Journal
JOURNAL OF INTERNATIONAL MEDICAL RESEARCH
Volume 40, Issue 6, Pages 2381-2393Publisher
SAGE PUBLICATIONS LTD
DOI: 10.1177/030006051204000637
Keywords
ASCITES; AQUARETIC EFFECT; DIURETIC; LIVER CIRRHOSIS; PHARMACOKINETICS; PHARMACODYNAMICS; TOLVAPTAN
Funding
- Otsuka Pharmaceutical, Osaka, Japan
- Otsuka Pharmaceutical
- MSD
- Chugai Pharmaceutical
- Takeda Pharmaceutical
Ask authors/readers for more resources
OBJECTIVES: This study investigated the pharmacokinetic and pharmacodynamic profile of tolvaptan, and verified its efficacy and safety in patients with liver cirrhosis-associated ascites, with insufficient response to conventional diuretic treatment. METHODS: This multicentre, double-blind, parallel-group study allocated patients with cirrhosis to receive either 3.75 or 7.5 mg/day tolvaptan orally, once daily, for 7 days. Pharmacokinetic, pharmacodynamic and efficacy variables were measured. RESULTS: Tolvaptan was shown to have high plasma concentrations, and prolonged duration of maximum concentration and half life, in these patients with impaired hepatic function. Tolvaptan resulted in dose-dependent decreases in body weight and ascites volume, and increases in urine output. There were no effects on urinary or serum electrolytes. Tolvaptan was well tolerated, with a good safety profile. CONCLUSIONS: Tolvaptan at 3.75 mg/day exerts some effects due to the pharmacokinetic profile in patients with liver cirrhosis. Tolvaptan at 7.5 mg/day is a clinically useful option for treating patients who do not respond well to conventional diuretics.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available