Li Ka Shing Knowledge Institute and Keenan Research Centre for Biomedical Science, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.
Annapurna Therapeutics, Philadelphia, PA, USA.
Diabetes Obes Metab. 2016 Sep;18(9):930-5. doi: 10.1111/dom.12679. Epub 2016 May 31.
Gastrointestinal (GI) adverse events (AEs) are the most frequently reported treatment-related AEs associated with glucagon-like peptide-1 receptor agonists (GLP-1RAs) in the treatment of type 2 diabetes mellitus. The GI safety of albiglutide, a once-weekly GLP-1RA, was assessed using data from five phase III studies. In a pooled analysis of four placebo-controlled trials, the most common GI AEs were diarrhoea (albiglutide, 14.5% vs. placebo, 11.5%) and nausea (albiglutide, 11.9% vs. placebo, 10.3%), with most patients experiencing 1-2 events. The majority were mild or moderate in intensity and their median duration was 3-4 days. Vomiting occurred in 4.9% of patients in the albiglutide vs. 2.6% in the placebo group. For both albiglutide and placebo, serious GI AEs (2.0% vs. 1.5%) and withdrawals attributable to GI AEs (1.7% vs. 1.5%) were low. In a 32-week trial of albiglutide 50 mg weekly versus liraglutide 1.8 mg daily, nausea occurred in 9.9% of patients in the albiglutide group vs. 29.2% in the liraglutide group. Vomiting occurred in 5.0% in the albiglutide vs. 9.3% in the liraglutide group. In conclusion, albiglutide has an acceptable GI tolerability profile, with nausea and vomiting rates slightly higher than those for placebo but lower than those for liraglutide.
胃肠道（GI）不良事件（AEs）是与 2 型糖尿病治疗中胰高血糖素样肽-1 受体激动剂（GLP-1RAs）相关的最常报告的治疗相关 AEs。使用来自五项 III 期研究的数据评估了每周一次的 GLP-1RA 阿必鲁肽的 GI 安全性。在四项安慰剂对照试验的汇总分析中，最常见的 GI AEs 是腹泻（阿必鲁肽，14.5%比安慰剂，11.5%）和恶心（阿必鲁肽，11.9%比安慰剂，10.3%），大多数患者经历 1-2 次事件。大多数为轻度或中度，中位持续时间为 3-4 天。呕吐发生在阿必鲁肽组的 4.9%的患者中，而安慰剂组为 2.6%。对于阿必鲁肽和安慰剂，严重的 GI AEs（2.0%比 1.5%）和因 GI AEs 而退出（1.7%比 1.5%）的发生率都较低。在一项为期 32 周的每周一次阿必鲁肽 50mg 与每日一次利拉鲁肽 1.8mg 的比较中，阿必鲁肽组的 9.9%患者发生恶心，而利拉鲁肽组为 29.2%。阿必鲁肽组的呕吐发生率为 5.0%，而利拉鲁肽组为 9.3%。总之，阿必鲁肽具有可接受的胃肠道耐受性，恶心和呕吐的发生率略高于安慰剂，但低于利拉鲁肽。
