Gasior Maria, Hudson James, Quintero Javier, Ferreira-Cornwell M Celeste, Radewonuk Jana, McElroy Susan L
*Formerly of Shire, Lexington, MA; †McLean Hospital/Harvard Medical School, Belmont, MA; ‡Hospital Universitario Infanta Leonor, Madrid, Spain; §Lindner Center of HOPE, Mason; and ∥University of Cincinnati College of Medicine, Cincinnati, OH.
J Clin Psychopharmacol. 2017 Jun;37(3):315-322. doi: 10.1097/JCP.0000000000000702.
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).
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.
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.
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.
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苯丙胺（LDX）在患有暴饮暴食症（BED）的成年人中的长期安全性和耐受性。
完成了3项前期研究之一的患有BED的成年人（年龄18 - 55岁）参加了一项为期52周的开放标签扩展研究（剂量优化，4周[初始滴定剂量，30毫克LDX；目标剂量，50或70毫克LDX]；剂量维持，48周）。安全性评估包括治疗中出现的不良事件（TEAE）的发生情况、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。
在604名入组参与者中，599名（521名女性和78名男性）构成安全性分析集，369名完成了研究。LDX的平均（标准差）暴露时间为284.3（118.84）天；344名参与者（57.4%）的LDX累积暴露持续时间为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%]；严重不良事件，17例[2.8%]）。报告的发生率大于或等于10%的治疗中出现的不良事件为口干（27.2%）、头痛（13.2%）、失眠（12.4%）和上呼吸道感染（11.4%）。在第52周/提前终止时（n = 597），与前期研究基线相比，收缩压和舒张压、脉搏及体重的平均（标准差）变化分别为2.19（11.043）和1.77（7.848）毫米汞柱、每分钟6.58（10.572）次心跳以及 - 7.04（7.534）千克。在哥伦比亚自杀严重程度评定量表上，有2例对任何主动自杀意念呈阳性反应；对自杀行为或自杀完成无阳性反应。
在这项为期12个月的开放标签扩展研究中，LDX在患有BED的成年人中的长期安全性和耐受性总体上与其在注意力缺陷/多动障碍中的既定情况一致。
