Halseth A, Shan K, Gilder K, Malone M, Acevedo L, Fujioka K
Orexigen Therapeutics, Inc.La Jolla CA USA.
Scripps Clinic La Jolla CA USA.
Obes Sci Pract. 2018 Feb 23;4(2):141-152. doi: 10.1002/osp4.156. eCollection 2018 Apr.
This multicenter, randomized, controlled, open-label trial examined weight-related quality of life, control over eating behaviour and sexual function after 26 weeks of treatment with either 32 mg naltrexone sustained release (SR)/360 mg bupropion SR plus a comprehensive lifestyle intervention program (NB + CLI, N = 153) or usual care (UC, N = 89), which included minimal lifestyle intervention.
Impact of Weight on Quality of Life-Lite, Binge Eating Scale and Arizona Sexual Experiences Scale were assessed at baseline (BL) and weeks 16 and 26.
NB + CLI and UC participants lost 9.46 and 0.94% respectively of initial body weight at week 26 (P < 0.0001). NB + CLI participants had greater improvements in Impact of Weight on Quality of Life-Lite total score than UC participants (P < 0.0001). In participants with moderate/severe Binge Eating Scale scores at BL, 91% of NB + CLI and 18% of UC participants experienced categorical improvements. In participants with Arizona Sexual Experiences Scale-defined sexual dysfunction at BL, 58% of NB + CLI and 19% of UC participants no longer met dysfunction criteria at week 26. The most frequent adverse events leading to discontinuation before week 26 in NB + CLI included nausea (10.5%); anxiety (3.3%); and headache, hypertension, insomnia and palpitations (1.3% each).
Compared with UC, participants treated with NB + CLI experienced greater improvements in weight-related quality of life, control over eating behaviour, and sexual function.
本多中心、随机、对照、开放标签试验研究了32毫克纳曲酮缓释剂(SR)/360毫克安非他酮SR联合综合生活方式干预计划(NB+CLI,N=153)或常规护理(UC,N=89,包括最少的生活方式干预)治疗26周后与体重相关的生活质量、饮食行为控制和性功能。
在基线(BL)、第16周和第26周评估体重对生活质量的影响-简易版、暴饮暴食量表和亚利桑那性体验量表。
在第26周时,NB+CLI组和UC组参与者分别减轻了初始体重的9.46%和0.94%(P<0.0001)。NB+CLI组参与者在体重对生活质量影响-简易版总分上的改善比UC组参与者更大(P<0.0001)。在基线时暴饮暴食量表得分中等/严重的参与者中,91%的NB+CLI组参与者和18%的UC组参与者有分类改善。在基线时具有亚利桑那性体验量表定义的性功能障碍的参与者中,58%的NB+CLI组参与者和19%的UC组参与者在第26周时不再符合功能障碍标准。NB+CLI组在第26周前导致停药的最常见不良事件包括恶心(10.5%);焦虑(3.3%);以及头痛、高血压、失眠和心悸(各1.3%)。
与UC相比,接受NB+CLI治疗的参与者在与体重相关的生活质量、饮食行为控制和性功能方面有更大改善。