Can Serum Albumin Level Affect the Pharmacological Action of Tolvaptan in Patients with Liver Cirrhosis? A Post Hoc Analysis of Previous Clinical Trials in Japan

Overview

Journal J Gastroenterol

Specialty Gastroenterology

Date 2015 Feb 19

PMID 25689936

Citations 19

Authors

Isao Sakaida

Koji Nakajima

Kiwamu Okita

Masatsugu Hori

Tohru Izumi

Masaya Sakurai

Yoshiyuki Shibasaki

Sayaka Tachikawa

Hidetsugu Tsubouchi

Hiromi Oka

Hiroyuki Kobayashi

Affiliations

Soon will be listed here.

Abstract

Background: Patients with hypoalbuminemia often fail to respond to increased doses of loop diuretics. We therefore performed a post hoc analysis to investigate the pharmacological action of tolvaptan and whether it is dependent on the serum albumin level.

Methods: This analysis was based on four previous clinical trials of tolvaptan in patients with liver cirrhosis who exhibited insufficient response to conventional diuretics. We analyzed the correlation between the change in the initial 24-h cumulative urine volume from baseline and the serum albumin level at baseline, and assessed potential predictive factors of response to tolvaptan.

Results: The correlation coefficient was 0.029 in the placebo group and -0.112 in the 7.5 mg tolvaptan group of patients with liver cirrhosis. Administration of tolvaptan provoked a stable response regardless of the serum albumin level. Tolvaptan use was identified as a significant predictor of pharmacological action, and was shown to change the initial urine volume by 885 mL (P < 0.0001) in liver cirrhosis patients.

Conclusions: In this post hoc analysis, tolvaptan increased the initial urine volume from baseline regardless of serum albumin levels. Use of tolvaptan as an add-on therapy to loop diuretics can be considered an optimal therapeutic option in patients with insufficient response to loop diuretics.

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