Khalse Maneesha, Bhargava Amit
Department of Medical Affairs, Lupin Ltd., Mumbai, Maharashtra, India.
Indian J Endocrinol Metab. 2018 Sep-Oct;22(5):689-695. doi: 10.4103/ijem.IJEM_104_18.
The U.S. Food and Drug Administration issued a guidance for pharmaceutical industry defining preapproval and postapproval requirements for the demonstration of cardiovascular (CV) safety for all new medications developed for glycemic management in type 2 diabetes. However, results published from the studies of dipeptidyl peptidase-4 (DPP-4) inhibitors are conflicting with regard to different CV endpoints. Upcoming CV outcome studies perhaps will be able to provide additional insights related to diabetes management and help to provide the answers to some of these concerns. This article provides a brief overview regarding how various CV safety evidence of DPP-4 inhibitor evolved over time that highlights possible implication in clinical practice and translates them into effective diabetes management.
美国食品药品监督管理局发布了一项针对制药行业的指南，明确了为2型糖尿病血糖管理而研发的所有新药物在批准前和批准后证明心血管（CV）安全性的要求。然而，关于二肽基肽酶-4（DPP-4）抑制剂的研究结果在不同的心血管终点方面存在矛盾。即将开展的心血管结局研究或许能够提供与糖尿病管理相关的更多见解，并有助于解答其中一些问题。本文简要概述了DPP-4抑制剂的各种心血管安全性证据是如何随时间演变的，强调了其在临床实践中的可能影响，并将其转化为有效的糖尿病管理。
