Tolvaptan therapy of Chinese cirrhotic patients with ascites after insufficient diuretic routine medication responses: a
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RESEARCH ARTICLE
Open Access
Tolvaptan therapy of Chinese cirrhotic patients with ascites after insufficient diuretic routine medication responses: a phase III clinical trial Jieting Tang1†, Yongfeng Wang1†, Tao Han2, Qing Mao3, Jun Cheng4, Huiguo Ding5, Jia Shang6, Qin Zhang7, Junqi Niu8, Feng Ji9, Chengwei Chen10, Jidong Jia11, Xiangjun Jiang12, Nonghua Lv13, Yueqiu Gao14, Zhenghua Wang1, Zhong Wei1, Yingxuan Chen1, Minde Zeng1 and Yimin Mao1*
Abstract Background: To determine the safety and efficacy of different doses of tolvaptan for treating Chinese cirrhotic patients with or without hyponatraemia who still had ascites after routine therapy with diuretics. Methods: In the present placebo-controlled, randomized, double-blinded, multicentre clinical trial, patients with cirrhotic ascites who failed to adequately respond to a combination of an aldosterone antagonist plus an orally administered loop diuretic were randomly placed at a 4:2:1 ratio into 3 groups [the 15 mg/day tolvaptan group (N = 301), 7.5 mg/day tolvaptan group (N = 153) and placebo group (N = 76)] for 7 days of treatment. The effects and safety were evaluated on days 4 and 7. A change in body weight from baseline on day 7 of treatment was the primary endpoint. Results: The administration of 7.5 or 15 mg/day tolvaptan significantly decreased body weight from baseline on day 7 of treatment compared to that with placebo treatment (P = 0.026; P = 0.001). For the secondary endpoints, changes in abdominal circumference from baseline and improvements in ascites were markedly different in the treatment groups and the placebo group on day 7 (P7.5 = 0.05, P15.0 = 0.002 and P7.5 = 0.037, P15.0 = 0.003), but there was no difference between the 7.5 mg/day and 15 mg/day dosage groups. The 24-h cumulative urine volume was higher in the 7.5 mg/day and 15 mg/day tolvaptan groups than the placebo group (P = 0.002, P
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