minerAlocorticoid Receptor antagonist Tolerability Study-Heart Failure - ARTS-HF

May 31, 2016
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Bayer Pharma AG
Date Presented:
08/31/2015
Date Published:
04/29/2016
Date Updated:
05/31/2016
Original Posted Date:
08/31/2015
References

Description:

The goal of the trial was to evaluate treatment with the mineralocorticoid receptor antagonist finerenone compared with eplerenone among subjects with heart failure and type 2 diabetes mellitus, and/or chronic kidney disease. Unlike spironolactone and eplerenone, which are distributed to the kidneys greater than to the heart, finerenone is evenly distributed between the kidneys and the heart, which might provide for more cardiac protection.

Contribution to the Literature: The ARTS-HF trial failed to show a reduction in NT-proBNP levels for finerenone versus eplerenone; however, secondary outcomes favored finerenone.

Study Design

  • Randomized
  • Parallel

Subjects with heart failure and type 2 diabetes mellitus, and/or chronic kidney disease were randomized to one of five different finerenone groups; 2.5 mg, 5 mg, 7.5 mg, 10 mg, or 15 mg daily, with up-titration to 5 mg, 10 mg, 15 mg, 20 mg, and 20 mg, respectively at 30 days versus eplerenone 25 mg every other day, with up-titration to 25 mg daily at 30 days, and further up-titration to 50 mg daily at 60 days.

Inclusion criteria:

  • Subjects presenting to the emergency department with worsening heart failure and type 2 diabetes mellitus, and/or chronic kidney disease
  • Total number of enrollees: 1,066
  • Duration of follow-up: 90 days
  • Mean patient age: 71 years

Principal Findings:

The primary outcome, percentage of individuals with a >30% decrease in plasma N-terminal pro–B-type natriuretic peptide (NT-proBNP) from baseline to day 90, occurred in 30.9%, 32.5%, 37.3%, 38.8%, and 34.2% in the 5 mg, 10 mg, 15 mg, 20 mg, and 20 mg finerenone dose groups, respectively, versus 37.2% of the eplerenone group (p = NS).

Secondary outcomes: All-cause death, cardiovascular hospitalizations, or worsening heart failure occurred least frequently in the finerenone 10 mg group versus the eplerenone group (hazard ratio 0.56; p = 0.016). All-cause death (p = 0.062) and cardiovascular death (p = 0.011) occurred less frequently in the finerenone versus eplerenone groups.

Interpretation:

Among patients with heart failure and type 2 diabetes mellitus, and/or chronic kidney disease, finerenone failed to show a reduction in NT-proBNP levels compared with eplerenone. Finerenone was more effective at reducing all-cause and cardiovascular mortality compared with eplerenone; however, these were secondary outcomes, which will need to be confirmed in appropriately powered clinical trials. The 10 mg dose of finerenone may be the appropriate dose for further study.

References:

Filippatos G, Anker SD, Böhm M, et al. A randomized controlled study of finerenone vs. eplerenone in patients with worsening chronic heart failure and diabetes mellitus and/or chronic kidney disease. Eur Heart J 2016;Apr 29:[Epub ahead of print].

Presented by Dr. Gerasimos Filippatos at the European Society of Cardiology Congress, London, August 31, 2015.

Keywords: Diabetes Mellitus, Type 2, Heart Failure, Mineralocorticoid Receptor Antagonists, Natriuretic Peptide, Brain, Peptide Fragments, Renal Insufficiency, Chronic, Secondary Prevention, Spironolactone, ESC Congress


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