{"created":"2023-05-15T16:33:11.833811+00:00","id":5335,"links":{},"metadata":{"_buckets":{"deposit":"de28ffa9-3ac0-4c54-828d-1ab5c6a1e868"},"_deposit":{"created_by":2,"id":"5335","owners":[2],"pid":{"revision_id":0,"type":"depid","value":"5335"},"status":"published"},"_oai":{"id":"oai:nagasaki-u.repo.nii.ac.jp:00005335","sets":["35:36"]},"author_link":["22491","22492","22493","22494","22490"],"item_2_biblio_info_6":{"attribute_name":"書誌情報","attribute_value_mlt":[{"bibliographicIssueDates":{"bibliographicIssueDate":"2014-04","bibliographicIssueDateType":"Issued"},"bibliographicIssueNumber":"4","bibliographicPageEnd":"371","bibliographicPageStart":"361","bibliographicVolumeNumber":"23","bibliographic_titles":[{"bibliographic_title":"Pharmacoepidemiology and Drug Safety"}]}]},"item_2_description_4":{"attribute_name":"抄録","attribute_value_mlt":[{"subitem_description":"Purpose: Abacavir is a nucleoside reverse transcriptase inhibitor indicated for human immunodeficiency virus (HIV) infection. In Japan, ZiagenR (300-mg abacavir sulfate) has been marketed since 1999. To obtain safety data on Ziagen, a mandatory postmarketing surveillance was conducted between September 1999 and September 2009. Methods: A joint survey [HIV-related Drug Surveys (HRD)] has been conducted involving manufacturers of drugs for HIV treatment in Japan. Safety data from total 643 cases (1345.7person-years) registered to the HRD surveys and received Ziagen were obtained. Adverse drug reaction (ADR) was defined as adverse event of which association with abacavir could not be \"ruled out.\" Results: It was found that the overall frequency of ADR was 47.6% (306/643); the common ADRs were \"hyperlipidemia,\" \"nausea,\" \"increased γ-glutamyltransferase level,\" \"increased blood triglycerides,\" \"abnormal hepatic function,\" and so on. Serious adverse events were reported in 65 subjects; however, none of the three fatal cases were clearly associated with Ziagen use. The survey-defined hypersensitivity has been infrequently reported in 15 subjects (2.3%). Although some studies had indicated of the association between abacavir and myocardial infarction, no ischemic heart diseases were reported in the present survey. Two of the three pregnant cases delivered normal neonates (one induced abortion). Conclusions: During the mandatory postmarketing survey of Ziagen, there were no cases of ischemic heart diseases, and the incidence of hypersensitivity was considerably low. These indicated that abacavir can be safely used in Japanese HIV+ population. However, the safety profile of Ziagen should be continued to be monitored through pharmacovigilance.","subitem_description_type":"Abstract"}]},"item_2_description_63":{"attribute_name":"引用","attribute_value_mlt":[{"subitem_description":"Pharmacoepidemiology and Drug Safety, 23(4), pp.361-371; 2014","subitem_description_type":"Other"}]},"item_2_publisher_33":{"attribute_name":"出版者","attribute_value_mlt":[{"subitem_publisher":"John Wiley and Sons Ltd"}]},"item_2_relation_12":{"attribute_name":"DOI","attribute_value_mlt":[{"subitem_relation_type":"isIdenticalTo","subitem_relation_type_id":{"subitem_relation_type_id_text":"10.1002/pds.3589","subitem_relation_type_select":"DOI"}}]},"item_2_rights_13":{"attribute_name":"権利","attribute_value_mlt":[{"subitem_rights":"c 2014 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd."},{"subitem_rights":"This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited."}]},"item_2_source_id_7":{"attribute_name":"ISSN","attribute_value_mlt":[{"subitem_source_identifier":"10538569","subitem_source_identifier_type":"ISSN"}]},"item_2_version_type_16":{"attribute_name":"著者版フラグ","attribute_value_mlt":[{"subitem_version_resource":"http://purl.org/coar/version/c_970fb48d4fbd8a85","subitem_version_type":"VoR"}]},"item_creator":{"attribute_name":"著者","attribute_type":"creator","attribute_value_mlt":[{"creatorNames":[{"creatorName":"Kurita, Tomoko"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Kitaichi, Tomomi"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Nagao, Takako"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Miura, Toshiyuki"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Kitazono, Yoshifumi"}],"nameIdentifiers":[{}]}]},"item_files":{"attribute_name":"ファイル情報","attribute_type":"file","attribute_value_mlt":[{"accessrole":"open_date","date":[{"dateType":"Available","dateValue":"2020-12-21"}],"displaytype":"detail","filename":"PDS23_361.pdf","filesize":[{"value":"239.0 kB"}],"format":"application/pdf","licensetype":"license_note","mimetype":"application/pdf","url":{"label":"PDS23_361.pdf","url":"https://nagasaki-u.repo.nii.ac.jp/record/5335/files/PDS23_361.pdf"},"version_id":"9ed309bd-b0c7-4902-974d-8fd3a99ac9fa"}]},"item_keyword":{"attribute_name":"キーワード","attribute_value_mlt":[{"subitem_subject":"Abacavir","subitem_subject_scheme":"Other"},{"subitem_subject":"Adverse drug reactions","subitem_subject_scheme":"Other"},{"subitem_subject":"Human immunodeficiency virus","subitem_subject_scheme":"Other"},{"subitem_subject":"Hypersensitivity","subitem_subject_scheme":"Other"},{"subitem_subject":"Japanese","subitem_subject_scheme":"Other"},{"subitem_subject":"Myocardial infarction","subitem_subject_scheme":"Other"},{"subitem_subject":"Pharmacoepidimiology","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":"Safety analysis of ZiagenR (abacavir sulfate) in postmarketing surveillance in Japan","item_titles":{"attribute_name":"タイトル","attribute_value_mlt":[{"subitem_title":"Safety analysis of ZiagenR (abacavir sulfate) in postmarketing surveillance in Japan"}]},"item_type_id":"2","owner":"2","path":["36"],"pubdate":{"attribute_name":"公開日","attribute_value":"2014-05-21"},"publish_date":"2014-05-21","publish_status":"0","recid":"5335","relation_version_is_last":true,"title":["Safety analysis of ZiagenR (abacavir sulfate) in postmarketing surveillance in Japan"],"weko_creator_id":"2","weko_shared_id":-1},"updated":"2023-05-16T03:07:04.581973+00:00"}