{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T04:58:43Z","timestamp":1790053123156,"version":"4.0.1"},"reference-count":27,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"9","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["JAHA"],"published-print":{"date-parts":[[2016,9]]},"abstract":"<jats:sec xml:lang=\"en\">\n            <jats:title>Background<\/jats:title>\n            <jats:p xml:lang=\"en\">\n              The\n              <jats:styled-content style=\"fixed-case\">PCSK<\/jats:styled-content>\n              9 antibody alirocumab (75\u00a0mg every 2\u00a0weeks; Q2W) as monotherapy reduced low\u2010density lipoprotein\u2010cholesterol (\n              <jats:styled-content style=\"fixed-case\">LDL<\/jats:styled-content>\n              \u2010C) levels by 47%. Because the option of a monthly dosing regimen is convenient,\n              <jats:styled-content style=\"fixed-case\">ODYSSEY CHOICE II<\/jats:styled-content>\n              evaluated alirocumab 150\u00a0mg Q4W in patients with inadequately controlled hypercholesterolemia and not on statin (majority with statin\u2010associated muscle symptoms), receiving treatment with fenofibrate, ezetimibe, or diet\u00a0alone.\n            <\/jats:p>\n          <\/jats:sec>\n          <jats:sec xml:lang=\"en\">\n            <jats:title>Methods and Results<\/jats:title>\n            <jats:p xml:lang=\"en\">\n              Patients were randomly assigned to placebo, alirocumab 150\u00a0mg Q4W or 75\u00a0mg Q2W (calibrator arm), with dose adjustment to 150\u00a0mg Q2W at week (W) 12 if W8 predefined\n              <jats:styled-content style=\"fixed-case\">LDL<\/jats:styled-content>\n              \u2010C target levels were not met. The primary efficacy endpoint was\n              <jats:styled-content style=\"fixed-case\">LDL<\/jats:styled-content>\n              \u2010C percentage change from baseline to W24. Mean baseline\n              <jats:styled-content style=\"fixed-case\">LDL<\/jats:styled-content>\n              \u2010C levels were 163.9\u00a0mg\/dL (alirocumab 150\u00a0mg Q4W, n=59), 154.5\u00a0mg\/dL (alirocumab 75\u00a0mg Q2W, n=116), and 158.5\u00a0mg\/dL (placebo, n=58). In the alirocumab 150\u00a0mg Q4W and 75\u00a0mg Q2W groups (49.1% and 36.0% of patients received dose adjustment, respectively), least\u2010squares mean\n              <jats:styled-content style=\"fixed-case\">LDL<\/jats:styled-content>\n              \u2010C changes from baseline to W24 were \u221251.7% and \u221253.5%, respectively (placebo [+4.7%]; both groups\n              <jats:italic>P<\/jats:italic>\n              &lt;0.0001 versus placebo). In total, 63.9% and 70.3% of alirocumab\u2010treated patients achieved their\n              <jats:styled-content style=\"fixed-case\">LDL<\/jats:styled-content>\n              \u2010C targets at W24. Treatment\u2010emergent adverse events occurred in 77.6% (alirocumab 150\u00a0mg Q4W), 73.0% (alirocumab 75\u00a0mg Q2W), and 63.8% (placebo) of patients, with injection\u2010site reactions among the most common treatment\u2010emergent adverse events.\n            <\/jats:p>\n          <\/jats:sec>\n          <jats:sec xml:lang=\"en\">\n            <jats:title>Conclusions<\/jats:title>\n            <jats:p xml:lang=\"en\">\n              Alirocumab 150\u00a0mg Q4W can be considered in patients not on statin with inadequately controlled hypercholesterolemia as a convenient option for lowering\n              <jats:styled-content style=\"fixed-case\">LDL<\/jats:styled-content>\n              \u2010C.\n            <\/jats:p>\n          <\/jats:sec>\n          <jats:sec xml:lang=\"en\">\n            <jats:title>Clinical Trial Registration<\/jats:title>\n            <jats:p xml:lang=\"en\">\n              <jats:styled-content style=\"fixed-case\">URL<\/jats:styled-content>\n              :\n              <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.clinicaltrials.gov\">http:\/\/www.clinicaltrials.gov<\/jats:ext-link>\n              . Unique identifier:\n              <jats:styled-content style=\"fixed-case\">NCT<\/jats:styled-content>\n              02023879.\n            <\/jats:p>\n          <\/jats:sec>","DOI":"10.1161\/jaha.116.003421","type":"journal-article","created":{"date-parts":[[2016,9,14]],"date-time":"2016-09-14T01:39:23Z","timestamp":1473817163000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":83,"title":["Efficacy and Safety of Alirocumab 150\u00a0mg Every 4\u00a0Weeks in Patients With Hypercholesterolemia Not on Statin Therapy: The ODYSSEY CHOICE II Study"],"prefix":"10.1161","volume":"5","author":[{"given":"Erik","family":"Stroes","sequence":"first","affiliation":[{"name":"Department of Vascular Medicine, Academic Medical Center, Amsterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John R.","family":"Guyton","sequence":"additional","affiliation":[{"name":"Duke University Medical Center, Durham, 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