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A pooled analysis of five multicenter, prospective, open-label single-arm studies was conducted, including 479 patients in the full analysis set (FAS) and 492 patients in the safety analysis set. Multivariate linear regression analysis of morning home systolic BP (SBP) and diastolic BP (DBP) changes from baseline to Week 12 in the FAS (primary endpoint) showed that male sex (estimated change 4.37\u2009mmHg), office pulse rate \u2265100 beats\/min (25.10\u2009mmHg), and calcium channel blocker (CCB) use as a basal antihypertensive agent (4.53\u2009mmHg) were significantly associated with a positive estimated change (weaker BP-lowering effect) in morning home SBP. CCB use (3.70\u2009mmHg) was associated with a positive estimated change in morning home DBP. Urine albumin\u2010to\u2010creatinine ratio 30 to &lt;300\u2009mg\/gCr (\u22124.13\u2009mmHg) was significantly associated with a negative estimated change (stronger BP-lowering effect) in morning home SBP. Based on multivariate logistic regression analysis, elevated baseline serum potassium level (\u22654.5 vs\u2009&lt;\u20094.5\u2009mEq\/L, odds ratio 13.502) was significantly associated with a high incidence of serum potassium level \u22655.5\u2009mEq\/L after esaxerenone treatment. In conclusion, factors associated with a strong BP-lowering effect of esaxerenone were female sex and use of renin\u2013angiotensin system inhibitors as a basal antihypertensive drug. Patients with baseline serum potassium levels \u22654.5\u2009mEq\/L had an increased risk of developing elevated serum potassium levels (\u22655.5\u2009mEq\/L) after esaxerenone treatment.<\/jats:p>","DOI":"10.1038\/s41440-024-01818-0","type":"journal-article","created":{"date-parts":[[2024,8,2]],"date-time":"2024-08-02T03:46:34Z","timestamp":1722570394000},"page":"2826-2839","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["Factors influencing the efficacy and safety of esaxerenone in hypertensive patients: a pooled analysis of five clinical studies on different comorbidities"],"prefix":"10.1038","volume":"47","author":[{"given":"Kazuomi","family":"Kario","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomohiro","family":"Katsuya","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jun","family":"Wada","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hirohiko","family":"Motoki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Koichiro","family":"Kuwahara","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenichi","family":"Tsujita","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takashi","family":"Taguchi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ayumi","family":"Tanabe","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tatsuo","family":"Shimosawa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,8,2]]},"reference":[{"key":"1818_CR1","doi-asserted-by":"publisher","first-page":"351","DOI":"10.1111\/jch.13751","volume":"22","author":"K Kario","year":"2020","unstructured":"Kario K, Park S, Chia YC, Sukonthasarn A, Turana Y, Shin J, et al. 2020 Consensus summary on the management of hypertension in Asia from the HOPE Asia Network. 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TK received honoraria from Daiichi Sankyo Co., Ltd., CureApp, Inc., and Novartis Pharma K.K. JW received honoraria for speakers\u2019 bureaus from Astra Zeneca and Daiichi Sankyo. K Kuwahara received honoraria from Alnylam Japan K.K., Otsuka Pharmaceutical Co., Ltd., Ono Pharmaceutical Co., Ltd., Kyowa Kirin Co., Ltd., AstraZeneca K.K., Astellas Pharma Inc., Novo Nordisk Pharma Ltd., Daiichi Sankyo Co., Ltd., Mitsubishi Tanabe Pharma Corporation, Eli Lilly Japan K.K., Nippon Boehringer Ingelheim Co., Ltd., Novartis Pharma, K.K., Bayer Yakuhin, Ltd., and Pfizer Japan Inc.; research funding from Novo Nordisk Pharma Ltd. and Kowa Co., Ltd.; scholarships or donations from Otsuka Pharmaceutical Co., Ltd., Nippon Boehringer Ingelheim Co., Ltd., Mitsubishi Tanabe Pharma Corporation, Taisho Pharmaceutical Co., Ltd., and Fukuda Denshi Co., Ltd.; and departmental endowments from Abbott Medical Japan LLC., Medtronic Japan Co., Ltd., Biotronik Japan, Inc., Boston Scientific Japan K.K., Japan Lifeline Co., Ltd., Terumo Corporation, Nipro Corporation, and Cordis Japan G.K. KT received honoraria from Abbott Medical Co., Ltd., Amgen K.K., Bayer Yakuhin, Ltd., Daiichi Sankyo Co., Ltd., Kowa Pharmaceutical Co., Ltd., Nippon Boehringer Ingelheim Co., Ltd., Novartis Pharma K.K., Otsuka Pharmaceutical Co., Ltd., Pfizer Japan Inc., Takeda Pharmaceutical Co., Ltd., and Terumo Corporation; research funding from Mochida Pharmaceutical Co., Ltd. and EA Pharma Co., Ltd.; scholarships or donations from Abbott Medical Co., Ltd., ITI Co., Ltd., Boehringer Ingelheim Japan, Otsuka Pharmaceutical Co., Ltd., and Boston Scientific Japan K.K.; and departmental endowments from Abbott Japan Co., Ltd., Boston Scientific Japan K.K., Fides-one, Inc., GM Medical Co., Ltd., ITI Co., Ltd., Kaneka Medix Co., Ltd., Nipro Corporation, Terumo Co., Ltd., Philips Japan Ltd., Getinge Group Japan K.K., Orbusneich Medical K.K., Abbott Medical Co., Ltd., Biotronik Japan, Inc., Boston Scientific Japan K.K., Fukuda Denshi Co., Ltd., Japan Lifeline Co., Ltd., Medtronic Japan Co., Ltd., and Nippon Boehringer Ingelheim Co., Ltd. TS had an employment\/leadership position\/advisory role with Sekisui Medical Co., Ltd. and EP Mediate Co., Ltd.; and received honoraria from Daiichi Sankyo Co., Ltd., Novartis Pharma K.K., Otsuka Pharmaceutical Co., Ltd., Sanofi K.K., Ion Retail Co., Ltd., and Ion Happicom Co., Ltd. TT and AT are employees of Daiichi Sankyo Co., Ltd., Tokyo, Japan. HM had no conflicts of interest to declare.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}