Efficacy of Dapagliflozin in Black vs. White Patients With HFrEF

Quick Takes

  • Dapagliflozin, compared with placebo, reduces the risk of worsening HF events, cardiovascular mortality, and all-cause death, and it improves symptoms similarly, in Black and White patients.
  • These findings suggest that SGLT2 inhibitors are beneficial in HF regardless of race.

Study Questions:

What is the efficacy and safety of dapagliflozin in Black and White patients with heart failure (HF) with reduced ejection fraction (HFrEF)?

Methods:

The study cohort was comprised of HFrEF patients enrolled in the DAPA-HF (Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure) trial. This included patients with New York Heart Association functional class II-IV with an ejection fraction of ≤40% and elevated N-terminal pro–B-type natriuretic peptide. Because >99% of Black patients were randomized in the Americas, this post hoc analysis considered Black and White patients enrolled only in North and South America. The primary outcome was the composite of a worsening HF event (HF hospitalization or urgent HF visit requiring intravenous therapy) or cardiovascular mortality.

Results:

Of the 4,744 patients randomized in DAPA-HF, 1,494 (31.5%) were enrolled in the Americas (North America: 677 [14.3%]; South America: 817 [17.2%]). Of these, 1,181 (79.0%) were White, and 225 (15.1%) were Black. Of the 225 Black patients, 121 (53.8%) and 104 (46.2%) were enrolled in North America and South America, respectively. Compared to White patients, Black patients had a higher risk of worsening HF or cardiovascular death (hazard ratio [HR], 1.37; 95% confidence interval [CI], 1.02-1.84), explained by a higher rate of worsening HF events (HR, 1.65; 95% CI, 1.17-2.33) rather than cardiovascular death (HR, 1.04; 95% CI, 0.67-1.61). Compared with placebo, dapagliflozin reduced the risk of the primary endpoint similarly in Black patients (HR, 0.62; 95% CI, 0.37-1.03) and White patients (HR, 0.68; 95% CI, 0.52-0.90; p for interaction = 0.70). The number of Black patients needed to treat throughout the trial (median follow-up, 18.4 months; interquartile range, 12.9-21.1 months) to prevent 1 from experiencing the primary composite endpoint was 11 (5-59), and the number needed to treat for White patients was 16 (10-46). Consistent benefits were observed for other prespecified outcomes, including the composite of total (first and repeat) HF hospitalizations and cardiovascular death (p for interaction = 0.43) and Kansas City Cardiomyopathy Questionnaire total symptom score. Study drug discontinuation and serious adverse events were not more frequent in the dapagliflozin group than in the placebo group in either Black or White patients.

Conclusions:

The study authors concluded that dapagliflozin reduced the risk of worsening HF and cardiovascular death, and it improved symptoms similarly, in Black and White patients, without an increase in adverse events.

Perspective:

This post hoc analysis suggests that dapagliflozin, compared with placebo, reduces the risk of worsening HF events, cardiovascular mortality, and all-cause death, and it improves symptoms similarly, in Black and White patients. These findings suggest that sodium glucose cotransporter 2 (SGLT2) inhibitors are beneficial in HF regardless of race.

Keywords: African Americans, Cardiomyopathies, Geriatrics, Heart Failure, Natriuretic Peptide, Brain, Race Factors, Risk, Secondary Prevention, Sodium-Glucose Transporter 2 Inhibitors, Stroke Volume


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