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.

译文

背景:一项为期12个月的开放标签扩展研究评估了成人暴食症(BED)的患者使用赖氨苯丙胺二甲酸酯(LDX)的长期安全性和耐受性。
方法:完成了三项前期研究之一的BED成人(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,为期4周[初始滴定剂量,30 mg LDX;目标剂量] ,50或70毫克LDX];维持剂量48周。安全性评估包括紧急治疗不良事件(TEAE)的发生,生命体征和体重评估以及哥伦比亚-自杀严重性等级量表的反应。
结果:在604名参与者中,有599名(521名女性和78名男性)进行了安全性分析,其中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暴露持续时间为12个月或更长时间。共有506位参与者(84.5%)报告了TEAE(导致治疗中断的TEAE,占54 [9.0%];严重的TEAE,占42 [7.0%];严重的TEAE,占17 [2.8%])。大于或等于10%的参与者报告的治疗紧急不良事件为口干(27.2%),头痛(13.2%),失眠(12.4%)和上呼吸道感染(11.4%)。在第52周/早期终止时(n = 597),收缩压和舒张压,脉搏和体重的平均(SD)变化为2.19(11.043)和1.77(7.848)mm Hg,每变化6.58(10.572)次分钟和-7.04(7.534)公斤。在《哥伦比亚自杀严重性等级量表》中,对任何积极的自杀观念有2个积极的回应。没有任何关于自杀行为或完全自杀的积极反应。
结论:在这项为期12个月的开放标签扩展研究中,LDX在BED成人中的长期安全性和耐受性通常与其针对注意力缺陷/多动障碍的既定特征相一致。

+1
+2
100研值 100研值 ¥99课程
检索文献一次
下载文献一次

去下载>

成功解锁2个技能,为你点赞

《SCI写作十大必备语法》
解决你的SCI语法难题!

技能熟练度+1

视频课《玩转文献检索》
让你成为检索达人!

恭喜完成新手挑战

手机微信扫一扫,添加好友领取

免费领《Endnote文献管理工具+教程》

微信扫码, 免费领取

手机登录

获取验证码
登录