Dapagliflozin is beneficial for reducing worsening disease and risk of death in both men and women with heart failure with reduced ejection fraction (HFrEF).
In new subgroup analysis data from the Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure trial (DAPA-HF) trial, an international team of investigators reported that outcomes in symptoms, physical function, and health-related quality of life were improved among patients with HFrEF treated with the SGLT2 inhibitor, regardless of sex.
The new findings support dapagliflozin for treating women patients, who have a clinical track record of greater burden from HF and worse treatment thereof than men patients.
The Drug
Assessed in DAPA-HF as a 10 mg, once-daily add-on therapy for the treatment of reduced HFrEF mortality and events, dapagliflozin (Farxiga) is an SGLT2 inhibitor previously approved by the US Food and Drug Administration (FDA) for the treatment of type 2 diabetes and heart failure in patients with or without diabetes.
Earlier this year, the FDA granted the drug Priority Review for the treatment of chronic kidney disease in patients with and without type 2 diabetes.
FARXIGA has the potential to be a truly transformational medicine across a breadth of diseases, including type 2 diabetes, heart failure with reduced ejection fraction and, if approved, chronic kidney disease,” Mene Pangalos, executive vice president of Biopharmaceuticals Research and Development, said at the time.
The Trial
Led by John J. V. McMurray, MD, of British Heart Foundation Cardiovascular Research Centre in Glasgow, Scotland, and funded by AstraZeneca, investigators sought to observe the efficacy and safety of dapagliflozin versus placebo among men and women with HFrEF previously observed in DAPA-HF.
The subgroup assessment included the phase 3 trial’s 410 sites across 20 countries. Eligible patients had HF with New York Heart Association functional class II through IV, with an ejection fraction of ≤40% and elevated N-terminal pro-B-type natrieuretic peptide (NT-proBNP) levels.
As investigators noted, women with HF have historically fared differently than men across a litany of regulated and investigated therapies, including:
- Digoxin
- Sacubitril/valsartan
- Intravenous (IV) ferric carboxymaltose
“Similarly, it has been suggested that the reduction in death in the large cardiovascular outcome trials with SGLT2 inhibitors may be less in women than in men with type 2 diabetes,” they wrote. “Within the past 2 years, SGLT2 inhibitors have also been shown to be a valuable treatment for HFrEF and it is clearly important to examine the effects of this therapy in women as well as men with HFrEF.”
Following DAPA-HF’s indication that dapagliflozin is overall beneficial for reduced risk of worsening HF events, cardiovascular and all-cause death, and improved symptoms, function, and quality of life for patients with HFrEF with and without type 2 diabetes, they sought a sex-stratified interpretation. Their primary outcome was composite episode of worsening HF requiring hospitalization or urgent IV treatment, or cardiovascular death.
Among the 4744 DAPA-HF trial participants, 1109 (23.4%) were women. McMurray and colleagues observed a similar reduction of HF event or cardiovascular death risks among both treated men (hazard ratio [HR], 0.73; 95% CI, 0.63 – 0.85) and women (HR, 0.79; 95% CI, 0.59 – 1.06). Men fared slightly better in meaningful symptom improvement, as per Kansas City Cardiomyopathy Questionnaire scores of ≥5 points (59% vs 57%).
Both groups reported similar decreases in worsening symptom scores for HF, and neither men nor women reported more frequent study drug discontinuation and serious adverse events when treated with dapagliflozin versus placebo.
Impact
In highlighting the findings, McMurray and colleagues called the consistent sex-based outcomes “reassuring” relative to discussion surrounding SGLT2 inhibitor use in women. A supplementary issue to that fact is the reduced representation of women in cardiovascular—and more specifically, HFrEF—clinical trials.
“The proportion of women in DAPA-HF was relatively low but similar to other global HFrEF trials,” they wrote. “Thus, women continue to be underrepresented in HF trials, and greater efforts should bemade to increase the proportion of women in HF trials.”
That said, the findings do further support SGLT2 inhibitor dapagliflozin as a new treatment option for patients with HFrEF, irrespective of sex.
The study, “Efficacy and Safety of Dapagliflozin in Men and Women With Heart Failure With Reduced Ejection Fraction,” was published online in JAMA Cardiology.
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