The high-level results from the DELIVER Phase III trial released on Monday show that AstraZeneca’s dapagliflozin has reached a statistically significant and clinically meaningful reduction in the primary composite endpoint of cardiovascular (CV) death or worsening heart failure (HF). According to the company’s press statement, the trial was conducted in patients with HF with mildly reduced or preserved ejection fraction.
According to experts, Heart Failure is a chronic, long-term condition that worsens over time. It affects nearly 64 million people globally and is associated with substantial morbidity and mortality. There are several main categories of Heart Failure-related to ejection fraction (EF), a measurement of the percentage of blood leaving the heart each time it contracts including HF with reduced EF (HFrEF) (LVEF less than or equal to 40 percent), HF with mildly reduced EF (HFmrEF) (LVEF 41-49 percent) and preserved EF (HFpEF) (LVEF greater than or equal to 50 percent).
Approximately half of all Heart Failure patients have mildly reduced or preserved EF with few therapeutic options available. Dapagliflozin already has approved indications relating to the treatment of type-2 diabetes (T2D), HFrEF, and chronic kidney disease (CKD), the company said in its press statement on Monday.
“We are delighted to have met the primary endpoint in this patient population which has few treatment options. 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,” 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 in a statement.
“Today’s groundbreaking results coupled with those from the DAPA-HF trial show that Dapagliflozin is effective in treating heart failure regardless of ejection fraction. These data build upon our previous studies demonstrating cardio renal protection across patients with either diabetes, chronic kidney disease or heart failure,” Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said in a statement.
The company also informed that the safety and tolerability profile of Dapagliflozin in the DELIVER Phase III trial were consistent with the well-established safety profile of the medicine. Moreover, the full DELIVER Phase III trial results will be submitted for presentation at a forthcoming medical meeting and regulatory submissions will be made in the coming months.