Lilly and BI announced this morning that they plan to investigate SGLT-2 inhibitor Jardiance (empagliflozin) as a treatment for chronic heart failure. The companies plan to initiate two outcomes trials in the next 12 months that will enroll patients with heart failure with and without type 2 diabetes. These studies were planned in light of the significant 38% risk reduction in CV death and 35% risk reduction in hospitalization for heart failure seen with Jardiance vs. placebo in EMPA-REG OUTCOME. We hope to hear more details on the planned design and timing of the studies during Lilly’s 1Q16 update on April 26. The potential for a heart failure indication for Jardiance has been a topic of speculation ever since the EMPA-REG OUTCOME results were reported and we are glad that the companies have decided to pursue it. In addition to the clinical results, we hope these studies can provide some insight into the mechanisms of Jardiance’s cardioprotective effects, which remain poorly understood. We are especially curious to see whether the results differ in patients with and without diabetes. We would also love to see a trial evaluating CV outcomes with Jardiance in a lower-risk population with type 2 diabetes, but we assume the incentives are not there for the companies to conduct what would likely be a very long and expensive study.
-- by Emily Regier and Kelly Close