Finerenone and all-cause hospitalization in cardiovascular-kidney-metabolic disease
J Ostrominski, E Barkoudah, B Claggett, G Filippatos, A Desai, P Jhund, C Lam, M Senni, A Voors, F Zannad, S Anker, R Agarwal, J Mcmurray, S Solomon, M VaduganathanAbstract
Background
The non-steroidal mineralocorticoid receptor antagonist, finerenone, has been shown to reduce heart failure (HF) hospitalizations in persons with cardiovascular, kidney, and metabolic (CKM) conditions. However, persons with CKM conditions exhibit a diverse spectrum of risk that may contribute to hospitalizations for any reason.
Purpose
To examine the effect of finerenone on all-cause hospitalization, overall and in key subgroups, in persons with CKM conditions.
Methods
In this prespecified analysis of FINE-HEART, a participant-level pooled analysis of the FIDELIO-DKD, FIGARO-DKD, and FINEARTS-HF trials, treatment effects of finerenone versus placebo on time-to-first all-cause hospitalization were evaluated overall and in prespecified subgroups.
Results
Over a median [IQR] follow-up of 2.9 [2.2, 3.5] years, 8,662 (45.6%; 44.8% in the finerenone arm and 46.4% in the placebo arm) of 18,991 participants experienced hospitalization for any cause. Hospitalization for any cause was associated with older age, male sex, Asian race, higher waist-to-height ratio, lower kidney function, and a history of established cardiovascular disease. The cumulative incidence of all-cause hospitalization was modestly but statistically significantly lower with finerenone compared with placebo (hazard ratio [HR], 0.95; 95% CI, 0.91 to 0.99; P=0.025) (Figure 1). Between-group difference in cumulative incidence at 4 years (52.9% with finerenone vs. 55.0% with placebo) corresponded to a number-needed-to-treat of 47 to prevent one hospitalization for any cause. Similar effects of finerenone were observed after accounting for the competing risk of all-cause death (subdistribution HR, 0.96; 95% CI, 0.92 to 1.00; P=0.049). Finerenone also reduced the composite of all-cause hospitalization or all-cause mortality (HR, 0.94; 95% CI, 0.91 to 0.98; P=0.007). There was no evidence of effect modification by trial (P for interaction=0.87), sex (P for interaction=0.18), race (P for interaction=0.87), KDIGO risk category (P for interaction=0.59), or other selected subgroups (Figure 2).
Conclusion
Hospitalization for any reason was common in FINE-HEART and reduced with finerenone. These findings add further support for the use of finerenone to reduce overall morbidity in adults with CKM conditions.For image description, please refer to the figure legend and surrounding text.For image description, please refer to the figure legend and surrounding text.