Key result
Dapagliflozin cuts worsening HF or CV death ~35% in Asian patients with HFrEF.
Why the study?
Patients with HFrEF in Asia exhibit many differences from those elsewhere, prompting investigation into the efficacy and safety of dapagliflozin versus placebo in Asian patients compared with those from other regions.
Does dapagliflozin 10 mg once daily reduce the risk of worsening heart failure or cardiovascular death in Asian patients with HFrEF to the same extent as in patients outside Asia?
RCT (n=4,744)
Double-blind
Randomized
Yes
Does dapagliflozin 10 mg once daily reduce the risk of worsening heart failure or cardiovascular death in Asian patients with HFrEF to the same extent as in patients outside Asia?
Despite marked baseline differences in demographics, clinical characteristics, and background therapies, dapagliflozin provides consistent reductions in worsening heart failure and cardiovascular death and is equally well tolerated in Asian patients with HFrEF compared with non-Asian patients.
Answers are grounded in this paper and cite their sources.
Supports dapagliflozin in Asian HFrEF patients; extends global trial consistency to this population.
Patients with heart failure with reduced ejection fraction (HFrEF) in Asia exhibit many differences from those in other parts of the world. This study sought to investigate the efficacy and safety of dapagliflozin, compared with placebo, in HFrEF patients in Asia, compared with those elsewhere, enrolled in the DAPA-HF (Dapagliflozin and Prevention of Adverse-outcomes in Heart Failure) trial. Patients in New York Heart Association functional class II to IV with a left ventricular ejection fraction ≤40% and elevated N-terminal pro–B-type natriuretic peptide were eligible for the DAPA-HF trial. The primary outcome in the DAPA-HF trial was the composite of an episode of worsening HF (HF hospitalization or urgent HF visit requiring intravenous therapy) or cardiovascular death. Of the 4,744 patients in the DAPA-HF trial, 1,096 (23.1%) were enrolled in Asia; 721 (15.2% overall, 65.8% of patients in Asia) were enrolled in East Asia (237 in China, 343 in Japan, and 141 in Taiwan), 138 (2.9% overall, 12.6% in Asia) in South-East Asia (Vietnam), and 237 (5.0% overall, 21.6% in Asia) in South Asia (India). Patients from Asia had similar rates of worsening HF events and mortality compared with patients elsewhere. Compared with placebo, dapagliflozin reduced the risk of the primary endpoint to the same extent in patients from Asia (HR: 0.65; 95% CI: 0.49 to 0.87) as elsewhere (HR: 0.77; 95% CI: 0.66 to 0.89) (P for interaction = 0.32). Consistent benefits were observed for the other prespecified outcomes and among the regions of Asia. Study drug discontinuation and prespecified adverse events did not differ between regions. Dapagliflozin, compared with placebo, reduced the risk of worsening HF events and cardiovascular death to the same extent in Asian patients as elsewhere. (Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure [DAPA-HF]; NCT03036124)
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Docherty et al. (2022) conducted an RCT in Heart failure with reduced ejection fraction (HFrEF) (n=4,744). Dapagliflozin vs. Matching placebo added to standard background treatment was evaluated on Composite of an episode of worsening heart failure (HF hospitalization or urgent HF visit requiring intravenous therapy) or cardiovascular death in Asian patients (HR 0.65, 95% CI 0.49-0.87, p=0.32 for interaction). Dapagliflozin reduced the risk of worsening HF or cardiovascular death in Asian patients (HR 0.65, 95% CI 0.49-0.87) consistently with non-Asian patients (P-interaction=0.32).
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