EC approves inclusion of CV and renal outcomes data for label of SGLT2i
The European Commission has approved a label update for the SGLT2 inhibitor dapagliflozin to include CV and renal data of the DECLARE-TIMI 58 trial. Majority of type 2 diabetes (T2DM) patients who were enrolled in this trial had no history of CVD.
In the DECLARE-TIMI 58 trial, dapagliflozin significantly reduced the composite endpoint of hospitalization for heart failure (HF) or CV death compared to placebo in T2DM patients. The other primary efficacy endpoint of major adverse CV events was not significantly different between groups. Safety profile with dapagliflozin was good, with no increase in amputations, fractures, bladder cancer of Fournier’s gangrene compared to placebo.
The DECLARE (Dapagliflozin Effect on Cardiovascular Events)-TIMI 58 was a large CV outcome trial evaluating the effect of dapagliflozin vs. placebo on CV outcomes in a broad population of >17,000 T2DM patients. It was a phase III, randomized, double-blinded, placebo-controlled, multicenter trial in T2DM patients with CV risk factors or established CVD. Results were published in The New England Journal of Medicine in Jan 2019.
Inclusion of DECLARE-TIMI-58 trial data to the label of dapagliflozin is under regulatory review in the US and China.