LATE BREAKING CLINICAL TRIAL (JCS 2016) : A Randomized Controlled Study of Finerenone vs. Eplerenone in Japanese Patients With Worsening Chronic Heart Failure and Diabetes and/or Chronic Kidney Disease
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- Sato Naoki
- Cardiology and Intensive Care Unit, Nippon Medical School, Musashi Kosugi Hospital
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- Ajioka Masayoshi
- Tosei General Hospital
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- Yamada Takahisa
- Division of Cardiology, Osaka General Medical Center
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- Kato Masaharu
- Bayer Yakuhin Ltd
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- Myoishi Masafumi
- Bayer Yakuhin Ltd
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- Yamada Takashi
- Bayer Yakuhin Ltd
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- Kim So-Young
- Global Clinical Development, Bayer HealthCare AG
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- Nowack Christina
- Global Clinical Development, Bayer HealthCare AG
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- Kolkhof Peter
- Heart Diseases Research, Global Drug Discovery, Bayer HealthCare AG
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- Shiga Tsuyoshi
- Department of Cardiology, Tokyo Women’s Medical University
書誌事項
- タイトル別名
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- A Randomized Controlled Study of Finerenone vs. Eplerenone in Japanese Patients With Worsening Chronic Heart Failure and Diabetes and/or Chronic Kidney Disease
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抄録
Background:Finerenone, a nonsteroidal mineralocorticoid receptor antagonist, was evaluated in Japanese patients with heart failure (HF) with reduced ejection fraction and chronic kidney disease and/or diabetes mellitus.Methods and Results:ARTS-HF Japan was a randomized, double-blind, phase 2b study. Patients (n=72) received oral, once-daily (o.d.) finerenone (2.5, 5, 7.5, 10 or 15 mg, up-titrated to 5, 10, 15, 20, or 20 mg, respectively, on day 30) or eplerenone (25 mg every other day, increased to 25 mg o.d. on day 30, and 50 mg on day 60) for 90 days. The primary endpoint was the proportion of individuals with a decrease of >30% in plasma NT-proBNP at day 90. Safety endpoints included the incidence of hyperkalemia. Decreases in NT-proBNP occurred in 23.1% of patients in the eplerenone group and 15.4%, 23.1%, 45.5%, 27.3% and 45.5% in the 2.5→5 mg, 5→10 mg, 7.5→15 mg, 10→20 mg and 15→20 mg finerenone groups, respectively (all P=NS). Mean changes in serum potassium levels were similar between groups.Conclusions:Because of the small sample size, limited conclusions can be drawn. Considering the results of ARTS-HF and that finerenone was well tolerated in Japanese patients in ARTS-HF Japan, the safety and efficacy of finerenone should be further explored in a large outcomes trial including Japanese patients. (Circ J 2016; 80: 1113–1122)
収録刊行物
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- Circulation Journal
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Circulation Journal 80 (5), 1113-1122, 2016
一般社団法人 日本循環器学会
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詳細情報 詳細情報について
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- CRID
- 1390001205107266944
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- NII論文ID
- 130005147667
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- NII書誌ID
- AA11591968
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- ISSN
- 13474820
- 13469843
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- NDL書誌ID
- 027269882
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- PubMed
- 27074824
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- 本文言語コード
- en
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- データソース種別
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- JaLC
- NDL
- Crossref
- PubMed
- CiNii Articles
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