Ji-Dong Jia1, Wen Xie2, Hui-Guo Ding3, Hua Mao4, Hui Guo5, Yonggang Li6, Xiaojin Wang7, Jie-Fei Wang8, Wei Lu9, Cheng-Zhong Li10, Yimin Mao11, Gui-Qiang Wang12, Yue-Qiu Gao13, Bangmao Wang14, Qin Zhang15, Yan Ge16, Vincent Wai-Sun Wong16,10. 1. Liver Research Center, Beijing Friendship Hospital, Capital Medical University, Beijing, China. 2. Beijing Di Tan Hospital, Capital Medical University, Beijing, China. 3. Department of Gastroenterology and Hepatology, Beijing You'an Hospital affiliated with Capital Medical University, Beijing, China. 4. Department of Gastroenterology, Zhujiang Hospital, Southern Medical University, Guangzhou, China. 5. 5 First Teaching Hospital, Tianjin University of Traditional Chinese Medicine, Tianjin, China. 6. Department of Integrative Medical Center, 302 Military Hospital of People's Liberation Army, Beijing, China. 7. Hospital 85 People's Liberation Army of China, Shanghai, China. 8. Shanghai Public Health Clinical Center Affiliated to Fudan University, Shanghai, China. 9. Tianjin Second People-s Hospital, Tianjin First Center Hospital, Tianjin, China. 10. Renji Hospital Shanghai, Jiao Tong University School of Medicine, Shanghai, China. 11. Peking University First Hospital, Beijing, China. 12. Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China. 13. Department of Gastroenterology, Tianjin Medical University General Hospital, Tianjin, China. 14. Tongren Hospital Shanghai, Jiaotong University School of Medicine, Shanghai, China. 15. Guangdong Second Traditional Chinese Medicine Hospital, Guangzhou, China. 16. Changhai Hospital, The Second Military Medical University, Shanghai, China.
Abstract
Introduction and aim. Hyponatremia is common in patients with decompensated cirrhosis and is associated with increased mortality. Tolvaptan, a vasopressor V2 receptor antagonist, can increase free water excretion, but its efficacy and safety in cirrhotic patients remain unclear. MATERIAL AND METHODS: We studied the usage and safety of tolvaptan in cirrhotic patients in a real-life, non-randomized, multicenter prospective cohort study. Forty-nine cirrhotic patients with hyponatremia were treated with tolvaptan 15 mg daily, and 48 patients not treated with tolvaptan in the same period served as controls. Improvement in serum sodium level was defined as an increase in serum sodium from < 125 to ≥ 125 mmol/L or from 125-134 to ≥ 135 mmol/L on day 7. RESULTS: Twenty-three (47%) patients in the tolvaptan group and 17 (35%) in the control group had normal serum sodium on day 7 (p = 0.25). Serum sodium improved in 30 (61%) patients in the tolvaptan group and 17 (35%) patients in the control group (p = 0.011). Adverse events occurred in 46-47% of patients in both groups, and tolvaptan was not associated with worsened liver function. No patient with normal serum sodium on day 7 died within 30 days of treatment, whereas 16% of those with persistent hyponatremia died (p = 0.0019). CONCLUSION: In conclusion, short-term tolvaptan treatment is safe and can improve serum sodium level in cirrhotic patients with hyponatremia. Normalization of serum sodium level is associated with better survival.
Introduction and aim. Hyponatremia is common in patients with decompensated cirrhosis and is associated with increased mortality. Tolvaptan, a vasopressor V2 receptor antagonist, can increase freewater excretion, but its efficacy and safety in cirrhotic patients remain unclear. MATERIAL AND METHODS: We studied the usage and safety of tolvaptan in cirrhotic patients in a real-life, non-randomized, multicenter prospective cohort study. Forty-nine cirrhotic patients with hyponatremia were treated with tolvaptan 15 mg daily, and 48 patients not treated with tolvaptan in the same period served as controls. Improvement in serum sodium level was defined as an increase in serum sodium from < 125 to ≥ 125 mmol/L or from 125-134 to ≥ 135 mmol/L on day 7. RESULTS: Twenty-three (47%) patients in the tolvaptan group and 17 (35%) in the control group had normal serum sodium on day 7 (p = 0.25). Serum sodium improved in 30 (61%) patients in the tolvaptan group and 17 (35%) patients in the control group (p = 0.011). Adverse events occurred in 46-47% of patients in both groups, and tolvaptan was not associated with worsened liver function. No patient with normal serum sodium on day 7 died within 30 days of treatment, whereas 16% of those with persistent hyponatremia died (p = 0.0019). CONCLUSION: In conclusion, short-term tolvaptan treatment is safe and can improve serum sodium level in cirrhotic patients with hyponatremia. Normalization of serum sodium level is associated with better survival.