{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,9]],"date-time":"2026-07-09T14:18:37Z","timestamp":1783606717822,"version":"3.55.0"},"reference-count":24,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2023,8,11]],"date-time":"2023-08-11T00:00:00Z","timestamp":1691712000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Hepatology Research"],"published-print":{"date-parts":[[2023,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Aim<\/jats:title><jats:p>Lustrombopag has been approved for the treatment of thrombocytopenia in patients with chronic liver diseases who are scheduled to undergo an invasive procedure. Here, we report the final results of a post\u2010marketing surveillance assessing the safety and effectiveness of lusutrombopag in Japan.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This multicenter, prospective, real\u2010world surveillance collected data from case report forms between October 2016 and May 2021. The observation period was 2\u00a0months after the first day of lusutrombopag treatment. Safety and effectiveness (proportion of patients avoiding preoperative platelet transfusion and responders who achieved platelet count increase from baseline) were assessed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The safety analysis set included 1033 (100.0%), 130 (12.6%), and 14 (1.4%) patients who received one or more, two or more, and three or more treatment cycle(s), and 482 (48.9%), 457 (46.3%), and 43 (4.4%) patients who were Child\u2013Pugh class A, B, and C, respectively. The most common serious adverse drug reactions were portal vein thrombosis, pancytopenia, and white blood cell count decrease, reported in 14 (1.36%), three (0.29%), and two (0.19%) patients, respectively. The incidence of adverse drug reactions was not higher in patients with Child\u2013Pugh class C or those undergoing retreatment cycles compared with other Child\u2013Pugh classes or the first treatment cycle, respectively. During the observation period of the first treatment cycle, 94.7% (889\/939) of patients avoided preoperative platelet transfusion and 82.8% (741\/895) of the patients met the responder criteria.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>This surveillance study further supports the safety and effectiveness of lusutrombopag in a broad range of patients with chronic liver diseases undergoing planned invasive procedures.<\/jats:p><\/jats:sec><jats:sec><jats:title>Clinical Trial Registration<\/jats:title><jats:p>JapicCTI\u2010163432.<\/jats:p><\/jats:sec>","DOI":"10.1111\/hepr.13945","type":"journal-article","created":{"date-parts":[[2023,7,27]],"date-time":"2023-07-27T08:17:22Z","timestamp":1690445842000},"page":"1105-1116","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Safety and effectiveness of lusutrombopag in patients who have chronic liver disease with thrombocytopenia and undergoing invasive procedures: Real\u2010world post\u2010marketing surveillance in Japan"],"prefix":"10.1111","volume":"53","author":[{"given":"Hitoshi","family":"Yoshiji","sequence":"first","affiliation":[{"name":"Department of Gastroenterology Nara Medical University  Kashihara Nara Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0004-8073-4676","authenticated-orcid":false,"given":"Junto","family":"Suzuki","sequence":"additional","affiliation":[{"name":"Pharmacovigilance Department Shionogi &amp; Co., Ltd.  Chuo\u2010ku Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masafumi","family":"Imasaki","sequence":"additional","affiliation":[{"name":"Pharmacovigilance Department Shionogi &amp; Co., Ltd.  Chuo\u2010ku Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eri","family":"Tsukimura","sequence":"additional","affiliation":[{"name":"PMS &amp; Pharmacoepidemiology Department Shionogi Pharmacovigilance Center Co., Ltd.  Chuo\u2010ku Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Makiko","family":"Miyano","sequence":"additional","affiliation":[{"name":"PMS &amp; Pharmacoepidemiology Department Shionogi Pharmacovigilance Center Co., Ltd.  Chuo\u2010ku Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masayuki","family":"Kurosaki","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology Musashino Red Cross Hospital  Musashino Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,8,11]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/liv.13317"},{"key":"e_1_2_11_3_1","unstructured":"StatPearls.Chronic liver disease.https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK554597\/. Accessed 31 March 2023."},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/hepr.13715"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1055\/s\u20100038\u20101666861"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2010.06.018"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/ejh.13342"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2019.03.070"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00535\u2010018\u20101499\u20102"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1159\/000504044"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2018.11.047"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.30561"},{"key":"e_1_2_11_13_1","unstructured":"Japan Pharmaceuticals and Medical Devices Agency.Mulpleta package insert.https:\/\/www.info.pmda.go.jp\/go\/pdf\/340018_3399010F1022_1_04. Accessed 31 March 2023."},{"key":"e_1_2_11_14_1","unstructured":"US Food and Drug Administration.Full prescribing information for Mulpleta.https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/210923s000lbl.pdf. Accessed 31 March 2023."},{"key":"e_1_2_11_15_1","unstructured":"European Medical Agency.Mulpleo: EPAR \u2010 Product information.https:\/\/www.ema.europa.eu\/en\/documents\/product\u2010information\/mulpleo\u2010epar\u2010product\u2010information_en.pdf. 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