Abstract
Purpose
Diuretics are recommended to treat volume overload with heart failure (HF), however, they may cause serum electrolyte imbalance, limiting their use. Moreover, patients with advanced HF could poorly respond to these diuretics. In this study, we evaluated the efficacy and safety of Tolvaptan, a competitive vasopressin V2-receptor antagonist developed as a new drug to treat volume overload in HF patients.
Methods
A phase III, multicenter, randomized, double-blind, placebo-controlled parallel study was performed to assess the efficacy and safety of tolvaptan in treating HF patients with volume overload despite the use of conventional diuretics. One hundred and ten patients were randomly assigned to receive either placebo or 15 mg/day tolvaptan for 7 consecutive days.
Results
Compared with placebo, tolvaptan administered for 7 days significantly reduced body weight and improved symptoms associated with volume overload. The safety profile of tolvaptan was considered acceptable for clinical use with minimal adverse effects.
Conclusion
Tolvaptan reduced volume overload and improved congestive symptoms associated with HF by a potent water diuresis (aquaresis).
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Disclosures
Editorial support for this manuscript was provided by Elsevier Japan K.K. This support was funded by Otsuka Pharmaceutical Co., Ltd.
Participating centers
The present study was conducted in the following institutions in Japan.
N.H.O. Hokkaido Cancer Center, N.H.O. Mito Medical Center, N.H.O. Takasaki National Hospital, N.H.O. Saitama National Hospital, N.H.O. Chiba Medical Center, N.H.O. Tokyo National Hospital, I.M.C.J. Toyama Hospital, N.H.O. Tokyo Medical Center, N.H.O. Yokohama Medical Center, N.H.O. Sagamihara National Hospital, N.H.O. Kanazawa Medical Center, N.H.O. Nagano National Hospital, N.H.O. Shizuoka Medical Center, N.H.O. Nagoya Medical Center, Toyota Memorial Hospital, N.H.O. Toyohashi Medical Center, N.H.O. Mie Chuo Medical Center, Sakurabashi Watanabe Hospital, Tazuke Kofukai Kitano Hospital, Osaka Red Cross Hospital, N.H.O. Osaka Medical Center, Osaka Rosai Hospital, N.H.O. Kobe Medical Center, N.H.O. Hamada Medical Center, N.H.O. Kure Medical Center, N.H.O. Fukuyama Medical Center, N.H.O. Higashihiroshima Medical Center, N.H.O. Kanmon Medical Center, N.H.O. Zentsuji National Hospital Kokura Memorial Hospital, N.H.O. Ureshino Medical Center, N.H.O. Nagasaki Medical Center, N.H.O. Nagasaki Medical Center Of Neurology, N.H.O. Kumamoto Medical Center, N.H.O. Beppu Medical Center, N.H.O. Matsumoto Medical Center, Kitasato Institute Hospital, Sanin Rosai Hospital, Chubu Tokushukai Hospital
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Matsuzaki, M., Hori, M., Izumi, T. et al. Efficacy and Safety of Tolvaptan in Heart Failure Patients with Volume Overload Despite the Standard Treatment with Conventional Diuretics: A Phase III, Randomized, Double-blind, Placebo-controlled Study (QUEST Study). Cardiovasc Drugs Ther 25 (Suppl 1), 33–45 (2011). https://doi.org/10.1007/s10557-011-6304-x
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DOI: https://doi.org/10.1007/s10557-011-6304-x