Abstracts

RATIONALE: Zonisamide (Zonegran?, ZNS) is a new antiepilepsy drug (AED) with a novel mechanism of action and a broad spectrum of activity. ZNS has recently been approved in the US and has been used in Japan for over 10 years. Because there are certain key issues (such as potential effects on reproductive health, hormonal contraceptives, and pregnancy) that should be considered when selecting an AED for female patients, the present review was conducted to provide a better understanding of women s issues with the use of ZNS. METHODS: Data on ZNS use in women from clinical trials and published studies were reviewed, and gender-specific efficacy and tolerability clinical trial data were examined. Data regarding pregnancy and birth defects were also reviewed. RESULTS: Data from two clinical trial databases revealed no statistically significant differences in efficacy (as assessed by seizure reduction or responder rate) or safety between men (n=145) and women (n=86). Tolerability was statistically significantly different between men and women (P<0.001). No significant gender-associated differences were noted for the following adverse events: anorexia, ataxia, diplopia, dizziness, and neuropsychological/neurocognitive dysfunction. Nine pregnancies occurred during ZNS adjunctive therapy clinical trials in the US, and their outcomes were: three normal births, three spontaneous abortions, two therapeutic abortions, and one instance of hypospadias. CONCLUSIONS: ZNS seems to be effective and well tolerated, and no significant gender differences have been noted for safety or efficacy. Though there is little information from US studies regarding pregnancy in ZNS-treated patients, reports from Japan have described 26 pregnancies in ZNS-treated women. All pregnancies in women on ZNS monotherapy and >