Avogaro Angelo
Cattedra di Malattie del Metabolismo, Dipartimento di Medicina, Università degli Studi, Padova.
G Ital Cardiol (Rome). 2016 Apr;17(4):248-52. doi: 10.1714/2214.23894.
The risk of morbidity and mortality from cardiovascular disease in patients with type 2 diabetes is about 2-fold higher compared to their non-diabetic counterparts. In December 2008, the Food and Drug Administration published guidelines for the evaluation of cardiovascular risk in new antidiabetic therapies. A shift of emphasis occurred from short-term glycated hemoglobin-centered trials to trials testing cardiovascular safety. The SAVOR-TIMI 53 and the EXAMINE trials with the dipeptidyl peptidase 4 (DPP-4) inhibitors saxagliptin and alogliptin were cardiovascular neutral. The publication of the results of the TECOS trial with sitagliptin, another DPP-4 inhibitor, the American Diabetes Association 2015 presentation of the ELIXA trial with lixisenatide, the first cardiovascular safety trial with glucagon-like peptide 1 receptor agonists, have also been completed. They both show cardiovascular neutrality in very high-risk diabetic patients. The results of these trials are interpreted in the context of diabetic treatment.
与非糖尿病患者相比,2型糖尿病患者发生心血管疾病的发病和死亡风险高出约两倍。2008年12月,美国食品药品监督管理局发布了关于评估新型抗糖尿病疗法心血管风险的指南。重点从以糖化血红蛋白为中心的短期试验转向了测试心血管安全性的试验。使用二肽基肽酶4(DPP-4)抑制剂沙格列汀和阿格列汀的SAVOR-TIMI 53试验和EXAMINE试验在心血管方面呈中性。另一种DPP-4抑制剂西他列汀的TECOS试验结果的发表,以及2015年美国糖尿病协会公布的利司那肽的ELIXA试验结果,这是首个使用胰高血糖素样肽1受体激动剂的心血管安全性试验,也已完成。它们在极高风险的糖尿病患者中均显示出心血管中性。这些试验结果将结合糖尿病治疗情况进行解读。