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In this episode, Muthiah Vadugnathan, MD, MPH, and Stephen Greene, MD, discuss finerenone and MRA data from ESC Congress 2024.
00:00 - Welcome and Introduction
01:18 - FINEARTS Study Design and Patient Population
03:04 - Inclusion of Hospitalized Patients
04:43 - Primary and Secondary Endpoints
05:56 - Challenges in Achieving Statistical Significance
07:39 - Health Status Improvement and Additional Analyses
10:01 - Combination Therapy and Future Trials
12:20 - Hyperkalemia and Steroidal vs. Non-Steroidal MRAs
15:30 - Conclusion and Acknowledgments
Already renowned as the world’s largest annual cardiology meeting, the 2024 iteration of the European Society of Cardiology (ESC) Congress may also be remembered as the dawn of a new era in heart failure, with the landmark FINEARTS-HF trial proving finerenone (Kerendia) offered significant benefits in a population of heart failure patients with a left ventricular ejection fraction (LVEF) greater than 40%.
The trial itself found itself as the subject of a special Hot Line session at the meeting, which featured a total of 3 presentations: FINEARTS-HF, FINE-HEART, and a meta-analysis of MRA use in patients with heart failure.
In this ESC Congress 2024 edition of Don’t Miss a Beat, Stephen Greene, MD, an advanced heart failure specialist at Duke University School of Medicine, discusses the prospect of finerenone in treatment algorithms for heart failure with Muthiah Vaduganathan, MD, MPH, codirector of the Center for Cardiometabolic Implementation Science of Brigham and Women’s Hospital, who served as an investigator on the FINEARTS-HF trial and presenter of FINE-HEART.
In the trial, use of finerenone was associated with a statistically significant 16% relative reduction in rate of primary outcome events compared with placebo therapy (rate ratio [RR], 0.84; 95% confidence interval [CI], 0.74 to 0.95; P = 0.007). Specifically, 1083 primary outcome events occurred among 624 patients in the finerenone group and 1283 primary outcome events occurred among 719 patients in the placebo group.
Data from ESC Congress 2024 offered further insight into the trial, with analysis of individual components of the primary endpoint revealing use of finerenone was associated with an 18% relative reduction in incidence of heart failure hospitalization (RR, 0.82; 95% CI, 0.71 to 0.94; P = .006) and nonsignificant 7% relative risk reduction for death from cardiovascular causes (hazard ratio, 0.93; 95% CI, 0.78 to 1.11). Additional data from ESC Congress 2024 demonstrated there was no differences between the finerenone and placebo groups for all-cause mortality (HR, 0.93; 95% CI 0.83–1.06) or the composite kidney outcome (HR, 1.33; 95% CI, 0.94 to 1.89).
Analysis of individual components of the primary endpoint revealing use of finerenone was associated with an 18% relative reduction in incidence of heart failure hospitalization (RR, 0.82; 95% CI, 0.71 to 0.94; P = .006) and nonsignificant 7% relative risk reduction for death from cardiovascular causes (hazard ratio, 0.93; 95% CI, 0.78 to 1.11). Additional data from ESC Congress 2024 demonstrated there was no statistically significant differences observed between the finerenone and placebo groups for all-cause mortality (HR, 0.93; 95% CI, 0.83 to 1.06) or the composite kidney outcome (HR, 1.33; 95% CI, 0.94 to 1.89).
Following the presentation of the FINEARTS-HF trial, Vaduganathan presented data from the FINE-HEART study, which was a prespecified analysis FIDELIO-DKD, FIGARO-DKD, and FINEARTS-HF aimed at describing the safety and efficacy of finerenone on cardiovascular, kidney, and mortality outcomes using participant-level data.
From the 3 trials, investigators formed a study cohort of 18,991 participants. This cohort had a mean age of 67 (SD, 10) years, 35% were women, and the median follow-up was 2.9 years.
Results of the analysis indicated use of finerenone contributed to a nonsignificant reduction in the relative risk of cardiovascular death compared to placebo therapy (4.44% vs 5.0%; HR, 0.89; 95% CI, 0.78 to 1.01; P = .076). Further analysis revealed finerenone use was associated with statistically significant reactions in the risk of all-cause mortality (HR, 0.91; 95% CI, 0.84 to 0.99; P = .027), risk of heart failure hospitalization (HR, 0.83; 95% CI, 0.75 to 0.92; P <.001) and the composite kidney outcome (HR, 0.80; 95% CI, 0.72 to 0.90; P <.001).
Safety analyses revealed finerenone use was associated with a reduced risk of adverse events than placebo (34.6% vs 36.6%), but serious adverse events leading to drug discontinuation were greater with finerenone (5.4% vs. 4.6%). Additionally, results suggested laboratory-defined hyperkalemia was greater with finerenone whereas laboratory-defined hypokalemia was lower.
Relevant disclosures for Vaduganathan include Amgen, AstraZeneca, Bayer AG, Boehringer Ingelheim Pharmaceuticals, Cytokinetics, Lexicon, and others. Relevant disclosures for Greene include Amgen, AstraZeneca, Bayer Healthcare Pharmaceuticals, Boehringer Ingelheim Pharmaceuticals, Cytokinetics, and others.
References:
SD Solomon, JJV McMurray, M Vaduganathan, et al. Finerenone in Heart Failure with Mildly Reduced or Preserved Ejection Fraction. Presented at: European Society of Cardiology Congress 2024. August 30 - September 2, 2024. London, UK.
M Vaduganthan, G Filippatos, BL Claggett, et al. Finerenone in Heart Failure and Chronic Kidney Disease with Type 2 Diabetes: the FINE-HEART pooled analysis of cardiovascular, kidney, and mortality outcomes. Presented at: European Society of Cardiology Congress 2024. August 30 - September 2, 2024. London, UK.
