Mineralocorticoid receptor antagonists had little effect on systolic blood pressure and reduced all-cause mortality (HR 0.72; 95% CI 0.64-0.82; P<0.001) regardless of baseline blood pressure.
RCT (n=4,396)
Does MRA therapy reduce mortality and affect systolic blood pressure across different baseline SBP categories in patients with HFrEF?
MRA treatment provides consistent mortality benefits in HFrEF without significantly increasing the risk of hypotension, even in patients with low baseline systolic blood pressure.
Effect estimate: HR 0.72 (95% CI 0.64 to 0.82)
p-value: p=< 0.001
OBJECTIVES: The purpose of this study was to investigate the effects of mineralocorticoid receptor antagonists (MRAs) on systolic blood pressure (SBP) and outcomes according to baseline SBP in patients with heart failure with reduced ejection fraction (HFrEF). BACKGROUND: MRAs are greatly underused in patients with HFrEF, often because of fear of adverse events. Concern about hypotension has been raised by the demonstration that MRAs are particularly effective treatment for resistant hypertension. METHODS: The effect of MRA therapy was studied in 4,396 patients with HFrEF randomized in the RALES (Randomized Aldactone Evaluation Study) and EMPHASIS-HF (Eplerenone in Mild Patients Hospitalization and Survival Study in Heart Failure) trials. RESULTS: Mean SBP change from baseline to 6 months was +1.4 ± 18.1 mm Hg in the placebo group and -1.2 ± 17.9 mm Hg in the MRA group. The between-treatment difference was 2.6 mm Hg (95% confidence interval CI: 1.5 to 3.6; p 105 to ≤115 mm Hg; HR: 0.78; 95% CI: 0.60 to 1.02; SBP >115 to ≤125 mm Hg; HR: 0.71; 95% CI: 0.53 to 0.94; SBP >125 to ≤135 mm Hg; HR: 0.79; 95% CI: 0.57 to 1.10; and SBP > 135 mm Hg; HR: 0.67; 95% CI: 0.50 to 0.90; p for interaction = 0.95). Hypotension was infrequent and not more common with MRA therapy than with placebo, overall (4.6% vs. 3.9%; p = 0.25) or in any SBP category. CONCLUSIONS: MRA treatment had little effect on SBP in patients with HFrEF, and the clinical benefits were not modified by baseline SBP. MRA treatment infrequently caused hypotension, even when the baseline SBP was low. The treatment discontinuation rates between MRA and placebo therapy were similar. Low SBP is not a reason to withhold MRA therapy in patients with HFrEF.
Serenelli et al. (Wed,) conducted a rct in Heart failure with reduced ejection fraction (HFrEF) (n=4,396). Mineralocorticoid receptor antagonists (MRAs) vs. Placebo was evaluated on All-cause mortality (HR 0.72, 95% CI 0.64 to 0.82, p=< 0.001). Mineralocorticoid receptor antagonists had little effect on systolic blood pressure and reduced all-cause mortality (HR 0.72; 95% CI 0.64-0.82; P<0.001) regardless of baseline blood pressure.