New Data Suggests That Young Women With Epilepsy

NEW DATA SUGGESTS THAT YOUNG WOMEN WITH EPILEPSY REQUIRE SPECIAL TREATMENT STRATEGY

Comparative Study Indicates Less Risk of Polycystic Ovary Syndrome Symptoms with Lamotrigine vs. Valproate

New York, NY, May 9, 2001 -- New data from an observational study comparing two commonly used epilepsy treatments, lamotrigine (Lamictalâ) and valproate (Depakoteâ), suggest that lamotrigine is less likely to be related to disorders associated with polycystic ovary syndrome (PCOS), a condition which causes infertility. The data was presented in Philadelphia today at the 53rd Annual Meeting of the American Academy of Neurology by Dr. Martha Morrell, Professor of Neurology at Columbia University College of Physicians & Surgeons and Director of the Columbia Comprehensive Epilepsy Center of NewYork-Presbyterian Hospital. The international study, which evaluated 222 women aged 18-35, was conducted in response to growing concerns among epilepsy specialists that their female patients may develop hormonal and metabolic disorders related to PCOS when taking anti-epileptic drugs. PCOS is one of the leading causes of infertility in women and is estimated to affect 5-10 percent of women of childbearing age. It is characterized by obesity, irregular or absent menses, ovarian cysts, high blood pressure and elevated lipid levels, elevated insulin levels or diabetes, infertility, excessive facial or body hair and thinning of scalp hair. In particular, several published studies have reported that extended exposure to valproate has been associated with the development of PCOS symptoms. “Many women with epilepsy receive their treatment from primary care and community physicians who may not be aware of recent information showing that infertility and menstrual disturbances may be associated with some antiepileptic drugs. While this type of study doesn’t allow for conclusions about drug-related causation, it certainly adds to the evidence that physicians caring for women with epilepsy should be alert to signs of menstrual irregularity, weight gain and infertility,” commented Dr. Morrell, who is a recognized expert in the treatment and reproductive health of women with epilepsy. The open-label, observational study involved 119 women taking Lamictalâ monotherapy and 103 women taking valproate monotherapy for a period of eight months to five years. The study required one blood test for measuring hormone, lipid and insulin levels, a one-time weight measurement for each participant, along with patient-reported weight at initiation of Lamictalâ or valproate treatment. In addition, the women completed menstrual diaries covering a three-cycle time frame and, for those with regular menstrual cycles, provided results of home urine ovulation tests performed over one menstrual cycle. “The new data indicate that lamotrigine compared favorably to the older drug valproate in several key areas. Patients on lamotrigine had lower androgen levels, or male hormones, which when elevated are believed to effect a number of changes that lead to PCOS,” said Dr. Morrell. “These patients on lamotrigine also reported more regular menstrual cycles, and their weight remained stable whereas those on valproate had gained weight since initiation of that treatment,” she added.

Key findings of various factors linked to PCOS assessed in the study are:

· Significantly higher androgen or male hormones found in valproate group: - Total serum testosterone: 0.96nmol/L valproate vs. 0.72 nmol/L Lamictalâ - Total serum androstenedione: 12.6 nmol/L valproate vs. 10.1 nmol/L Lamictalâ).

· Lamictalâ group was weight-gain neutral while the valproate group showed an increase: While the mean weight in the Lamictalâ group was the same at the initiation of therapy and the study visit, (71.5 kg/71.5 kg), the mean weight of the valproate group increased during this timespan (63.0 kg/67.7 kg).

· Lamictalâ group had shorter menstrual cycles while valproate group had longer cycles: Lamictalâ therapy was associated with slightly shorter and more regular menstrual cycles. Patients on valproate reported longer and more variable cycle lengths than Lamictalâ patients – 31.5 days vs. 29.5 days

According to the Epilepsy Foundation, more than one million American women and girls have epilepsy, a neurological condition that makes people susceptible to seizures. A seizure is a change in sensation, awareness, or behavior brought about by a brief electrical disturbance in the brain. There are many different types of seizures. The kind of seizure a person has depends on which part and how much of the brain is affected by the electrical disturbance that produces seizures. Experts divide seizures into generalized seizures and partial seizures. Partial seizures are the most common form of seizure in adults, affecting six out of every ten people with epilepsy. The research was funded by GlaxoSmithKline.

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