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
Department of Paediatrics, Paracelsus Medical University, Salzburg, Austria.
Obesity Research Unit, Paracelsus Medical University, Salzburg, Austria.
Pediatr Obes. 2020 Jul;15(7):e12624. doi: 10.1111/ijpo.12624. Epub 2020 Feb 16.
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.
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.
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.
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.
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.
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。
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。
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）。
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。
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。
