托吡酯用于肥胖相关暴食症的长期治疗

Topiramate in the long-term treatment of binge-eating disorder associated with obesity.

作者信息

McElroy Susan L, Shapira Nathan A, Arnold Lesley M, Keck Paul E, Rosenthal Norman R, Wu Shu-Chen, Capece Julie A, Fazzio Lydia, Hudson James I

机构信息

Psychopharmacology Research Program, Department of Psychiatry, University of Cincinnati College of Medicine, Cincinnati, Ohio 45267-0559, USA.

出版信息

J Clin Psychiatry. 2004 Nov;65(11):1463-9. doi: 10.4088/jcp.v65n1104.

DOI:10.4088/jcp.v65n1104

PMID:15554757

Abstract

BACKGROUND

This study assessed the long-term effectiveness and tolerability of topiramate in binge-eating disorder (BED) with obesity.

METHOD

Sixty-one patients with BED (DSM-IV-TR criteria) and obesity enrolled in a 14-week, single-center, randomized, double-blind, placebo-controlled study. Completers (N = 35) were offered participation in a 42-week, open-label extension trial of topiramate. Fifteen patients who received topiramate and 16 patients who received placebo in the double-blind study entered the open-label trial. Topiramate was titrated from 25 mg/day to a maximum of 600 mg/day. The primary endpoint was change from baseline to final visit in weekly binge frequency using the last observation carried forward for all patients who received topiramate. Baseline for patients receiving double-blind topiramate was the beginning of the controlled study; for patients receiving placebo, baseline was the beginning of the open-label trial. Open-label data were gathered from December 1998 to November 2000.

RESULTS

Forty-four patients (31 who received topiramate in the open-label trial plus 13 who received topiramate in the double-blind study only) received at least 1 dose of topiramate; 43 patients provided outcome measures at a median final dose of 250 mg/day. Mean weekly binge frequency declined significantly from baseline to final visit for all 43 patients (-3.2; p < .001), for the 15 patients who received topiramate during the controlled and open-label studies (-4.0; p < .001), and for the 15 patients who received topiramate only during the open-label trial (-2.5; p = .044). Patients also exhibited statistically significant reduction in body weight. The most common reasons for topiramate discontinuation were protocol nonadherence (N = 17) and adverse events (N = 14).

CONCLUSION

Topiramate treatment was associated with enduring improvement in some patients with BED and obesity but was also associated with a high discontinuation rate.

摘要

背景

本研究评估了托吡酯对伴有肥胖症的暴食症（BED）的长期疗效及耐受性。

方法

61例符合《精神疾病诊断与统计手册》第四版修订版（DSM-IV-TR）标准的BED肥胖患者参与了一项为期14周的单中心随机双盲安慰剂对照研究。完成者（N = 35）受邀参与一项为期42周的托吡酯开放标签扩展试验。双盲研究中15例接受托吡酯治疗的患者和16例接受安慰剂治疗的患者进入开放标签试验。托吡酯剂量从25毫克/天滴定至最大600毫克/天。主要终点是使用所有接受托吡酯治疗患者的末次观察值向前递推法得出的从基线到末次访视时每周暴食频率的变化。接受双盲托吡酯治疗患者的基线为对照研究开始时；接受安慰剂治疗患者的基线为开放标签试验开始时。开放标签数据收集时间为1998年12月至2000年11月。

结果

44例患者（31例在开放标签试验中接受托吡酯治疗，13例仅在双盲研究中接受托吡酯治疗）接受了至少1剂托吡酯；43例患者在平均最终剂量为250毫克/天时提供了结局指标。43例患者从基线到末次访视时每周平均暴食频率均显著下降（-3.2；p < .001），15例在对照研究和开放标签研究中接受托吡酯治疗的患者（-4.0；p < .001），以及15例仅在开放标签试验中接受托吡酯治疗的患者（-2.5；p = .044）。患者体重也出现了具有统计学意义的下降。托吡酯停药的最常见原因是未遵守方案（N = 17）和不良事件（N = 14）。