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Metabolic measures 12 months after a randomised controlled trial of treatment of clozapine associated obesity and diabetes with exenatide (CODEX).
Journal of Psychiatric Research ( IF 4.8 ) Pub Date : 2020-02-18 , DOI: 10.1016/j.jpsychires.2020.02.015
Dan Siskind 1 , A Russell 2 , C Gamble 3 , A Baker 4 , P Cosgrove 4 , L Burton 4 , S Kisely 1
Affiliation  

Clozapine is associated with obesity and type 2 diabetes. Glucagon-like-peptide-1 (GLP-1) receptor agonists such as exenatide can counter clozapine-associated GLP-1 dysregulation. Our 24-week randomized, controlled, open-label, pilot trial of once-weekly extended-release subcutaneous exenatide or usual care (CODEX) (n = 28), found exenatide was associated with significantly greater weight loss. We examined whether this effect was maintained at 12-months post-intervention. We followed up CODEX trial participants at 12-months post trial endpoint, collecting information on weight, BMI, waist circumference, blood pressure, fasting glucose, HbA1c, and use of metformin. The primary outcome of interest was change in weight from trial baseline to 12-months post endpoint and trial endpoint to 12-months post endpoint compared between former exenatide and usual care participants. Only HbA1c differed between baseline and 12-months post endpoint between the exenatide and control groups. From endpoint to 12-month follow up there were significantly greater increases among the former exenatide versus former usual care participants for weight, BMI, HbA1c and proportion with >5% weight gain. Stratifying results by whether participants used metformin post trial did not alter proportion with >5% weight gain. Although there were no significant differences in weight and BMI between baseline and 12-month post endpoint, there were significant increases in weight and BMI in the 12 months post endpoint for the former exenatide group. This was irrespective of metformin use and is in keeping with studies of other GLP-1RA agents. Further studies on GLP-1RAs use beyond 24 weeks for people with clozapine associated weight gain are needed.

中文翻译:

用艾塞那肽(CODEX)治疗氯氮平相关性肥胖和糖尿病的随机对照试验后12个月进行了代谢测量。

氯氮平与肥胖症和2型糖尿病有关。胰高血糖素样肽1(GLP-1)受体激动剂(如艾塞那肽)可以抵抗氯氮平相关的GLP-1失调。我们对每周一次的缓释皮下艾塞那肽或常规护理(CODEX)(n = 28)进行的为期24周的随机,对照,开放标签的试验性研究发现,艾塞那肽与体重减轻明显相关。我们检查了干预后12个月是否能维持这种效果。我们在试验终点后的12个月对CODEX试验参与者进行了随访,收集了有关体重,BMI,腰围,血压,空腹血糖,HbA1c和二甲双胍使用情况的信息。感兴趣的主要结果是前艾塞那肽和常规护理参与者之间的体重变化,从试验基线至终点后12个月,从试验终点至终点后12个月。在艾塞那肽和对照组之间,基线之间和终点后12个月之间只有HbA1c有所不同。从终点到12个月随访,体重,BMI,HbA1c和体重增加> 5%的人群中,前艾塞那肽组与以前的常规护理组受试者相比,显着增加。通过参与者是否在试验后使用二甲双胍来分层结果,体重增加> 5%不会改变比例。尽管基线和终点后12个月之间的体重和BMI没有显着差异,前艾塞那肽组终点后12个月体重和BMI显着增加。这与二甲双胍的使用无关,并且与其他GLP-1RA药物的研究一致。需要对氯氮平相关体重增加的人使用GLP-1RA超过24周的进一步研究。
更新日期:2020-02-20
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