A Phase 3, Multicenter, Open-Label, 12-Month Extension Safety and Tolerability Trial of Lisdexamfetamine Dimesylate in Adults With Binge Eating Disorder
A Phase 3, Multicenter, Open-Label, 12-Month Extension Safety and Tolerability Trial of Lisdexamfetamine Dimesylate in Adults With Binge Eating Disorder
复制标题
DOI：
10.1097/jcp.0000000000000702
复制
发表时间：
2017-06-01
影响因子：
2.9
通讯作者：
McElroy, Susan L.
中科院分区：
文献类型：
--
作者：
Gasior, Maria;Hudson, James;McElroy, Susan L.
背景：一项为期 12 个月的开放标签扩展研究评估了二甲磺酸赖右安非他明 (LDX) 对暴食症 (BED) 成人的长期安全性和耐受性。方法：已完成 3 项先前研究中的 1 项的 BED 成人（18-55 岁）被纳入一项为期 52 周的开放标签扩展研究（剂量优化，4 周[初始滴定剂量， 30 mg LDX；目标剂量，50 或 70 mg LDX]；维持剂量，48 周）。安全性评估包括治疗引起的不良事件 (TEAE) 的发生、生命体征和体重评估以及哥伦比亚自杀严重程度评定量表反应。 结果：在 604 名入组参与者中，599 名（521 名女性和 78 名男性）包含安全性分析组，369 名完成了研究。平均 (SD) LDX 暴露时间为 284.3 (118.84) 天； 344 名参与者 (57.4%) 的累积 LDX 暴露时间为 12 个月或更长。共有 506 名参与者 (84.5%) 报告了 TEAE（导致治疗中断的 TEAE，54 例 [9.0%]；严重 TEAE，42 例 [7.0%]；严重 TEAE，17 例 [2.8%]）。大于或等于 10% 的参与者报告的治疗引起的不良事件包括口干（27.2%）、头痛（13.2%）、失眠（12.4%）和上呼吸道感染（11.4%）。第 52 周/提前终止 (n = 597) 时收缩压和舒张压、脉搏和体重相对于先前研究基线的平均 (SD) 变化分别为 2.19 (11.043) 和 1.77 (7.848) mm Hg、每分钟 6.58 (10.572) 次心跳和 -7.04 (7.534) kg。在哥伦比亚自杀严重程度评定量表上，对于任何主动的自杀意念都有 2 项积极反应；结论：在这项为期 12 个月的开放标签扩展研究中，LDX 对 BED 成人的长期安全性和耐受性总体上与其针对注意力缺陷/多动障碍的既定特征一致。
Background: A 12-month, open-label extension study assessed the long-term safety and tolerability of lisdexamfetamine dimesylate (LDX) in adults with binge eating disorder (BED).Methods: Adults (aged 18-55 y) with BED who completed 1 of 3 antecedent studies were enrolled in a 52-week, open-label extension study (dose optimization, 4 weeks [initial titration dose, 30-mg LDX; target doses, 50-or 70-mg LDX]; dose maintenance, 48 weeks). Safety evaluations included the occurrence of treatment-emergent adverse events (TEAEs), vital sign and weight assessments, and Columbia-Suicide Severity Rating Scale responses.Results: Of the 604 enrolled participants, 599 (521 women and 78 men) comprised the safety analysis set, and 369 completed the study. Mean (SD) LDX exposure was 284.3 (118.84) days; cumulative LDX exposure duration was 12 months or longer in 344 participants (57.4%). A total of 506 participants (84.5%) reported TEAEs (TEAEs leading to treatment discontinuation, 54 [9.0%]; severe TEAEs, 42 [7.0%]; serious TEAEs, 17 [2.8%]). Treatment-emergent adverse events reported in greater than or equal to 10% of participants were dry mouth (27.2%), headache (13.2%), insomnia (12.4%), and upper respiratory tract infection (11.4%). Mean (SD) changes from antecedent study baseline in systolic and diastolic blood pressure, pulse, and weight at week 52/early termination (n = 597) were 2.19 (11.043) and 1.77 (7.848) mm Hg, 6.58 (10.572) beats per minute, and -7.04 (7.534) kg, respectively. On the Columbia-Suicide Severity Rating Scale, there were 2 positive responses for any active suicidal ideations; there were no positive responses for suicidal behavior or completed suicides.Conclusions: In this 12-month, open-label, extension study, the long-term safety and tolerability of LDX in adults with BED were generally consistent with its established profile for attention-deficit/hyperactivity disorder.