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Phase 3 DELIVER Trial Meets Primary Endpoint with Dapagliflozin

Dapagliflozin was associated with reducing the primary composite endpoint of CV death or worsening HF in patients with HF with mildly reduced or preserved ejection fraction.

New findings from the phase 3 DELIVER trial reported dapagliflozin (Farxiga) was associated with a statistically significant and clinically meaningful reduction in the primary composite endpoint of cardiovascular (CV) death or worsening heart failure (HF), according to a press release from AstraZeneca.

The DELIVER trial was conducted in patients with HF with mildly reduced or preserved ejection fraction, defined as left ventricular ejection fraction (LVEF) greater than 40%.

“We are delighted to have met the primary endpoint in this patient population which has few treatment options,” said Scott Solomon, MD, Professor of Medicine, Harvard Medical School and Brigham and Women’s Hospital and Principal Investigator of the DELIVER Phase 3 trial. “DELIVER is the largest and broadest trial to date in heart failure with mildly reduced or preserved ejection fraction. The results of DELIVER extend the benefit of dapagliflozin to the full spectrum of patients with heart failure.”

The DELIVER trial was an international, randomized, double-blind, parallel-group phase 3 trial created to evaluate the efficacy of dapagliflozin with placebo in the treatment of HF patients with LVEF ≥40% with or without type 2 diabetes (T2D). As the largest clinical trial to date in HF patients with EF ≥40%, a total of 6,263 patients were randomized.

Its primary endpoint was event-driven, as the time to first occurrence of CV death, hospitalization for HF, or an urgent HF visit. Secondary endpoints consisted of the total number of HF events and CV death, change from baseline in total symptom score of the KCCQ at 8 months, time to occurrence of CV death and time to the occurrence of death from any cause.

As a chronic, long-term condition, HF affects nearly 64 million people globally. Approximately half of all HF patients have mildly reduced or preserved EF with few treatment options available. Dapagliflozin has approved indications for the treatment of T2D, heart failure with reduced ejection fraction (HFrEF), and chronic kidney disease (CKD).

Safety and tolerability profile of dapagliflozin within the phase 3 DELIVER trial were consistent with the well-established safety profile of the medicine in previous trials.

Full results from the phase 3 DELIVER trial will be submitted for presentation at an upcoming medical meeting, with regulatory submission expected in the coming months.

“Today’s groundbreaking results coupled with those from the DAPA-HF trial show that Farxiga is effective in treating heart failure regardless of ejection fraction,” said Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca in an accompanying statement. “These data build upon our previous studies demonstrating cardiorenal protection across patients with either diabetes, chronic kidney disease or heart failure.”