Tolvaptan for improvement of hepatic edema: A phase 3, multicenter, randomized, double-blind, placebo-controlled trial
Tolvaptan for improvement of hepatic edema: A phase 3, multicenter, randomized, double-blind, placebo-controlled trial
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DOI：
10.1111/hepr.12098
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发表时间：
2014-01-01
影响因子：
4.2
通讯作者：
Okita, Kiwamu
中科院分区：
文献类型：
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作者：
Sakaida, Isao;Kawazoe, Seiji;Okita, Kiwamu
目的肝水肿主要表现为腹水、下肢水肿及不能耐受的症状。有些患者对常规利尿剂治疗反应不充分。因此，需要一种新的治疗选择。我们进行了一项3期研究，以确认tolvaptan对肝水肿相关的肝cirrhosis.MethodsIn我们的多中心，随机，双盲，安慰剂对照试验，肝硬化患者表现出对常规利尿剂反应不足，随机分配到7天的管理，无论是tolvaptan在7.5mg/天或安慰剂作为一个附加治疗，以常规利尿剂。主要结果是体重从基线的变化。ResultsOf 164合格的患者，84被分配到托伐普坦和80安慰剂。安慰剂组和托伐普坦组末次给药日体重较基线的变化分别为-0.44 kg（标准差[SD]，1.93）和-1.95 kg（SD，1.77）（P
AimHepatic edema is manifested by ascites, lower limb edema and intolerable symptoms. Some patients insufficiently respond to the conventional diuretic therapy. Therefore, a novel therapeutic option is required. We conducted a phase 3 study to confirm therapeutic effect of tolvaptan on hepatic edema associated with liver cirrhosis.MethodsIn our multicenter, randomized, double-blind, placebo-controlled trial, liver cirrhosis patients who showed insufficient response to conventional diuretics were randomly assigned to 7-day administration of either tolvaptan at 7.5mg/day or placebo as an add-on therapy to conventional diuretics. The primary outcome was change in bodyweight from baseline.ResultsOf 164 eligible patients, 84 were assigned to tolvaptan and 80 to placebo. Change in bodyweight from baseline on the final dosing day was -0.44kg (standard deviation [SD], 1.93) in the placebo group and -1.95kg (SD, 1.77) in the tolvaptan group (P