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艾塞那肽在等待减肥手术的糖尿病患者中的临床疗效。

Clinical effectiveness of exenatide in diabetic patients waiting for bariatric surgery.

作者信息

Iglesias P, Civantos S, Vega B, Pavón I, Guijarro G, Monereo S

机构信息

Department of Endocrinology, Hospital Rey Juan Carlos, Madrid, Spain,

出版信息

Obes Surg. 2015 Mar;25(3):575-8. doi: 10.1007/s11695-014-1563-9.

Abstract

BACKGROUND

Bariatric surgery constitutes the most effective treatment for severely obese type 2 diabetic patients. Exenatide is a glucagon-like peptide 1 receptor agonist that can improve glycemic control and cause weight loss in patients with type 2 diabetes. Clinical experience with exenatide in obese patients with type 2 diabetes waiting for bariatric surgery has not been reported. The aim of the study was to evaluate, in clinical practice, weight and metabolic effects of exenatide (after 3 and 6 months) in patients with type 2 diabetes and obesity waiting for bariatric surgery.

METHODS

A total of 100 diabetic adult subjects with a BMI ≥ 35 kg/m(2) were included. Primary endpoints were changes in weight and HbA1c after 6 months of treatment. Secondary endpoints were changes from baseline of a variety of clinical measures (triglycerides levels, blood pressure, and waist circumference). Data were analyzed at 3 and 6 months of follow-up.

RESULTS

Treatment for 6 months with exenatide decreased significantly body weight (-12.5 kg) and waist circumference (-13 cm). Twenty percent of patients reduced their BMI under 35 kg/m(2) and significantly improved their metabolic profile (HbA1c <7 %). Significant and maintained decreases in HbA1c of 1 % were observed in the 3 and 6 months cohorts. Triglycerides levels and blood pressure also decreased from baseline to the end of the study. Treatment was discontinued in 19 % of patients mainly due to drug inefficacy (6 %) or adverse events (4 %).

CONCLUSIONS

Exenatide twice daily (BID) leads to early, robust, and significant weight loss in a subset of patients with diabetes and severe obesity before bariatric surgery. Clinical trials are needed to confirm the benefits of GLP-1 agonists in type 2 diabetic obese patients or high-risk super-obese patients waiting for bariatric surgery.

摘要

背景

减肥手术是重度肥胖2型糖尿病患者最有效的治疗方法。艾塞那肽是一种胰高血糖素样肽1受体激动剂,可改善2型糖尿病患者的血糖控制并导致体重减轻。尚未有关于艾塞那肽在等待减肥手术的肥胖2型糖尿病患者中的临床经验报道。本研究的目的是在临床实践中评估艾塞那肽(3个月和6个月后)对等待减肥手术的2型糖尿病和肥胖患者体重及代谢的影响。

方法

共纳入100名BMI≥35kg/m²的成年糖尿病患者。主要终点是治疗6个月后的体重和糖化血红蛋白(HbA1c)变化。次要终点是各种临床指标(甘油三酯水平、血压和腰围)相对于基线的变化。在随访的3个月和6个月时对数据进行分析。

结果

使用艾塞那肽治疗6个月后,体重显著下降(-12.5kg),腰围减小(-13cm)。20%的患者BMI降至35kg/m²以下,代谢状况显著改善(HbA1c<7%)。在3个月和6个月的队列中均观察到HbA1c显著且持续下降1%。甘油三酯水平和血压从基线到研究结束也有所下降。19%的患者停止治疗,主要原因是药物无效(6%)或不良事件(4%)。

结论

每日两次(BID)使用艾塞那肽可使一部分等待减肥手术的糖尿病和严重肥胖患者早期实现显著且可观的体重减轻。需要进行临床试验来证实胰高血糖素样肽-1(GLP-1)激动剂对等待减肥手术的2型糖尿病肥胖患者或高危超级肥胖患者的益处。

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