在我国2型糖尿病患者中开展心血管终点事件临床研究的风险控制的探讨

Discussion on risk management of cardiovascular outcome study in Chinese patients with type 2 diabetes

2008年12月17日美国食品药品监督管理局(FDA)发布了"糖尿病领域指南:治疗2型糖尿病新药的心血管风险评价指导原则"。该指导原则针对如何证明一种新的治疗2型糖尿病的药物不会造成不可接受的心血管风险的增加提出了建议。目前全球正在2型糖尿病患者中开展多个以心血管事件为研究终点的大规模、长期临床研究,我国也将有选择的参与此类研究。此文件旨在阐述并提出在我国2型糖尿病患者中开展心血管终点事件临床研究的风险控制考虑,为今后开展此类研究提供指导性建议。

In December 2008,the FDA issued the guidance for industry diabetes mellitus： Developing drugs and therapeutic biologics for treatment and prevention,which makes recommendations about how to demonstrate that a new antidiabetic therapy to treat type 2 diabetes is not associated with an unacceptable increase in cardiovascular risk.Recently,some pharmaceutical industries are considering the participation of international multi-center cardiovascular risk assessment in China.In order to ensure to minimize the risk of clinical trials,CDE provides recommendations on risk management of cardiovascular outcome study in Chinese patients with type 2 diabetes.