Boehringer Ingelheim and Lilly announced results from a new sub-analysis showing that the addition of Jardiance (empagliflozin) to standard of care in patients with type 2 diabetes (T2D) at high risk of cardiovascular (CV) events, consistently reduced the risk for heart failure hospitalization or cardiovascular death across all sub-groups, regardless of heart failure status at baseline, compared to placebo. The data, which were part of a pre-specified analysis of secondary endpoints of the EMPA-REG OUTCOME trial, were presented at the 2015 Scientific Sessions of the American Heart Association in Orlando, Fla.
The new data demonstrated that Jardiance, when added to standard of care in patients with T2D at high risk of CV events, reduced the risk of the composite endpoint of rates of hospitalization for heart failure or death from heart failure by 39% compared with placebo.
EMPA-REG OUTCOME was a long-term, multicenter, randomized, double-blind, placebo-controlled trial of more than 7,000 patients with T2D at high risk for CV events. The study assessed the effect of adding Jardiance 10mg or 25mg to standard of care compared to placebo added to standard of care. The primary endpoint was defined as time to first occurrence of CV death, non-fatal heart attack or non-fatal stroke. Results showed that Jardiance significantly reduced the risk of CV death, non-fatal heart attack or non-fatal stroke by 14% vs. placebo over a median of 3.1 years. Risk of CV death was reduced by 38%, with no significant difference in the risk of non-fatal heart attack or non-fatal stroke. Treatment with Jardiance also resulted in a 32% reduced risk of all-cause mortality and a 35% reduced risk for heart failure hospitalization.
Jardiance, a sodium-glucose co-transporter 2 inhibitor, is indicated as adjunct to diet and exercise to improve glycemic control in adults with T2D.