一项针对肥胖青少年的每周一次艾塞那肽治疗的为期6个月的随机、双盲、安慰剂对照试验。
A 6-month randomized, double-blind, placebo-controlled trial of weekly exenatide in adolescents with obesity.
作者信息
Weghuber D, Forslund A, Ahlström H, Alderborn A, Bergström K, Brunner S, Cadamuro J, Ciba I, Dahlbom M, Heu V, Hofmann J, Kristinsson H, Kullberg J, Ladinger A, Lagler F B, Lidström M, Manell H, Meirik M, Mörwald K, Roomp K, Schneider R, Vilén H, Widhalm K, Zsoldos F, Bergsten P
机构信息
Department of Paediatrics, Paracelsus Medical University, Salzburg, Austria.
Obesity Research Unit, Paracelsus Medical University, Salzburg, Austria.
出版信息
Pediatr Obes. 2020 Jul;15(7):e12624. doi: 10.1111/ijpo.12624. Epub 2020 Feb 16.
BACKGROUND
Pharmacological treatment options for adolescents with obesity are very limited. Glucagon-like-peptide-1 (GLP-1) receptor agonist could be a treatment option for adolescent obesity.
OBJECTIVE
To investigate the effect of exenatide extended release on body mass index (BMI)-SDS as primary outcome, and glucose metabolism, cardiometabolic risk factors, liver steatosis, and other BMI metrics as secondary outcomes, and its safety and tolerability in adolescents with obesity.
METHODS
Six-month, randomized, double-blinded, parallel, placebo-controlled clinical trial in patients (n = 44, 10-18 years, females n = 22) with BMI-SDS > 2.0 or age-adapted-BMI > 30 kg/m according to WHO were included. Patients received lifestyle intervention and were randomized to exenatide extended release 2 mg (n = 22) or placebo (n = 22) subcutaneous injections given once weekly. Oral glucose tolerance tests (OGTT) were conducted at the beginning and end of the intervention.
RESULTS
Exenatide reduced (P < .05) BMI-SDS (-0.09; -0.18, 0.00), % BMI 95th percentile (-2.9%; -5.4, -0.3), weight (-3 kg; -5.8, -0.1), waist circumference (-3.2 cm; -5.8, -0.7), subcutaneous adipose tissue (-552 cm ; -989, -114), 2-hour-glucose during OGTT (-15.3 mg/dL; -27.5, -3.1), total cholesterol (11.6 mg/dL; -21.7, -1.5), and BMI (-0.83 kg/m ; -1.68, 0.01) without significant change in liver fat content (-1.36; -3.12, 0.4; P = .06) in comparison to placebo. Safety and tolerability profiles were comparable to placebo with the exception of mild adverse events being more frequent in exenatide-treated patients.
CONCLUSIONS
Treatment of adolescents with severe obesity with extended-release exenatide is generally well tolerated and leads to a modest reduction in BMI metrics and improvement in glucose tolerance and cholesterol. The study indicates that the treatment provides additional beneficial effects beyond BMI reduction for the patient group.
背景
肥胖青少年的药物治疗选择非常有限。胰高血糖素样肽-1（GLP-1）受体激动剂可能是治疗青少年肥胖的一种选择。
目的
以体重指数（BMI）标准差积分（BMI-SDS）作为主要结局指标，以糖代谢、心脏代谢危险因素、肝脏脂肪变性及其他BMI指标作为次要结局指标，研究艾塞那肽缓释剂对肥胖青少年的疗效及其安全性和耐受性。
方法
对符合世界卫生组织标准、BMI-SDS＞2.0或年龄适应性BMI＞30kg/m²的44例患者（年龄10 - 18岁，女性22例）进行为期6个月的随机、双盲、平行、安慰剂对照临床试验。患者接受生活方式干预，并随机分为两组，分别皮下注射每周1次的2mg艾塞那肽缓释剂（n = 22）或安慰剂（n = 22）。在干预开始和结束时进行口服葡萄糖耐量试验（OGTT）。
结果
与安慰剂相比，艾塞那肽降低了（P＜0.05）BMI-SDS（-0.09；-0.18，0.00）、BMI第95百分位数（-2.9%；-5.4，-0.3）、体重（-3kg；-5.8，-0.1）、腰围（-3.2cm；-5.8，-0.7）、皮下脂肪组织（-552cm³；-989，-114）、OGTT期间2小时血糖（-15.3mg/dL；-27.5，-3.1）、总胆固醇（-11.6mg/dL；-21.7，-1.5）和BMI（-0.83kg/m²；-1.68，0.01），而肝脏脂肪含量无显著变化（-1.36；-3.12，0.4；P = 0.06）。除了接受艾塞那肽治疗的患者轻度不良事件更频繁外，其安全性和耐受性与安慰剂相当。
结论
用艾塞那肽缓释剂治疗重度肥胖青少年一般耐受性良好，可使BMI指标适度降低，葡萄糖耐量和胆固醇水平得到改善。该研究表明，对于该患者群体，该治疗除了降低BMI外还具有额外的有益作用。
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