{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,15]],"date-time":"2026-07-15T12:05:52Z","timestamp":1784117152018,"version":"3.55.0"},"reference-count":36,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"21","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["JAHA"],"published-print":{"date-parts":[[2024,11,5]]},"abstract":"<jats:sec xml:lang=\"en\">\n                    <jats:title>Background<\/jats:title>\n                    <jats:p xml:lang=\"en\">Evolocumab is the first monoclonal antibody against proprotein convertase subtilisin\/kexin type 9 approved in Japan for familial hypercholesterolemia (FH) and hypercholesterolemia; however, data on its safety and effectiveness in the real\u2010world setting in Japan are limited.<\/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                      This real\u2010world, postmarketing, single\u2010arm study assessed the safety and effectiveness of low\u2010density lipoprotein cholesterol lowering with evolocumab in patients with homozygous\/heterozygous familial hypercholesterolemia and hypercholesterolemia with high risk in Japan (668 sites). The primary safety end point was the incidence (percentage) and number of patients with adverse drug reactions and serious adverse events during the 104\u2010week follow\u2010up. Primary effectiveness end points included the percentage change in low\u2010density lipoprotein cholesterol levels from baseline to week 12, assessed using 2\u2010sided paired\n                      <jats:italic toggle=\"no\">t<\/jats:italic>\n                      tests. The safety and effectiveness sets comprised 3724 (homozygous FH, n=108; heterozygous FH, n=2009; hypercholesterolemia with high risk, n=1607) and 2797 (homozygous FH, n=91; heterozygous FH, n=1615; hypercholesterolemia with high risk, n=1091) patients, respectively. Overall, mean age and disease duration were 63.2 and 12.3\u2009years, respectively. Serious adverse drug reactions and serious adverse events were experienced by 0.5% and 10.3% of patients; the incidence rates of myocardial infarction and stroke were 0.7% and 0.3%, respectively. A significant mean\u00b1SD percentage change in low\u2010density lipoprotein cholesterol levels was observed at week 12 among patients with homozygous FH (\u221245.7%\u00b128.2;\n                      <jats:italic toggle=\"no\">P<\/jats:italic>\n                      &lt;0.001), heterozygous FH (\u221255.9%\u00b128.8;\n                      <jats:italic toggle=\"no\">P<\/jats:italic>\n                      &lt;0.001), and hypercholesterolemia with high risk (\u221263.3%\u00b123.7;\n                      <jats:italic toggle=\"no\">P<\/jats:italic>\n                      &lt;0.001).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec xml:lang=\"en\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p xml:lang=\"en\">Evolocumab was well tolerated, and real\u2010world patients with familial hypercholesterolemia and hypercholesterolemia with high risk in Japan had sustained low\u2010density lipoprotein cholesterol reduction.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec xml:lang=\"en\">\n                    <jats:title>REGISTRATION<\/jats:title>\n                    <jats:p xml:lang=\"en\">\n                      URL:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.clinicaltrials.gov\">https:\/\/www.clinicaltrials.gov<\/jats:ext-link>\n                      ; Unique Identifier: NCT02808403.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1161\/jaha.124.035809","type":"journal-article","created":{"date-parts":[[2024,10,29]],"date-time":"2024-10-29T07:51:07Z","timestamp":1730188267000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":3,"title":["Safety and Effectiveness of Low\u2010Density Lipoprotein Cholesterol\u2013Lowering Therapy With Evolocumab for Familial Hypercholesterolemia\/Hypercholesterolemia in Japan: A Real\u2010World, Postmarketing, Single\u2010Arm Study"],"prefix":"10.1161","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3033-4813","authenticated-orcid":false,"given":"Koutaro","family":"Yokote","sequence":"first","affiliation":[{"name":"Chiba University Graduate School of Medicine","place":["Chiba, Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6645-6404","authenticated-orcid":false,"given":"Junya","family":"Ako","sequence":"additional","affiliation":[{"name":"Kitasato University School of Medicine","place":["Sagamihara, Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7669-231X","authenticated-orcid":false,"given":"Kazuo","family":"Kitagawa","sequence":"additional","affiliation":[{"name":"Tokyo Women\u2019s Medical University School of Medicine","place":["Tokyo, Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-5422-6456","authenticated-orcid":false,"given":"Nobuhiro","family":"Osada","sequence":"additional","affiliation":[{"name":"Amgen K.K.","place":["Tokyo, Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Feng","family":"Sheng","sequence":"additional","affiliation":[{"name":"Amgen K.K.","place":["Tokyo, Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masae","family":"Sonoda","sequence":"additional","affiliation":[{"name":"Amgen K.K.","place":["Tokyo, Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8121-7484","authenticated-orcid":false,"given":"Tamio","family":"Teramoto","sequence":"additional","affiliation":[{"name":"Teikyo University","place":["Tokyo, Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","reference":[{"key":"e_1_3_2_2_2","unstructured":"World Health Organization . 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