Atomoxetine for weight reduction in obese women: a preliminary randomised controlled trial
Atomoxetine for weight reduction in obese women: a preliminary randomised controlled trial
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DOI：
10.1038/sj.ijo.0803223
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发表时间：
2006-07-01
影响因子：
4.9
通讯作者：
Allison, DB
中科院分区：
文献类型：
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作者：
Gadde, KM;Yonish, GM;Allison, DB
背景和目的：托莫西汀是一种强效中枢去甲肾上腺素摄取抑制剂，目前已上市用于治疗注意力缺陷/多动障碍（ADHD）。了解到去甲肾上腺素能药物可用于帮助肥胖个体减肥，我们进行了这项初步研究，以评估托莫西汀在肥胖成人中的短期疗效和安全性。设计：在为期12周的随机、双盲、安慰剂对照试验中，于2004年5月至2004年12月在美国杜克大学医学中心进行。参与者：共30名肥胖女性（平均值（s.e.）体重指数为36.1（0.6）kg/m2）。干预措施：参与者被随机分配接受托莫西汀（n=15）或安慰剂（n=15）。建议所有参与者遵循平衡的低热量饮食（500千卡/天的赤字）。托莫西汀治疗起始剂量为25 mg/天口服，在1周内逐渐增加至100 mg/天。安慰剂的剂量是相同的。测量：体重（公斤）是主要的结果测量。其他测量包括腰围、血压和心率、空腹血糖和血脂以及抑郁症状。结果：对至少完成一次随机分组后评估的参与者的可用数据进行末次观察结转分析，结果表明托莫西汀组（n=12）在12周期间比安慰剂组（n=14）减轻更多体重（平均值（s.e.）-3.6（1.0）kg（-3.7%损失）vs 0.1（0.4）kg（0.2%增加）; F-4，F-96 11.9; P < 0.0001）。托莫西汀组有三名参与者体重减轻>= 5%，而安慰剂组没有。结论：托莫西汀表现出适度的短期减肥疗效相对于安慰剂在这个初步研究的肥胖妇女。
Background and objective: Atomoxetine is a potent central norepinephrine uptake inhibitor, currently marketed for treatment of attention-deficit/hyperactivity disorder (ADHD). With the understanding that noradrenergic agents could be useful in assisting obese individuals to lose weight, we conducted this preliminary study to evaluate short-term efficacy and safety of atomoxetine in obese adults.Design: At 12-week randomised, double-blind, placebo-controlled trial, conducted at Duke University Medical Centre, USA, from May 2004 to December 2004.Participants: A total of 30 obese women (mean (s.e.) body mass index of 36.1 (0.6) kg/m(2)).Interventions: Participants were randomly assigned to receive atomoxetine (n=15) or placebo (n=15). All participants were advised to follow a balanced hypocaloric diet (500 kcal/day deficit). Atomoxetine therapy was started at 25 mg/day orally, with gradual increase to 100 mg/day over 1 week. Placebo dosing was identical.Measurements: Body weight in kilograms was the primary outcome measure. Other measurements included waist circumference, blood pressure and heart rate, fasting plasma glucose and lipids, and depressive symptoms.Results: Last-observation-carried-forward analysis of the available data for participants who had completed at least one post-randomisation assessment, demonstrated that the atomoxetine group (n=12) lost more body weight over the 12-week period than the placebo (n=14) group (mean (s.e.) -3.6 (1.0) kg (-3.7% loss) vs 0.1 (0.4) kg (0.2% gain); F-4,F-96 11.9; P < 0.0001). Three participants in the atomoxetine group and none in the placebo group lost >= 5% weight. Side effects were minimal.Conclusion: Atomoxetine demonstrated modest short-term weight loss efficacy relative to placebo in this preliminary study of obese women.