Medical Research and Development, Amylin Pharmaceuticals, Inc., San Diego, CA, USA.
Diabetes Obes Metab. 2012 May;14(5):387-98. doi: 10.1111/j.1463-1326.2011.01533.x. Epub 2011 Dec 27.
The objective of this systematic review was to assess the published literature on the effectiveness of exenatide twice daily (exenatide) in clinical practice, specifically its effects on haemoglobin A1c (A1C), fasting glucose (FG), weight, systolic blood pressure (SBP), medication use, hospitalization and cardiovascular disease (CVD) outcomes. A systematic literature search using the MEDLINE database of English language literature published between January 2005 and May 2011 was performed. The review included retrospective or prospective observational studies that included 100 or more patients per treatment group. A total of 15 studies meeting the inclusion criteria were identified. The studies revealed significant reductions of -0.4 to -0.9% in A1C, -10 mg/dl in FG, -2 to -11 kg in body weight and -2 to -11 mmHg in SBP. Statistically significant reductions in the use or dosage of either oral glucose-lowering medications or insulin after initiating exenatide treatment were found in every observational study that assessed medication changes, including reductions in dosage of up to 75% in sulphonylureas dosages, 22% in metformin, 66% in thiazolidinediones (TZD) or TZD combination therapy and 75% in prandial insulin. Exenatide-treated patients experienced significantly lower rates of all-cause and CVD-related hospitalization and CVD events than patients treated with other therapies overall. In this review of observational studies, exenatide initiation was associated with significant reductions in clinically relevant outcomes. Improvements in A1C, FG, weight and SBP in the observational studies in this review were consistent with improvements observed in controlled clinical trials.
本系统评价的目的是评估已发表的关于每日两次给予艾塞那肽(exenatide)的临床实践效果的文献,具体为其对糖化血红蛋白(HbA1c)、空腹血糖(FBG)、体重、收缩压(SBP)、药物使用、住院和心血管疾病(CVD)结局的影响。检索了 MEDLINE 数据库中 2005 年 1 月至 2011 年 5 月间发表的英文文献,进行了系统文献检索。本评价纳入了每个治疗组包含 100 例以上患者的回顾性或前瞻性观察性研究。共确定了 15 项符合纳入标准的研究。这些研究显示,HbA1c 降低了 -0.4 至 -0.9%,FBG 降低了 10mg/dl,体重降低了 -2 至 -11kg,SBP 降低了 -2 至 -11mmHg。所有评估药物变化的观察性研究都发现,起始应用艾塞那肽后,口服降糖药物或胰岛素的使用率或剂量显著降低,包括磺脲类药物剂量降低高达 75%,二甲双胍降低 22%,噻唑烷二酮(TZD)或 TZD 联合治疗降低 66%,餐时胰岛素降低 75%。与接受其他治疗的患者相比,接受艾塞那肽治疗的患者的全因和与 CVD 相关的住院和 CVD 事件发生率显著降低。在本观察性研究的评价中,起始应用艾塞那肽与临床相关结局的显著改善相关。本评价中观察性研究的 HbA1c、FBG、体重和 SBP 的改善与对照临床试验中的改善一致。