HIGHER INCIDENCE OF COMPONENTS OF POLYCYSTIC OVARY SYNDROME IN YOUNG WOMEN WITH EPILEPSY TREATED WITH VALPROATE VERSUS LAMOTRIGINE
Abstract number :
1.214
Submission category :
Year :
2005
Submission ID :
5299
Source :
www.aesnet.org
Presentation date :
12/3/2005 12:00:00 AM
Published date :
Dec 2, 2005, 06:00 AM
Authors :
1Martha J. Morrell, 2Frances S. Hayes, 2Patrick M. Sluss, 3Clay R. Warnock, 3Heather S. Conklin, and 3Jouko I. Isojarvi
To evaluate the development of components of polycystic ovary syndrome (PCOS) in women with epilepsy (WWE) initiating either valproate (VPA) or lamotrigine (LTG) therapy for epilepsy. Eligibility criteria for this prospective, randomized, open-label, multicenter study (LAM30007) included age 13-40 years, regular menstrual cycles; no concurrent hormonal medications; no prior LTG or VPA; and either newly diagnosed [[lt]2 weeks prior antiepileptic drug (AED)] or inadequately controlled epilepsy (only 1 chronic AED[ge]3 months). Subjects were randomized to VPA or LTG and were treated for up to 12 months. Serum androgen levels were measured every three months and urinary pregnanediol glucuronide levels weekly for two 3-month periods. The primary endpoint was components of PCOS defined as development of hyperandrogenism (serum testosterone or DHEA-S above the 95th percentile) or ovulatory dysfunction (2 or more anovulatory cycles, by urinary pregnanediol glucuronide assay) during the study. To exclude the confounding effect of puberty on the results, a post-hoc analysis was conducted in women who were [gt]2 years post menarche. The primary endpoint was analyzed using a 2-sided Cochran Mantel-Haenszel test, controlling for grouped center and epilepsy status at enrollment (newly diagnosed vs. inadequately controlled). Age-specific comparisons were analyzed using a 2-sided Fisher[apos]s exact test. A total of 363 women (177 LTG, 186 VPA) ages 12 to 40 years were evaluated. A greater proportion of women in the VPA group developed components of PCOS when compared to women in the LTG group (36% VPA vs 23% LTG; p=0.007). The high incidence of components of PCOS was evident in the VPA group if the medication was started at 25 years of age or younger (44% VPA vs. 23% LTG, p=0.002), whereas the incidence was similar in the treatment groups if the medication was started after age 25 (24%VPA vs. 22% LTG). This large, multiethnic, prospective, randomized study shows that a greater proportion of WWE receiving VPA than LTG develop components of PCOS symptoms, especially if the medication is started before age 26 years. (Supported by GlaxoSmithKline.)