Zonisamide for weight loss in obese adults - A randomized controlled trial
Zonisamide for weight loss in obese adults - A randomized controlled trial
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DOI：
10.1001/jama.289.14.1820
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发表时间：
2003-04-09
影响因子：
120.7
通讯作者：
Krishnan, KRR
中科院分区：
文献类型：
--
作者：
Gadde, KM;Franciscy, DM;Krishnan, KRR
Context Zonisamide is a marketed antiepileptic drug that has serotonergic and dopaminergic activity in addition to blockade of sodium and calcium channels. Weight loss was an adverse effect associated with zonisamide treatment in epilepsy clinical trials.Objective To evaluate the efficacy of zonisamide for weight loss in obese adults.Design and Setting Sixteen-week randomized, double-blind, placebo-controlled trial with an optional single-blind extension of the same treatment for another 16 weeks, conducted at Duke University Medical Center from March 2001 to March 2002.Participants Fifty-five (92%) women and 5 (8%) men (mean [SE] body mass index, 36.3 [0.5]; mean age, 37.0 (1.0) years).Interventions Patients were randomly assigned to receive zonisamide (n=30) or placebo (n=30). All participants were prescribed a balanced hypocaloric diet (500 kcal/d deficit) and compliance was monitored with self-rated food diaries. Zonisamide therapy was started at 100 mg/d orally, with gradual increase to 400 mg/d and further increase to 600 mg/d for patients losing less than 5% of body weight at the end of 12 weeks. Placebo dosing was identical.Main Outcome Measure Change in body weight.Results Of the 60 randomized patients, 51 completed the 16-week acute phase. In an intent-to-treat analysis using the available data for all randomized participants with the last observation carried forward, the zonisamide group lost more body weight than the placebo group (mean [SE], 5.9 [0.8] kg [6.0% loss] vs 0.9 [0.4] kg [1.0% loss]; t=5.5; P
