{"created":"2023-06-19T10:43:35.832445+00:00","id":3842,"links":{},"metadata":{"_buckets":{"deposit":"7efc6172-906f-471e-b002-664066a9d660"},"_deposit":{"created_by":11,"id":"3842","owners":[11],"pid":{"revision_id":0,"type":"depid","value":"3842"},"status":"published"},"_oai":{"id":"oai:shiga-med.repo.nii.ac.jp:00003842","sets":["30:59:221"]},"author_link":["8473","538","8471","8472"],"item_4_biblio_info_6":{"attribute_name":"書誌情報","attribute_value_mlt":[{"bibliographicIssueDates":{"bibliographicIssueDate":"2021-02","bibliographicIssueDateType":"Issued"},"bibliographicIssueNumber":"3","bibliographicPageEnd":"387","bibliographicPageStart":"373","bibliographicVolumeNumber":"22","bibliographic_titles":[{},{"bibliographic_title":"Expert opinion on pharmacotherapy","bibliographic_titleLang":"en"}]}]},"item_4_creator_2":{"attribute_name":"著者(ヨミ)","attribute_type":"creator","attribute_value_mlt":[{"creatorNames":[{"creatorName":"前川, 聡"}],"nameIdentifiers":[{},{},{}]}]},"item_4_description_4":{"attribute_name":"抄録","attribute_value_mlt":[{"subitem_description":"Objective:\nTo evaluate the long-term safety and effectiveness of ipragliflozin in real-world clinical practice in Japanese patients with type 2 diabetes mellitus (T2DM). ","subitem_description_type":"Abstract"},{"subitem_description":"Research design and methods:\nThis post-marketing surveillance study (STELLA-LONG TERM) included Japanese patients newly initiated on ipragliflozin between 17 July 2014 and 16 October 2015 (data lock: 30 September 2019). Survey items included demographics, treatments, adverse drug reactions (ADRs), vital signs, and laboratory variables. ","subitem_description_type":"Abstract"},{"subitem_description":"Results:\nOf 11,424 registered patients, safety and efficacy analysis sets comprised of 11,051 and 8,763 patients, respectively. ADRs occurred in 2,129 patients (19.27%) and serious ADRs occurred in 210 patients (1.90%). Renal and urinary disorders (n = 739, 6.69%), particularly polyuria/pollakiuria (n = 612, 5.54%) and volume depletion-events, including dehydration (n = 243, 2.20%), comprised the most common ADRs. Mean (SD) change in hemoglobin A1c (─0.66 [1.25] %), fasting plasma glucose (─28.8 [50.1] mg/dL) and body weight (─3.33 [4.32] kg) from baseline to 36 months were statistically significant (P < 0.001). ","subitem_description_type":"Abstract"},{"subitem_description":"Conclusions:\nThe safety profile of long-term ipragliflozin treatment in routine clinical practice is consistent with previously reported interim data at 12 or 24 months and pre-approval clinical trials. Ipragliflozin treatment was also associated with sustained improvements in efficacy parameters for over 3 years. ","subitem_description_type":"Abstract"}]},"item_4_description_42":{"attribute_name":"資源タイプ","attribute_value_mlt":[{"subitem_description":"Journal Article","subitem_description_type":"Other"}]},"item_4_publisher_32":{"attribute_name":"出版者","attribute_value_mlt":[{"subitem_publisher":"Springer Japan"}]},"item_4_relation_10":{"attribute_name":"PubMed番号","attribute_value_mlt":[{"subitem_relation_type_id":{"subitem_relation_type_id_text":"33012212","subitem_relation_type_select":"PMID"}}]},"item_4_relation_11":{"attribute_name":"DOI","attribute_value_mlt":[{"subitem_relation_name":[{"subitem_relation_name_text":"10.1080/14656566.2020.1817388"}],"subitem_relation_type_id":{"subitem_relation_type_id_text":"https://doi.org/10.1080/14656566.2020.1817388","subitem_relation_type_select":"DOI"}}]},"item_4_source_id_7":{"attribute_name":"ISSN","attribute_value_mlt":[{"subitem_source_identifier":"1744-7666","subitem_source_identifier_type":"ISSN"}]},"item_access_right":{"attribute_name":"アクセス権","attribute_value_mlt":[{"subitem_access_right":"metadata only access","subitem_access_right_uri":"http://purl.org/coar/access_right/c_14cb"}]},"item_creator":{"attribute_name":"著者","attribute_type":"creator","attribute_value_mlt":[{"creatorNames":[{"creatorName":"NAKAMURA, Ichiro"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"MAEGAWA, Hiroshi"}],"nameIdentifiers":[{},{},{}]},{"creatorNames":[{"creatorName":"TOBE, Kazuyuki"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"UNO, Satoshi"}],"nameIdentifiers":[{}]}]},"item_keyword":{"attribute_name":"キーワード","attribute_value_mlt":[{"subitem_subject":"Ipragliflozin","subitem_subject_language":"en","subitem_subject_scheme":"Other"},{"subitem_subject":"Japan","subitem_subject_language":"en","subitem_subject_scheme":"Other"},{"subitem_subject":"post-marketing surveillance","subitem_subject_language":"en","subitem_subject_scheme":"Other"},{"subitem_subject":"real-world evidence","subitem_subject_language":"en","subitem_subject_scheme":"Other"},{"subitem_subject":"sodium-glucose cotransporter 2 inhibitor","subitem_subject_language":"en","subitem_subject_scheme":"Other"},{"subitem_subject":"type 2 diabetes mellitus","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":"Real-World Evidence for Long-Term Safety and Effectiveness of Ipragliflozin in Japanese Patients with Type 2 Diabetes Mellitus : final Results of a 3-Year Post-Marketing Surveillance Study (STELLA-LONG TERM).","item_titles":{"attribute_name":"タイトル","attribute_value_mlt":[{"subitem_title":"Real-World Evidence for Long-Term Safety and Effectiveness of Ipragliflozin in Japanese Patients with Type 2 Diabetes Mellitus : final Results of a 3-Year Post-Marketing Surveillance Study (STELLA-LONG TERM)."}]},"item_type_id":"4","owner":"11","path":["221"],"pubdate":{"attribute_name":"公開日","attribute_value":"2021-04-16"},"publish_date":"2021-04-16","publish_status":"0","recid":"3842","relation_version_is_last":true,"title":["Real-World Evidence for Long-Term Safety and Effectiveness of Ipragliflozin in Japanese Patients with Type 2 Diabetes Mellitus : final Results of a 3-Year Post-Marketing Surveillance Study (STELLA-LONG TERM)."],"weko_creator_id":"11","weko_shared_id":-1},"updated":"2023-06-19T11:36:59.980146+00:00"}