{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,3]],"date-time":"2026-10-03T02:39:06Z","timestamp":1790995146110,"version":"4.1.0"},"reference-count":13,"publisher":"Oxford University Press (OUP)","issue":"8","license":[{"start":{"date-parts":[[2020,2,5]],"date-time":"2020-02-05T00:00:00Z","timestamp":1580860800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"},{"start":{"date-parts":[[2020,2,5]],"date-time":"2020-02-05T00:00:00Z","timestamp":1580860800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"name":"FOURIER"},{"DOI":"10.13039\/100002429","name":"AMGEN","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100002429","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2021,7,23]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>Some trials have reported diminished efficacy for statins in the elderly, and in women compared with men. We examined the efficacy and safety of evolocumab by patient age and sex in the FOURIER trial, the first major cardiovascular outcome trial of a PCSK9 inhibitor.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and results<\/jats:title>\n                    <jats:p>FOURIER was a randomised, double blind trial, comparing evolocumab with placebo in 27,564 patients with atherosclerotic cardiovascular disease receiving statin therapy (median follow-up 2.2 years). The primary endpoint was cardiovascular death, myocardial infarction, stroke, hospitalisation for unstable angina or coronary revascularisation. Cox proportional hazards models were used to assess the efficacy of evolocumab versus placebo stratified by quartiles of patient age and by sex. There were small variations in the cardiovascular event rate across the age range (for the primary endpoint, Kaplan\u2013Meier at 3 years 15.6%, &amp;gt;69 years, vs. 15.1%, \u226456 years, P\u2009=\u20090.45); however, the relative efficacy of evolocumab was consistent regardless of patient age (for the primary endpoint (Q1 hazard ratio, 95% confidence interval) 0.83, 0.72\u20130.96, Q2 0.88, 0.76\u20131.01, Q3 0.82, 0.71\u20130.95, Q4 0.86, 0.74\u20131.00; Pinteraction\u2009=\u20090.91), and the key secondary endpoint (cardiovascular death, myocardial infarction, stroke) (Q1 0.74 (0.61\u20130.89), Q2 0.83 (0.69\u20131.00), Q3 0.78 (0.65\u20130.94), Q4 0.82 (0.69\u20130.98)); Pinteraction\u2009=\u20090.81). Women had a lower primary endpoint rate than men (Kaplan\u2013Meier at 3 years 12.5 vs. 15.3%, respectively, P\u2009&amp;lt;\u20090.001). Relative risk reductions in the primary endpoint and key secondary endpoint were similar in women (0.81 (0.69\u20130.95) and 0.74 (0.61\u20130.90), respectively) compared with men (0.86 (0.80\u20130.94) and 0.81 (0.73\u20130.90), respectively), Pinteraction\u2009=\u20090.48 and 0.44, respectively. Adverse events were more common in women and with increasing age but, with the exception of injection site reactions, there were no important significant differences reported by those assigned evolocumab versus placebo.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The efficacy and safety of evolocumab are similar throughout a broad range of ages and in both men and women.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/2047487320902750","type":"journal-article","created":{"date-parts":[[2020,2,5]],"date-time":"2020-02-05T00:50:00Z","timestamp":1580863800000},"page":"805-812","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":92,"title":["LDL-cholesterol lowering with evolocumab, and outcomes according to age and sex in patients in the FOURIER Trial"],"prefix":"10.1093","volume":"28","author":[{"given":"Peter","family":"Sever","sequence":"first","affiliation":[{"name":"National Heart and Lung Institute, Imperial College London , UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ioanna","family":"Gouni-Berthold","sequence":"additional","affiliation":[{"name":"Polyclinic for Endocrinology, Diabetes and Preventive Medicine, University of Cologne , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anthony","family":"Keech","sequence":"additional","affiliation":[{"name":"NHMRC Clinical Trials Centre, University of Sydney , Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Giugliano","sequence":"additional","affiliation":[{"name":"TIMI Study Group, Brigham and Women\u2019s Hospital and Harvard Medical School , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Terje R","family":"Pedersen","sequence":"additional","affiliation":[{"name":"Centre for Preventive Medicine, Ullev\u00e5l University Hospital , Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"KyungAh","family":"Im","sequence":"additional","affiliation":[{"name":"TIMI Study Group, Brigham and Women\u2019s Hospital and Harvard Medical School , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Huei","family":"Wang","sequence":"additional","affiliation":[{"name":"Clinical Development, Amgen Inc. , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Beat","family":"Knusel","sequence":"additional","affiliation":[{"name":"Clinical Development, Amgen Inc. , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marc S","family":"Sabatine","sequence":"additional","affiliation":[{"name":"TIMI Study Group, Brigham and Women\u2019s Hospital and Harvard Medical School , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michelle L","family":"O\u2019Donoghue","sequence":"additional","affiliation":[{"name":"TIMI Study Group, Brigham and Women\u2019s Hospital and Harvard Medical School , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2020,2,5]]},"reference":[{"key":"2023080117122306400_zwaa237-B1","doi-asserted-by":"crossref","first-page":"94","DOI":"10.1016\/j.ahj.2015.11.015","article-title":"Rationale and design of the Further cardiovascular OUtcomes Research with PCSK9 Inhibition in subjects with Elevated Risk trial","volume":"173","author":"Sabatine","year":"2016","journal-title":"Am Heart J"},{"key":"2023080117122306400_zwaa237-B2","doi-asserted-by":"crossref","first-page":"1713","DOI":"10.1056\/NEJMoa1615664","article-title":"FOURIER Steering Committee and Investigators. Evolocumab and clinical outcomes in patients with cardiovascular disease","volume":"376","author":"Sabatine","year":"2017","journal-title":"N Engl J Med"},{"key":"2023080117122306400_zwaa237-B3","doi-asserted-by":"crossref","first-page":"407","DOI":"10.1016\/S0140-6736(18)31942-1","article-title":"Efficacy and safety of statin therapy in older people: a meta-analysis of individual participant data from 28 randomised controlled trials","volume":"393","year":"2019","journal-title":"Lancet"},{"key":"2023080117122306400_zwaa237-B4","first-page":"606","article-title":"LDL cholesterol still a problem in old age? A Mendelian randomization study","volume":"2","author":"Postmus","year":"2015","journal-title":"Int J Epidemiol"},{"key":"2023080117122306400_zwaa237-B5","doi-asserted-by":"crossref","first-page":"2243","DOI":"10.1001\/jama.291.18.2243","article-title":"Drug treatment of hyperlipidemia in women","volume":"291","author":"Walsh","year":"2004","journal-title":"JAMA"},{"key":"2023080117122306400_zwaa237-B6","doi-asserted-by":"crossref","first-page":"25","DOI":"10.1016\/j.ijcard.2008.08.001","article-title":"Impact of gender in primary prevention of coronary heart disease with statin therapy: a meta-analysis","volume":"138","author":"Petretta","year":"2010","journal-title":"Int J Cardiol"},{"key":"2023080117122306400_zwaa237-B7","doi-asserted-by":"crossref","first-page":"1397","DOI":"10.1016\/S0140-6736(14)61368-4","article-title":"Cholesterol Treatment Trialists\u2019 (CTT) Collaboration. Efficacy and safety of LDL-lowering therapy among men and women: meta-analysis of individual data from 174,000 participants in 27 randomised trials","volume":"385","author":"Fulcher","year":"2015","journal-title":"Lancet"},{"key":"2023080117122306400_zwaa237-B8","doi-asserted-by":"crossref","first-page":"1971","DOI":"10.1001\/jama.2016.15212","article-title":"Statins for primary prevention in older adults: uncertainty and the need for more evidence","volume":"316","author":"Gurwitz","year":"2016","journal-title":"JAMA"},{"key":"2023080117122306400_zwaa237-B9","doi-asserted-by":"crossref","first-page":"636","DOI":"10.1177\/2047487315569401","article-title":"EUROASPIRE IV: A European Society of Cardiology survey on lifestyle, risk factor and therapeutic management of coronary patients from 24 European countries","volume":"23","author":"Kotseva","year":"2016","journal-title":"Eur J Prev Cardiol"},{"key":"2023080117122306400_zwaa237-B10","doi-asserted-by":"crossref","first-page":"844","DOI":"10.1177\/2047487318766612","article-title":"A Bayesian network meta-analysis of PCSK9 inhibitors, statins and ezetimibe with or without statins for cardiovascular outcomes","volume":"25","author":"Khan","year":"2018","journal-title":"Eur J Prev Cardiol"},{"key":"2023080117122306400_zwaa237-B11","doi-asserted-by":"crossref","first-page":"e006901","DOI":"10.1161\/JAHA.117.006901","article-title":"Efficacy and safety of adding ezetimibe to statin therapy among women and men: insight from IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial)","volume":"6","author":"Kato","year":"2017","journal-title":"JAHA"},{"key":"2023080117122306400_zwaa237-B12","doi-asserted-by":"crossref","first-page":"2387","DOI":"10.1056\/NEJMoa1410489","article-title":"Ezetimibe added to statin therapy after acute coronary syndromes","volume":"372","author":"Cannon","year":"2015","journal-title":"N Engl J Med"},{"key":"2023080117122306400_zwaa237-B13","doi-asserted-by":"crossref","first-page":"2097","DOI":"10.1056\/NEJMoa1801174","article-title":"ODYSSEY OUTCOMES Committees and Investigators. 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