Randomized clinical trials on the cardiovascular effects of hypoglycemic drugs on people with type 2 diabetes mellitus began more than fifty years ago. In the last decade, the emergence of new classes of hypoglycemic drugs has led to the development of randomized clinical trials to assess their cardiovascular safety. Known as Cardiovascular Outcome Trials, they have provided a lot of new information that needs to be critically appraised if the knowledge obtained is to be applicable in clinical practice. To this end, the current article first comments on the guidelines to which these trials have adhered, then reviews some concepts for improving their interpretation (such as different types of analyses, the definition of objectives and the evaluation of their results), and concludes by mentioning the new guidelines to which future trials designed to evaluate the safety of new hypoglycemic drugs should adhere.
Keywords: Análogos del receptor del GLP1; Cardiovascular disease; Cardiovascular risk; DDP4 inhibitor; Diabetes tipo 2; Enfermedad cardiovascular; Ensayo clínico aleatorizado; GLP-1 receptor agonist; Inhibidor de la DDP4; Inhibidor del co-transportador sodio-glucosa 2; Randomized clinical trial; Riesgo cardiovascular; SGLT2 inhibitor; Type 2 diabetes.
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