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Analysis hints at sudden cardiac death reduction with finerenone

FIDELITY mortality analysis presented in a Hot Line Session today at ESC Congress 2022

Diabetes and the Heart
Cardiovascular Pharmacotherapy

Barcelona, Spain – 29 Aug 2022: Finerenone does not reduce the risk of all-cause death in patients with type 2 diabetes and kidney disease but does lower the likelihood of sudden cardiac death, according to late breaking research presented in a Hot Line session today at ESC Congress 2022.1

It is estimated that patients with type 2 diabetes and chronic kidney disease have a 16-year shorter life expectancy than their peers without these conditions.2 Most deaths in these patients are due to cardiovascular disease,3 with an incidence up to six-fold higher than the general population.4 With the prevalence of chronic kidney disease and type 2 diabetes rising, more efforts are needed to improve survival in this patient population.5

A previous FIDELITY analysis, presented at ESC Congress 2021, showed that the nonsteroidal mineralocorticoid receptor antagonist finerenone reduced the risk of cardiovascular and renal outcomes compared with placebo in 13,026 patients with type 2 diabetes and chronic kidney disease enrolled in the FIDELIO-DKD and FIGARO-DKD trials.6-9 The current analysis evaluated the causes of mortality in the FIDELITY population. Causes of death were adjudicated by an independent clinical event committee blinded to treatment allocation.

This was a prespecified, exploratory analysis of individual patient data pooled from FIDELIO-DKD and FIGARO-DKD. The analysis included 13,026 patients with type 2 diabetes and chronic kidney disease randomised to treatment with finerenone or placebo. All patients were optimally treated with a renin-angiotensin system inhibitor. The median duration of follow up was 3.0 years. The average age of participants was 64.8 years and 69.8% were men.

The main analysis of this substudy examined rates of all-cause mortality and different causes of mortality in the intention-to-treat population. The incidence of all-cause mortality was 8.5% with finerenone (2.76 events per 100 patient-years) compared with 9.4% with placebo (3.10 events per 100 patient-years; hazard ratio [HR] 0.89; 95% confidence interval [CI] 0.79–1.00; p=0.051), where the between-group difference narrowly missed statistical significance. Mortality was most commonly attributed to cardiovascular causes (4.9% in the finerenone group vs. 5.6% in the placebo group), followed by infection (1.5% vs. 1.4%, respectively) and malignancy (1.2% vs. 1.6%, respectively). An analysis of the components of cardiovascular mortality showed that finerenone significantly reduced the relative risk of sudden cardiac death (the most common form of cardiovascular mortality) by 25% compared with placebo (HR 0.75; 95% CI 0.57–0.996; p=0.046).

All-cause mortality and cardiovascular mortality were also assessed in a prespecified on-treatment analysis, which included events that occurred while patients were receiving treatment and for up to 30 days after the last dose of study medication. In this analysis, finerenone was associated with an 18% relative risk reduction in all-cause mortality (HR 0.82; 95% CI 0.70–0.96; p=0.014) and cardiovascular mortality (HR 0.82; 95% CI 0.67–0.99; p=0.040) versus placebo.

Professor Gerasimos Filippatos of the National and Kapodistrian University of Athens, Greece said: “In this analysis of patients with type 2 diabetes and kidney disease, mortality was primarily attributed to cardiovascular events. The effect of finerenone on all-cause mortality, cardiovascular mortality and sudden cardiac death was consistent irrespective of estimated glomerular filtration rate (eGFR) or urine albumin-to-creatinine ratio (UACR) at baseline, but seemingly more pronounced in patients with a higher baseline eGFR. This indicates that earlier initiation of finerenone might be warranted to maximise its protective effects in these patients.”



Notes to editor

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This press release accompanies both a presentation and an ESC press conference at ESC Congress 2022. It does not necessarily reflect the opinion of the European Society of Cardiology.


Funding: FIDELITY was a prespecified pooled analysis of individual patient data from FIDELIO-DKD and FIGARO-DKD. FIDELITY, FIDELIO-DKD and FIGARO-DKD were funded by Bayer AG.


Disclosures: Gerasimos Filippatos discloses lecture fees and/or membership of clinical trial/registry committees sponsored by Amgen, Bayer, Boehringer Ingelheim, Medtronic, Novartis, Servier and Vifor. He has also received research grants from the European Union. Prof Filippatos is Senior Consulting Editor of the Journal of the American College of Cardiology: Heart Failure, and is Past President of the Heart Failure Association of the ESC and Past Dean of the University of Cyprus. 


References and notes

1FIDELITY will be discussed during Hot Line Session 8 on Monday 29 August at 08:30 to 10:00 CEST in the Barcelona auditorium.

2Wen CP, Chang CH, Tsai MK, et al. Diabetes with early kidney involvement may shorten life expectancy by 16 years. Kidney Int. 2017;92:388–396.

3Ang YG, Heng BH, Saxena N, et al. Annual all-cause mortality rate for patients with diabetic kidney disease in Singapore. J Clin Transl Endocrinol. 2016;4:1–6.

4Afkarian M, Sachs MC, Kestenbaum B, et al. Kidney disease and increased mortality risk in type 2 diabetes. J Am Soc Nephrol. 2013;24:302–308.

5Li H, Lu W, Wang A, et al. Changing epidemiology of chronic kidney disease as a result of type 2 diabetes mellitus from 1990 to 2017: estimates from global burden of disease 2017. J Diabetes Invest. 2021;12:346–356.

6Agarwal R, Filippatos G, Pitt B, et al. Cardiovascular and kidney outcomes with finerenone in patients with type 2 diabetes and chronic kidney disease: the FIDELITY pooled analysis. Eur Heart J. 2022;43:474–484.

7Bakris GL, Agarwal R, Anker SD, et al. Effect of finerenone on chronic kidney disease outcomes in type 2 diabetes. N Engl J Med. 2020;383:2219–2229.

8Filippatos G, Anker SD, Agarwal R, et al. Finerenone and cardiovascular outcomes in patients with chronic kidney disease and type 2 diabetes. Circulation. 2021;143:540–552.

9Pitt B, Filippatos G, Agarwal R, et al. Cardiovascular events with finerenone in kidney disease and type 2 diabetes. N Engl J Med. 2021;385:2252–2263.


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