Olanzapine/samidorphan combination consistently mitigates weight gain across various subgroups of patients

奥氮平 体重增加 医学 体质指数 子群分析 重量变化 内科学 随机对照试验 双相情感障碍 多巴胺拮抗剂 精神分裂症(面向对象编程) 减肥 体重 精神科 氟哌啶醇 置信区间 肥胖 锂(药物) 多巴胺
作者
Jonathan M. Meyer,Adam Simmons,Ying Jiang,Christine Graham,Sergey Yagoda,David McDonnell
出处
期刊:CNS spectrums [Cambridge University Press]
卷期号:28 (4): 478-481 被引量:8
标识
DOI:10.1017/s1092852922000967
摘要

Abstract Objective A combination of olanzapine and the opioid receptor antagonist samidorphan (OLZ/SAM) has been approved in the United States for the treatment of adults with schizophrenia or adults with bipolar I disorder. In a phase 3 study in adults with schizophrenia (ENLIGHTEN-2), OLZ/SAM treatment was associated with significantly less weight gain compared with olanzapine. Prespecified subgroup analyses explored the consistency of the weight mitigation effect of OLZ/SAM vs olanzapine across demographic subgroups in ENLIGHTEN-2. Methods The multicenter, randomized, double-blind ENLIGHTEN-2 study (NCT02694328) included outpatients aged 18–55 years with a diagnosis of schizophrenia based on DSM-5 criteria, a body mass index (BMI) of 18 to 30 kg/m 2 , and stable body weight (self-reported change ≤5% for ≥3 months before study entry). Patients were randomized 1:1 to receive OLZ/SAM or olanzapine for 24 weeks. Co-primary endpoints (previously reported) were percent change in body weight and proportion of patients with at least 10% weight gain from baseline at week 24. Prespecified exploratory subgroup analyses by sex, age, self-reported race, and baseline BMI were conducted. Results At week 24, treatment with OLZ/SAM resulted in numerically less percent weight gain than with olanzapine across all subgroups evaluated. The proportion of patients with at least 10% weight gain was smaller in each subgroup treated with OLZ/SAM vs olanzapine. Conclusion In these exploratory subgroup analyses from the ENLIGHTEN-2 study, weight-mitigating effects of OLZ/SAM vs olanzapine were observed consistently across patient subgroups and were in line with results from the overall study population.
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