Weight Loss Associated with Use of Zonisamide in European and US Clinical Trials.
Abstract number :
3.140
Submission category :
Year :
2001
Submission ID :
2296
Source :
www.aesnet.org
Presentation date :
12/1/2001 12:00:00 AM
Published date :
Dec 1, 2001, 06:00 AM
Authors :
T.E. Welty, PharmD, Pharmacy Practice, McWhorter School of Pharmacy Samford University, Birmingham, AL; R.I. Kuzniecky, MD, Neurology, University of Alabama Birmingham, Birmingham, AL; N. Limdi, PharmD, Pharmacy, University of Alabama Birmingham, Birmingh
RATIONALE: Zonisamide (ZNS) has been associated with weight loss. To better understand weight loss in patients receiving ZNS, a retrospective review of data from 3 studies (2 US, 1 European) of ZNS was undertaken.
METHODS: Data from the 912US, 912EU, and 922 trials were analyzed. A global evaluation of weight loss or gain was performed with a separate analysis of data from each trial. Patients were categorized into subgroups, if they lost [gt]5 lbs, gained [gt]5 lbs, or maintained weight. Comparison was made between weights at the end of baseline and the end of the double-blind phase. The double-blind phases lasted 3-5 months. Descriptive statistics and nonparametric tests were utilized to analyze data.
RESULTS: Data from 314 patients were evaluated. Combined data showed that 74.5% of patients receiving ZNS lost or maintained weight compared to 54.9% receiving placebo (p=0.001). In the 912US trial, 82.9% of patients on ZNS lost or maintained weight compared to 51.4% of patients on placebo (p=0.001). For the 912EU trial, 76.1% on ZNS lost or maintained weight compared to 62.1% on placebo (p=0.078). In the 922 trial, 68.1% on ZNS lost or maintained weight compared to 52.0% on placebo (p=0.001).
Weight Outcomes for Combined Trials
The mean weight loss for all patients was 4.3 [plusminus] 4.6 lbs. The mean weight loss for the 912EU study was less (2.9 [plusminus] 4.1 lbs) compared to the 912US (5.9 [plusminus] 5.3 lbs) and the 922 (4.1 [plusminus] 3.9 lbs) trials.
CONCLUSIONS: A significant number of patients taking ZNS lost weight. When ZNS is initiated, 25-30% of patients will experience [gt]5 lbs weight loss. Differences in weight loss between the various trials indicate that patient-specific characteristics may determine the amount of weight loss.[table]
Support: Supported by a grant from Elan Pharmaceuticals.
Disclosure: Grant - Elan Pharmaceuticals, Abbott, Glaxo Smith Kline; Consulting - Elan; Honoraria - Elan, Abbott, Glaxo SmithKline, Pfizer, Novartis, UCB Pharma, Ortho-McNeil