{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,9]],"date-time":"2026-07-09T14:19:50Z","timestamp":1783606790908,"version":"3.55.0"},"reference-count":18,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2019,7,22]],"date-time":"2019-07-22T00:00:00Z","timestamp":1563753600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100005612","name":"Shionogi","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100005612","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Hepatology Research"],"published-print":{"date-parts":[[2019,10]]},"abstract":"<jats:sec><jats:title>Aim<\/jats:title><jats:p>Lusutrombopag is approved for the treatment of thrombocytopenia in chronic liver disease patients undergoing invasive procedures. This real\u2010world surveillance assesses the safety and effectiveness of lusutrombopag in Japan.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This ongoing, multicenter, prospective, real\u2010world surveillance is collecting data from case report forms between October 2016 and May 2021. Interim data up to September 2018 were used to evaluate safety (adverse events and adverse drug reactions [ADRs]) and effectiveness (proportion of patients avoiding preoperative platelet transfusion and change in platelet count from baseline).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The safety analysis set included 331 patients. The mean baseline platelet count was 46.2\u2009\u00b1\u200913.7\u2009\u00d7\u200910<jats:sup>9<\/jats:sup>\/L. Of 377 invasive procedures, radiofrequency ablation (110 procedures, 29.2%) was the most frequent. The mean time from starting lusutrombopag treatment to invasive procedure was 12.3\u00a0days. Incidences of serious adverse events and ADRs were 8.76% and 3.32%, respectively. Six cases (1.81%) of portal vein thrombosis were considered serious adverse events; of these, four cases (1.21%) were classified as serious ADRs. Of 300 patients who underwent an invasive procedure (excluding those with platelet transfusion refractoriness), 282 (94.0%) avoided preoperative platelet transfusion. In patients with platelet measurements before and after lusutrombopag administration who did not undergo platelet transfusion, the mean maximum change in platelet count from baseline was 41.7\u2009\u00b1\u200931.4\u2009\u00d7\u200910<jats:sup>9<\/jats:sup>\/L (range, \u22126 to 276; <jats:italic>n<\/jats:italic>\u2009=\u2009286). All patients receiving second (<jats:italic>n<\/jats:italic>\u2009=\u200920) and third (<jats:italic>n<\/jats:italic>\u2009=\u20091) treatments avoided preoperative platelet transfusion without developing any ADRs.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>This real\u2010world surveillance further supports the safety and effectiveness of lusutrombopag in patients with chronic liver disease undergoing invasive procedures.<\/jats:p><\/jats:sec>","DOI":"10.1111\/hepr.13392","type":"journal-article","created":{"date-parts":[[2019,6,22]],"date-time":"2019-06-22T11:43:40Z","timestamp":1561203820000},"page":"1169-1181","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":20,"title":["Safety and effectiveness of lusutrombopag in Japanese chronic liver disease patients with thrombocytopenia undergoing invasive procedures: Interim results of a postmarketing surveillance"],"prefix":"10.1111","volume":"49","author":[{"given":"Ritsue","family":"Sasaki","sequence":"first","affiliation":[{"name":"Pharmacovigilance Department Shionogi  Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chikako","family":"Shiino","sequence":"additional","affiliation":[{"name":"Postmarketing Surveillance &amp; Pharmacoepidemiology Department, Shionogi Pharmacovigilance Center  Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michio","family":"Imawari","sequence":"additional","affiliation":[{"name":"Institute for Gastrointestinal and Liver Diseases, Shin\u2010Yurigaoka General Hospital  Kawasaki Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roy","family":"Bentley","sequence":"additional","affiliation":[{"name":"Global Market Access, Shionogi  Florham Park New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bin","family":"Cai","sequence":"additional","affiliation":[{"name":"Global Observational Research, Epidemiology and Health Outcomes, Shionogi  Florham Park New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manami","family":"Yoshida","sequence":"additional","affiliation":[{"name":"Medical Affairs, Shionogi  Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nezam","family":"Afdhal","sequence":"additional","affiliation":[{"name":"Liver Center, Beth Israel Deaconess Medical Center  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2019,7,22]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00535-009-0128-5"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.3748\/wjg.v20.i10.2595"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/liv.13317"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2010.06.018"},{"key":"e_1_2_8_6_1","first-page":"39","article-title":"The pathophysiology of thrombocytopenia in chronic liver disease","volume":"8","author":"Mitchell O","year":"2016","journal-title":"Hepat Med"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-015-0525-4"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2018.11.047"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.30561"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00535-018-1499-2"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.14740\/jocmr2328w"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/1097-0096(200009)28:7<332::AID-JCU3>3.0.CO;2-9"},{"key":"e_1_2_8_13_1","first-page":"259","article-title":"Pathophysiological view of the management of portal vein thrombosis [In Japanese]","volume":"61","author":"Matsutani S","year":"2010","journal-title":"Kan tan sui"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2036.2009.04182.x"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1111\/hepr.13305"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0211122"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.3748\/wjg.v24.i46.5271"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2018.05.025"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-018-0949-8"}],"container-title":["Hepatology Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fhepr.13392","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/hepr.13392","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/hepr.13392","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/hepr.13392","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,8]],"date-time":"2023-09-08T11:14:50Z","timestamp":1694171690000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/hepr.13392"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,7,22]]},"references-count":18,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2019,10]]}},"alternative-id":["10.1111\/hepr.13392"],"URL":"https:\/\/doi.org\/10.1111\/hepr.13392","archive":["Portico"],"relation":{},"ISSN":["1386-6346","1872-034X"],"issn-type":[{"value":"1386-6346","type":"print"},{"value":"1872-034X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,7,22]]},"assertion":[{"value":"2019-04-05","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-06-14","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-07-22","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}