{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T19:25:28Z","timestamp":1790796328302,"version":"4.1.0"},"reference-count":31,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2018,6,28]],"date-time":"2018-06-28T00:00:00Z","timestamp":1530144000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cardiovascular Therapeutics"],"published-print":{"date-parts":[[2018,10]]},"abstract":"<jats:title>Summary<\/jats:title><jats:sec><jats:title>Aim<\/jats:title><jats:p><jats:styled-content style=\"fixed-case\">PCSK<\/jats:styled-content>9 inhibitors (<jats:styled-content style=\"fixed-case\">PCSK<\/jats:styled-content>9i) effectively lower cholesterol levels in randomized trials with reduction in cardiovascular outcomes and favorable safety profile. However, the access to <jats:styled-content style=\"fixed-case\">PCSK<\/jats:styled-content>9i is limited due to high cost and data regarding the use of <jats:styled-content style=\"fixed-case\">PCSK<\/jats:styled-content>9i in real\u2010world practice is limited.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Data on all patients submitted for approval of <jats:styled-content style=\"fixed-case\">PCSK<\/jats:styled-content>9i at a regional lipid clinic, outside of clinical trials. Patients' profile, approval rates, low\u2010density lipoprotein cholesterol (<jats:styled-content style=\"fixed-case\">LDL<\/jats:styled-content>\u2010C) reduction rates, and adverse events were evaluated.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Recommendation for <jats:styled-content style=\"fixed-case\">PCSK<\/jats:styled-content>9i was given to 133 patients; 16 did not receive insurance approval and additional 16 were approved but did not initiate therapy. Of the 101 treated patients (47% females; mean age 61\u00a0\u00b1\u00a011\u00a0years), 52 had probable\/definite familial hypercholesterolemia (<jats:styled-content style=\"fixed-case\">FH<\/jats:styled-content>) (peak <jats:styled-content style=\"fixed-case\">LDL<\/jats:styled-content>\u2010C level 305\u00a0\u00b1\u00a087\u00a0mg\/dL vs non\u2010<jats:styled-content style=\"fixed-case\">FH<\/jats:styled-content> 204\u00a0\u00b1\u00a039\u00a0mg\/dL) and 62% had an established cardiovascular disease. Statin intolerance was reported by 77%. Follow\u2010up lipid panel was available in 66\/101 patients: mean <jats:styled-content style=\"fixed-case\">LDL<\/jats:styled-content>\u2010C reduction was 59%\u00a0\u00b1\u00a019. Subjects with heterozygous <jats:styled-content style=\"fixed-case\">FH<\/jats:styled-content> had similar <jats:styled-content style=\"fixed-case\">LDL<\/jats:styled-content>\u2010C decrease than those with non\u2010<jats:styled-content style=\"fixed-case\">FH<\/jats:styled-content> (59%\u00a0\u00b1\u00a022 vs 60%\u00a0\u00b1\u00a014, <jats:italic>P<\/jats:italic>\u00a0=\u00a0.792). <jats:styled-content style=\"fixed-case\">LDL<\/jats:styled-content>\u2010C &lt;\u00a0100\u00a0mg\/dL was achieved by 76%, <jats:styled-content style=\"fixed-case\">LDL<\/jats:styled-content>\u2010C\u00a0&lt;\u00a070\u00a0mg\/dL by 58% and <jats:styled-content style=\"fixed-case\">LDL<\/jats:styled-content>\u2010C\u00a0&lt;\u00a040\u00a0mg\/dL by 18% of those with follow\u2010up data. Side effects were reported by 10%, mainly musculoskeletal complaints and flu\u2010like symptoms, and 15% have discontinued treatment.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Patient selection by a regional lipid clinic resulted in a high real\u2010world <jats:styled-content style=\"fixed-case\">PCSK<\/jats:styled-content>9i insurance approval, with efficacy and safety comparable to randomized clinical trials. Cost and medication nonadherence are potential barriers to successful implementation of therapy in routine clinical care.<\/jats:p><\/jats:sec>","DOI":"10.1111\/1755-5922.12439","type":"journal-article","created":{"date-parts":[[2018,6,4]],"date-time":"2018-06-04T16:21:10Z","timestamp":1528129270000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":32,"title":["Lipid\u2010lowering therapy with <scp>PCSK<\/scp>9\u2010inhibitors in the real\u2010world setting: Two\u2010year experience of a regional lipid clinic"],"prefix":"10.1111","volume":"36","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2391-8397","authenticated-orcid":false,"given":"Barak","family":"Zafrir","sequence":"first","affiliation":[{"name":"Cardiovascular Department Lady Davis Carmel Medical Center  Haifa Israel"},{"name":"Clalit Health Services  Haifa 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