Sodium-glucose co-transporter-2 inhibitors: A cardiovascular outcome trial analysis

Abstract

Cardiovascular outcome trials (CVOTs) have to be done by sponsors who wish to launch new antidiabetic drugs in the US, since the December 2008 US Food and Drug Administration ruling, which was subsequently accepted by the European Medicines (Evaluation) Agency (EMA) in 2012. However, the medical community asks the question, “So What?” as they are not convinced of the clinical relevance of CVOTs. The patients selected in CVOTs are necessarily high risk, so that they develop major adverse cardiovascular events quickly, but then, the results are extrapolatable to only a certain percentage of patients seen in the clinical practice. Doctors believe that these trials only serve a regulatory need. At the same time, these trials do provide a lot of good data, but it needs to be interpreted well, and extrapolated appropriately to patients in practice as there are differences between what happens in a randomized control trial and in the real world. Hence, the need for this article which serves to dissect the CVOTs of sodium-glucose co-transporter-2 inhibitors, so that doctors are able to better read this evidence. However, the question of which gliflozin is the best cannot be answered by these trials as these are not head to head trials. All the more reason why one needs to look at the data holistically and be empowered to make the right decision for individual patients, hoping to match the best patient for the best drug, rather than determine which drug is better.