■延长释放(ER)纳曲酮/安非他酮(NB)在四个随机组中与安慰剂相比,体重减轻更大,56周的审判。NB与长期维持体重减轻的关系仍然未知。
■我们对四个第三阶段进行了事后分析,随机化,双盲,安慰剂对照,56周的研究(COR-I,COR-II,COR-BMOD,和COR-DM),安慰剂对照心血管结局试验LIGHT(208周),和随机的,开放标签试验点燃(78周)。纳入的受试者用NB32mg/360mg或安慰剂治疗,与基线,第16周和最终时间点数据。主要结果是Kaplan-Meier估计的每个研究的体重减轻维持长达204周。
■我们的分析包括来自10,198个参与者的数据(NB=5412;安慰剂=4786)。与NB相比,体重下降≥5%或≥10%的患者比例在数值上较高。安慰剂在所有研究和时间点。在第52周和第56周,在COR-BMOD和COR-I/-II中,在第52周和第104周和第208周的LIGHT研究中,≥5%的体重减轻维持差异具有统计学意义。对于≥10%的减肥保养,在第52周和第56周,COR-I/COR-II差异有统计学意义.
■这些数据表明,NB可以作为长期,全面的减肥和减肥维护策略。
■OrexigenTherapeutics,公司和加拿大BauschHealth。
UNASSIGNED: Extended-release (ER) naltrexone/bupropion (NB) was associated with greater weight loss than placebo in four randomized, 56-week trials. The association of NB with longer-term maintenance of weight loss remains unknown.
UNASSIGNED: We conducted a post-hoc analysis of four phase III, randomized, double-blind, placebo-controlled, 56-week studies (COR-I, COR-II, COR-BMOD, and COR-DM), the placebo-controlled cardiovascular outcomes trial LIGHT (208 weeks), and the randomized, open-label trial IGNITE (78 weeks). Included subjects were treated with NB 32 mg/360 mg or placebo, with baseline, week 16, and final time point data. The primary outcome was Kaplan-Meier-estimated weight loss maintenance in each study for up to 204 weeks.
UNASSIGNED: Our analysis included data from 10,198 particpants (NB=5412; placebo=4786). Proportions of patients with ≥5% or ≥10% weight loss maintenance were numerically higher for NB vs. placebo in all studies and time points. Differences were statistically significant for ≥5% weight loss maintenance in COR-BMOD and COR-I/-II at weeks 52 and 56 and the LIGHT study at weeks 52, 104, and 208. For ≥10% weight loss maintenance, differences were statistically significant in COR-I/COR-II at weeks 52 and 56.
UNASSIGNED: These data suggest that NB could be used as part of long-term, comprehensive weight loss and weight loss maintenance strategies.
UNASSIGNED: Orexigen Therapeutics, Inc. and Bausch Health Canada.