Luis R. Patino, Jeffrey R. Strawn, Caleb M. Adler, Thomas J. Blom, Jeffrey A. Welge, Melissa P. DelBello
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引用次数: 0
Abstract
Objective
To assess the safety and efficacy of exenatide in overweight or obese patients treated with olanzapine.
Methods
Adults with stable major mood or psychotic disorders were randomized to double-blind exenatide or placebo for 16 weeks. Weight and body mass index (BMI) were monitored throughout the study. A secondary objective was to evaluate the tolerability of exenatide and its effects on mood and psychotic symptoms.
Results
A significant difference in weight change was detected between the treatment groups. Participants in the exenatide group experienced on average a minor weight loss, while participants in the placebo group on average experienced weight gain (−0.5 kg [−0.6 %] vs. +2.6 kg [+2.8 %], both p < .01). The most common side effects in the exenatide group were gastrointestinal symptoms and headaches. There were no clinically meaningful differences between the groups in changes to mood or psychotic symptoms.
Conclusions
Exenatide is effective and well-tolerated for attenuating olanzapine-associated weight gain.
Clinical trial registration information
Exenatide for the Treatment of Weight Gain Associated with Olanzapine in Obese Adults. NCT00845507
目的评价艾塞那肽在奥氮平治疗的超重或肥胖患者中的安全性和有效性。方法稳定的重性情绪障碍或精神障碍的成年人随机分为双盲组艾塞那肽组和安慰剂组,治疗16周。在整个研究过程中监测体重和身体质量指数(BMI)。次要目的是评估艾塞那肽的耐受性及其对情绪和精神病症状的影响。结果两组患者体重变化差异有统计学意义。艾塞那肽组的参与者平均有轻微的体重减轻,而安慰剂组的参与者平均体重增加(- 0.5 kg [- 0.6%] vs. +2.6 kg [+ 2.8%], p <;. 01)。艾塞那肽组最常见的副作用是胃肠道症状和头痛。两组之间在情绪或精神病症状的变化方面没有临床意义的差异。结论塞那肽对减轻奥氮平相关体重增加有效且耐受性良好。临床试验注册信息:艾塞那肽治疗肥胖成人与奥氮平相关的体重增加。NCT00845507
期刊介绍:
The Journal of Affective Disorders publishes papers concerned with affective disorders in the widest sense: depression, mania, mood spectrum, emotions and personality, anxiety and stress. It is interdisciplinary and aims to bring together different approaches for a diverse readership. Top quality papers will be accepted dealing with any aspect of affective disorders, including neuroimaging, cognitive neurosciences, genetics, molecular biology, experimental and clinical neurosciences, pharmacology, neuroimmunoendocrinology, intervention and treatment trials.