Efectividad y seguridad de los inhibidores del receptor mineralocorticoide en el tratamiento de la insuficiencia cardiaca: estudio comparativo en vida real

Abstract

INTRODUCTION: Spironolactone and eplerenone are both recommended for the treatment of heart failure and reduced ejection fraction (HFrEF) according to practice guidelines, as both drugs demonstrated consistent reductions of mortality and morbidity in these patients. However, given the absence of direct comparative studies, it is not known whether any differences regarding their prognostic benefit can exist between them. OBJECTIVES: We aimed to evaluate the effectiveness of spironolactone and eplerenone in patients with HFrEF in a real-world clinical setting. METHODS: Using Fine-Gray´s competing risk regression, we compared the clinical outcomes of 293 patients with chronic heart failure (HF) and left ventricular ejection fraction <40% treated with eplerenone and 293 propensity-score matched individuals treated with spironolactone. Study subjects were selected from a prospective cohort of 1404 ambulatory patients with HFrEF seen since 2010 to 2019 in a single specialized HF clinic, among which 992 received a mineralocorticoid receptor antagonist at baseline. Median follow-up was 3.95 years. RESULTS: No statistically significant differences between patients treated with eplerenone versus spironolactone were observed with regard to the risk of the primary composite end-point cardiovascular death or HF hospitalization [hazard ratio (HR) 0.95; 95% confidence interval (95% CI) 0.73-1.23; p=0.677]. However, eplerenone use was associated to lower cardiovascular mortality (HR 0.55; 95% CI 0.35-0.85; p=0.008) and lower all-cause mortality (HR 0.67; 95% CI 0.47-0.95; p=0.027). The incidence of drug suspension due to side effects (HR 0.58; 95% CI 0.40-0.85; p=0.005) and drug suspension due to any reason (HR 0.70; 95% CI 0.51-0.97; p=0.033) were lower among patients treated with eplerenone. CONCLUSIONS: In this observational, real-world, propensity-score matched study of patients with HFrEF, no statistically significant differences between patients treated with eplerenone versus spironolactone were observed with regard to the risk of the primary composite end-point cardiovascular death or HF hospitalization. However, eplerenone was associated to lower cardiovascular mortality and lower all-cause mortality than spironolactone.