhere from 1 to 3-cm of additional length. Girth was not measured.

By Raymond Pak, MD

Reference:
J Sex Med 2006; 3(Suppl 1) Abstract 102.
Montague DK, Angermeier KW.

Editorial Comments:

Those of us who treat male sexual dysfunction on a regular basis know that complaints about penile length are ubiquitous: patients with ED and no prior surgery complain the penis is shrinking; patients following successful implant complain the penis shorter; patients having successful surgical correction of Peyronie's curvature with grafting complain the penis is shorter; patients having prostatectomy complain the penis is shorter. There have been numerous studies over the years that have attempted to verify these complaints and isolate their specific pathologies.

Dr. Montague has documented a very practical resource for the implanting surgeon. This work suggests that stretched preoperative penile length is a good indicator of penile cylinder size. Furthermore, this simple 'visual aide' may serve as a useful adjunct to informed consent. Patient satisfaction and expectation are strongly linked in penile prosthetic surgery.

UroToday - the only urology website with original content written by global urology key opinion leaders actively engaged in clinical practice.

To access the latest urology news releases from UroToday, go to:
http://www.urotoday.com
Continue to Read more ...

Causes And Prevention Of Back Pain And Injuries


Stress appears to be the leading risk factor for back pain and injuries, said Michael R. Bracko, Ed.D., FACSM today during an address at the American College of Sports Medicine (ACSM) 10th-annual Health & Fitness Summit & Exposition in Orlando. A properly designed and executed fitness program hastens recovery and often prevents back injuries.

Sixty to 80 percent of the population in North America will suffer from back pain or injuries at some point during their lives, with one to five percent of that group suffering chronic back pain that lasts six months or longer. Back pain is the most frequent cause of activity limitation among those under 45. Although 80 to 90 percent of individuals will recover from back pain within three to six days of their injury, statistics estimate $31 million is spent on office visits to physicians for back pain, but only three percent of that total cost goes to prevention of back pain.

Stress at home and in the workplace most often creates back problems. "Stress manifests itself to cause our muscles to go 'Boing!' and into a spasm to cause us to cry, not get out of bed, worry about coughing, worry about our jobs, and worry about not being able to work again, among other things," said Bracko. "Managing stress, knowing other risk factors and working it all out through exercise is a great way to keep back injuries at bay."

Individual Risk Factors

In addition to controlling stress in one's personal life, activities at home, recreation, exercise and family life can contribute to the potential of a back injury. Other factors include:

-- Lack of sleep/fatigue
-- Emotional instability
-- Family problems
-- Substance abuse
-- Lack of physical activity/too much physical activity
-- Poor muscle endurance and poor trunk muscle stabilization
-- Excessive weight

Occupational Risk Factors

The workplace is a unique contributor to opportunities for back pain and injuries. Truck drivers, nurses and young workers have the highest rates of back injury. In one study, only half of low-back injured workers, off work for six months or longer, returned their regular jobs. Several studies have documented an increased risk of disc herniation for those who perform sedentary jobs characterized by sitting.

Other risk factors include:

-- Heavy physical work
-- Static posture - sitting and standing
-- Repetitive work (bending, twisting, pushing, pulling and lifting)
-- Slipping, tripping or falling
-- Twisting while spine is loaded (carrying something)
-- Vibration while driving
-- Fatigue/poor muscle endurance (excessive overtime, work-to-rest ratio)
-- "Attitude" at work leading to accidents (poor or high-risk attitude)
-- Lack of work satisfaction and lack of motivation
-- Mental fatigue (forgetting to lift properly)

For office workers, Bracko noted the general rule is to be seated in an ergonomically-sound chair with the ankles, knees, hips, and elbows at approximately 90 - 100 degrees.

Exercise for Prevention

A variety of exercises can be performed in an attempt to prevent back injuries, but being active is key to disc health, says Bracko. Exercise is the best method of reducing the negative effects of stress, in addition to improving general health. Bracko specifically recommends training abdominal muscles to help strengthen and support the back.

"People tend to bend at the waist because it is less fatiguing," said Bracko. "But, pay close attention to posture while lifting or stretching. It is important to maintain the natural curves in spine to avoid a back injury."

The American College of Sports Medicine (ACSM) is the largest sports medicine and exercise science organization in the world. More than 20,000 International, National and Regional members are dedicated to promoting and integrating scientific research, education and practical applications of sports medicine and exercise science to maintain and enhance physical performance, fitness, health and quality of life.

American College of Sports Medicine (ACSM)
Continue to Read more ...

Apricot Seeds At High Doses Can Be Fatal

Apricot seeds are taken by many people as a cancer treatment as they contain high doses of Vitamin B17, an immune system enhancer. However, apricot seeds also contain cyanide, a poison.

The Food Standards Agency (UK) has advised people to take no more than two bitter apricot kernels a day. Higher doses could be dangerous for human health.

According to the Food Standards Agency (FSA), it has received reports from various parts of the world of people overdosing with apricot seeds.

A UK retailer, Julian Gray, was selling 10 seeds a day doses of apricot seeds. The retailer says it will re-sell them at not such a high dose (the present dose is not longer for sale).

There is controversy about apricot seeds and the claims made about it as a cancer cure. At Medical News Today we have had hundreds of letters from patients on this subject. Some people say it is wonderful while others say it made them feel worse.
Continue to Read more ...

Treating Summer Insect Stings And Bites

Buzzing bees, marching ants and swarms of mosquitos are just as much a part of summer as warm weather, blooming flowers and kids enjoying time off from school. And if your child has plans to spend the summer months outdoors playing, chances are he'll encounter some insects along the way.

For most children, the biting and stinging insects of summer are just minor annoyances - but for some, they can represent a serious problem, says Margie Andreae, M.D., associate professor, Department of Pediatrics and Communicable Diseases at the University of Michigan Medical School.

"The vast majority of people will only have a localized reaction to a bug bite or sting," says Andreae. "However, about 3 percent of the population may develop an allergic reaction, including symptoms of a rash and hives that are distant from the site of the bite or sting that will require medical attention."

To take the sting out of summer, Andreae offers tips to help treat insect bites and stings, and advice on how to prevent mosquito and tick bites.

5 tips for treating insect stings

-- Remove the stinger. The first thing to do when stung by a bee or wasp is to look at the site to see if there's any remaining stinger. If there is, Andreae recommends that an adult use a firm object like a credit card to sweep across the site and pull out the stinger. Don't squeeze or pinch the skin to remove the stinger. This will cause additional venom to be released into the bite.

-- Clean the area. Use soap and water to thoroughly cleanse the site of the sting before applying ice or hydrocortisone cream.

-- Apply ice. "Most people are going to develop redness and swelling at the site of the sting," says Andreae. "A good approach to treating those reactions is to apply a cool compress or ice to the area."

-- Add hydrocortisone cream. Adding hydrocortisone cream to the site of the sting will help relieve redness and pain.

-- Take a pain reliever and an antihistamine. "You also can use Benadryl in the oral form to control redness, swelling and irritation, as well as ibuprofen or Tylenol to relieve the pain," says Andreae.

Should a severe allergic reaction occur - difficulty breathing or swallowing - Andreae says to call 911 and seek emergency care immediately.

Protecting your family against mosquito bites and West Nile Virus

Surprisingly, the most common insect to cause problems that bring children in for medical treatment are mosquitoes, Andreae says.

"Mosquito bites generally cause a localized reaction in most children. But parents often mistake this reaction as something more severe, such as an infection, which brings them into the clinic for evaluation by a physician," she says.

The incidence of a severe reaction to a mosquito bite, however, is extremely rare. If such a reaction were to occur, it would happen about three to four days after the insect bite happened - that's the time when the bite should be healing and nearly gone, says Andreae.


West Nile Virus, which is transmitted by mosquitoes, also is a concern during the warm summer months, and can be most harmful to people over age 50.

"Approximately one out of 150 people bitten by a mosquito infected with West Nile Virus will develop a severe illness," says Andreae. "Those who develop a severe illness will initially experience flu-like symptoms that will develop into severe symptoms of a headache, coma or even seizures."

Fortunately, Andreae says there are several ways to protect yourself and your child against mosquito bites.

How to avoid summer insect bites



-- Use insect repellents with DEET. Most over-the-counter repellents now contain DEET, and are safe to use on children as young as 2 months old, and adults. "The concentration of DEET that's most often recommended for children is 10 percent; up to 30 percent is safe for adults," says Andreae. "The percent of concentration of DEET in a product is related to the length of time that it provides protection, not necessarily the strength or maximum protection against being bitten. For the product containing 10 percent DEET, it usually provides somewhere around two to three hours of protection against insect bites."

-- Stay away from open beverages that contain sweetener. Sweetened beverages like soda and juice attract stinging insects.

-- Avoid areas with standing water. Standing water provides nice, moist breeding grounds for mosquitoes. "To keep your backyard safe, empty or cover pools at the end of the day, and don't leave any potted plants outside that may contain standing water," says Andreae.

-- Dress appropriately. Always wear shoes and dress in long pants and a lightweight long-sleeved shirt to cover skin and provide protection against biting and stinging insects.

Ticks and Lyme disease

People who live in the northeast and upper Midwest need to be on the look-out for ticks carrying Lyme disease this summer. Those at the greatest risk are people who spend a lot of time outdoors, especially in wooded areas.

About 80 percent of individuals with Lyme disease will develop a rash that looks like a bull's-eye near the bite. The rash is often accompanied by flu-like symptoms such as fever or headache, nausea and vomiting. Some people, however, may only develop flu-like symptoms and not a rash, notes Andreae.

"There's a small number of people who will go on to develop secondary illness or complications from Lyme disease that most often affect large joints and cause pain and swelling," says Andreae. "So any individual with a rash at the site of a known tick bite should by evaluated by a medical professional for possible treatment and testing for Lyme disease."

For more information, visit these web sites:

UMHS Health Topics A-Z: Itchy or painful insect bites
med.umich.edu/1libr/pa/pa_insectis_hhg.htm

UMHS Health Topics A-Z: West Nile Virus
med.umich.edu/1libr/pa/pa_westnile_crs.htm

UMHS Health Topics A-Z: Lyme disease
med.umich.edu/1libr/pa/pa_lymedis_hhg.htm

UMHS Health Topics A-Z: Bee or Yellow Jacket stings
med.umich.edu/1libr/pa/pa_beesting_hhg.htm

KidsHealth: What to do when you're bugged by bugs
kidshealth.org

American Academy of Allergy, Asthma & Immunology: Stinging insect allergy
aaaai.org
Continue to Read more ...

Woman In Vegetative State Communicated Through Her Thoughts

A woman who had suffered severe brain injury in a car accident and was in a vegetative state managed to communicate just by using her thoughts, say scientists from the UK and Belgium. They scanned her brain and discovered that she was able to understand verbal commands - she could even visualize herself playing tennis when verbally triggered to do so by the scientists.

You can read about this discovery in the journal Science.

The scientists could not say how common this ability might be among other patients who are diagnosed as being in a 'vegetative state'. They added that she might be one in a million, as all vegetative patients are different and have damage to different parts of their brain.

FMRI (functional magnetic resonance imaging) was used to record brain activity in the woman five months after her accident. Doctors had diagnosed her as being in a persistent vegetative state. When a person is in a persistent vegetative state he/she has lost cognitive neurological function and awareness of the environment, but keep non-cognitive neurological function and preserved sleep-wake cycle. In lay terms, it roughly means the person is technically alive but his/her brain is dead.

While mapping her brain the scientists asked her to visualize simple tasks.

Team leader Dr Adrian Owen, Medical Research Council's Cognition and Brain Sciences Unit, Cambridge, UK said "The tasks we chose are based on many years of brain imaging research that shows different areas of the brain are activated when we perform different kinds of tasks."

The scientists were startled to find that her brain patterns, when she was asked to imagine herself playing tennis or moving around her home, displayed the same activated cortical areas in a manner indistinguishable from that of the healthy volunteers.

Dr. Owen added, "It tells us the patient could understand speech, because of course, we asked her to do these things. It also tells us that she is able to perform simple tasks in her head, such as imagining certain scenarios. We see this as a proof of principle: we have found a way to show that a patient is aware when existing clinical methods have been unable to provide that information."

"Detecting Awareness in the Vegetative State"
Adrian M. Owen, Martin R. Coleman, Melanie Boly, Matthew H. Davis, Steven Laureys, John D. Pickard
Science 8 September 2006:
Vol. 313. no. 5792, p. 1402
DOI: 10.1126/science.1130197
Click Here To View Abstract
Continue to Read more ...

Paralyzed Girl Forgives Man Who Shot Her And Shattered Her Spine

A five-year-old girl, Kai Leigh Harriott, wheelchair bound after a bullet paralyzed her three years ago, forgave the man who shot her and told him what he had done to her was wrong. She did this to his face, in court.

After breaking down and crying, the girl picked up a glass of water, took a sip, and said to Anthony Warren 'What you done to me was wrong ... but I still forgive him.' Anthony Warren had pleaded guilty to shooting her, shots that paralyzed the girl.

Kai Lee Harriot used to be able to walk. She had been a healthy little girl. Almost three years ago she had been sitting on a porch. Warren had had an argument with some people who lived in the first floor of the house (a building which housed three families). He returned at about 11pm and shot three times at the house. His target had been the person he had had an argument with - not Kai. Kai, three years' old at the time, was hit by one of the bullets. She had been sitting there on the porch with her older sister.

The bullet shattered the little girl's spine. From that moment onwards she lost all movement from the chest down.

Warren was sentenced to 13-15 years in prison and 5 years' probation.

Hopefully, one day, as medicine makes new headways in neuroscience, Kai may eventually be able to get up from her wheelchair and walk again, unaided. I am humbled by her benevolence. She will always be an example to me of how good and untainted a human can be. I am 50 and she is five - yet she is light-years ahead of me.
Continue to Read more ...

FDA Approves First Generic Version Of Flonase

The Food and Drug Administration (FDA) today approved Fluticasone Propionate Nasal Spray, the first generic version of the brand name drug Flonase, giving American consumers an additional, lower cost alternative when choosing prescription drug products.

"Except for their price, which is much lower, generic drugs are in every way equivalent to their brand name counterparts," said Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research. "Offering consumers a choice of safe, effective, and reasonably priced generic drug products is an extremely important priority for FDA. Today's approval is part of our ongoing commitment to provide generic forms of products to the public."

Generic drug products are used to fill over 50 percent of all prescriptions, and since they cost a fraction of the price of trade name drugs, the economic impact of FDA's generic drug program is profound. Through hard work, prioritization, and optimizing efficiencies, FDA's Office of Generic Drugs continues to make record numbers of generic products available. In 2005 alone, FDA approved 452 generic drug applications, the second highest total on record.

Fluticasone Propionate Nasal Spray treats the nasal symptoms of seasonal and chronic (long-lasting) allergic and nonallergic rhinitis, an inflammation of the lining of the nose that can make it stuffy and runny. This product is approved for use in both adults and children 4 years and older.

Fluticasone Propionate Nasal Spray contains a synthetic, trifluorinated corticosteroid with anti-inflammatory activity. Corticosteroids are natural substances found in the body that help fight inflammation. Fluticasone propionate, like other corticosteroids, does not have an immediate effect on allergic symptoms. A decrease in nasal symptoms (stuffiness, runniness, itching, and sneezing) has been noted in some patients 12 hours after initial treatment. Common side effects of fluticasone propionate nasal spray are headache, sore throat and nose bleed.

The brand name product or innovator drug for fluticasone propionate is Flonase, manufactured by GlaxoSmithKline and approved in October, 1994. The drug's patent, including the pediatric exclusivity, expired in May 2004 and the new dosing schedule exclusivity with its associated pediatric exclusivity expired on November 23, 2005. FDA received several citizen petitions questioning the approval criteria for the drug's bioequivalence and for other aspects of nasal sprays related to today's action. The FDA submits generic drug applications to the same thorough and rigorously scientific review for safety, effectiveness and quality as the applications for new drugs. Consumers and health professionals can be assured that an approved generic drug is bioequivalent to a brand name drug and is its equal in dosage form, strength, route of administration, quality, performance characteristics, and intended use.

After reviewing the issues raised in the petitions, FDA determined that its current standards for approval are appropriate.

Fluticasone propionate nasal spray is manufactured by Roxane Laboratories of Columbus, OH.

For additional information related to FDA's Office of Generic Drugs, click here.

http://www.fda.gov
Continue to Read more ...

Eye Colour Is A Clue To Paternity

Before you request a paternity test, spend a few minutes looking at your child's eye color. It may just give you the answer you're looking for. According to Bruno Laeng and colleagues, from the University of Tromso, Norway, the human eye color reflects a simple, predictable and reliable genetic pattern of inheritance. Their studies1, published this week in the Springer journal Behavioral Ecology and Sociobiology, show that blue-eyed men find blue-eyed women more attractive than brown-eyed women. According to the researchers, it is because there could be an unconscious male adaptation for the detection of paternity, based on eye color.

The laws of genetics state that eye color is inherited as follows:

1. If both parents have blue eyes, the children will have blue eyes.

2. If both parents have brown eyes, a quarter of the children will have blue eyes, and three quarters will have brown eyes.

3. The brown eye form of the eye color gene (or allele) is dominant, whereas the blue eye allele is recessive.

It then follows that if a child born to two blue-eyed parents does not have blue eyes, then the blue-eyed father is not the biological father. It is therefore reasonable to expect that a man would be more attracted towards a woman displaying a trait that increases his paternal confidence, and the likelihood that he could uncover his partner's sexual infidelity.

Eighty-eight male and female students were asked to rate facial attractiveness of models on a computer. The pictures were close-ups of young adult faces, unfamiliar to the participants. The eye color of each model was manipulated, so that for each model's face two versions were shown, one with the natural eye color (blue/brown) and another with the other color (brown/blue). The participants' own eye color was noted.

Both blue-eyed and brown-eyed women showed no difference in their preferences for male models of either eye color. Similarly, brown-eyed men showed no preference for either blue-eyed or brown-eyed female models. However, blue-eyed men rated blue-eyed female models as more attractive than brown-eyed models.

In a second study, a group of 443 young adults of both sexes and different eye colors were asked to report the eye color of their romantic partners. Blue-eyed men were the group with the largest proportion of partners of the same eye color.

According to Bruno Laeng and colleagues, "It is remarkable that blue-eyed men showed such a clear preference for women with the same eye color, given that the present experiment did not request participants to choose prospective sexual mates, but only to provide their aesthetic or attractiveness responses�based on face close-up photographs." Blue-eyed men may have unconsciously learned to value a physical trait that can facilitate recognition of own kin.
Continue to Read more ...

Is A Hormone (aldosterone) The Key To Anxiety?

Animal studies have suggested a relationship between corticosteroids and anxiety. Pilot investigation by a group of Italian researchers headed by Nicoletta Sonino (Univeristy of Padova) suggests that aldosterone may play an important role in fear and anxiety also in humans.

Except for 3 case reports of Conn's syndrome presenting as depression, psychosocial factors have not been explored in primary aldosteronism. The Authors investigated psychological correlates in primary aldosteronism using methods that were found to be sensitive and reliable in psychosomatic research. Ten consecutive newly diagnosed patients with primary aldosteronism were studied: 5 males/5 females; mean age (SD) 45.5 (6.6) years, age range 34-54 years; 4 with an aldosterone-producing adenoma and 6 with idiopathic aldosteronism.

The Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) for eliciting psychiatric diagnoses, and a shortened version of the structured interview for subclinical psychological syndromes, the Diagnostic Criteria for Psychosomatic Research (DCPR), were administered. Seven patients (2 with aldosterone-producing adenoma and 5 with idiopathic hyperaldosteronism) received both DSM-IV and DCPR diagnoses, while 3 had neither. As to DSM-IV, generalized anxiety disorder was detected in 6 cases (in 1 it was associated with panic disorder and in 1 with major depression) and obsessive-compulsive disorder in 1.

The most frequent DCPR cluster was demoralization (5 cases), while persistent somatization occurred in 2 cases (associated with demoralization in 1) and irritable mood in 1. The results of this investigation published in the Sept issue of Psychotherapy and Psychosomatics show that the occurrence of anxiety disorders in patients with primary aldosteronism was much higher than that found in the general population and in primary care. Since an association between hyperaldosteronism and anxiety has also been suggested in previous animal studies, it seems worthwhile to gain further knowledge on clinical aspects by larger population studies.

About the JOURNAL OF PSYCHOTHERAPY AND PSYCHOSOMATICS

The International Federation for Psychotherapy (IFP) is an organization of national, regional, and school-oriented psychotherapy societies. Its goals are to facilitate and promote international communication among the various schools, professional groups and cultures within psychotherapy. The IFP organizes international congresses and conferences on psychotherapy. The IFP promotes the development of psychotherapy in practice, teaching and research and encourages and supports appropriate standards in the practice of psychotherapy. "Psychotherapy and Psychosomatics" is the official journal of the IFP. IFP, Culmannstrasse 8, CH-8091 Zurich.

http://www.karger.com
Continue to Read more ...

Coffee Protects Alcohol Drinkers From Liver Disease

Drinking coffee protects alcohol drinkers from developing liver disease, says a new study carried out at the Kaiser Permanente Medical Care Program, California, USA. According to the researchers, one cup of coffee per day lowered the incidence of cirrhosis of the liver for alcohol drinkers by 22%.

Study leader, Dr. Arthur Klatsky, stressed that alcohol drinking, especially excess drinking, is linked to various different physical risks. As such, said Klatsky, the study's findings should not be interpreted as a licence to booze to your heart's content. He advised people not to consumer more than three alcoholic drinks a day.

This is not the first study to link coffee consumption to less liver disease. Another study published in Gastroentorology in December, 2005, had similar findings.

This new study was much larger than last years'. The new study was able to look more into each cause of cirrhosis and how coffee is linked a lower incidence of them.

The Kaiser Permanente study looked at information on 125,000 people with healthy livers from 1978 to 1985. Information had been collected about their alcohol, coffee and tea drinking habits. Of the 330 people who had developed cirrhosis of the liver by 2001, 199 had done so as a result of consuming alcohol. The researchers found that the incidence of cirrhosis went down 22% for each cup of coffee consumed per person per day.

You can read about this study in the Archives of Internal Medicine, June 12 issue.

Scientists are still unsure what it is in the coffee that provides the protection. It cannot be the caffeine because tea has caffeine but does not provide the same protection. Clinical trials are needed to further identify the relationship between coffee and how it lowers the incidence of liver disease.
Continue to Read more ...

FDA Approves ZOSTAVAX(R), Merck's New Vaccine For Prevention Of Shingles In Adults Age 60 And Older

The U.S. Food and Drug Administration (FDA) has approved Merck's new vaccine ZOSTAVAX(R) [Zoster Vaccine Live (Oka/Merck)] for prevention of herpes zoster (shingles) in individuals 60 years of age and older.

Shingles is a frequently painful disease marked by a blistering rash. Caused by the reactivation of the virus that causes chickenpox, shingles can lead to severe complications including long-term nerve pain (postherpetic neuralgia), which can last for months or even years. ZOSTAVAX is not a treatment for shingles or postherpetic neuralgia. ZOSTAVAX is given as a single dose by injection.

"ZOSTAVAX is the first and only medical option approved for the prevention of shingles," said William Schaffner, M.D., professor of preventive medicine, Vanderbilt University School of Medicine, Nashville. "Approval of a vaccine against shingles represents a major public health advance for people 60 and older."

Anyone who has been infected with chickenpox -- that's more than 90 percent of adults in the United States -- is at risk for developing shingles. The incidence and severity of shingles, as well as the frequency and severity of its complications, increase with age. About 40 to 50 percent of the estimated 1 million cases of shingles that occur in the United States each year occur in people age 60 and older. Shingles can be unpredictable and can occur without warning at any time.

"This vaccine is clinically important because it can prevent a disease that may cause pain in some patients," said Ann Arvin, M.D., professor of pediatrics, infectious diseases and microbiology and immunology, Stanford University School of Medicine, who studied the vaccine. "ZOSTAVAX is unique because in contrast to other vaccines that help prevent a primary infection, ZOSTAVAX helps prevent reactivation of a virus that's already inside the body."

Shingles usually starts as an unusual or painful sensation on one side of the body or face, followed by a blistering rash. Pain from shingles can be mild to severe and may occur just prior to the development of the rash, during the eruption of the rash and as long-term nerve pain (postherpetic neuralgia). Postherpetic neuralgia has been described as tender, burning, throbbing, stabbing, shooting and/or sharp pain. Other complications, such as scarring, allodynia (pain from an innocuous stimulus such as the touch of soft clothing or a light breeze), pneumonia, visual impairment and hearing loss also can occur as the result of shingles. Treating shingles and postherpetic neuralgia can be difficult, often requiring a multifaceted approach.


ZOSTAVAX is contraindicated in persons with a history of anaphylactic/anaphylactoid reaction to gelatin, neomycin, or any other component of the vaccine; with a history of primary or acquired immunodeficiency states including leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic system; with AIDS or other clinical manifestations of infection with human immunodeficiency viruses; and with active untreated tuberculosis. ZOSTAVAX is also contraindicated in persons on immunosuppressive therapy including high-dose corticosteroids and in women who are or may be pregnant.

Vaccination with a live, attenuated vaccine, such as ZOSTAVAX, may result in a more extensive vaccine-associated rash or disseminated disease in individuals who are immunosuppressed. Safety and efficacy of ZOSTAVAX have not been evaluated in individuals on immunosuppressive therapy, nor in individuals receiving daily topical or inhaled corticosteroids or low-dose oral corticosteroids. The use of ZOSTAVAX in individuals with a previous history of shingles has not been studied.

Studies of ZOSTAVAX Included More Than 40,000 People

The approval of ZOSTAVAX is based on studies of more than 40,000 people, more than 21,000 of whom received active vaccine. The efficacy and safety of a single dose of ZOSTAVAX was evaluated in the largest of these studies, the landmark Shingles Prevention Study (SPS) of 38,546 men and women age 60 and over who had no previous history of shingles. This randomized, double-blind, placebo-controlled study was a Department of Veterans Affairs study conducted in collaboration with the National Institute of Allergy and Infectious Diseases at the National Institutes of Health and Merck at 22 U.S. research sites.

In the study, participants were randomized to groups given either ZOSTAVAX (N=19,270) or a placebo (N=19,276) and followed for the development of shingles for a median duration of 3.1 years. All subjects with clinically diagnosed shingles were offered antiviral treatment, as well as standard-of-care treatment for pain, as necessary.

ZOSTAVAX significantly reduced the risk of developing shingles compared with placebo by 51 percent (315 cases [5.4 cases per 1,000 person-years] vs. 642 cases [11.1 cases per 1,000 person-years], respectively; p<0.001) in the SPS. Efficacy of ZOSTAVAX for the prevention of shingles was highest for those 60 to 69 years of age and declined with increasing age.

Overall, the benefit of ZOSTAVAX in the prevention of long-term nerve pain from shingles (postherpetic neuralgia) can be primarily attributed to the vaccine's effect on the prevention of shingles. Vaccination with ZOSTAVAX reduced the incidence of long-term nerve pain from shingles in individuals 70 years of age and older who were vaccinated with ZOSTAVAX but went on to develop shingles. Following completion of the SPS, a separate analysis was conducted to evaluate the reduction in postherpetic neuralgia in the group of individuals who had been vaccinated with ZOSTAVAX but who had developed shingles. In the analysis, ZOSTAVAX reduced the overall incidence of postherpetic neuralgia by a statistically significant 39 percent compared to the placebo group. A statistically significant reduction in postherpetic neuralgia was seen in individuals aged 70 to 79 (55 percent) and a nonstatistically significant reduction in postherpetic neuralgia was seen in those aged 60 to 69 (5 percent) and 80 and older (26 percent) in the analysis.

Safety Profile of ZOSTAVAX

In the Adverse Event Monitoring Study (AEMS), which included a subgroup of individuals from the SPS, vaccine-related injection site and systemic adverse events seen in the first 42 days after vaccination in 1 percent or greater of the individuals who received ZOSTAVAX (n=3,345) included headache (1.4 percent) and the following injection-site reactions: erythema (33.7 percent), pain/tenderness (33.4 percent), swelling (24.9 percent), hematoma (1.4 percent), pruritus (6.6 percent), and warmth (1.5 percent). Most of these adverse experiences were reported as mild in intensity.

In the overall study population in the SPS, serious adverse experiences (SAEs) occurred at a similar rate (1.4 percent) in subjects vaccinated with ZOSTAVAX or placebo. In the AEMS, the rate of SAEs was increased in the group who received ZOSTAVAX (1.9 percent) as compared to the placebo group (1.3 percent) in the first 42 days after vaccination. Investigator-determined, vaccine-related serious adverse experiences were reported for two subjects vaccinated with ZOSTAVAX (asthma exacerbation and polymyalgia rheumatica) and three subjects who received placebo (Goodpasture's syndrome, anaphylactic reaction, and polymyalgia rheumatica).

In the entire SPS study population, the rates of overall cardiovascular events (0.4 percent) including coronary artery disease related conditions (0.2 percent) were similar in subjects vaccinated with ZOSTAVAX or placebo. In the AEMS of the SPS, in the first 42 days after vaccination, the rate of overall cardiovascular events was higher after ZOSTAVAX (0.6 percent) than after placebo (0.4 percent), including the rate of coronary artery disease-related conditions (ZOSTAVAX, 0.3 percent; placebo, 0.2 percent).

Selected Important Information about ZOSTAVAX

ZOSTAVAX is indicated for prevention of herpes zoster (shingles) in individuals 60 years of age and older. ZOSTAVAX is not a treatment for shingles or postherpetic neuralgia. As with any vaccine, vaccination with ZOSTAVAX may not result in protection of all vaccine recipients.

Patients should be informed of the theoretical risk of transmitting the vaccine virus to close contacts (including household contacts) who may be pregnant and have not had chickenpox or been vaccinated against chickenpox, or contacts who have problems with their immune system. The risk of transmitting the attenuated vaccine virus to a susceptible individual should be weighed against the risk of developing natural shingles that could be transmitted to a susceptible individual.

The duration of protection after vaccination with ZOSTAVAX is unknown. In the SPS, protection with ZOSTAVAX was demonstrated through four years of follow-up. The need for revaccination has not been defined. ZOSTAVAX is not a substitute for VARIVAX(R) (Varicella Virus Vaccine Live [Oka/Merck]) and ZOSTAVAX should not be used in children.

Concurrent administration of ZOSTAVAX and antiviral medications known to be effective against the varicella zoster virus has not been evaluated. Concurrent administration of ZOSTAVAX and other vaccines has not been evaluated.

Merck Commitment to Vaccines

"Merck is pleased to introduce the first and only shingles vaccine - the result of nearly two decades of Merck vaccine research," said Mark Feinberg, M.D., Ph.D., vice president of policy, public health and medical affairs, Merck Vaccines. "The Company is also very pleased to announce that we will make ZOSTAVAX and all of Merck's other adult vaccines available free of charge through a new patient assistance program for vaccines for low-income individuals for whom the vaccines are medically appropriate."

Through this new program, Merck will provide free vaccines to adults who are uninsured and who are unable to afford vaccines. Merck's vaccines will become available through this program in the third quarter of 2006.

Outside the United States, ZOSTAVAX was approved for licensure in the European Union and in Australia earlier this month, and Merck has filed regulatory applications for ZOSTAVAX in other world markets. Merck will begin to commercialize ZOSTAVAX outside of the U.S. in 2007. In addition, the FDA and other regulatory agencies around the world are now reviewing applications for GARDASIL(R) (quadrivalent human papillomavirus types 6, 11, 16, 18, recombinant vaccine), Merck's investigational HPV and cervical cancer vaccine. In February, the FDA approved ROTATEQ(R) (rotavirus vaccine, live, oral pentavalent), Merck's rotavirus vaccine.

Pricing and CPT Code for ZOSTAVAX

ZOSTAVAX, a frozen vaccine, is available for ordering by physicians and Merck expects to begin shipping the vaccine soon. The catalog price of ZOSTAVAX is $145.35 purchased as a 10-pack of single-dose vials of lyophilized vaccine with sterile diluent and $152.50 purchased as a single-dose vial of vaccine with sterile diluent.

The American Medical Association has established the Current Procedural Terminology (CPT*)(R) code "CPT 90736 Zoster (shingles) vaccine, live, for subcutaneous use" for ZOSTAVAX. CPT codes allow for the identification and potential reimbursement of existing common procedures, services and products, new and emerging technologies as well as the collection of data to facilitate performance issues.

About Merck

Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit http://www.merck.com.

Merck Forward-Looking Statement

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the cautionary statements in Item 1 of Merck's Form 10-K for the year ended Dec. 31, 2005, and in its periodic reports on Form 10-Q and Form 8-K, which the Company incorporates by reference.

ZOSTAVAX(R) [Zoster Vaccine Live (Oka/Merck)] is the registered trademark of Merck & Co., Inc., Whitehouse Station, NJ, USA.

*Current Procedural Terminology (CPT) is a registered trademark of the American Medical Association.

For more information on ZOSTAVAX, visit
http://www.ZOSTAVAX.com
Continue to Read more ...
Related Posts Plugin for WordPress, Blogger...

Popular Posts