title: Utility and safety of tolvaptan in cirrhotic patients with hyponatremia: A prospective cohort study.
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.
  
  
  
  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.
  
  
  
  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).
  
  
  
  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.
authors.affiliation: Liver Research Center, Beijing Friendship Hospital, Capital Medical University, Beijing, China.
authors.forename: Ji-Dong
authors.initials: JD
authors.lastname: Jia
authors.affiliation: Beijing Di Tan Hospital, Capital Medical University, Beijing, China.
authors.forename: Wen
authors.initials: W
authors.lastname: Xie
authors.affiliation: Department of Gastroenterology and Hepatology, Beijing You'an Hospital affiliated with Capital Medical University, Beijing, China.
authors.forename: Hui-Guo
authors.initials: HG
authors.lastname: Ding
authors.affiliation: Department of Gastroenterology, Zhujiang Hospital, Southern Medical University, Guangzhou, China.
authors.forename: Hua
authors.initials: H
authors.lastname: Mao
authors.affiliation: 5 First Teaching Hospital, Tianjin University of Traditional Chinese Medicine, Tianjin, China.
authors.forename: Hui
authors.initials: H
authors.lastname: Guo
authors.affiliation: Department of Integrative Medical Center, 302 Military Hospital of People's Liberation Army, Beijing, China.
authors.forename: Yonggang
authors.initials: Y
authors.lastname: Li
authors.affiliation: Hospital 85 People's Liberation Army of China, Shanghai, China.
authors.forename: Xiaojin
authors.initials: X
authors.lastname: Wang
authors.affiliation: Shanghai Public Health Clinical Center Affiliated to Fudan University, Shanghai, China.
authors.forename: Jie-Fei
authors.initials: JF
authors.lastname: Wang
authors.affiliation: Tianjin Second People-s Hospital, Tianjin First Center Hospital, Tianjin, China.
authors.forename: Wei
authors.initials: W
authors.lastname: Lu
authors.affiliation: Renji Hospital Shanghai, Jiao Tong University School of Medicine, Shanghai, China.
authors.forename: Cheng-Zhong
authors.initials: CZ
authors.lastname: Li
authors.affiliation: Peking University First Hospital, Beijing, China.
authors.forename: Yimin
authors.initials: Y
authors.lastname: Mao
authors.affiliation: Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.
authors.forename: Gui-Qiang
authors.initials: GQ
authors.lastname: Wang
authors.affiliation: Department of Gastroenterology, Tianjin Medical University General Hospital, Tianjin, China.
authors.forename: Yue-Qiu
authors.initials: YQ
authors.lastname: Gao
authors.affiliation: Tongren Hospital Shanghai, Jiaotong University School of Medicine, Shanghai, China.
authors.forename: Bangmao
authors.initials: B
authors.lastname: Wang
authors.affiliation: Guangdong Second Traditional Chinese Medicine Hospital, Guangzhou, China.
authors.forename: Qin
authors.initials: Q
authors.lastname: Zhang
authors.affiliation: Changhai Hospital, The Second Military Medical University, Shanghai, China.
authors.forename: Yan
authors.initials: Y
authors.lastname: Ge
authors.affiliation: Changhai Hospital, The Second Military Medical University, Shanghai, China.|Renji Hospital Shanghai, Jiao Tong University School of Medicine, Shanghai, China.
authors.forename: Vincent Wai-Sun
authors.initials: VW
authors.lastname: Wong
mesh_terms: D000368:Aged; D065092:Antidiuretic Hormone Receptor Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D001552:Benzazepines / Q000009:adverse effects / Q000627:therapeutic use*; D015415:Biomarkers / Q000097:blood; D016022:Case-Control Studies; D002681:China; D005260:Female; D006801:Humans; D007010:Hyponatremia / Q000097:blood / Q000188:drug therapy* / Q000209:etiology / Q000401:mortality; D053208:Kaplan-Meier Estimate; D008103:Liver Cirrhosis / Q000150:complications* / Q000175:diagnosis / Q000401:mortality; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012307:Risk Factors; D012964:Sodium / Q000097:blood*; D013997:Time Factors; D000077602:Tolvaptan; D016896:Treatment Outcome
chemical_list: D065092:Antidiuretic Hormone Receptor Antagonists; D001552:Benzazepines; D015415:Biomarkers; D000077602:Tolvaptan; D012964:Sodium