Apr 29 2004
Two studies presented today at the American Academy of Neurology (AAN) 56th Annual Meeting show that pregabalin, when used as an add-on treatment for epilepsy, does not affect male reproductive function or interfere with the effectiveness of oral contraceptives.
"Men with epilepsy have been known to have lower than expected fertility rates and antiepileptic drugs can further impair fertility rates. In women, many anti-epileptic medications are known to reduce the effectiveness of oral contraceptives, which can lead to unexpected pregnancies in patients with epilepsy," said Dr. Martha Morrell, professor of neurology at Columbia University and director of the Columbia Comprehensive Epilepsy Center.
"Pregabalin will provide an additional treatment option that may allow people with epilepsy better manage issues related to their reproductive health."
Pregabalin Does Not Impair Male Reproductive Function In a 14-week, double-blind, placebo-controlled, multicenter study, 46 healthy men between the ages of 18 and 55 were treated with pregabalin 200 mg TID or placebo to determine the percent of sperm with normal motility. Men treated with pregabalin and placebo had similar baseline sperm motility, and by the end of the trial there was no significant difference.
These data suggest pregabalin will not produce detrimental effects on male reproductive function. The most common adverse events reported were somnolence, concentration difficulty and dizziness.
The majority of adverse events related to pregabalin treatment were mild to moderate. Pregabalin Does Not Alter the Effectiveness of Oral Contraceptives In a second study, one ortho-novum 1/35 tablet was administered once daily for the first 21 days of three consecutive menstrual cycles to 16 women.
Pregabalin 200 mg TID was co-administered with the oral contraceptive during the last menstrual cycle. Blood plasma samples were collected at the end of the second (oral contraception alone) and third menstrual cycles (oral contraception plus pregabalin) 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 ovulation did not occur during the administration of pregabalin.
The most common adverse events reported were insomnia, headache, dizziness and constipation. The majority of adverse events related to pregabalin treatment were mild to moderate.
The efficacy and safety of pregabalin has been tested in more than 10,000 patients.
Pregabalin is currently under review by the U.S. Food and Drug Administration as adjunctive therapy in the treatment of partial seizures, for the management of neuropathic pain associated with diabetic peripheral neuropathy and herpes zoster (post-herpetic neuralgia), and for the treatment of generalized anxiety disorder in adults.
Epilepsy, a chronic neurologic condition that is characterized by seizures, affects an estimated 50 million people worldwide, with 2.5 million people affected in the United States alone. Although the cause of epilepsy is uncertain, it can be associated with neurologic disorders including head injuries, tumors and stroke.
Current treatment options focus on preventing or decreasing the frequency of seizures.