Primary end point similarly reduced for men and women with dapagliflozin; no differences in secondary outcomes, safety events
WEDNESDAY, Nov. 16, 2022 (HealthDay News) — Dapagliflozin is similarly beneficial for women and men with heart failure, according to a study published online Nov. 7 in Circulation.
Xiaowen Wang, M.D., from Harvard Medical School in Boston, and colleagues examined the impact of sex on the efficacy and safety of dapagliflozin among 11,007 patients (35 percent women) in a prespecified patient-level pooled analysis of the Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure (DAPA-HF) and Dapagliflozin Evaluation to Improve the Lives of Patients with Preserved Ejection Fraction Heart Failure (DELIVER) trials. Clinical outcomes were compared by sex.
The researchers found that women were less likely than men to experience cardiovascular (CV) death, all-cause death, and heart failure hospitalizations (adjusted hazard ratios, 0.69, 0.69, and 0.82, respectively) and total events (adjusted rate ratio, 0.77) after adjustment for baseline differences. The primary end point of worsening heart failure or CV death was reduced similarly in men and women with dapagliflozin, with no differences seen in secondary outcomes or safety events related to sex. Across the entire ejection fraction spectrum, the benefit of dapagliflozin was observed, with no modification by sex. No sex-related differences were noted in serious adverse events, adverse events, or drug discontinuation due to adverse events.
“Across the full spectrum of ejection fraction in heart failure, women and men derived similar benefits from dapagliflozin, compared with placebo, for both the primary outcome of CV death or worsening heart failure and secondary outcomes including improvement in health status,” the authors write. “Dapagliflozin was safe and well-tolerated in both sexes.”
Several authors disclosed financial ties to pharmaceutical companies, including AstraZeneca, which manufactures dapagliflozin and funded the DAPA-HF and DELIVER trials.
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