{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,17]],"date-time":"2026-03-17T13:01:45Z","timestamp":1773752505219,"version":"3.50.1"},"reference-count":23,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2017,2,6]],"date-time":"2017-02-06T00:00:00Z","timestamp":1486339200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Hepatology Research"],"published-print":{"date-parts":[[2017,10]]},"abstract":"<jats:sec><jats:title>Aim<\/jats:title><jats:p>Loop diuretics and spironolactone are used in patients with hepatic edema, but they are sometimes associated with insufficient responses as well as adverse events. Tolvaptan, a vasopressin type 2 receptor antagonist, was approved for hepatic edema in 2013. A large\u2010scale post\u2010marketing surveillance study has been carried out to evaluate the effectiveness and safety of tolvaptan in real\u2010world clinical settings.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Patients with hepatic cirrhosis with insufficient response to conventional diuretics were enrolled. The observational period was up to 6\u00a0months. Changes in body weight and clinical symptoms were measured to evaluate effectiveness. The incidence of adverse drug reactions was summarized as a safety measure.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of 970 patients enrolled, 463 were included in the safety analysis. Of this group, 340 were included in the effectiveness analysis. Decreases in body weight from baseline were \u22122.38\u00a0kg on day 7 and \u22123.52\u00a0kg on day 14. Ascites and bloated feeling was significantly improved within 14\u00a0days. The mean change in body weight depended on estimated glomerular filtration rate levels. The most frequently reported adverse drug reaction was thirst (6.9% of patients). Serum sodium level of \u2265146\u00a0mEq\/L was observed in 12 patients (2.7%).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>In the real\u2010world clinical setting, tolvaptan showed aquaretic effectiveness in patients with cirrhosis. The mean change in body weight depended on renal function. We recommend tolvaptan use for hepatic cirrhosis at a stage in which the renal function is maintained.<\/jats:p><\/jats:sec>","DOI":"10.1111\/hepr.12852","type":"journal-article","created":{"date-parts":[[2016,12,13]],"date-time":"2016-12-13T10:33:23Z","timestamp":1481625203000},"page":"1137-1146","source":"Crossref","is-referenced-by-count":37,"title":["Effectiveness and safety of tolvaptan in liver cirrhosis patients with edema: Interim results of post\u2010marketing surveillance of tolvaptan in liver cirrhosis (START study)"],"prefix":"10.1111","volume":"47","author":[{"given":"Isao","family":"Sakaida","sequence":"first","affiliation":[{"name":"Department of Gastroenterology and Hepatology, Graduate School of Medicine Yamaguchi University  Ube Yamaguchi Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shuji","family":"Terai","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, Graduate School of Medical and Dental Sciences Niigata University  Niigata Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masayuki","family":"Kurosaki","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology Musashino Red Cross Hospital  Musashino Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Moriyoshi","family":"Yasuda","sequence":"additional","affiliation":[{"name":"Department of Pharmacovigilance Otsuka Pharmaceutical Co.Ltd.  Osaka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mitsuru","family":"Okada","sequence":"additional","affiliation":[{"name":"Department of Pharmacovigilance Otsuka Pharmaceutical Co.Ltd.  Osaka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kosuke","family":"Bando","sequence":"additional","affiliation":[{"name":"Department of Pharmacovigilance Otsuka Pharmaceutical Co.Ltd.  Osaka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yasuhiko","family":"Fukuta","sequence":"additional","affiliation":[{"name":"Department of Pharmacovigilance Otsuka Pharmaceutical Co.Ltd.  Osaka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2017,2,6]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0801209"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00535-016-1216-y"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/hepr.12099"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.1177\/0300060513480089"},{"key":"e_1_2_6_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/hepr.12098"},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/hepr.12455"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/hepr.12547"},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.1186\/cc5713"},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.1152\/ajprenal.00195.2005"},{"key":"e_1_2_6_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jjcc.2015.09.020"},{"key":"e_1_2_6_12_1","doi-asserted-by":"publisher","DOI":"10.1253\/circj.CJ-13-1255"},{"key":"e_1_2_6_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jjcc.2012.08.020"},{"key":"e_1_2_6_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0272-6386(12)70272-X"},{"key":"e_1_2_6_15_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00535-015-1052-5"},{"key":"e_1_2_6_16_1","doi-asserted-by":"publisher","DOI":"10.2169\/internalmedicine.55.6819"},{"key":"e_1_2_6_17_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00535\u2010016\u20101233\u2010x"},{"key":"e_1_2_6_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/hepr.12778"},{"key":"e_1_2_6_19_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.21412"},{"key":"e_1_2_6_20_1","doi-asserted-by":"publisher","DOI":"10.1111\/hepr.12495"},{"key":"e_1_2_6_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2012.07.020"},{"key":"e_1_2_6_22_1","doi-asserted-by":"publisher","DOI":"10.1253\/circj.CJ-66-0093"},{"key":"e_1_2_6_23_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40261-016-0434-7"},{"key":"e_1_2_6_24_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0168-8278(03)00007-2"}],"container-title":["Hepatology Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fhepr.12852","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/hepr.12852","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,24]],"date-time":"2023-09-24T15:08:40Z","timestamp":1695568120000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/hepr.12852"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2017,2,6]]},"references-count":23,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2017,10]]}},"alternative-id":["10.1111\/hepr.12852"],"URL":"https:\/\/doi.org\/10.1111\/hepr.12852","archive":["Portico"],"relation":{},"ISSN":["1386-6346","1872-034X"],"issn-type":[{"value":"1386-6346","type":"print"},{"value":"1872-034X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2017,2,6]]}}}