[Towards evidence-based medicine: large-scale intervention trials with glucagon-like peptide-1 receptor agonists].

The primary goal of antihyperglycemic therapy in type 2 diabetes mellitus is to reduce cardiovascular morbidity and mortality. As a consequence, drugs used for the treatment of diabetes must be safe with respect to cardiovascular risk. It would be ideal if antidiabetic drugs could also promote cardiovascular protection mechanisms independent of improved glucose control. Glucagon-like peptide-1 (GLP-1) receptor agonists might indeed be such drugs. Experimental studies in animal models as well as preliminary results in man have provided evidence that GLP-1 receptor agonists may have protective effects on the cardiovascular system. In addition, registration trial data have demonstrated that treatment with liraglutide is associated with a significant improvement in several cardiovascular risk factors. However, definite confirmation of both absolute cardiovascular safety and potential cardiovascular protective effects of GLP-1 receptor agonists can only be provided by large, randomized, controlled intervention trials specifically designed to answer these questions. The design of such ongoing trials is described in this article.