{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,26]],"date-time":"2026-10-26T18:41:40Z","timestamp":1793040100866,"version":"4.5.0"},"reference-count":27,"publisher":"Oxford University Press (OUP)","issue":"17","license":[{"start":{"date-parts":[[2020,11,30]],"date-time":"2020-11-30T00:00:00Z","timestamp":1606694400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Sanofi and Regeneron Pharmaceuticals, Inc"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,2,3]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>To obtain safety and efficacy data of alirocumab, a proprotein convertase subtilisin\/kexin type 9 inhibitor, in a real-life setting in high cardiovascular (CV) risk patients with heterozygous familial hypercholesterolaemia (HeFH) or very-high low-density lipoprotein cholesterol (LDL-C) levels despite maximally tolerated dose of statin \u00b1 other lipid-lowering therapies (MTD \u00b1 LLTs). ODYSSEY APPRISE was a prospective, single-arm, Phase 3b open-label (\u226512\u2009weeks to \u2264 30\u2009months) European\/Canadian study with alirocumab.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and results<\/jats:title>\n                    <jats:p>Patients received alirocumab 75 or 150\u2009mg every 2\u2009weeks, with dose adjustment based on physician\u2019s judgment. In total, 994 patients were enrolled and treated. The mean [standard deviation (SD)] duration of alirocumab exposure was 72.4 (42.5) weeks. Patients with HeFH were younger [mean (SD) age of 53.8 (11.6) vs. 61.6 (10.1) years], more likely to be female (41.7% vs. 29.1%) and had higher baseline LDL-C compared with non-familial hypercholesterolaemia (non-FH) patients [mean (SD) of 5.1 (1.7) vs. 4.1 (1.1) mmol\/L]. The overall incidence of treatment-emergent adverse events (TEAEs) was 71.6%; common TEAEs included nasopharyngitis (7.8%), myalgia (7.1%), and headache (6.2%). At Week 12, mean (SD) LDL-C was reduced by 54.8 (20.1)% from baseline [2.6 (1.2) mmol\/L], maintained for the trial duration. LDL-C was reduced below 1.8\u2009mmol\/L and\/or by \u226550% reduction from baseline in 69.1% of patients overall, and for 64.7 and 77.4% of the HeFH and non-FH subgroups, respectively.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>In a real-life setting in patients with hypercholesterolaemia and high CV risk, alirocumab was generally well tolerated and resulted in clinically significant LDL-C reductions.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/eurjpc\/zwaa097","type":"journal-article","created":{"date-parts":[[2020,12,31]],"date-time":"2020-12-31T23:13:55Z","timestamp":1609456435000},"page":"1864-1872","source":"Crossref","is-referenced-by-count":34,"title":["Safety and efficacy of alirocumab in a real-life setting: the ODYSSEY APPRISE study"],"prefix":"10.1093","volume":"28","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5185-3666","authenticated-orcid":false,"given":"Daniel","family":"Gaudet","sequence":"first","affiliation":[{"name":"ECOGENE-21 and Clinical Lipidology Unit, Community Gene Medicine Center, Department of Medicine, Universit\u00e9 de Montr\u00e9al, Chicoutimi, QC G7H 7K9, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jos\u00e9 Luis","family":"L\u00f3pez-Send\u00f3n","sequence":"additional","affiliation":[{"name":"IdiPaz, CIBER-CV, UAM, Hospital Universitario La Paz, Madrid 20846, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maurizio","family":"Averna","sequence":"additional","affiliation":[{"name":"Department of Health Promotion Sciences, Maternal and Infantile Care, Internal Medicine and Medical Specialties\u2014PROMISE, School of Medicine, University of Palermo, Palermo 90133, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gr\u00e9gory","family":"Bigot","sequence":"additional","affiliation":[{"name":"IviData Life Sciences, Levallois-Perret 92300, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maciej","family":"Banach","sequence":"additional","affiliation":[{"name":"Department of Hypertension, Medical University of Lodz, Lodz 90-419, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexia","family":"Letierce","sequence":"additional","affiliation":[{"name":"Sanofi, Chilly-Mazarin 91380, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Megan","family":"Loy","sequence":"additional","affiliation":[{"name":"Sanofi, Bridgewater, NJ 08807, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rita","family":"Samuel","sequence":"additional","affiliation":[{"name":"Regeneron Pharmaceuticals, Inc., Tarrytown, NY 10591, 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