Define-HF and Emperial Trials: Lessons Learned

Abstract

Sodium Glucose co-transporter inhibitors (SGLT-2i) have firmly established their position in the management of type 2 diabetes mellitus (T2DM) and have also expanded their indication for use. There were different outcomes benefits with the three SGLT-2i, resulting from differences in patient population studied, primary end-points chosen and statistical testing hierarchy. Although the outcome benefits complemented each other, the subtle differences were blown out of proportion by interested lobbies, eyeing a larger pie of the market share. The corporate war intensified with the publication and top-line results of 2 two recent symptom-based trials in patients with heart failure (DEFINEHF & EMPERIAL). Once again, the differences were subtle and there were more similarities than differences. Diuretics provide the desired symptom relief whereas SGLT-2i are associated with hard end-point outcome benefits. In view of the profound benefits associated with the use of SGLT-2i two additional categories of studies were launched. The first explored the area of symptomatic relief and the second concentrated on the mechanistic benefits. This review looks in depth at the different types of trials conducted with SGLT-2i and their similarities which is supported by all the recently published guidelines.