GLP-1RA CVOT结局与法规解读

Interpretation of CVOT Results of GLP-1RAs and the Relevant Regulations

降糖药物的治疗能否带来心血管结局的改变一直是探索的焦点。近年来,多项心血管结局试验(CVOT)结果陆续公布。这些结果将给美国食品药品监督管理局(FDA)、欧洲药品管理局(EMA)的法规修订以及糖尿病管理的临床实践带来哪些重要影响?同类药物的CVOT结果是否具有类效应?本文以胰高糖素样肽-1受体激动剂(GLP-1RA)为例,通过追溯CVOT开展的源起,深入剖析该类药物CVOT的异同,评述法规指导下GLP-1RA心血管适应证的获批及其临床指导意义。

Whether glucose-lowering medications could bring about changes in cardiovascular outcomes has always been the focus.In recent years,the results of several cardiovascular outcome trials(CVOTs)have been gradually released.What critical impacts will these results exert on the revision of regulations by U.S.Food and Drug Administration(FDA)and European Medicines Agency(EMA),and the clinical practice of diabetes management?Do the CVOT results of the drugs in the same class demonstrate similar effect?Through tracing back to the origin of CVOT development,this article takes the glucagon-like peptide-1 receptor agonists(GLP-1RAs)as an example,analyzes in-depth the similarities and differences of GLP-1RA CVOTs,and commentates on the approval of cardiovascular indications of GLP-1RAs under the regulatory guidance and the relevant clinical instructive significance.