Phase III trial with SGLT2i in HFpEF meets primary endpoint
Results from the DELIVER phase III trial showed that the SGLT2 inhibitor dapagliflozin resulted in a statistically significant reduction in the primary composite endpoint of CV death or worsening heart failure (HF) in patients with HFmrEF or HFpEF (LVEF>40%).
DELIVER was an international, randomized, double-blind, parallel-group, placebo-controlled, event-driven phase III trial in which the efficacy of dapagliflozin was examined compared to placebo in 6,263 HF patients with LVEF >40% with or without T2DM. Primary endpoint was time to first occurrence of CV death, hospitalization for HF or an urgent HF visit. Secondary endpoints include total number of HF events and CV death, changes from baseline in the total symptom score of the Kansas City Cardiomyopathy Questionnaire at 8 months, time to CV death and time to death from any cause.
Dr. Scott Solomon, Professor of Medicine at Harvard Medical School and Brigham and Women’s Hospital and Principal Investigator of the DELIVER Phase III trial, said: “The results of DELIVER extend the benefit of dapagliflozin to the full spectrum of patients with heart failure.”
Safety and tolerability of dapagliflozin in the DELIVER trial were consistent with that seen in previous trials.
Dapagliflozin has already been approved for indications related to treatment of T2DM, HFrEF and CKD.