Significant CV benefits shown for Jardiance (empagliflozin) in type 2 diabetes patients-Boehringer/Eli Lilly

Boehringer and Eli Lilly drug Jardiance (empagliflozin) significantly reduced the risk of the combined endpoint of cardiovascular (CV) death, non-fatal heart attack or non-fatal stroke by 14 percent when added to standard of care in patients with type 2 diabetes (T2D) at high risk of CV events, according to results from the EMPA-REG OUTCOME trial. Of the 7,020 treated patients, more than 97 percent completed the trial and vital status was available for more than 99 percent of these patients at study end.

There was a 38 percent reduction in CV death, with no significant difference in the risk of non-fatal heart attack or non-fatal stroke. In addition, treatment with Jardiance resulted in a lower risk of all-cause mortality (32 percent reduction) and hospitalization for heart failure (35 percent reduction). The overall safety profile of Jardiance was consistent with previous trials. The incidence of diabetic ketoacidosis was at or below 0.1 percent and similar across all treatment groups. These data were presented at the European Association for the Study of Diabetes Annual Meeting and simultaneously published in the New England Journal of Medicine.

Comment: Jardiance on its own appears to offer little differentiation from rival SGLT2 inhibitors Invokana (Janssen's canagliflozin) and Forxiga/Farxiga (AstraZeneca's dapagliflozin). Both Invokana and Forxiga have already faced safety worries over the risk of genital and urinary tract infections, and cost-effectiveness regulators in the UK (NICE) and Germany (IQWiG) have taken issue with Forxiga, too, stating that they were not convinced it works any better than competitors already in use.