Mkrtumyan A M, Markova T N, Mishchenko N K
A. I. Yevdokimov Moscow State University of Medicine and Dentistry.
A. I. Yevdokimov Moscow State University of Medicine and Dentistry; City Clinical Hospital №52, Moscow.
Kardiologiia. 2019 Jul 19;59(7):76-83. doi: 10.18087/cardio.2019.7.10267.
In 2008 the Food and Drug Administration has revised approval process for new antidiabetic agents and introduced a requirement to demonstrate the cardiovascular safety in an international multicenter trial. Currently cardiovascular outcome trials of dipeptidyl peptidase-4 (DPP-4) inhibitors (SAVOR-TIMI53, EXAMINE and TECOS), sodium-glucose cotransporter 2 inhibitors (EMPAREG, CANVAS), glucagon-like peptide-1 receptor agonists (ELIXA, EXSCEL LEADER and SUSTAIN-6), ultralong-acting and insulin (DEVOTE) have been completed. The trials confirmed cardiovascular safety of these glucose-lowering medications, and in addition, EMPA-REG OUTCOME (empagliflozin), CANVAS (canagliflozin) and LEADER (liraglutide) have also demonstrated cardioprotective effect of sodium-glucose cotransporter 2 inhibitors and glucagon-like peptide-1 receptor agonists. These data led to the changes of clinical guidelines for the management of type 2 diabetes.
2008年，美国食品药品监督管理局修订了新型抗糖尿病药物的审批流程，并提出在国际多中心试验中证明心血管安全性的要求。目前，二肽基肽酶-4（DPP-4）抑制剂（SAVOR-TIMI53、EXAMINE和TECOS）、钠-葡萄糖协同转运蛋白2抑制剂（EMPAREG、CANVAS）、胰高血糖素样肽-1受体激动剂（ELIXA、EXSCEL、LEADER和SUSTAIN-6）以及超长效胰岛素（DEVOTE）的心血管结局试验已经完成。这些试验证实了这些降糖药物的心血管安全性，此外，EMPA-REG OUTCOME（恩格列净）、CANVAS（卡格列净）和LEADER（利拉鲁肽）还证明了钠-葡萄糖协同转运蛋白2抑制剂和胰高血糖素样肽-1受体激动剂的心脏保护作用。这些数据导致了2型糖尿病管理临床指南的改变。
