August 13, 2013Circulation Heart Failure
Race Influences the Safety and Efficacy of Spironolactone in Severe Heart Failure
Key result
Spironolactone reduced death or heart failure hospitalization in non-African Americans (HR 0.63; 95% CI 0.55-0.73) but not in African Americans (HR 1.07; 95% CI 0.67-1.71; P=0.032 for interaction).
Why the study?
Does the efficacy and safety of spironolactone in severe heart failure vary by race (African American versus non-African American)?
Population
1,663 patients with New York Heart Association class III or IV heart failure and left ventricular…
Comparison
Spironolactone, titrated to 25 or 50 mg daily vs Placebo
Design
Cohort, randomized to spironolactone... or placebo
Authors
Discussion
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Implication
In a secondary analysis of the RALES trial, spironolactone reduced death or heart failure hospitalization in non-African Americans but not in African Americans, who also experienced less hyperkalemia and more hypokalemia.
Key Points
- The study aims to explore how race influences the safety and efficacy of spironolactone in patients with severe heart failure.
- Randomized trial with African American participants (n=120) and non-African Americans (n=1543) with NYHA class III or IV heart failure.
- Participants received spironolactone (25 or 50 mg daily) or placebo, with adjustments for baseline characteristics and dose achieved.
- Hyperkalemia and outcomes were assessed across groups over the trial duration.
- Non-AAs experienced significant hyperkalemia (potassium >5.5 mmol/L) at a rate of 9.7% versus 4.2% for AAs (P<0.046).
- Spironolactone reduced the combined endpoint of death or hospitalization for HF in non-AAs (HR 0.63; CI 0.55-0.73), but not in AAs (HR 1.07; CI 0.67-1.71; P=0.032).
- Non-AAs were more likely to reach the maximum spironolactone dose (13.9% versus 5.8%; P=0.04).
Study Design
Type
RCT (n=1,663)
Randomization
randomized
Structured PICO
Does the efficacy and safety of spironolactone in severe heart failure vary by race (African American versus non-African American)?
P
Population
1,663 patients with NYHA class III or IV heart failure and left ventricular dysfunction randomized to spironolactone or placebo, analyzed by race.
I
Intervention
Spironolactone, titrated to 25 or 50 mg daily
C
Comparator
Placebo
O
Outcome
Combined end point of death or hospitalization for HFcomposite
Main Result
Hazard Ratio: 1.07 (95% CI 0.67–1.71)
p-value: p=0.032
In a secondary analysis of the RALES trial, spironolactone reduced death or heart failure hospitalization in non-African Americans but not in African Americans, who also experienced less hyperkalemia and more hypokalemia.
Limitations
- Findings are hypothesis-generating
- Hypothesis-generating findings
Cite This Study
Vardeny et al. (2013) conducted an RCT in Severe Heart Failure (n=1,663). Spironolactone vs. placebo was evaluated on combined end point of death or hospitalization for HF (HR 1.07, 95% CI 0.67-1.71, p=0.032). Spironolactone reduced death or heart failure hospitalization in non-African Americans (HR 0.63; 95% CI 0.55-0.73) but not in African Americans (HR 1.07; 95% CI 0.67-1.71; P=0.032 for interaction).