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Eur Heart J. 2016 Jul 14;37(27):2105-14. doi: 10.1093/eurheartj/ehw132. Epub 2016 Apr 29.

A randomized controlled study of finerenone vs. eplerenone in patients with worsening chronic heart failure and diabetes mellitus and/or chronic kidney disease.

Author information

1
Department of Cardiology, National and Kapodistrian University of Athens, School of Medicine, Attikon University Hospital, Rimini 1, Haidari, Athens 12462, Greece geros@otenet.gr.
2
Department of Innovative Clinical Trials, University Medical Centre Gottingen, Gottingen, Germany.
3
Universitatsklinikum des Saarlandes, Klinik für Innere Medizin III, Homburg, Germany.
4
Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.
5
Heart Centre, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
6
Centre of Cardiovascular Research and Education in Therapeutics, Monash University, Melbourne, Australia.
7
Research Centre of the Italian Association of Hospital Cardiologists, Florence, Italy.
8
Medical University, Clinical Military Hospital, Wrocław, Poland.
9
University of Groningen, Groningen, Netherlands.
10
Inserm, CHU Department of Cardiology, Université de Lorraine, Nancy, France.
11
Global Clinical Development, Bayer Pharma AG, Leverkusen, Germany.
12
Global Clinical Development, Bayer Plc, Newbury, UK.
13
Heart Diseases Research, Global Drug Discovery, Bayer Pharma AG, Leverkusen, Germany.
14
Global Research & Development Statistics, Bayer Pharma AG, Leverkusen, Germany.
15
M.A.R.C.O. GmbH & Co. KG, Dusseldorf, Germany.
16
University of Michigan Medical School, Ann Arbor, MI, USA.

Abstract

AIMS:

To evaluate oral doses of the non-steroidal mineralocorticoid receptor antagonist finerenone given for 90 days in patients with worsening heart failure and reduced ejection fraction and chronic kidney disease and/or diabetes mellitus.

METHODS AND RESULTS:

Miner Alocorticoid Receptor antagonist Tolerability Study-Heart Failure (ARTS-HF) was a randomized, double-blind, phase 2b multicentre study (ClinicalTrials.gov: NCT01807221). Of 1286 screened patients, 1066 were randomized. Patients received oral, once-daily finerenone (2.5, 5, 7.5, 10, or 15 mg, uptitrated to 5, 10, 15, 20, or 20 mg, respectively, on Day 30) or eplerenone (25 mg every other day, increased to 25 mg once daily on Day 30, and to 50 mg once daily on Day 60) for 90 days. The primary endpoint was the percentage of individuals with a decrease of >30% in plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) from baseline to Day 90. A key exploratory endpoint was a composite clinical endpoint of death from any cause, cardiovascular hospitalizations, or emergency presentation for worsening HF until Day 90. Mean age ranged from 69.2 to 72.5 years in different treatment groups (standard deviation 9.7-10.6 years). Decreases in NT-proBNP of >30% from baseline occurred in 37.2% of patients in the eplerenone group and 30.9, 32.5, 37.3, 38.8, and 34.2% in the 2.5→5, 5→10, 7.5→15, 10→20, and 15→20 mg finerenone groups, respectively (P = 0.42-0.88). Except for the 2.5→5 mg finerenone group, the composite clinical endpoint occurred numerically less frequently in finerenone-treated patients compared with eplerenone; this difference reached nominal statistical significance in the 10→20 mg group (hazard ratio 0.56, 95% confidence interval, CI, 0.35; 0.90; nominal P = 0.02), despite the fact that this phase 2 study was not designed to detect statistical significant differences. A potassium level increase to ≥5.6 mmol/L at any time point occurred in 4.3% of patients, with a balanced distribution among all treatment groups.

CONCLUSION:

Finerenone was well tolerated and induced a 30% or greater decrease in NT-proBNP levels in a similar proportion of patients to eplerenone. The finding of reduced clinical events in the finerenone 10→20 mg group should be further explored in a large outcomes trial.

KEYWORDS:

Finerenone; Mineralocorticoid receptor antagonists; Worsening heart failure

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