DPP-4抑制剂利格列汀的心血管安全性——CARMELINA研究解读

Cardiovascular Safety of DPP-4 Inhibitor Linagliptin: Focus and Interpretation of CARMELINA Study

自2008年美国食品与药品管理局(Food and Drug Administration,FDA)和欧洲药品管理局(European Medicines Agency,EMA)针对降糖药物心血管安全性行业标准发布后,新上市降糖药物均开展了各自的心血管结局研究.近年,二肽基肽酶-4(dipeptidyl peptidase-4,DPP-4)抑制剂在指南及临床应用中的地位逐步升高,其有效性、心血管安全性和耐受性均受到关注.目前,针对DPP-4抑制剂这一类药物的心血管安全性的研究已经完成了4项,其中最近完成的一项研究是第54届欧洲糖尿病研究学会(European Association for the Study of Diabetes,EASD)年会上正式公布的CARMELINA研究.该研究结果显示,在心血管和(或)肾脏疾病高风险的2型糖尿病患者中,在标准治疗基础上,联合应用利格列汀与安慰剂相比具有相似的长期心血管与肾脏安全性.本文将对这一研究结果及其对于临床实践的意义进行解读.

The newly-marketing drugs had been respectively investigated on cardiovascular outcome since Food and Drug Administration(FDA)and European Medicines Agency(EMA)publish standard evaluating for cardiovascular safety of hypoglycemic agents in 2008.Recently,the status of dipeptidyl peptidase-4(DPP-4)inhibitors was gradually rising.Its efficacy,cardiovascular safety and tolerance had been taken into account.Until now,four clinical trials of cardiovascular safety of DPP-4 inhibitors had been accomplished.The result of CARMELINA study(the latest trial)had been issued in 54th European Association for the Study of Diabetes(EASD).This study showed that the standard therapy combined with linagliptin had the similar long-term cardiovascular and renal safety than with placebo in type 2 diabetes who had high risk of cardiovascular and(or)renal diseases.This review will interpret the results and clinical significance of CARMELINA study.