{"created":"2024-10-29T00:23:32.717749+00:00","id":2006349,"links":{},"metadata":{"_buckets":{"deposit":"2cfd3f9f-8781-4652-8f25-8d5186cfcd99"},"_deposit":{"created_by":7,"id":"2006349","owners":[7],"pid":{"revision_id":0,"type":"depid","value":"2006349"},"status":"published"},"_oai":{"id":"oai:tokushima-u.repo.nii.ac.jp:02006349","sets":["1713853213384:1713853295607"]},"author_link":["309"],"control_number":"2006349","item_10001_biblio_info_7":{"attribute_name":"書誌情報","attribute_value_mlt":[{"bibliographicIssueDates":{"bibliographicIssueDate":"2018-11-30","bibliographicIssueDateType":"Issued"},"bibliographicIssueNumber":"3","bibliographicPageEnd":"227","bibliographicPageStart":"218","bibliographicVolumeNumber":"73","bibliographic_titles":[{"bibliographic_title":"Journal of Cardiology","bibliographic_titleLang":"en"}]}]},"item_10001_description_5":{"attribute_name":"抄録","attribute_value_mlt":[{"subitem_description":"Background: Alirocumab, a fully human monoclonal antibody to proprotein convertase subtilisin/kexin type 9, given every 2 weeks (Q2W), significantly reduced low-density lipoprotein cholesterol (LDL-C) levels in Japanese hypercholesterolemic patients on background statin. We evaluated alirocumab 150 mg every 4 weeks (Q4W) in patients on lowest-dose statin or non-statin lipid-lowering therapy (LLT).\nMethods: ODYSSEY NIPPON was a double-blind study conducted in Japanese patients with LDL-C≥100 mg/dL (heterozygous familial hypercholesterolemia or non-familial  hypercholesterolemia with coronary heart disease) or ≥120 mg/dL (non-familial hypercholesterolemia, Japan Atherosclerosis Society category III) on atorvastatin 5 mg/day or non-statin LLT. Patients were randomized (1:1:1) to subcutaneous alirocumab 150 mg Q4W, alirocumab 150 mg Q2W, or placebo for the 12-week double-blind treatment period (DBTP), followed by a 52-week open-label treatment period (OLTP). At entry into the OLTP, patients received alirocumab 150 mg Q4W, with possible up-titration to 150 mg Q2W at Week 24.\nResults: Least-square mean percent change in LDL-C from baseline at Week 12 (primary efficacy endpoint) was -43.8% for alirocumab Q4W, -70.1% for Q2W, and -4.3% for placebo. During the OLTP, mean LDL-C change from baseline was -45.1% at Week 20, with a further reduction at Week 36, with achieved levels maintained to Week 64. Percent of patients with≥1 adverse event (DBTP) was 51.9% with alirocumab Q4W, 47.2% with Q2W, and 46.4% with placebo. Most common adverse events were infections and infestations (25.9%, 22.6%, 17.9%, respectively), gastrointestinal disorders (13.0%, 9.4%, 12.5%), nervous system disorders (5.6%, 7.5%, 10.7%), and general disorders and administration-site conditions (3.7%, 11.3%, 5.4%).\nConclusions: Hypercholesterolemic Japanese patients who tolerate only lowest-strength dose statin or non-statin LLT can achieve robust LDL-C reduction with alirocumab 150 mg Q4W, in addition to their current LLT. Alirocumab 150 mg Q4W dosing was efficacious and generally well tolerated without new safety concerns.","subitem_description_language":"en","subitem_description_type":"Abstract"}]},"item_10001_publisher_8":{"attribute_name":"出版者","attribute_value_mlt":[{"subitem_publisher":"Elsevier Ltd.","subitem_publisher_language":"en"},{"subitem_publisher":"Japanese College of Cardiology","subitem_publisher_language":"en"}]},"item_10001_rights_15":{"attribute_name":"権利情報","attribute_value_mlt":[{"subitem_rights":"© 2018 The Authors. ISDN. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).","subitem_rights_language":"en"}]},"item_10001_source_id_9":{"attribute_name":"収録物ID","attribute_value_mlt":[{"subitem_source_identifier":"09145087","subitem_source_identifier_type":"ISSN"},{"subitem_source_identifier":"AN10070473","subitem_source_identifier_type":"NCID"}]},"item_10001_version_type_20":{"attribute_name":"出版タイプ","attribute_value_mlt":[{"subitem_version_resource":"http://purl.org/coar/version/c_970fb48d4fbd8a85","subitem_version_type":"VoR"}]},"item_1715043197608":{"attribute_name":"アクセス権","attribute_value_mlt":[{"subitem_access_right":"open access"}]},"item_1722929371688":{"attribute_name":"出版社版DOI","attribute_value_mlt":[{"subitem_relation_name":[{"subitem_relation_name_language":"ja","subitem_relation_name_text":"10.1016/j.jjcc.2018.10.004"}],"subitem_relation_type_id":{"subitem_relation_type_id_text":"https://doi.org/10.1016/j.jjcc.2018.10.004","subitem_relation_type_select":"DOI"}}]},"item_1723180141928":{"attribute_name":"EID","attribute_value_mlt":[{"subitem_identifier_type":"URI","subitem_identifier_uri":"350359"}]},"item_creator":{"attribute_name":"著者","attribute_type":"creator","attribute_value_mlt":[{"creatorNames":[{"creatorName":"テラモト, タミオ","creatorNameLang":"ja"},{"creatorName":"テラモト, タミオ","creatorNameLang":"ja-Kana"},{"creatorName":"Teramoto, Tamio","creatorNameLang":"en"}]},{"creatorNames":[{"creatorName":"キヨスエ, アリヒロ","creatorNameLang":"ja"},{"creatorName":"キヨスエ, アリヒロ","creatorNameLang":"ja-Kana"},{"creatorName":"Kiyosue, Arihiro","creatorNameLang":"en"}]},{"creatorNames":[{"creatorName":"イシガキ, ヤスシ","creatorNameLang":"ja"},{"creatorName":"イシガキ, ヤスシ","creatorNameLang":"ja-Kana"},{"creatorName":"Ishigaki, Yasushi","creatorNameLang":"en"}]},{"creatorNames":[{"creatorName":"ハラダ シバ, マリコ","creatorNameLang":"ja"},{"creatorName":"ハラダ シバ, マリコ","creatorNameLang":"ja-Kana"},{"creatorName":"Harada-Shiba, Mariko","creatorNameLang":"en"}]},{"creatorNames":[{"creatorName":"カワバタ, ユミコ","creatorNameLang":"ja"},{"creatorName":"カワバタ, ユミコ","creatorNameLang":"ja-Kana"},{"creatorName":"Kawabata, Yumiko","creatorNameLang":"en"}]},{"creatorNames":[{"creatorName":"オザキ, アスカ","creatorNameLang":"ja"},{"creatorName":"オザキ, アスカ","creatorNameLang":"ja-Kana"},{"creatorName":"Ozaki, Asuka","creatorNameLang":"en"}]},{"creatorNames":[{"creatorName":"Baccara-Dinet, Marie T.","creatorNameLang":"en"}]},{"creatorAffiliations":[{"affiliationNameIdentifiers":[{"affiliationNameIdentifier":"","affiliationNameIdentifierScheme":"ISNI","affiliationNameIdentifierURI":"http://www.isni.org/isni/"}],"affiliationNames":[{"affiliationName":"","affiliationNameLang":"ja"}]}],"creatorNames":[{"creatorName":"佐田, 政隆","creatorNameLang":"ja"},{"creatorName":"サタ, マサタカ","creatorNameLang":"ja-Kana"},{"creatorName":"Sata, Masataka","creatorNameLang":"en"}],"familyNames":[{"familyName":"佐田","familyNameLang":"ja"},{"familyName":"サタ","familyNameLang":"ja-Kana"},{"familyName":"Sata","familyNameLang":"en"}],"givenNames":[{"givenName":"政隆","givenNameLang":"ja"},{"givenName":"マサタカ","givenNameLang":"ja-Kana"},{"givenName":"Masataka","givenNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"309","nameIdentifierScheme":"WEKO"},{"nameIdentifier":"173932/profile-ja.html","nameIdentifierScheme":"徳島大学 教育研究者総覧","nameIdentifierURI":"http://pub2.db.tokushima-u.ac.jp/ERD/person/173932/profile-ja.html"},{"nameIdentifier":"80345214","nameIdentifierScheme":"e-Rad","nameIdentifierURI":"https://nrid.nii.ac.jp/ja/search/?qm=80345214"}]}]},"item_files":{"attribute_name":"ファイル情報","attribute_type":"file","attribute_value_mlt":[{"accessrole":"open_access","date":[{"dateType":"Available","dateValue":"2019-04-12"}],"displaytype":"detail","filename":"joc_73_3_218.pdf","filesize":[{"value":"1.06 MB"}],"format":"application/pdf","licensetype":"license_5","mimetype":"application/pdf","url":{"objectType":"fulltext","url":"https://tokushima-u.repo.nii.ac.jp/record/2006349/files/joc_73_3_218.pdf"},"version_id":"a31caf03-51be-4f0a-9399-25d21c911c48"}]},"item_keyword":{"attribute_name":"キーワード","attribute_value_mlt":[{"subitem_subject":"Alirocumab","subitem_subject_language":"en","subitem_subject_scheme":"Other"},{"subitem_subject":"Hypercholesterolemia","subitem_subject_language":"en","subitem_subject_scheme":"Other"},{"subitem_subject":"Statin","subitem_subject_language":"en","subitem_subject_scheme":"Other"},{"subitem_subject":"Cardiovascular risk","subitem_subject_language":"en","subitem_subject_scheme":"Other"},{"subitem_subject":"PCSK9 inhibitor","subitem_subject_language":"en","subitem_subject_scheme":"Other"}]},"item_language":{"attribute_name":"言語","attribute_value_mlt":[{"subitem_language":"eng"}]},"item_resource_type":{"attribute_name":"資源タイプ","attribute_value_mlt":[{"resourcetype":"journal article","resourceuri":"http://purl.org/coar/resource_type/c_6501"}]},"item_title":"Efficacy and safety of alirocumab 150 mg every 4 weeks in hypercholesterolemic patients on non-statin lipid-lowering therapy or lowest strength dose of statin : ODYSSEY NIPPON","item_titles":{"attribute_name":"タイトル","attribute_value_mlt":[{"subitem_title":"Efficacy and safety of alirocumab 150 mg every 4 weeks in hypercholesterolemic patients on non-statin lipid-lowering therapy or lowest strength dose of statin : ODYSSEY NIPPON","subitem_title_language":"en"}]},"item_type_id":"40001","owner":"7","path":["1713853295607"],"pubdate":{"attribute_name":"PubDate","attribute_value":"2019-04-12"},"publish_date":"2019-04-12","publish_status":"0","recid":"2006349","relation_version_is_last":true,"title":["Efficacy and safety of alirocumab 150 mg every 4 weeks in hypercholesterolemic patients on non-statin lipid-lowering therapy or lowest strength dose of statin : ODYSSEY NIPPON"],"weko_creator_id":"7","weko_shared_id":-1},"updated":"2025-01-29T06:58:52.689424+00:00"}