Zonisamide for Weight Reduction in Obese Adults A 1-Year Randomized Controlled Trial
Zonisamide for Weight Reduction in Obese Adults A 1-Year Randomized Controlled Trial
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DOI：
10.1001/2013.jamainternmed.99
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发表时间：
2012-11-12
影响因子：
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通讯作者：
Bray, George A.
中科院分区：
文献类型：
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作者：
Gadde, Kishore M.;Kopping, Mariko F.;Bray, George A.
研究背景：肥胖者不能通过改变生活方式达到足够的减肥效果，非手术治疗的选择有限。我们评估了抗癫痫药物唑尼沙胺在接受饮食和生活方式指导的肥胖患者中促进体重减轻的有效性和耐受性。方法：这是一项为期1年的随机、双盲、安慰剂对照试验，于2006年1月9日至2011年9月20日在杜克大学医学中心进行。共有225名肥胖（平均[SD]体重指数，37.6 [4.9]）参与者，包括134名女性（59.6%）和91名男性（40.4%），无糖尿病。(Body质量指数的计算方法是体重（千克）除以身高（米）的平方。干预措施是每天服用安慰剂（n = 74），200毫克唑尼沙胺（n = 76），或400毫克唑尼沙胺（n = 75），除了饮食和生活方式咨询营养师1年。主要结果是体重在1 year.Results的变化：225例随机患者，218（96.9%）提供了1年的随访评估。体重变化为-4.0 kg（95% CI，-5.8至-2.3 kg;最小二乘均值，-3.7%）安慰剂组，-4.4 kg（-6.1至-2.6 kg;-3.9%; P =.79 vs安慰剂），400 mg唑尼沙胺为-7.3 kg（-9.0至-5.6 kg;-6.8%; P =.009 vs安慰剂）。在分类分析中，23（31.1%）分配至安慰剂组，26（34.2%; P =.72）分配给200 mg唑尼沙胺，41（54.7%; P =.007）分配到400 mg唑尼沙胺达到5%或更高的体重减轻;体重减轻10%或以上的相应数字分别为6例（8.1%）、17例（22.4%; P = 0.02）和24例（32.0%; P <0.001）。胃肠道，神经系统和精神不良事件发生率较高，唑尼沙胺比安慰剂。结论：唑尼沙胺在每日剂量为400毫克适度增强减肥实现与饮食和生活方式的咨询，但不良事件的发生率很高。
Background: Obese individuals who have failed to achieve adequate weight loss with lifestyle changes have limited nonsurgical therapeutic options. We evaluated the efficacy and tolerability of zonisamide, an antiepileptic drug, for enhancing weight loss in obese patients receiving diet and lifestyle guidance.Methods: This was a 1-year, randomized, double-blind, placebo-controlled trial conducted from January 9, 2006, through September 20, 2011, at Duke University Medical Center. A total of 225 obese (mean [SD] body mass index, 37.6 [4.9]) participants included 134 women (59.6%) and 91 men (40.4%) without diabetes mellitus. (Body mass index is calculated as weight in kilograms divided by height in meters squared.) Interventions were daily dosing with placebo (n = 74), 200 mg of zonisamide (n = 76), or 400 mg of zonisamide (n = 75), in addition to diet and lifestyle counseling by a dietitian for 1 year. Primary outcome was change in body weight at 1 year.Results: Of the 225 randomized patients, 218 (96.9%) provided 1-year follow-up assessments. Change in body weight was -4.0 kg (95% CI, -5.8 to -2.3 kg; least squares mean, -3.7%) for placebo, -4.4 kg (-6.1 to -2.6 kg; -3.9%; P = .79 vs placebo) for 200 mg of zonisamide, and -7.3 kg (-9.0 to -5.6 kg; -6.8%; P = .009 vs placebo) for 400 mg of zonisamide. In the categorical analysis, 23 (31.1%) assigned to placebo, 26 (34.2%; P = .72) assigned to 200 mg of zonisamide, and 41 (54.7%; P = .007) assigned to 400 mg of zonisamide achieved 5% or greater weight loss; for 10% or greater weight loss, the corresponding numbers were 6 (8.1%), 17 (22.4%; P = .02), and 24 (32.0%; P < .001). Gastrointestinal, nervous system, and psychiatric adverse events occurred at a higher incidence with zonisamide than with placebo.Conclusion: Zonisamide at the daily dose of 400 mg moderately enhanced weight loss achieved with diet and lifestyle counseling but had a high incidence of adverse events.