Long-term administration of Tolvaptan to patients with decompensated cirrhosis
Kengo Kanayama, Tetsuhiro Chiba, Kazufumi Kobayashi, Keisuke Koroki, Toru Maruta, Hiroaki Kanzaki, Yuko Kusakabe, Tomoko Saito, Souichiro Kiyono, Masato Nakamura, Sadahisa Ogasawara, Eiichiro Suzuki, Yoshihiko Ooka, Shingo Nakamoto, Shin Yasui, Tatsuo Kanda, Hitoshi Maruyama, Jun Kato, Naoya Kato
Abstract
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.