The Food and Drug Administration (FDA) has expanded the approval of Farxiga (dapagliflozin) to include treatment of heart failure (HF) patients regardless of left ventricular ejection fraction (LVEF) status. Previously, the sodium-glucose cotransporter 2 (SGLT2) inhibitor had only been approved for HF patients with reduced ejection fraction (HFrEF).
The approval was based on data from the phase 3 DELIVER trial (ClinicalTrials.gov Identifier: NCT03619213), a placebo-controlled, event-driven study that included 6263 patients 40 years of age and older with HF and LVEF of greater than 40%, with or without type 2 diabetes. Patients were randomly assigned 1:1 to receive dapagliflozin 10 mg or placebo once daily, in addition to background therapy.
The primary composite endpoint was the time to first occurrence of cardiovascular (CV) death, hospitalization for HF or an urgent HF visit, in the full study population, as well as in patients with LVEF of less than 60%.
Over a median follow-up of 2.3 years, treatment with dapagliflozin reduced the composite outcome of CV death or worsening of HF by 18% compared with placebo (hazard ratio [HR], 0.82; 95% CI, 0.73-0.92; P <.001). Worsening HF occurred in 11.8% (n=368) of patients in the dapagliflozin arm and 14.5% (n=455) of patients in the placebo arm (HR, 0.79; 95% CI, 0.69-0.91); CV death occurred in 7.4% (n=231) of patients in the dapagliflozin arm and 8.3% (n=261) of patients in the placebo arm (HR, 0.88; 95% CI, 0.74-1.05). The findings were consistent among patients with LVEF of less than 60%, as well as among those with or without diabetes.
Additionally, a pooled analysis of data from the phase 3 DAPA-HF (ClinicalTrials.gov Identifier: NCT03036124) and DELIVER trials showed a significant reduction in CV death among HF patients treated with dapagliflozin, compared with placebo, irrespective of LVEF. Over a median follow-up of 22 months, dapagliflozin reduced the risk of CV death by 14% (HR, 0.86; 95% CI, 0.76-0.97; P =.01), death from any cause by 10% (HR, 0.90; 95% CI, 0.82-0.99; P =.03), total (first and repeat) hospitalization for HF by 29% (HR, 0.71; 95% CI, 0.65-0.78; P <.001), and the composite of death from CV causes, myocardial infarction, or stroke by 10% (HR, 0.90; 95% CI, 0.81-1.00; P =.045).
“Approximately half of heart failure patients die within 5 years of diagnosis, highlighting an urgent unmet need for well-tolerated treatment options that can bring life-saving benefits and reduce the risk of cardiovascular death,” said Ruud Dobber, Executive Vice-President, BioPharmaceuticals Business Unit, AstraZeneca. “The approval of Farxiga in the US not only reinforces AstraZeneca’s commitment to reducing the burden of this complex and life-threatening disease, but will help patients across the full spectrum of heart failure lead healthier lives.”
This article originally appeared on MPR