{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,18]],"date-time":"2026-04-18T15:19:03Z","timestamp":1776525543322,"version":"3.51.2"},"reference-count":29,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2018,10,21]],"date-time":"2018-10-21T00:00:00Z","timestamp":1540080000000},"content-version":"vor","delay-in-days":20,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100002429","name":"Amgen","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100002429","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Cardiology"],"published-print":{"date-parts":[[2018,10]]},"abstract":"<jats:sec><jats:title>Background<\/jats:title><jats:p>Evolocumab significantly lowers low\u2010density lipoprotein cholesterol (LDL\u2010C) when dosed 140\u2009mg every 2 weeks (Q2W) or 420\u2009mg monthly (QM) subcutaneously.<\/jats:p><\/jats:sec><jats:sec><jats:title>Hypothesis<\/jats:title><jats:p>LDL\u2010C changes are comparable among different patient subgroups in a pooled analysis of data from phase 3 trials.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A total of 3146 patients received \u22651 dose of evolocumab or control in four 12\u2010week phase 3 studies. Percent change from baseline in LDL\u2010C for evolocumab 140\u2009mg Q2W or 420\u2009mg QM vs control was reported as the average of week 10 and 12 values. Quantitative and qualitative interactions between treatment group and subgroup by dose regimen were tested.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>In the pooled analysis, treatment differences vs placebo or ezetimibe were similar for both 140\u2009mg Q2W and 420\u2009mg QM doses across ages (&lt;65\u2009years, \u226565\u2009years); gender; race (Asian, black, white, other); ethnicity (Hispanic, non\u2010Hispanic); region (Europe, North America, Asia Pacific); glucose tolerance status (type 2 diabetes mellitus, metabolic syndrome, neither); National Cholesterol Education Program risk categories (high, moderately high, moderate, low); and European Society of Cardiology\/European Atherosclerosis Society risk categories (very high, high, moderate, or low). Certain low\u2010magnitude variations in LDL\u2010C lowering among subgroups led to significant quantitative interaction <jats:italic>P<\/jats:italic> values that, when tested by qualitative interaction, were not significant. The incidences of adverse events were similar across groups treated with each evolocumab dosing regimen or control.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Consistent reductions in LDL\u2010C were observed in the evolocumab group regardless of demographic and disease characteristics.<\/jats:p><\/jats:sec>","DOI":"10.1002\/clc.23049","type":"journal-article","created":{"date-parts":[[2018,8,18]],"date-time":"2018-08-18T04:14:50Z","timestamp":1534565690000},"page":"1328-1335","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":20,"title":["Consistent LDL\u2010C response with evolocumab among patient subgroups in PROFICIO: A pooled analysis of 3146 patients from phase 3 studies"],"prefix":"10.1002","volume":"41","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9555-6260","authenticated-orcid":false,"given":"Erik","family":"Stroes","sequence":"first","affiliation":[{"name":"Department of Vascular Medicine Academic Medical Center of Amsterdam  Amsterdam Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jennifer G.","family":"Robinson","sequence":"additional","affiliation":[{"name":"Departments of Epidemiology and Medicine University of Iowa  Iowa City Iowa"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Frederick J.","family":"Raal","sequence":"additional","affiliation":[{"name":"Department of Medicine University of the Witwatersrand, Faculty of Health Sciences  Johannesburg South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert","family":"Dufour","sequence":"additional","affiliation":[{"name":"Institut de recherches cliniques de Montr\u00e9al Universit\u00e9 de Montr\u00e9al  Montreal Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Sullivan","sequence":"additional","affiliation":[{"name":"Department of Clinical Biochemistry Prince Alfred Hospital  Camperdown Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Helina","family":"Kassahun","sequence":"additional","affiliation":[{"name":"Amgen Inc.  Thousand Oaks California"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuhui","family":"Ma","sequence":"additional","affiliation":[{"name":"Amgen Inc.  Thousand Oaks California"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Scott M.","family":"Wasserman","sequence":"additional","affiliation":[{"name":"Amgen Inc.  Thousand Oaks California"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael J.","family":"Koren","sequence":"additional","affiliation":[{"name":"Jacksonville Center for Clinical Research  Jacksonville Florida"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2018,10,21]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cjca.2016.07.510"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacl.2013.10.001"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehs092"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1161\/01.cir.0000437738.63853.7a"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehr158"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2014.02.615"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.115.018381"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.108.838466"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2017.07.745"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1316222"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(12)61770-X"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1253\/circj.CJ-14-0130"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2014.03.018"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(12)61771-1"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.112.144055"},{"key":"e_1_2_7_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(14)61399-4"},{"key":"e_1_2_7_18_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2014.4030"},{"key":"e_1_2_7_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2014.03.019"},{"key":"e_1_2_7_20_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2012.25790"},{"key":"e_1_2_7_21_1","doi-asserted-by":"publisher","DOI":"10.2307\/2530862"},{"key":"e_1_2_7_22_1","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehu085"},{"key":"e_1_2_7_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.bbrc.2007.07.029"},{"key":"e_1_2_7_24_1","doi-asserted-by":"publisher","DOI":"10.1210\/en.2004-0228"},{"key":"e_1_2_7_25_1","doi-asserted-by":"publisher","DOI":"10.1210\/endo.138.9.5404"},{"key":"e_1_2_7_26_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0002-9378(96)70322-8"},{"key":"e_1_2_7_27_1","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2009-0141"},{"key":"e_1_2_7_28_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.113.005873"},{"key":"e_1_2_7_29_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjcard.2016.04.037"},{"key":"e_1_2_7_30_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2009.10.009"}],"container-title":["Clinical Cardiology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fclc.23049","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/clc.23049","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/clc.23049","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/clc.23049","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,9]],"date-time":"2023-09-09T18:14:05Z","timestamp":1694283245000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/clc.23049"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,10]]},"references-count":29,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2018,10]]}},"alternative-id":["10.1002\/clc.23049"],"URL":"https:\/\/doi.org\/10.1002\/clc.23049","archive":["Portico"],"relation":{},"ISSN":["0160-9289","1932-8737"],"issn-type":[{"value":"0160-9289","type":"print"},{"value":"1932-8737","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,10]]},"assertion":[{"value":"2018-06-11","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-08-13","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-10-21","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}