title: Efficacy and safety of a 14-day administration of tolvaptan in the treatment of patients with ascites in hepatic oedema.
abstract: OBJECTIVE
  To investigate the efficacy and safety of 14 days' orally administered tolvaptan as adjunctive treatment for hepatic oedema in Japanese liver cirrhosis patients with insufficient response to conventional diuretics, with the option to increase dose in those who did not respond initially.
  
  
  METHODS
  This multicentre, single-arm, phase 3 study allocated patients with liver cirrhosis and persistent ascites to 7-day treatment with 7.5 mg/day tolvaptan followed by an additional 7 days' treatment. Responders at day 7 (achieving ≥ 1 kg body-weight reduction) continued on 7.5 mg/day tolvaptan; nonresponders (<1 kg body-weight reduction) received 15 mg/day tolvaptan. Conventional diuretic treatment continued throughout. The primary endpoint was change in body weight from baseline, as a marker of ascites volume.
  
  
  RESULTS
  A total of 51 patients received 7.5 mg/day tolvaptan for 7 days, which caused a significant reduction in mean body weight (55% response rate). During the second 7-day treatment period, 30 patients received 7.5 mg/day tolvaptan and 13 patients received tolvaptan 15 mg/day: response rates were 43% and 23%, respectively. Two serious adverse events were observed. Serum sodium was within normal range.
  
  
  CONCLUSIONS
  Tolvaptan therapy for 14 days (with possible dose increase as necessary), in combination with conventional diuretics, effectively reduced body weight in patients with hepatic oedema.
authors.affiliation: Department of Gastroenterology and Hepatology, Yamaguchi University Graduate School of Medicine, Yamaguchi, Japan. sakaida@yamaguchi-u.ac.jp
authors.forename: Isao
authors.initials: I
authors.lastname: Sakaida
authors.forename: Satoyoshi
authors.initials: S
authors.lastname: Yamashita
authors.forename: Tomoo
authors.initials: T
authors.lastname: Kobayashi
authors.forename: Masafumi
authors.initials: M
authors.lastname: Komatsu
authors.forename: Terufumi
authors.initials: T
authors.lastname: Sakai
authors.forename: Yasuji
authors.initials: Y
authors.lastname: Komorizono
authors.forename: Mitsuru
authors.initials: M
authors.lastname: Okada
authors.forename: Kiwamu
authors.initials: K
authors.lastname: Okita
mesh_terms: D000368:Aged; D001201:Ascites / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D001552:Benzazepines / Q000627:therapeutic use*; D001835:Body Weight / Q000187:drug effects; D004232:Diuretics / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D004487:Edema / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D008099:Liver / Q000187:drug effects / Q000378:metabolism / Q000473:pathology; D008103:Liver Cirrhosis / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D020011:Protective Agents / Q000627:therapeutic use*; D012964:Sodium / Q000097:blood; D000077602:Tolvaptan; D016896:Treatment Outcome
chemical_list: D001552:Benzazepines; D004232:Diuretics; D020011:Protective Agents; D000077602:Tolvaptan; D012964:Sodium
keywords: Ascites; aquaretic effect; body weight; diuretic; hepatic oedema; liver cirrhosis; tolvaptan