Wednesday, November 7, 2012

Pradaxa (Dabigatran) Bleeding Rates No Higher Than Warfarin, Says FDA

Bleeding rates linked to new use of Pradaxa (Dabigatran) are no higher than they are with new users of warfarin, says a new FDA Drug Safety communication report update (November 2, 2012).

The FDA (Food and Drug Administration) carried out an evaluation on Pradaxa after receiving several post-marketing reports of bleeding among new users.

The Agency says its investigation, which focused on bleeding occurring in the stomach and intestines, as well as bleeding in the brain (intracranial hemorrhage), among new Pradaxa versus warfarin users, found that Pradaxa's bleeding rates are no higher than warfarin's.

The FDA looked at data from insurance claims and the FDA's Mini-Sentinel pilot of the Sentinel Initiative. The results of the Mini-Sentinel assessment show that bleeding rates between the two medications are similar, and consistent with data from the clinical trials that were used during the approval process of Pradaxa (the RE-LY trial).

The Agency says it is continuing to monitor various data sources in the ongoing safety review of Pradaxa.

Medications for patients with non-valvular atrial fibrillation

Patients with non-valvular atrial fibrillation (AF) are at significantly higher risk of developing stroke and blood clots. AF is the most common heart rhythm abnormality, in which the upper chambers of the atria, in the heart, beat irregularly and rapidly.

The two most important medications prescribed to AF patients are warfarin and Pradaxa, to reduce the risk of stroke and blood clots.

While Pradaxa and warfarin are effective, they can cause potentially serious and sometimes fatal bleeding. All anticoagulant medications have this risk.

Recommendations regarding Pradaxa remain unchanged

The FDA emphasizes that Pradaxa "provides an important health benefit when used as directed." It has not altered its recommendations regarding the medication.

Doctors who prescribe Pradaxa must follow the dosing recommendations in the drug label carefully, especially if the patient has renal impairment (improperly functioning kidneys), to minimize the risk of bleeding.

If you have atrial fibrillation and are on Pradaxa, do not stop taking it before discussing with your doctor. If you stop taking the drug suddenly, your risk of stroke will increase. Strokes are potentially serious, permanently disabling and fatal events.

The FDA says it is conducting two planned, protocol-based observational assessments of Pradaxa, which assess patients and evaluate reports of bleeding. Any relevant data that becomes available on bleeding risks related to Pradaxa will be reported immediately, the Agency added.

About Pradaxa (Dabigatran)

Pradaxa (Dabigatran) was approved by the US FDA in October 2010, in capsule form for the prevention of strokes and blood clots in patients with atrial fibrillation. Pradaxa was approved the following year by EMA (European Medicines Agency), in August 2011, for AF patients who are at risk of stroke.

It was the first stroke prevention medication to be approved in 50 years for individuals with AF, according to Pradaxa markers, Boehringer Ingelheim.

Pradaxa (Dabigatran) is a thrombin inhibitor anticoagulant - it inhibits thrombin. Thrombin is a blood enzyme involved in the blood clotting process. Experts believe that it will eventually replace warfarin as the preferred anticoagulant in the majority of cases, because it does not require frequent blood tests for international normalized ratio monitoring, and offers similar efficacy results.

Pradaxa competes with Johnson & Johnson's and Bayer's Xarelto

Bristol-Myers Squibb and Pfizer Inc. have submitted Eliquis (Apixaban) to the FDA for approval. According to many Wall Street analysts, Eliquis is the most impressive of the new generation of oral anticoagulants to replace warfarin.

A Phase III clinical trial (ARISTOTLE) found that patients on Eliquis had better stroke or systemic embolism protection and less bleeding than those on warfarin. Eliquis was shown to reduce stroke or systemic embolism risk by 21%, major bleeding risk by 31%; mortality was reduced by 11%.

Some facts about atrial fibrillation

  • 5 million people are thought to suffer from atrial fibrillation in the USA, and 6 million in the European Union

  • Atrial fibrillation is the most common cardiac arrhythmia (irregular heart condition)

  • Approximately 1 in every 4 people age 40+ years in the USA and Europe are expected to develop AF

  • An AF patient has a five times greater risk of stroke than people without the condition

  • In the USA, 15% of all strokes are thought to be caused by AF

  • Half of all AF patients who have a stroke die within 12 months of the stroke. This figure is considerably higher than stroke cases among non-AF patients. 24% of AF patients die within 30 days of having a stroke
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In Children With 22q11.2 Deletion Syndrome, Higher Anxiety Associated With Poorer Functioning

UC Davis researchers have found that for children with the genetic disorder known as chromosome 22q11.2 deletion syndrome anxiety - but not intelligence - is linked to poorer adaptive behaviors, such as self-care and communication skills, that affect daily life. The developmental syndrome, which is associated with a constellation of physical, cognitive and psychiatric problems, usually is apparent at birth or early childhood, and leads to lifelong challenges.

The study findings suggest that helping children cope with fear-based symptoms may be the best strategy for increasing independence and protecting against psychiatric problems later in life. The article, titled, "An examination of the relationship of anxiety and intelligence to adaptive functioning in children with chromosome 22q11.2 deletion syndrome," is published online in the Journal of Developmental and Behavioral Pediatrics. It will appear in the December 2012 print issue of the journal.

"Our study confirmed our impressions from seeing patients with 22q deletion syndrome that those with more severe anxiety symptoms tend to be most impaired in their everyday functioning," said Kathleen Angkustsiri, lead study author and assistant professor of developmental and behavioral pediatrics with the UC Davis MIND Institute. "It highlights the critical importance of recognizing and treating anxiety in these very vulnerable children."

The disorder also is known as velocardiofacial syndrome, referring to some of the common physical anomalies associated with the disorder, as well as DiGeorge syndrome, after one of the first physicians to describe it. The currently preferred name of chromosome 22q11.2 deletion syndrome identifies the location on the twenty-second chromosome where a small piece of DNA is missing. It is inherited in an autosomal dominant fashion, meaning that the child of a parent with the syndrome has a 50 percent chance of developing the syndrome; however, in 90 to 95 percent of cases, no family history of the syndrome is known, and the mutation arises for the first time in the affected person. The syndrome is estimated to affect about 1 in 2,000-4,000 people, making it the second most common condition after Down syndrome, another genetically based developmental disorder.

Manifestations of the syndrome vary among affected individuals. It may be diagnosed soon after birth because of symptoms related to heart defects as well as anomalies of the mouth, palate and throat, affecting feeding, speech and facial structure. Children with 22q11.2 deletion syndrome have a high prevalence of mental-health disorders such as anxiety and attention deficit hyperactivity disorder (ADHD), and IQs usually are in the borderline-to-low range. In early adulthood, about 30 percent may develop a psychiatric disorder such as schizophrenia.

The study evaluated 78 children with the syndrome, ages seven to 15 years, with a battery of standardized tests related to behavior, anxiety, adaptive functioning and intelligence. Thirty-six typically developing children with no known genetic syndromes were also evaluated for comparison. Assessment involved neuropsychological testing and developmental-behavioral pediatric evaluation of the children as well as parent questionnaires about their child's symptoms.

Mean anxiety scores were found to be significantly higher in children with 22q11.2 deletion syndrome than in typically developing children. Fifty-eight percent of children with the syndrome were found to have at least one elevated anxiety score, although only 19 percent had previously been diagnosed with an anxiety disorder.

In addition, higher anxiety scores correlated with lower adaptive function among children with the syndrome. Adaptive functioning is a measure of age-appropriate everyday living skills surrounding self-care, home and school living, communication and other factors. Specific anxiety subscales that were associated with poorer adaptive behavior included panic-agoraphobia (anxiety associated with unfamiliar environments), physical injury and obsessive-compulsive disorder.

"Anxiety appears to be under-identified by health-care professionals despite known elevated risk in this population," Angkustsiri said. "It is possible that more aggressively recognizing and treating anxiety in these children will prevent more severe problems as they enter adulthood."

For reasons that are not well understood, children with 22q11.2 deletion syndrome have a high risk of developing schizophrenia as they reach adulthood. In the general population, anxiety disorders also are associated with schizophrenia.

No relationship was found in the study between IQ and adaptive skills in children with 22q11.2 deletion syndrome, although an association was found in typically developing children and has been found in other studies of children with developmental disorders. The study authors postulate that the lack of correlation in 22q11.2 deletion syndrome could be explained by anxiety, so that because of fearfulness, children do not attain the maximal adaptive functional skills one might expect given their intellectual potential. In addition, children may not be reaching their optimal learning potential because of being distracted by worries or compulsions during learning opportunities.

The good news is that we have many good interventions to treat anxiety, such as medications and counseling, while cognitive impairments are not as amenable to treatment," said Angkustsiri. "We are hopeful that targeting anxiety can make a difference for children with this disorder, as well as in other vulnerable children."

The researchers are further studying factors that contribute to children with 22q11.2 deletion syndrome either being a "struggler" (characterized by high anxiety and low adaptive functioning) or someone who is coping -- a "coper" -- as well as interventions that may help the strugglers to become copers.

"This study provides an important key to significantly helping children with 22q deletion syndrome cope better with everyday life and improve their outcomes," said Tony J. Simon, principal investigator of the study and professor of psychiatry and behavioral sciences at UC Davis and the MIND Institute.

"The effects of anxiety should not be underestimated, and physicians caring for children with special needs should be proactive in diagnosing and treating it."

The team recently has started the "22q Healthy Minds Clinic" in order to put this research into practice. A team including a developmental-behavioral pediatrician or child psychiatrist, child psychologist, and cognitive neuroscientist evalutes children with 22q11.2 deletion syndrome and provides recommentations for intervention.
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Indoor Laundry Drying Could Be Bad For Your Health

A combination of prolonged wet weather and reducing use of tumble dryers as a way to cut fuel bills, may encourage people to dry more clothes indoors, for instance on drying frames or by draping on radiators. But according to researchers in Scotland, this could pose health risks by increasing moisture that encourages moulds and dust mites, which is bad for people prone to asthma.

Also, while the intention may be to save energy and cost, that is not necessarily the result, say the researchers, from the Mackintosh Environmental Architecture Research Unit (MEARU) at The Glasgow School of Art, working with Strathclyde and Caledonian universities, because in order to dry off the 2 litres that the average load of washing releases into the air, people often turn up the heating.

The three-year research project, titled "Environmental Assessment of Domestic laundering", was funded by the Engineering and Physical Sciences Research Council (EPSRC). A report and press statement were released on 2 November.

Report co-author, Colin Porteous, a professor at MEARU, says:

"Because of increased awareness of the energy consumption of tumble dryers many people are choosing to dry clothes passively within their home."

"This results not only in a severe energy penalty, because of increased heating demand, but also a potential health risk due to higher moisture levels," he adds.

Socks drying indoors
Researchers suggest a strong correlation between drying laundry indoors and increased spore growth, which can exacerbate symptoms for sufferers of asthma, hay fever and other allergies.

The researchers examined the laundry habits of residents in a wide demographic mix living in social housing in the West of Scotland, and also carried out a detailed analysis of air quality and energy consumption.

They concluded indoor drying of laundry poses environmental, economic and health problems, and the tendency in the UK toward building smaller, more airtight homes, only serves to make things worse.

In ill-ventilated rooms, putting clothes on radiators to dry can account for up to a third of the moisture in the air, and creates ideal conditions for mould spores to grow and dust mites to thrive. Both these conditions are known triggers of asthma.

The researchers also point out that indoor drying of clothes that contain fabric conditioner is likely to increase the amount of cancer-causing chemicals in the air.

Indoor laundry drying also leads to increased use of energy, as radiators are often turned up to help the drying process, and/or windows are opened. This just worsens fuel poverty, already a major issue in the West of Scotland, say the researchers.

The team recommends people dry their laundry outdoors whenever possible, or use energy-efficient, condensing tumble dryers. If you have to dry your clothes indoors, then place them by a south facing window (the message is for people in the UK), using natural light and heat. An even better method is to place the clothes on a south-facing balcony, if you have one.

They also suggest, when creating new housing stock, planners and builders should make sure the designs cater for ways of drying laundry that do not contribute to poor air quality. The researchers have published a design guide with suggestions like: upgrading balconies and sunspaces, ensuring new homes have a drying space with its own heating and ventilation, communal laundry and drying facilities, and installing energy-efficient appliances.

The team is now discussing its findings with social housing authorities, with a view to their proposals being adopted as Housing Associations upgrade existing stock and build new homes.

However they argue more sweeping changes are necessary, including updating the Building Regulations so they apply to all new housing. Such a move would have many benefits, says Porteous:

"Our research gives strong justification for the changes both in terms of health and wellbeing, and associated economic impacts. It is our hope that current statutory and advisory standards will be modified to take them on board ensuring a healthy and economically sustainable living environment."
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Repair Of Multiple Sclerosis Brain Damage May Be Possible

In what they describe to the press as a "life-changer" for millions of people with the disease, researchers in the US report this week a study where they discovered blocking an enzyme in the brain may help repair the damage associated with multiple sclerosis (MS), and other brain diseases.

The findings are due to be published online this week in the Annals of Neurology.

Myelin Damage

In MS, the protective sheath or myelin around nerve fibers is damaged or destroyed, disrupting the ability of nerve cells to communicate with each other. This process, called demyelination, is what causes the range of sensory, movement and cognitive problems typical of the disease.

Lead researcher of the new study, Larry Sherman, a professor at Oregon Health & Science University, heads a lab that had been studying MS and other disorders where myelin gets damaged for nearly 15 years.

Back in 2005, Sherman's team published a study in Nature Medicine reporting their discovery that a sugar molecule called hyaluronic acid appears to play a key role in demyelination. They found large deposits of hyaluronic acid at sites of myelin damage in humans and animals, and suggested the sugar itself stops remyelination, or repair of damaged myelin, by preventing the cells that form the myelin from differentiating at the damage sites.

Today's news comes as The Lancet this week reports two successful trials of a new drug for MS that "reboots" the immune system so it does not attack the nerve fibers.

Enzyme Prevents Myelin Repair

MRI of brain showing multiple sclerosis
Multiple sclerosis is a chronic disease that attacks the brain, spinal cord and optic nerves
Now, in their latest findings, Sherman and colleagues propose that it is not hyaluronic acid, but the compounds it breaks down into when in the presence of an enzyme called hyaluronidase, that prevents remyelination or myelin repair.

They found very high levels of the enzyme in brain lesions of patients with multiple sclerosis and in the nervous systems of mice with an MS-like disease.

When they blocked the activity of the enzyme in the mice with the MS-like disease, myelin-forming cell differentiation was restored.

But perhaps the more significant result of the study was that the drug the researchers used to restore myelin repair, also led to improved nerve cell function.

New Target for Drugs to Promote Myelin Repair

"What this means is that we have identified a whole new target for drugs that might promote repair of the damaged brain in any disorder in which demyelination occurs," says Sherman in a statement.

"Any kind of therapy that can promote remyelination could be an absolute life-changer for the millions of people suffering from MS and other related disorders," he adds.

Sherman, who is also a senior scientist in the Division of Neuroscience at the Oregon National Primate Research Center, says the next step is to develop a drug that specifically targets the effect of hyaluronidase.

He says the drug they used in the study would not be suitable for humans because it has potentially serious side effects. But a drug designed just for blocking hyaluronidase would most likely have few, if any, side effects he suggests.

The findings are likely to impact research and drug development for MS and a range of other disorders involving demyelination, including complications arising from premature birth.

Not an MS Cure

Sherman also makes the point that blocking the enzyme does not constitute a cure for MS. Other factors could be contributing to demyelination in MS and related diseases. But the discovery of the enzyme, and finding a way to block it, may at the very least "lead to new ways to promote the repair of brain and spinal cord damage either by targeting this enzyme alone or by inhibiting the enzyme in conjunction with other therapies," he says.

Grants from the National Institutes of Health, Fast Forward, LLC (a subsidiary of the National Multiple Sclerosis Society), the Laura Fund for Multiple Sclerosis Research, the March of Dimes Birth Defects Foundation and the American Heart Association, helped fund the study.
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Math Anxiety: The Brain Can Feel The Pain

Worry about math can trigger regions of the brain associated with the experience of physical pain and instinctive risk detection, according to a new study conducted by researchers at the University of Chicago and published in PLOS ONE.

Ian Lyons and his team of researchers discovered that in people who experience high levels of anxiety when anticipating math tasks, encountering math increases activity in regions of the brain connected with the feeling of physical pain. The more elevated a person's math anxiety, the greater the appearance of neural activity is.

The investigators explained, "We provide the first neural evidence indicating the nature of the subjective experience of math-anxiety."

Researchers analyzed 14 adults who experienced anxiety from math based on their answers from a questionnaire about math. Questions measured their anxiety by asking their feelings when receiving a math book, having math requirements for graduation, and walking to math class. Further testing revealed these individuals were not generally anxious and that their heightened feelings of anxiety were due to math-specific situations.

The study participants were then tested in an fMRI machine measuring their brain activity as they did math. They were asked to verify equations as well as solve world puzzles.

The fMRI scans showed the worry of upcoming math events triggered a response in the brain similar to physical pain. The higher the anxiety about math, the more math anticipation activated the posterior insula, a piece of tissue deep in the brain located above the ear, and is connected to acknowledging threats to the body as well as physical pain.

Previous research has told us that children with a higher mathematic anxiety have a decreased performance level in mathematics. They feel uncomfortable when doing mathematic tasks.

A separate study done by the Stanford University School, says that children who experience math anxiety exhibit an altered brain function. In other words, these panicky and frightened feelings can actually decrease activity in the area of the brain that deals with math.

Earlier studies have indicated that other forms of psychological stress, like a traumatic break-up, or social rejection, can also cause feelings of physical pain. However, this particular study analyzes the pain response connected with anticipating an anxiety-inducing event, instead of the pain connected to the stressful event itself.

This new study points out that just the anticipation of a distressing event could be associated with the activation of neural regions contributing to processing physical pain.

The authors conclude that their findings suggest that it is not the act of performing a mathematical task that prompts this response, but rather the anticipation of math.

These results give a possible neural platform for the observation that people with high math anxiety are more likely to avoid math-related situations, like math classes and math-related careers. Therefore, avoidance comes from experiencing this painful anxiety.
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