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This study evaluated efficacy and safety of early addition of ezetimibe (EZ) with atorvastatin (AS), prior to reaching the maximally tolerated dose of statin, in very high-risk patients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This phase 4 (NCT05761444), multicenter, randomized, open-label, active-controlled study enrolled patients (\u2265\u200930 years) with very high-risk of ASCVD. Eligible patients had LDL-C\u2009\u2265\u200970\u00a0mg\/dL with low\/moderate intensity statin monotherapy or statin-na\u00efve or not been on stable statin regimen prior to enrollment. Patients were randomized 1:1 to EZ10\/AS40 mg combination therapy or AS40 mg statin alone for 12 weeks. Primary endpoint was percentage change in LDL-C from baseline to week 6.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Patients (\n                      <jats:italic>N<\/jats:italic>\n                      \u2009=\u2009137) received EZ\/AS (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200967) or AS (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200970) once a day. The EZ\/AS lipid-lowering effect was statistically greater than AS monotherapy at week 6 (LSMD: \u02d721.2;\n                      <jats:italic>P<\/jats:italic>\n                      \u2009&lt;\u20090.0001) and week 12 (LSMD: \u02d716.0;\n                      <jats:italic>P<\/jats:italic>\n                      \u2009&lt;\u20090.0001). At week 12, higher proportions of patients who received EZ\/AS achieved target LDL-C\u2009&lt;\u200955\u00a0mg\/dL (55.0% vs. 15.4%;\n                      <jats:italic>P<\/jats:italic>\n                      \u2009&lt;\u20090.0001) and LDL-C\u2009&lt;\u200970\u00a0mg\/dL (85.0% vs. 58.5%;\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u20090.0009) than in AS group. Higher reduction from baseline was observed for lipid parameters in EZ\/AS group than AS monotherapy. Incidence of adverse events were comparable between EZ\/AS and AS groups.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Early combination of EZ with AS, rather than a stepwise approach, significantly reduced LDL-C levels and improved LDL-C reduction target achievement compared to AS monotherapy in very high-risk patients with dyslipidemia with no new safety issues.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>NCT05761444; Registration date: March 9, 2023.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s12872-026-05594-2","type":"journal-article","created":{"date-parts":[[2026,2,11]],"date-time":"2026-02-11T12:46:09Z","timestamp":1770813969000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["The role of early ezetimibe combination with atorvastatin in patients with atherosclerotic cardiovascular disease"],"prefix":"10.1186","volume":"26","author":[{"given":"Si-Hyuck","family":"Kang","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sung Uk","family":"Kwon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jong-Young","family":"Lee","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Suk Min","family":"Seo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chang-Wook","family":"Nam","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gyung-Min","family":"Park","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Young Joon","family":"Hong","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Won Young","family":"Lee","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jung Eun","family":"Jang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"In-Ho","family":"Chae","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,2,11]]},"reference":[{"key":"5594_CR1","doi-asserted-by":"crossref","unstructured":"Grundy SM, Stone NJ, Bailey AL, Beam C, Birtcher KK, Blumenthal RS, et al. 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