{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T16:25:42Z","timestamp":1793291142211,"version":"4.5.0"},"reference-count":43,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2025,12,24]],"date-time":"2025-12-24T00:00:00Z","timestamp":1766534400000},"content-version":"vor","delay-in-days":1,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100001003","name":"Boehringer Ingelheim","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100001003","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,1,6]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>Aldosterone synthase inhibition may affect cortisol synthesis due to homology between CYP11B2 (aldosterone synthase) and CYP11B1. The selectivity of vicadrostat, a highly selective aldosterone synthase inhibitor, for aldosterone suppression was evaluated by corticosteroid assessment in participants with albuminuric CKD (with or without T2D) in a randomized, double-blind, placebo-controlled phase 2 trial (NCT05182840)<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>After randomization to receive empagliflozin 10\u2005mg once-daily or matched placebo for an 8-week run-in (plus renin\u2013angiotensin system inhibitors), 586 participants were re-randomized to receive vicadrostat (3, 10, or 20\u2005mg once-daily) or matched placebo for 14 weeks, with a 4-week follow-up. Our analysis included 410 participants who completed treatment. Plasma corticosteroids (aldosterone, cortisol, corticosterone, 11-deoxycorticosterone, and 11-deoxycortisol) were measured using liquid chromatography tandem mass spectrometry. Effects were evaluated via mixed effects models for repeated measures.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Dose-dependent suppression of plasma aldosterone was observed, with maximum suppression at week 14 resulting in geometric mean changes of \u221249.5% (95% CI: \u221268.7, \u221218.5) and \u221252.1% (\u221270.7, \u221221.6) for vicadrostat 20\u2005mg given with and without empagliflozin, respectively. From baseline to week 14, increases were observed in mean plasma corticosterone, 11-deoxycorticosterone, and 11-deoxycortisol. Plasma 11-deoxycorticosterone increased by 222.8% (95% CI: 103.2, 412.7) and 231.5% (95% CI: 106.4, 432.2) for vicadrostat 20\u2005mg given with or without empagliflozin, respectively, and plasma 11-deoxycortisol increased by 112.5% (95% CI: 36.0, 231.9) and 121.0% (95% CI: 40.0, 249.0) for the same dose groups. No increase or decrease in plasma cortisol was observed across vicadrostat dose groups with or without empagliflozin. Aldosterone suppression was sustained to 4 weeks post-treatment, while precursor levels normalized within 1 week of treatment cessation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Vicadrostat, with or without background empagliflozin, selectively suppressed aldosterone over cortisol. These findings will be explored in a phase 3 trial program.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/ejendo\/lvaf265","type":"journal-article","created":{"date-parts":[[2025,12,20]],"date-time":"2025-12-20T12:50:41Z","timestamp":1766235041000},"page":"46-57","source":"Crossref","is-referenced-by-count":4,"title":["Pharmacodynamics of vicadrostat for aldosterone synthase inhibition in patients with CKD"],"prefix":"10.1093","volume":"194","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5984-576X","authenticated-orcid":false,"given":"Isabella A","family":"Gashaw","sequence":"first","affiliation":[{"name":"Experimental Medicine Cardiovascular, Renal and Metabolic, Boehringer Ingelheim Pharma GmbH & Co. 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