Literature

Clinical Pearls & Morning Reports

Posted by Carla Rothaus, MD

Published October 23, 2024

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Did the addition of finerenone to usual care improve outcomes in this trial?

Solomon et al. conducted a placebo-controlled trial that assessed whether finerenone, in addition to usual therapy, reduced the rate of total worsening heart failure events and death from cardiovascular causes among patients with heart failure and mildly reduced or preserved ejection fraction. Read the NEJM Original Article here.

Clinical Pearls

Q: What is known about the use of steroidal mineralocorticoid receptor antagonists in patients with heart failure and mildly reduced or preserved ejection fraction?

A: Steroidal mineralocorticoid receptor antagonists reduce morbidity and mortality among patients with heart failure and reduced ejection fraction, but their efficacy in those with heart failure and mildly reduced or preserved ejection fraction has not been established, despite the suggestion of a potential benefit in the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist (TOPCAT) trial. Even with the recent availability of therapeutic options, including sodium–glucose cotransporter 2 inhibitors, there remains an unmet need in this population.

Q: What is finerenone?

A: Finerenone is a nonsteroidal mineralocorticoid receptor antagonist with physiochemical properties that are distinct from those of steroidal mineralocorticoid receptor antagonists, such as spironolactone. In two large outcomes trials involving patients with chronic kidney disease and type 2 diabetes, finerenone reduced the risk of kidney disease progression and cardiovascular events, including hospitalization for heart failure.

Morning Report Questions

Q: Did the addition of finerenone to usual care improve outcomes in this trial?

A: In patients with heart failure and mildly reduced or preserved ejection fraction, finerenone resulted in a significantly lower rate of a composite of total worsening heart failure events and death from cardiovascular causes (the primary outcome) than placebo. For each component of the primary outcome, the rate was lower in the finerenone group than in the placebo group, and the results for the primary outcome were consistent across all prespecified subgroups. Finerenone was associated with a moderate benefit with respect to improvement in patient-reported health status, as measured by the Kansas City Cardiomyopathy Questionnaire total symptom score, but not with respect to improvement in the New York Heart Association functional class or the risk of the kidney composite outcome. The overall incidence of serious adverse events was similar in the two trial groups, although elevated creatinine levels and hyperkalemia occurred more frequently and hypokalemia occurred less frequently in the finerenone group than in the placebo group.

Q: What were some of the limitations of this trial?

A: The trial enrolled few Black patients owing to the global distribution of enrollment, although the percentage of Black patients was proportional to the population percentage on a regional basis. All the prespecified subgroups were underpowered, so the results of the subgroup analysis should be interpreted with caution. The authors cannot determine on the basis of these data whether similar benefits would have been observed with other mineralocorticoid receptor antagonists.

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