{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T16:12:11Z","timestamp":1790957531981,"version":"4.1.0"},"reference-count":45,"publisher":"BMJ","issue":"3","license":[{"start":{"date-parts":[[2024,3,20]],"date-time":"2024-03-20T00:00:00Z","timestamp":1710892800000},"content-version":"unspecified","delay-in-days":19,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004326","name":"Bayer AG","doi-asserted-by":"crossref","award":["Not applicable"],"award-info":[{"award-number":["Not applicable"]}],"id":[{"id":"10.13039\/100004326","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2024,2,20]]},"published-print":{"date-parts":[[2024,3]]},"abstract":"<jats:sec><jats:title>Objectives<\/jats:title><jats:p>This study aimed to evaluate the efficacy and safety of finerenone, a selective, non-steroidal mineralocorticoid receptor antagonist, on cardiovascular and kidney outcomes by age and\/or sex.<\/jats:p><\/jats:sec><jats:sec><jats:title>Design<\/jats:title><jats:p>FIDELITY post hoc analysis; median follow-up of 3 years.<\/jats:p><\/jats:sec><jats:sec><jats:title>Setting<\/jats:title><jats:p>FIDELITY: a prespecified analysis of the FIDELIO-DKD and FIGARO-DKD trials.<\/jats:p><\/jats:sec><jats:sec><jats:title>Participants<\/jats:title><jats:p>Adults with type 2 diabetes and chronic kidney disease receiving optimised renin\u2013angiotensin system inhibitors (N=13 026).<\/jats:p><\/jats:sec><jats:sec><jats:title>Interventions<\/jats:title><jats:p>Randomised 1:1; finerenone or placebo.<\/jats:p><\/jats:sec><jats:sec><jats:title>Primary and secondary outcome measures<\/jats:title><jats:p>Cardiovascular (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or hospitalisation for heart failure (HHF)) and kidney (kidney failure, sustained \u226557% estimated glomerular filtration rate (eGFR) decline or renal death) composite outcomes.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Mean age was 64.8 years; 45.2%, 40.1% and 14.7% were aged &lt;65, 65\u201374 and \u226575 years, respectively; 69.8% were male. Cardiovascular benefits of finerenone versus placebo were consistent across age (HR 0.94 (95% CI 0.81 to 1.10) (&lt;65 years), HR 0.84 (95% CI 0.73 to 0.98) (65\u201374 years), HR 0.80 (95% CI 0.65 to 0.99) (\u226575 years); P<jats:sub>interaction<\/jats:sub>=0.42) and sex categories (HR 0.86 (95% CI 0.77 to 0.96) (male), HR 0.89 (95% CI 0.35 to 2.27) (premenopausal female), HR 0.87 (95% CI 0.73 to 1.05) (postmenopausal female); P<jats:sub>interaction<\/jats:sub>=0.99). Effects on HHF reduction were not modified by age (P<jats:sub>interaction<\/jats:sub>=0.70) but appeared more pronounced in males (P<jats:sub>interaction<\/jats:sub>=0.02). Kidney events were reduced with finerenone versus placebo in age groups &lt;65\u2009and 65\u201374 but not \u226575; no heterogeneity in treatment effect was observed (P<jats:sub>interaction<\/jats:sub>=0.51). In sex subgroups, finerenone consistently reduced kidney events (P<jats:sub>interaction<\/jats:sub>=0.85). Finerenone reduced albuminuria and eGFR decline regardless of age and sex. Hyperkalaemia increased with finerenone, but discontinuation rates were &lt;3% across subgroups. Gynaecomastia in males was uncommon across age subgroups and identical between treatment groups.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Finerenone improved cardiovascular and kidney composite outcomes with no significant heterogeneity between age and sex subgroups; however, the effect on HHF appeared more pronounced in males. Finerenone demonstrated a similar safety profile across age and sex subgroups.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial registration numbers<\/jats:title><jats:p><jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"isrctn\" xlink:href=\"NCT02540993\">NCT02540993<\/jats:ext-link>,<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"isrctn\" xlink:href=\"NCT02545049\">NCT02545049<\/jats:ext-link>.<\/jats:p><\/jats:sec>","DOI":"10.1136\/bmjopen-2023-076444","type":"journal-article","created":{"date-parts":[[2024,6,2]],"date-time":"2024-06-02T10:38:13Z","timestamp":1717324693000},"page":"e076444","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":41,"title":["Finerenone cardiovascular and kidney outcomes by age and sex: FIDELITY post hoc analysis of two phase 3, multicentre, double-blind 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