Efficacy and Safety of Lisdexamfetamine for Treatment of Adults With Moderate to Severe Binge-Eating Disorder A Randomized Clinical Trial
Efficacy and Safety of Lisdexamfetamine for Treatment of Adults With Moderate to Severe Binge-Eating Disorder A Randomized Clinical Trial
复制标题
DOI：
10.1001/jamapsychiatry.2014.2162
复制
发表时间：
2015-03-01
期刊：
影响因子：
25.8
通讯作者：
Gasior, Maria
中科院分区：
文献类型：
--
作者：
McElroy, Susan L.;Hudson, James I.;Gasior, Maria
重要性暴饮暴食症（BED）是一种与精神病理学症状和肥胖相关的公共卫生问题，可能与代谢综合征相关，缺乏批准的药物治疗。目的：研究利右苯丙胺二甲磺酸盐（一种苯丙胺前药）治疗中度至重度BED.DESIGN，SETTING，AND PARTICIPANTS的有效性和安全性。2011年5月10日至2012年1月30日在30个研究中心进行的安慰剂对照临床试验。安全性和意向性治疗分析包括259和255成人BED.INTERVENTIONS二甲磺酸利右苯丙胺的剂量为30，50，或70毫克/天或安慰剂提供给研究参与者（1：1：1：1）。在3周内滴定剂量并维持8周。我们在最后一次给药后平均（SD）7（2）天随访参与者。主要结果和测量我们使用转换的log（每周的暴饮暴食（BE）天数）+1的混合效应模型评估了以每周天数（基线至第11周）测量的暴饮暴食（BE）行为的变化。次要措施包括BE停止4周。安全性评估包括治疗后出现的不良事件、生命体征和体重变化。结果在第11周，50 mg/d组（最小二乘[LS]均值[SE]变化，-1.49 [0.066]; P = 0.008）和70 mg/d组（LS均值[SE]变化，-1.57 [0.067]; P = 0.008）每周对数转换的BE天数减少。
IMPORTANCE Binge-eating disorder (BED), a public health problem associated with psychopathological symptoms and obesity and possibly with metabolic syndrome, lacks approved pharmacotherapies.OBJECTIVE To examine the efficacy and safety of lisdexamfetamine dimesylate, a dextroamphetamine prodrug, to treat moderate to severe BED.DESIGN, SETTING, AND PARTICIPANTS We performed a randomized, double-blind, parallel-group, forced dose titration, placebo-controlled clinical trial at 30 sites from May 10, 2011, through January 30, 2012. Safety and intention-to-treat analyses included 259 and 255 adults with BED, respectively.INTERVENTIONS Lisdexamfetamine dimesylate at dosages of 30, 50, or 70mg/d or placebo were provided to study participants (1: 1: 1: 1). Dosages were titrated across 3weeks and maintained for 8 weeks. We followed up participants for a mean (SD) of 7 (2) days after the last dose.MAIN OUTCOMES AND MEASURES We assessed the change in binge-eating (BE) behaviors measured as days perweek (baseline to week 11) with a mixed-effects model using transformed log (BE days perweek) + 1. Secondary measures included BE cessation for 4 weeks. Safety assessments included treatment-emergent adverse events, vital signs, and change in weight.RESULTS At week 11, log-transformed BE days perweek decreased with the 50-mg/d (least squares [LS] mean [SE] change, -1.49 [0.066]; P =.008) and 70-mg/d (LS mean [SE] change, -1.57 [0.067]; P