关于我国降糖药物心血管结局临床试验的认识和监管考虑

Cognition and regulatory considerations of cardiovascular outcome trials of hypoglycemic drugs in China

心血管风险作为2型糖尿病慢性并发症之一,是导致患者死亡的主要原因。随着心血管结局临床试验的广泛开展和对于降糖药物心血管结局试验认识的不断深入,此文旨在阐述当前对我国降糖药物心血管结局临床试验的认识和监管考虑。

Cardiovascular risk,as one of the chronic complications of type 2 diabetes,is the major cause of mortality in patients.With the extensive development of cardiovascular outcome trials and the deepening understanding of the cardiovascular outcome of hypoglycemic drugs,this article aims to elaborate the current understanding and regulatory considerations of the clinical research on cardiovascular outcomes of hypoglycemic drugs in China.