Levetiracetam Weight Change during Placebo Controlled Clinical Trials
Abstract number :
2.172
Submission category :
Year :
2001
Submission ID :
2745
Source :
www.aesnet.org
Presentation date :
12/1/2001 12:00:00 AM
Published date :
Dec 1, 2001, 06:00 AM
Authors :
R. Sheth, MD, Department of Neurology, University of Wisconsin-Madison, Madison, WI; B.E. Gidal, PharmD, Department of Neurology, University of Wisconsin-Madison, School of Pharmacy, Madison, WI; R. Maganti, MD, Department of Neurology, University of Wisc
RATIONALE: Increases in body weight are an important and clinically significant adverse effect of several antiepileptic drugs including valproate and gabapentin. Weight gain may contribute to medication non-compliance or discontinuation. Furthermore, for patients who do remain on medication, undesired weight gain may have adverse medical implications as well. Levetiracetam (LEV) is a recently approved AED indicated for adjunctive treatment of partial seizures. The objective of the present evaluation was to examine the effects of LEV treatment on body weight in adult patients.
METHODS: We reviewed data derived from 4 prospective, placebo-controlled randomized, clinical trials conducted both in the US and Europe. These studies evaluated LEV adjunctive therapy in n = 1023 patients. Analysis was conducted on data pooled from these studies. Wilcoxon signed rank test and Wilcoxon rank sum test were used for statistical comparisons, with significance assigned at p [lt] 0.05.
RESULTS: Weight data was available in n = 1004 patients (mean age = 37.3 ([plusminus] 11.5) years, 53.3% men/46.7% women). There were no significant differences in baseline demographics between LEV or placebo treatment groups. Median LEV dose and duration of treatment were 2000 mg/day (maximum dose of 4000 mg/day) & 18 weeks (maximum = 25.8 weeks), respectively. Concomitant AED therapy (all patients) included CBZ = 66.7%, PHT = 20.8%, VPA = 20.0%, GBP = 9.2%, LTG = 9.0%.
Mean body weight at baseline vs final study visit for LEV was 74 ([plusminus] 16.6) vs 74 ([plusminus] 16.7) kg and for placebo was 72.5 ([plusminus] 15.5) vs 72.8 ([plusminus] 16.0) kg. Therefore the change in body weight (baseline - final visit) was + 0.01 ([plusminus] 2.96) kg for LEV (p = 0.628) vs + 0.32 ([plusminus] 2.8) kg for placebo (p = 0.010). There were no statistically significant differences between treatment groups (p = 0.057).
Clinically significant weight change, defined as [gte] 7% change from baseline weight, occurred in 8.5% of LEV treated patients (4.3% had a weight increase/4.3% decrease) vs 9.2% (5.8% increase/3.5% decrease) of placebo treated patients. Additional analyses by gender demonstrated no effect of LEV on body weight in either males or females.
CONCLUSIONS: We conclude that adjunctive treatment with LEV was not associated with weight change during placebo controlled clinical trials of at least 4 months duration at doses up to 4000 mg/day. LEV would appear to be a weight neutral AED.
Support: A grant from UCB Pharma.
Disclosure: Salary - Magnus -UCB Pharma; Herbeuval -UCB Pharma. Grant - UCB Pharma, Pfizer, Glaxo Smith Kline. Consulting - Glaxo Smith Kline. Honoraria - Glaxo Smith Kline, Pfizer, UCB-Pharma, Abbott.