Non-steroidal anti-inflammatory drugs inhibit ovulation after just 10 days

The results of a new study show that diclofenac, naproxen and etoricoxib significantly inhibit ovulation in women with mild musculoskeletal pain. Of the women receiving NSAIDs, only 6.3 percent (diclofenac), 25 percent (naproxen) and 27.3 percent (etoricoxib) ovulated, compared with 100 percent of the control group.

New findings suggest that readily available non-steroidal anti-inflammatory drugs (NSAIDs) could have a harmful effect on fertility.

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The results of a study presented today at the European League Against Rheumatism Annual Congress (EULAR 2015) show that diclofenac, naproxen and etoricoxib significantly inhibit ovulation in women with mild musculoskeletal pain. Of the women receiving NSAIDs, only 6.3 percent (diclofenac), 25 percent (naproxen) and 27.3 percent (etoricoxib) ovulated, compared with 100 percent of the control group.

These findings suggest that readily available non-steroidal anti-inflammatory drugs (NSAIDs) could have a harmful effect on fertility, and should be used with caution in women wishing to start a family.

'After just ten days of treatment we saw a significant decrease in progesterone, a hormone essential for ovulation, across all treatment groups, as well as functional cysts in one third of patients,' said study investigator Professor Sami Salman, Department of Rheumatology, University of Baghdad, Iraq. 'These findings show that even short-term use of these popular, over-the-counter drugs could have a significant impact on a women's ability to have children. This needs to be better communicated to patients with rheumatic diseases, who may take these drugs on a regular basis with little awareness of the impact.'

NSAIDs are among the most commonly used drugs worldwide, and are taken by more than 30 million people every day. Available without prescription, NSAIDS are largely used for the treatment of pain, inflammation and fever -- all common features of rheumatic conditions.

Thirty nine women of childbearing age who suffer from back pain took part in the study, and received diclofenac (100mg once daily), naproxen (500mg twice daily) and etoricoxib (90mg once daily) or placebo. Treatment was given for 10 days from day 10 of the onset of the menstrual cycle; hormonal analysis (progesterone level) and follicle diameter were conducted via blood sample and ultra sonsography respectively. At the end of the NSAID treatment period, the dominant follicle remained unruptured in 75 percent, 25 percent and 33 percent of patients receiving diclofenac, naproxen and etoricoxib respectively. Rupturing of the dominant follicle, and subsequent release of an oocyte (unfertilised egg), is essential for ovulation to occur.

'These findings highlight the harmful effects NSAIDs may have on fertility, and could open the door for research into a new emergency contraception with a more favourable safety profile than those currently in use,' concluded Professor Sami Salman.

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Story Source:

The above post is reprinted from materials provided by European League Against Rheumatism.

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Erectile Dysfunction Tied To Long Term Painkiller Use

A new study suggests that long term use of opioid prescription painkillers for back pain is tied to a higher risk of erectile dysfunction (ED). The findings are published in the 15 May online issue of the journal Spine.

Lead author Richard A. Deyo, an investigator with the Kaiser Permanente Center for Health Research says in a statement:

"Men who take opioid pain medications for an extended period of time have the highest risk of ED."

With his colleagues, Deyo, who is also Professor of Evidence-based Family Medicine at Oregon Health & Science University, found the link by analyzing electronic health records of over 11,000 men enrolled in a health plan.

They believe theirs is the first study to find such a link using electronic health records.

The reason they did the study was because men with chronic pain sometimes experience erectile dysfunction because of depression, smoking, age, or opioid-related hypogonadism (low testosterone due to painkiller use).

But little is known, they note, about how common ED is in men with back pain, and which risk factors may be important.

So they searched the electronic records to find out if men taking prescription painkillers were also the ones most likely to be prescribed testosterone replacement or medications for ED.

They found 11,327 men in Oregon and Washington enrolled in the Kaiser Permanente health plan who went to see their doctor complaining of back pain in 2004.

For each patient they identified, they looked at his pharmacy records covering six months before and six months after the back pain visit to find out if they had received opioids and testosterone replacement or ED medications.

The analysis showed that over 19% of men who took high-dose opioids (classed as more than 120 mg of morphine-equivalent) for at least four months were also prescribed testosterone replacement or medications for ED. This compared with only 7% who received ED prescriptions but did not take opioids.

Of the men who took low-dose opioids for at least four months, 12% also received prescribed testosterone replacement or medications for ED.

In looking at other factors, Deyo and colleagues found being over 60, having depression or other illnesses, or taking sleeping pills (sedative hypnotics like benzodiazepines), were all independently linked to ED. Age was the biggest factor, with men aged 60 to 69 being 14 times more likely to be receiving prescriptions for ED medications than men aged 18 to 29.

However, when they took out the effects of these factors in the figures, they found patients taking high-dose opioids were still 50% more likely to be given prescriptions for ED than men those who did not take the painkillers.

Deyo says just because they have found this link, it does not necessarily mean that prescription painkillers actually cause ED, but it is "something patients and clinicians should be aware of when deciding if opioids should be used to treat back pain."

Deyo has spent over 30 decades studying treatments for back pain. He says that while there is "no question" that for some patients taking opioids is the right treatment for back pain, "there is also increasing evidence that long-term use can lead to addiction, fatal overdoses, sleep apnea, falls in the elderly, reduced hormone production, and now erectile dysfunction".

The US Centers for Disease Control and Prevention (CDC) say prescription opioid use in the United States has grown enormously. Between 1999 and 2010, sales quadrupled.

A survey published in 2008 in the journal Pain, suggested that 4.3 million adult Americans regularly use opioids. The ones most commonly prescribed are hydrocodone, oxycodone, and morphine.

Researchers from the CDC also reported recently that in 30% of deaths from overdosing on opioid painkillers, patients had also taken benzodiazepines.

Written by Catharine Paddock PhD

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Premature ejaculation drug helps control, satisfaction and time

Data presented today demonstrates that men taking dapoxetine hydrochloride for the treatment of premature ejaculation (PE) experienced significant improvements in sexual function, including ejaculatory control, satisfaction with sexual intercourse for men and their partners, and increases in intravaginal ejaculatory latency time (IELT)*. The U.S. Food and Drug Administration is currently reviewing a New Drug Application for dapoxetine, which if approved, would be the first prescription product indicated for the treatment of PE. These data were presented at the 100th Annual Scientific Meeting of the American Urological Association.

According to the American Urological Association, premature ejaculation may be the most common male sexual disorder. It is estimated that PE may affect 27 percent to 34 percent of men across all age ranges**, in contrast to erectile dysfunction, which is estimated to affect 10 percent to 12 percent of all men, who are usually older in age. PE can be a lifelong condition experienced from the beginning of sexual activity or can develop after years of satisfactory sexual activity.

"The impact premature ejaculation can have on men and their partners can be devastating for a relationship and, currently, there are no truly optimal therapies for PE," says Jon L. Pryor, M.D., chairman and program director of the Department of Urologic Surgery at the University of Minnesota and lead investigator of the dapoxetine phase III clinical trials. "The results with dapoxetine are compelling. They demonstrate that, for the first time, a medicine can be taken by men on an on-demand basis and provide significant improvement in their PE condition. The unique profile of dapoxetine translated into targeted treatment of PE compared to existing therapies. There are meaningful improvements in this study across all primary and secondary endpoints, including a three-to-four fold increase in IELT."

Phase III Trial Design and Results

The phase III clinical trials studied 2,614 men with PE aged 18-77 in monogamous sexual relationships of greater than six months. PE was defined as persistent or recurrent ejaculation sooner than desired either before or shortly after penetration, typically reflecting an IELT of two minutes or less, over which the sufferer has minimal or no control.

Men in the studies were randomized to receive 30 mg or 60 mg of dapoxetine over 12 weeks in two identical, double-blind, placebo-controlled, multicenter trials. Patients were asked to take study medication one-to-three hours before intercourse. Participants had IELT of two minutes or less in at least 75 percent of intercourse episodes occurring during the two-week baseline run-in period prior to treatment.


The studies examined changes from baseline for mean IELT as monitored by a stopwatch; measured the subject's ejaculatory control and sexual satisfaction on a five-point scale from "very poor to very good" and measured the partner's satisfaction with sexual intercourse from "very poor to very good." The results showed:

-- Men taking dapoxetine 30 mg and 60 mg experienced more than a three-to-four fold increase in mean IELT compared with placebo (P-value <0.0001 at 30 mg and 60 mg). IELT increased significantly with the first dose of dapoxetine, and increases in IELT were maintained over the 12-week study period.

-- The percentage of men rating control over ejaculation as "fair to very good" increased dramatically for dapoxetine 30 mg (2.5 percent to 51.8 percent) and 60 mg (3.3 percent to 58.4 percent) compared to placebo (3.5 percent to 26.4 percent).

-- The percentage of men rating sexual satisfaction as "good to very good" almost doubled with dapoxetine 30 mg (20.2 percent to 38.7 percent) and 60 mg (22.3 percent to 46.5 percent), respectively, in comparison to placebo (21.6 percent to 24.6 percent).

-- The percentage of partners rating sexual satisfaction as "good to very good" almost doubled with dapoxetine 30 mg (20.4 percent to 39 percent) and 60 mg (24.8 percent to 47.4 percent), respectively, compared to placebo (20.1 percent to 25.2 percent).

The study also found that dapoxetine was generally well tolerated, with most side effects of mild-to-moderate severity. The most common adverse events reported with both 30 mg and 60 mg doses of dapoxetine were nausea, followed by headache.

About Premature Ejaculation (PE)

Although PE is one of the most common male sexual disorders, it remains widely under-diagnosed and under-treated. Most physicians do not screen for PE and patients are extremely reluctant to talk about the condition with their partners or health care professionals. PE can have a significant impact on many aspects of a man's life. It can affect his and his partner's sexual satisfaction and their ability to build and maintain relationships - both sexual and non-sexual - and can impact a man's general sense of self-confidence.

An observational study published in the May 2005 issue of The Journal of Sexual Medicine found that patient-reported outcome measures (PROs), such as control over ejaculation, satisfaction with sexual intercourse and distress are important factors in assessing the benefit of treatments for PE in clinical studies. The study found that men with PE and their partners reported higher ratings for interpersonal difficulty, lack of control over ejaculation and dissatisfaction with sexual intercourse.

About Ortho Urology

Ortho Urology, a unit of Ortho-McNeil Pharmaceutical, Inc., has a proven track record of leadership in the field of urology and is committed to providing patients with products that help them live healthier lives and improve their quality of life. Ortho Urology has a history of clinical expertise and is committed to bringing patients the most advanced options in urology with products such as ELMIRON� (pentosan polysulfate sodium) and DITROPAN XL� (oxybutynin chloride).

* Intravaginal Ejaculatory Latency Time (IELT) - IELT was first introduced in 1994. It is used in clinical setting involving the study of premature ejaculation. A stopwatch may be operated by either partner and is activated when the male enters the female and stopped when a man ejaculates. The amount of time this process takes is known as intravaginal ejaculatory latency time or IELT.

** Represents Hispanic, Caucasian and African American men.

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