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Antiepileptic Pregabalin Appears Safe With Regard to Fertility Issues: Presented at AAN

By Ed Susman

SAN FRANCISCO, CA -- April 30, 2004 -- The new anti-epileptic drug, pregabalin, appears to be safe for men and women concerned about the fertility issues that affect epileptics.

In 2 separate studies presented here April 28^th at the American Academy of Neurology 56^th Annual Meeting, scientists found that pregabalin does not affect male reproductive function or interfere with the effectiveness of oral contraceptives.

"Pregabalin will provide an additional treatment option that may allow people with epilepsy to better manage issues related to their reproductive health," said Martha Morrell, MD, Professor of Neurology, Columbia University, and director, Columbia Comprehensive Epilepsy Center, New York, United States.

Dr. Morrell was the lead author of a double-blind, placebo-controlled, multicentre study that enrolled 46 healthy men between the ages of 18 and 55 for 14 weeks, to determine whether pregabalin had any impact on sperm motility. All participants had similar baseline sperm motility.

Participants were assigned to receive either placebo or pregabalin 200 mg 3 times a day. Thirty men received the active ingredient, while the other 16 received placebo.

"No significant differences between pregabalin and placebo were observed at the end of the double-blind treatment period," Dr. Morrell reported. "There was no indication of a detrimental effect of pregabalin on reproductive function."

Dr. Morrell also examined other parameters that might create problems in reproduction, but determined that pregabalin does not alter the metabolism or protein binding of sex-steroid hormones, such as testosterone, involved in spermatogenesis.

"These data suggest [that] pregabalin will not compound epilepsy-related disturbances in reproductive function in males," Dr. Morrell said. "Men with epilepsy have been known to have lower than expected fertility rates, and anti-epileptic drugs can further impair fertility rates."

In a second study, researchers scrutinised the impact of pregabalin on women who are using birth-control pills for family-planning issues..

Many anti-epileptic medications are known to reduce the effectiveness of oral contraceptives, which can lead to unexpected pregnancies in patients with epilepsy. Howard Bockbrader, PhD, researcher, Clinical Pharmacokinetics and Pharmacodynamics Department, Pfizer Global Research and Development, Ann Arbor, Michigan, United States, noted that 1 Ortho-novum 1/35 tablet was administered once daily to 16 women for the first 21 days of 3 consecutive menstrual cycles. Pregabalin 200 mg 3 times a day was co-administered with the oral contraceptive during the last menstrual cycle.

Blood-plasma samples were collected at the end of the second and third menstrual cycles to measure the effect of pregabalin on the suppression of ovulation. Results of these comparisons showed that pregabalin had no significant effect on the pharmacokinetics of the oral contraceptive, indicating that ovulation did not occur during the administration of pregabalin.

"Ethinyl estradiol and norethindrone pharmacokinetic profiles following daily administration of the birth-control tablets are unaffected by pregabalin doses," Dr. Bockbrader concluded. "Concomitant administration of pregabalin does not affect the oral contraceptive's ability to prevent ovulation. Concomitant administration of an oral contraceptive does not affect the steady state concentrations of pregabalin."

The pregabalin studies were supported by Pfizer Inc. Pregabalin is currently under review for licensure by the United States Food and Drug Administration.

Women who are pregnant cannot afford to discontinue their epilepsy medication, noted Mark Yerby, MD, MPH, professor of neurology, public health and preventive medicine as well as professor of obstetrics and gynecology, Oregon Health Science University, Portland, United States, who was presenting new guidelines on the treatment of epilepsy at the meeting on April 26^th. Dr. Yerby said that some epilepsy drugs interfere with the effectiveness of oral contraceptives, and have led to unwanted pregnancies.


[Presentation titles: "A Double-Blind, Placebo-Controlled, Parallel-Group Study To Assess the Effects of Pregabalin on Reproductive Function in Healthy Males." Abstract #:P04.096. "Pregabalin Does Not Alter the Effectiveness of an Oral Contraceptive." Abstract #P04.097]

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