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An analysis of DAPA-HF indicates the efficacy and safety profile of dapagliflozin was consistent regardless of patient sex, highlighting the potential of the SGLT2 inhibitor for heart failure patients.
A prespecified analysis of the landmark DAPA-HF trial indicates the effects of dapagliflozin (Farxiga) were present and consistent in patients with heart failure with reduced ejection fraction (HFrEF), regardless of sex.
Results of the analysis suggested the 1109 women included in the phase 3 trial experienced similar efficacy and safety from dapagliflozin, with investigators noting no major differences in risk of worsening heart failure or cardiovascular death.
“In DAPA-HF, dapagliflozin, compared with placebo, reduced the risk of worsening HF events, cardiovascular death, and all-cause death and improved symptoms, physical function, and health-related quality of life similarly in men and women,” wrote investigators. “These findings provide further support for dapagliflozin as a new treatment option for patients with HFrEF.”
Approved in May 2020 for reducing the risk reduce the risk of cardiovascular death and hospitalization for heart failure in patients with HFrEF, recent research suggests 4-in-5 HFrEF patients met the criteria for being prescribed the SGLT2 inhibitor. As part of the pivotal DAPA-HF trial, a series of prespecified analyses were designed to further assess the effects of dapagliflozin in different subgroups and biomarkers.
In the current analysis, investigators hoped to assess potential differences in efficacy and safety of dapagliflozin among the 1109 women, which represented 23.4% of the 4744-patient cohort. Of this group of 1109, 564 received dapagliflozin and 545 received placebo. Compared to their male counterparts, the cohort of women was older, more often Black, less often Asian, less likely to have atrial fibrillation COPD, and had a lower eGFR.
Briefly, all patients included in DAPA-HF were classified as NYHA class II-IV, had an ejection fraction of 40% or less, and had elevated levels of NT-proBNP. Patients who underwent randomization were assigned in a 1:1 ratio to receive treatment with once-daily dapagliflozin 10 mg or placebo in addition to guideline-recommended therapy.
Upon analysis, results indicated dapagliflozin was associated with a reduced risk of worsening heart failure events or cardiovascular death to a similar extent in men (HR, 0.73; 95% CI, 0.63-0.85) and women (HR, 0.79; 95% CI, 0.59-1.06) (P for interaction=.67). Investigators also noted consistent benefits were observed when assessing individual components of the primary outcome and all-cause mortality.
Further analysis suggests dapagliflozin increased the proportion of patients with a meaningful improvement in KCCQ-TSS (men, 59% vs 50%; women, 57% vs 54%; P for interaction=.14) and decreased the proportion with worsening symptoms (men, 25% vs 34%; women, 27% vs 31%; P for interaction=.15), irrespective of sex when compared to placebo therapy. Investigators also noted these results were consistent when assessing using the KCCQ-CS and KCCQ-OSS.
Additionally, investigators performed further subgroup analyses based on sex and diabetes status. In this analysis, investigators found dapagliflozin reduced the risk of worsening heart failure, cardiovascular death, and all-cause mortality, irrespective of sex, in patients with and without diabetes.
When assessing safety profile, results indicated study drug discontinuation (13.2% vs 12.7%) and adverse events leading to discontinuation (4.1% vs 5.1%) were not more frequent among those receiving dapagliflozin than those receiving placebo therapy.
“Despite concerns that women experience more adverse drug reactions than men and are more likely to discontinue treatment, data on safety and tolerability in DAPA-HF were reassuring,” wrote investigators.
This study, “Efficacy and Safety of Dapagliflozin in Men and Women with Heart Failure with Reduced Ejection Fraction,” was published in JAMA Cardiology.