Eckel Robert H, Farooki Azeez, Henry Robert R, Koch Gary G, Leiter Lawrence A
University of Colorado Anschutz Medical Campus, Aurora, CO.
Memorial Sloan Kettering Cancer Center, New York, NY.
Clin Diabetes. 2019 Oct;37(4):316-337. doi: 10.2337/cd19-0001.
Cardiovascular disease is the leading cause of morbidity and mortality in people with diabetes, and deaths from heart disease are two to four times higher among adults with type 2 diabetes. Trials such as the U.K. Prospective Diabetes Study, ACCORD (Action to Control Cardiovascular Risk in Diabetes), ADVANCE (Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation), and VADT (Veteran's Affairs Diabetes Trial) produced mixed findings regarding whether intensive glycemic control results in improved cardiovascular (CV) outcomes for patients with diabetes. In response to concerns, including the CV safety of the thiazolidinedione rosiglitazone, the U.S. Food and Drug Administration and subsequently the European Medicines Agency issued guidance that trials should be conducted to prove that antihyperglycemic agents have acceptable CV risk profiles. In this article, the authors review the study designs and results of CV outcomes trials conducted with sodium-glucose cotransporter 2 inhibitors and glucagon-like peptide 1 receptor agonists and discuss how these may affect clinical practice.
心血管疾病是糖尿病患者发病和死亡的主要原因,2型糖尿病成年人的心脏病死亡率高出两到四倍。诸如英国前瞻性糖尿病研究、控制糖尿病患者心血管风险行动(ACCORD)、糖尿病和血管疾病行动:培哚普利吲达帕胺片控制评估(ADVANCE)以及退伍军人事务部糖尿病试验(VADT)等试验,在强化血糖控制是否能改善糖尿病患者的心血管(CV)结局方面得出了不一致的结果。针对包括噻唑烷二酮类药物罗格列酮的心血管安全性等问题,美国食品药品监督管理局以及随后的欧洲药品管理局发布了指导意见,即应进行试验以证明降糖药物具有可接受的心血管风险状况。在本文中,作者回顾了使用钠-葡萄糖协同转运蛋白2抑制剂和胰高血糖素样肽1受体激动剂进行的心血管结局试验的研究设计和结果,并讨论了这些结果可能如何影响临床实践。