Express Pharma

Dapagliflozin meets primary endpoint in Deliver phase-III trial

Reduces risk of cardiovascular death or worsening heart failure in patients with preserved ejection fraction

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Results from the Deliver and DAPA-HF phase-III trials demonstrate Dapagliflozin’s efficacy in heart failure regardless of ejection fraction. High-level results from the Deliver phase-III trial showed AstraZeneca’s Dapagliflozin reached a statistically significant and clinically meaningful reduction in the primary composite endpoint of Cardio Vascular (CV) death or worsening Heart Failure (HF). The trial was conducted in patients with HF with mildly reduced or preserved ejection fraction (defined as Left Ventricular Ejection Fraction [LVEF] greater than 40 per cent), AstraZeneca said in a statement.

Further, according to the statement, there are several main categories of HF 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 per cent), HF with mildly reduced EF (HFmrEF) (LVEF 41-49 per cent) and preserved EF (HFpEF) (LVEF greater than or equal to 50 per cent). Approximately, half of all HF patients have mildly reduced or preserved EF with few therapeutic options available. Dapagliflozin already has approved indications relating to the treatment of type-II diabetes, HFrEF and Chronic Kidney Disease (CKD).

Dr Scott Solomon, Professor, Medicine, Harvard Medical School and Brigham and Women’s Hospital and Principal Investigator of the Deliver phase-III trial, said in the statement, “……..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 safety and tolerability profile of Dapagliflozin in the trial were consistent with the well-established safety profile of the medicine. The complete trial results will be submitted for presentation at a forthcoming medical meeting and regulatory submissions will be made in the coming months.

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