Ahrén Bo, Carr Molly C, Murphy Karen, Perkins Christopher, Rendell Marc, Mallory Jason, Wilson Timothy, Johnson Susan
Department of Clinical Services Division of Medicine, Lund University, Lund, Sweden.
Pharma Research & Development, GlaxoSmithKline, Collegeville, PA, USA.
Diabetes Res Clin Pract. 2017 Apr;126:230-239. doi: 10.1016/j.diabres.2017.02.017. Epub 2017 Feb 20.
Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) stimulate the incretin system and lower glycaemic parameters in type 2 diabetes mellitus (T2DM). This analysis of clinical studies of up to 3years evaluated the safety of albiglutide, a GLP-1 RA, in people with T2DM.
Integrated safety analysis included seven phase-3 T2DM studies of albiglutide compared with placebo and/or active comparators (a dipeptidyl peptidase-4 inhibitor, GLP-1 RA, insulin, sulphonylurea, and thiazolidinedione).
Studies of 32months (HARMONY 7), 1year (HARMONY 6), and 3years (HARMONY 1-5), reported similar rates of adverse events (AEs) (84.8%, 82.3%), and serious AEs (13.1%, 12.9%) between albiglutide and all comparators, respectively. AEs that did not differ between the groups included symptomatic or severe hypoglycaemia as well as nausea (12.0%, 11.3%) and vomiting (5.3%, 4.7%) for albiglutide and all comparators, respectively. According to the Medical Dictionary for Regulatory Activities preferred terms, only diarrhoea (13.7%, 9.9%), injection-site reaction (9.0%, 2.0%), and peripheral oedema (4.5%, 6.8%) had at least 2% difference between the albiglutide and all-comparator groups. In a similar integrated analysis, pancreatitis occurred more often with albiglutide (0.3%, 0.1%). Renal and cardiac function did not differ between the two groups.
In an integrated analysis of seven phase 3 clinical trials, albiglutide-treated patients experienced frequencies of AEs (including cardiovascular and renal) similar to the all-comparators group treated with other T2DM medications or placebo. Albiglutide treatment was associated with higher rates of diarrhoea and injection-site reactions, but not increased nausea and vomiting, versus all comparators.
胰高血糖素样肽-1受体激动剂（GLP-1 RAs）可刺激肠促胰岛素系统并降低2型糖尿病（T2DM）患者的血糖参数。这项长达3年的临床研究分析评估了GLP-1 RA类药物阿必鲁泰在T2DM患者中的安全性。
综合安全性分析纳入了7项阿必鲁泰的3期T2DM研究，将其与安慰剂和/或活性对照药（二肽基肽酶-4抑制剂、GLP-1 RA、胰岛素、磺脲类药物和噻唑烷二酮类药物）进行比较。
为期32个月（HARMONY 7）、1年（HARMONY 6）和3年（HARMONY 1-5）的研究分别报告，阿必鲁泰组与所有对照药组之间的不良事件（AE）发生率（84.8%，82.3%）和严重AE发生率（13.1%，12.9%）相似。两组间无差异的AE包括有症状的或严重低血糖，以及阿必鲁泰组与所有对照药组分别出现的恶心（12.0%，11.3%）和呕吐（5.3%，4.7%）。根据《监管活动医学词典》的首选术语，只有腹泻（13.7%，9.9%）、注射部位反应（9.0%，2.0%）和外周水肿（4.5%，6.8%）在阿必鲁泰组与所有对照药组之间至少有2%的差异。在一项类似的综合分析中，阿必鲁泰组胰腺炎的发生率更高（0.3%，0.1%）。两组间肾功能和心功能无差异。
在7项3期临床试验的综合分析中，接受阿必鲁泰治疗的患者发生AE（包括心血管和肾脏相关AE）的频率与接受其他T2DM药物或安慰剂治疗的所有对照药组相似。与所有对照药相比，阿必鲁泰治疗与更高的腹泻和注射部位反应发生率相关，但恶心和呕吐并未增加。
