{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,30]],"date-time":"2026-07-30T12:52:06Z","timestamp":1785415926457,"version":"3.56.0"},"reference-count":27,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2020,8,12]],"date-time":"2020-08-12T00:00:00Z","timestamp":1597190400000},"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":[[2020,10]]},"abstract":"<jats:sec><jats:title>Aim<\/jats:title><jats:p>Lusutrombopag is approved for thrombocytopenia in chronic liver disease patients planned to undergo invasive procedures. In previous clinical studies, lusutrombopag treatment was stopped in patients with an increase in platelet count (PC) of \u226520\u2009\u00d7\u200910<jats:sup>9<\/jats:sup>\/L from baseline and whose PC was \u226550\u2009\u00d7\u200910<jats:sup>9<\/jats:sup>\/L (discontinuation criteria). We assessed the influence of platelet monitoring during lusutrombopag treatment in lusutrombopag\u2010na\u00efve patients.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In this open\u2010label study, Child\u2013Pugh class A and B (A\/B) patients were enrolled and treated with lusutrombopag (3\u00a0mg\/day) for 7\u00a0days. In the treatment\u2010na\u00efve A\/B\u20101 group, the discontinuation criteria were applied on day 6. In the treatment\u2010na\u00efve A\/B\u20102 group, the criteria were not applied. In a non\u2010na\u00efve A\/B group, the criteria were applied on days 3 and 5\u20137. The main efficacy end\u2010point was the proportion of patients without platelet transfusion (PT) before the primary invasive procedure.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>In the A\/B\u20101, A\/B\u20102, and non\u2010na\u00efve A\/B groups, the proportions of patients without PT were 80.9% (38\/47), 83.0% (39\/47), and 75.0% (6\/8), respectively. The mean durations of PC\u2009\u2265\u200950\u2009\u00d7\u200910<jats:sup>9<\/jats:sup>\/L without PT were 20.7, 20.3, and 22.8\u00a0days, respectively. Excessive PC increases (\u2265200\u2009\u00d7\u200910<jats:sup>9<\/jats:sup>\/L) were not detected in any group. Treatment\u2010related adverse events occurred in 4.3%, 6.4%, and 0% of A\/B\u20101, A\/B\u20102, and non\u2010na\u00efve A\/B patients, respectively. Severe portal vein thrombosis occurred in one A\/B\u20102 patient (PC 75\u2009\u00d7\u200910<jats:sup>9<\/jats:sup>\/L at onset).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>No meaningful efficacy and safety differences were observed among the groups with or without discontinuation criteria and the non\u2010na\u00efve group. These findings support lusutrombopag treatment without platelet monitoring and retreatment with lusutrombopag.<\/jats:p><\/jats:sec>","DOI":"10.1111\/hepr.13544","type":"journal-article","created":{"date-parts":[[2020,7,1]],"date-time":"2020-07-01T20:10:05Z","timestamp":1593634205000},"page":"1141-1150","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Is platelet monitoring during 7\u2010day lusutrombopag treatment necessary in chronic liver disease patients with thrombocytopenia undergoing planned invasive procedures? A phase IIIb open\u2010label study"],"prefix":"10.1111","volume":"50","author":[{"given":"Kazushi","family":"Numata","sequence":"first","affiliation":[{"name":"Gastroenterological Center Yokohama City University Medical Center  Yokohama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katsuaki","family":"Tanaka","sequence":"additional","affiliation":[{"name":"Gastroenterological Center Yokohama City University Medical Center  Yokohama Japan"},{"name":"Gastroenterological Center Japanese Red Cross Hadano Hospital  Hadano Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takayuki","family":"Katsube","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology and Pharmacokinetics Shionogi &amp; Co., Ltd.  Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toshimitsu","family":"Ochiai","sequence":"additional","affiliation":[{"name":"Biostatistics Center Shionogi &amp; Co., Ltd.  Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takahiro","family":"Fukuhara","sequence":"additional","affiliation":[{"name":"Clinical Development Shionogi &amp; Co., Ltd.  Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takeshi","family":"Kano","sequence":"additional","affiliation":[{"name":"Project Management Shionogi &amp; Co., Ltd.  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