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Phase III clinical pharmacology study of tolvaptan.

Author(s): Inomata T, Izumi T, Matsuzaki M, Hori M, Hirayama A; Tolvaptan Investigators.

Affiliation(s): Department of Cardio-Angiology, Kitasato University School of Medicine, 1-15-1 Kitasato, Minamiku, Sagamihara, Kanagawa, 252-0373, Japan. inotaka@med.kitasato-u.ac.jp

Publication date & source: 2011, Cardiovasc Drugs Ther. , 25 Suppl 1:S57-65

PURPOSE: This study aimed to investigate the pharmacokinetics, pharmacodynamics, efficacy and safety of tolvaptan, an orally effective vasopressin V2-receptor antagonist. METHODS: This was a multicenter, randomized, double-blind, parallel group study. Tolvaptan was administered at 7.5 or 15 mg, in combination with furosemide, for 7 days in Japanese heart failure (HF) patients with volume overload that had not resolved despite receiving furosemide. RESULTS: The blood concentration of tolvaptan was maintained at a higher concentration for a longer time in patients who received 15 mg/day when compared with patients who received 7.5 mg/day. Tolvaptan increased urine volume and increased weight loss dose-dependently when used in combination with furosemide. Importantly, tolvaptan enhanced water diuresis without affecting blood electrolyte levels. CONCLUSION: Tolvaptan exerts diuretic effects and causes body weight loss at the low dose of 7.5 mg; however, these effects were less than those elicited by 15 mg tolvaptan.

Page last updated: 2013-02-10

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