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首页> 外文期刊>The journal of clinical psychiatry >Topiramate in the Long-Term Treatment of Binge-Eating Disorder Associated With Obesity.
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Topiramate in the Long-Term Treatment of Binge-Eating Disorder Associated With Obesity.

机译：托吡酯在肥胖相关的暴食症长期治疗中的应用。

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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.
机译：背景：本研究评估了托吡酯在肥胖症的暴食症（BED）中的长期疗效和耐受性。方法：61名患有BED（DSM-IV-TR标准）且肥胖的患者参加了一项为期14周，单中心，随机，双盲，安慰剂对照的研究。为完成者（N = 35）提供了一项为期42周的托吡酯开放标签扩展试验的参与。在双盲研究中，有15名接受托吡酯的患者和16名接受安慰剂的患者进入了开放标签试验。托吡酯的滴定度从25毫克/天增加到最大600毫克/天。主要终点是使用所有接受托吡酯治疗的患者进行的最后观察从每周暴饮次数从基线到最终访视的变化。接受双盲托吡酯治疗的患者的基线是对照研究的开始。对于接受安慰剂的患者，基线是开放标签试验的开始。从1998年12月至2000年11月收集开放标签数据。结果：44例患者（其中31例在开放标签试验中接受托吡酯加13例仅在双盲研究中接受托吡酯）接受了至少1剂托吡酯; 43位患者以250 mg /天的中位最终剂量提供了结局指标。从基线到最终访视的所有43名患者的平均每周暴饮暴食次数均显着下降（-3.2; p <.001），在对照和开放标签研究期间接受托吡酯的15名患者（-4.0; p <.001），对于仅在开放标签试验中接受托吡酯的15名患者（-2.5; p = .044）。患者还显示出体重的统计学显着降低。托吡酯停用的最常见原因是治疗方案不依从（N = 17）和不良事件（N = 14）。结论：托吡酯治疗与一些BED和肥胖患者的持久改善有关，但也与较高的停药率有关。

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