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Efficacy and safety of esaxerenone in patients with hypertension and concomitant heart failure

Hypertension Research volume 44, pages 601–603 (2021)Cite this article

Conventional mineralocorticoid receptor antagonists (MRAs) have limited usefulness in patients with hypertension (HT) and concomitant heart failure (HF) because of adverse effects, including hyperkalemia and impaired renal function [1, 2]. Esaxerenone (ESAX) is a novel nonsteroidal MRA that may overcome the limitations of conventional MRAs [3]. However, the efficacy and safety of ESAX remain unclear in patients with HT and concomitant HF for whom current guidelines recommend treatment with MRAs.

From April 2019 to February 2020, we identified 48 patients with HT concomitant with HF in the outpatient clinic who satisfied two criteria (1) office systolic blood pressure (SBP) ≥ 140 mmHg and/or diastolic blood pressure (DBP) ≥ 90 mmHg; (2) home SBP ≥ 135 mmHg and/or DBP ≥ 85 mmHg) despite treatment with more than two antihypertensive agents, including angiotensin-converting enzyme inhibitors (ACEis), angiotensin II receptor blockers (ARBs), beta blockers, calcium channel blockers, diuretics (thiazide diuretics and/or loop diuretics), and MRAs. HF was defined as New York Heart Association (NYHA) class II or III and plasma B-type natriuretic peptide (BNP) > 40 pg/mL or NT-Pro-BNP > 125 pg/mL [4]. BP measurement and its target values were based on the current Japanese guidelines [1, 4]. Of the patients, 39 were treated with ESAX and included in the present study. ESAX was initially administered at 2.5 or 1.25 mg (if eGFR was below 60 mL/min/1.73 m2) and titrated to 5.0 mg to achieve the target home BP. All patients were followed through clinic visits at least every 2 weeks, without any changes in concomitant antihypertensive agents during the study period. The mean home SBP and DBP for each 2-week interval were also calculated. We evaluated ESAX efficacy and safety at 24 weeks of retrospective administration. The primary efficacy outcome measure was the change in home SBP/DBP; the secondary outcome measure was the change in plasma BNP level from at least 4 weeks before ESAX administration until week 24. The safety outcome measure was the incidence of treatment-related adverse events (TRAEs), defined as treatment-related abnormal laboratory findings or symptoms that caused discontinuation of ESAX. All patients provided written informed consent, and the present study was approved by the Ethics Committee on Human Investigation at each institution and conducted in accordance with the Declaration of Helsinki (64th The World Medical Association General Assembly, Fortaleza, Brazil, 2013).

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Authors and Affiliations

  1. Department of Cardiovascular Medicine, Kitasato University School of Medicine, Sagamihara, Japan

    Takashi Naruke, Kenji Maemura, Takumi Oki, Mayu Yazaki, Teppei Fujita, Yuki Ikeda, Takeru Nabeta, Shunsuke Ishii, Yoshiyasu Minami, Hidehira Fukaya, Takao Shimohama & Junya Ako

  2. Department of Cardiovascular Medicine, Odawara Municipal Hospital, Odawara, Japan

    Takashi Naruke, Masaru Yuge & Takeo Kawaguchi

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  1. Takashi Naruke
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Naruke, T., Maemura, K., Oki, T. et al. Efficacy and safety of esaxerenone in patients with hypertension and concomitant heart failure. Hypertens Res 44, 601–603 (2021). https://doi.org/10.1038/s41440-020-00606-w

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