Finerenone Consistently Reduced Cardiorenal Risk Regardless of ASCVD History in FIDELITY

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In patients with type 2 diabetes and chronic kidney disease with and without history of CVD, finerenone was associated with improved CV and kidney outcomes.

Finerenone (Kerendia®, Bayer), a nonsteroidal mineralocorticoid receptor antagonist, may be an effective treatment to reduce risk of adverse cardiovascular (CV) and renal outcomes in patients with type 2 diabetes (T2D)-associated chronic kidney disease (CKD) regardless of history of atherosclerotic cardiovascular disease (ASCVD).

The suggestion is based on new findings from a prespecified subgroup analysis of the FIDELITY trial program of finerenone and presented at the American College of Cardiology’s (ACC) 2022 Scientific Sessions. The analysis of >13 000 patients found a consistent salutary effect of finerenone across cardiorenal outcomes in patients with T2D and CKD that reflected both primary and secondary CVD prevention populations.

“In patients with chronic kidney disease associated with type 2 diabetes, cardiovascular complications are among the most frequent causes of death. However, there is limited data on how the risk of cardiovascular events could be reduced in these patients,” said Javed Butler, MD, MPH, MBA, president of the Baylor Scott & White Research Institute, senior vice president for Baylor Scott & White Health, and distinguished professor of medicine at the University of Mississippi, in a press release from Bayer.

“In patients with chronic kidney disease associated with type 2 diabetes, cardiovascular complications are among the most frequent causes of death."

The primary FIDELITY pooled analysis combined results from 2 large phase 3 randomized clinical trials with finerenone, FIDELIO-DKD and FIGARO-DKD, which together examined CV and renal outcomes across a broad spectrum of CKD severity in patients with T2D. The investigators looked to gain “more robust estimates” of the agent’s safety and efficacy.

Results of this analysis, the primary FIDELITY pooled analysis, published in February 2022, showed significant risk reduction with finerenone vs placebo of 14% (HR, 0.86; 95% CI, 0.78–0.95) for the composite CV outcome (CV death, nonfatal MI, nonfatal stroke, or hospitalization for heart failure [HHF]) and of 23% (HR, 0.77 [95% CI, 0.67-0.88]) for the composite renal outcome (kidney failure, sustained ≥57% decrease in eGFR from baseline over ≥4 weeks, or renal death).

The new analysis, presented at ACC by lead author Gerasimos Filippatos, MD, professor of cardiology, National and Kapodistrian University of Athens School of Medicine, Athens, used the pooled data to assess the effect of finerenone in a prespecified subgroup divided by presence or absence of ASCVD.


FIDELIO-DKD and FIGARO-DKD enrolled a total of 13 026 patients with T2D and associated CKD. Of these, 5935 (45/6%) had a history of ASCVD at baseline and 7091 had no history. When they reviewed baseline characteristics between the 2 groups the FIDELITY investigators found lower values for eGFR and UACR among those with ASCVD vs those without but reported blood pressure and HbA1c mutually well controlled. Regarding baseline medications patients with ASCVD were more likely than those without to be prescribed beta-blockers, statins, and insulin.

Filippatos et al reported that over a median follow-up of 3 years, patients with a history of ASCVD were at approximately a 2-fold increased risk of the composite CV outcome (CV death, nonfatal MI, nonfatal stroke, or hospitalization for heart failure) vs those without (HR, 2.09 [95% CI, 1.89-2.30]).

When they evaluated the treatment effects of finerenone vs placebo the researchers found finerenone use was associated with a 17% (HR, 0.83 [95% CI, 0.74-0.94]) reduction in risk of the composite cardiovascular outcome among those with a history of ASCVD and a 9% (HR, 0.91 [95% CI, 0.78-1.06]) reduction in risk among those without a history of ASCVD. The effect of finerenone on the composite kidney outcome was also consistent across patients with and without ASCVD with a reduction of 29% (HR, 0.71, 95% CI, 95% CI 0.57–0.88) and 19% (HR 0,81, 95% CI 0.68–0.97), respectively.

Analysis of treatment-emergent adverse events indicated the safety profile of finerenone was similar between patients with and without a history of ASCVD.

Fillipatos emphasized in closing his presentation that the data point to use of finerenone for both primary and secondary prevention of CV disease as well as prevention of renal decline in a patient population already vulnerable to death from cardiac event.

Reference: Filippatos GS, Anker SD, Pitt B, et al. Finerenone and cardiorenal outcomes by hisotry of cardivascular disease in patients wtih type 2 diabetes and chronic kidney didsease: FIDELITY analyses. No additional information currently available. To be updated.