Int J Med Sci 2020; 17(7):874-880. doi:10.7150/ijms.41454 This issue

Research Paper

Long-term administration of Tolvaptan to patients with decompensated cirrhosis

Kengo Kanayama1, Tetsuhiro Chiba1✉, Kazufumi Kobayashi1, Keisuke Koroki1, Susumu Maruta1, Hiroaki Kanzaki1, Yuko Kusakabe1, Tomoko Saito1, Soichiro Kiyono1, Masato Nakamura1, Sadahisa Ogasawara1, Eiichiro Suzuki1, Yoshihiko Ooka1, Shingo Nakamoto1, Shin Yasui1, Tatsuo Kanda2, Hitoshi Maruyama3, Jun Kato1, Naoya Kato1

1. Department of Gastroenterology, Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan.
2. Department of Gastroenterology and Hepatology, Nihon University School of Medicine, 30-1 Oyaguchi-Kamicho, Itabashi-ku, Tokyo 173-8610, Japan.
3. Department of Gastroenterology, Juntendo University School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan.

This is an open access article distributed under the terms of the Creative Commons Attribution License ( See for full terms and conditions.
Kanayama K, Chiba T, Kobayashi K, Koroki K, Maruta S, Kanzaki H, Kusakabe Y, Saito T, Kiyono S, Nakamura M, Ogasawara S, Suzuki E, Ooka Y, Nakamoto S, Yasui S, Kanda T, Maruyama H, Kato J, Kato N. Long-term administration of Tolvaptan to patients with decompensated cirrhosis. Int J Med Sci 2020; 17(7):874-880. doi:10.7150/ijms.41454. Available from

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Aim: Tolvaptan, an oral vasopressin-2 antagonist, sometimes improves hepatic edema including ascites in patients with decompensated cirrhosis. In this study, we examined the effectiveness and survival advantage in patients with the long-term administration of tolvaptan.

Methods: A total of 115 patients with refractory ascites who were treated with tolvaptan were retrospectively analyzed based on their clinical records. Patients with a decrease in body weight of ≥1.5 kg from the baseline on day 7 were determined as responders. Re-exacerbation was defined as a return to the baseline BW, dose escalation of conventional diuretics, or abdominal drainage.

Results: Of the 115 patients, 84 were included in this analysis. Response to tolvaptan treatment was observed in 55 out of the 84 patients (65.5%), with a mean weight reduction of 2.52 kg. Multivariate analyses demonstrated that body mass index (≥24) and urinary specific gravity (≥1.018) were significant predictors of the response to tolvaptan. However, cumulative re-exacerbation rates in responders at 6 and 12 months were 42.4 and 60.1%, respectively. Child-Pugh (classification C), HCC complication, and serum sodium levels (≥133 mEq/L) were determined as independent prognostic factors impacting overall survival (OS). Although there were no significant differences in OS between tolvaptan responders and non-responders, the responders without re-exacerbation within 3 months showed significantly longer OS than those with re-exacerbation within 3 months.

Conclusion: A persistent therapeutic response, but not early response to tolvaptan, was associated with favorable survival of decompensated cirrhotic patients.

Keywords: Tolvaptan, Cirrhosis, Ascites, HCC