Current perspectives on cardiovascular outcome trials in diabetes

Cardiovascular Diabetology

Review

Lars Rydén¹  Oliver Schnell²  Eberhard Standl²  Antonio Ceriello³ 

[1] Cardiology Unit, Department of Medicine K2, Karolinska Institutet, 171 76, Stockholm, Sweden;Forschergruppe Diabetes e.V., Munich, Ingolstaedter Landstrasse 1, 85764, Neuherberg (Munich), Germany;Institut d’Investigacions Biomèdiques August Pi i Sunyer-IDIBAPS, Mallorca, 183, 08036, Barcelona, Spain;IRCCS MultiMedica, Via Milanese, 300, 20099, Milan, Italy;

关键词: Cardiovascular risk;    Diabetes;    CVOT;    Non-inferiority;    Cardiovascular safety;   

DOI  :  10.1186/s12933-016-0456-8

 received in 2016-07-23, accepted in 2016-09-23,  发布年份 2016

来源: Springer

【 摘 要 】

Cardiovascular disease (CVD) is one of the most common diabetes-associated complications, as well as a leading cause for death in type 2 diabetes patients (T2D). Despite the well-known correlation between the two, up until the 2008 FDA industry guidance for licensing of new anti-hyperglycemic drugs, which required an investigation of cardiovascular outcomes (CVO) of glucose-lowering agents, only a few studies had looked into the relationship between glucose lowering drugs and cardiovascular (CV) risk. Thereafter, CVOT design has focused on non-inferiority short-term studies on high-risk patient populations aiming at capturing CV safety issues. Despite the wealth of information and useful data provided by CVOTs, this approach still suffers from certain limitations. The present review will condense the main results of the most recently completed CVOTs, reflect on the lessons learned, discuss on the issues presented by current CVOT design and offer some suggestions for improvement.

【 授权许可】

CC BY   
© The Author(s) 2016