The Efficacy and Safety of Short-Term Tolvaptan Usage in Patients with Acute Decompensated Heart Failure

Yen Hung Lin, Cheng Hsuan Tsai, Chern En Chiang, Jen Yuan Kuo, Wei Hsian Yin, Ming Shien Wen, Ping Han Lo, Ping Yen Liu, Tsung Hsien Lin, Zhih Cherng Chen, Kou Gi Shyu, Ming Jui Hung, Juey Jen Hwang, Chuen Den Tseng

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2 引文 斯高帕斯(Scopus)

摘要

Background: Patients admitted with acute decompensated heart failure (ADHF) have a poor prognosis and poor quality of life due to dyspnea and edema. Tolvaptan, a vasopressin V2 receptor antagonist, is an effective water diuretic. This study aimed to evaluate the efficacy and safety of a short course of tolvaptan to treat volume overload in patients with ADHF. Methods: We conducted a phase III, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a short course of tolvaptan (15 mg/day for 4 days) in hospitalized ADHF patients with volume overload despite the use of conventional diuretics. The primary end-point was the change in body weight after 4 days of treatment. The secondary end-points were the change in intake/output balance, change in serum sodium/potassium concentrations, physician/patient assessed signs and symptoms of heart failure after 4 days of treatment, and all-cause mortality in 1 month. Results: A total of 110 patients were screened, and 91 were randomized to receive 15 mg/day of tolvaptan for 4 days (n = 46) or matching placebo (n = 45). Compared to the placebo-treated patients, tolvaptan significantly reduced body weight (-1.36 + 2.13 kg in the tolvaptan group vs.-0.59 + 1.27 kg in the placebo group, p = 0.0394). The tolvaptan group also had a negative intake/urine volume balance compared to the placebo group (-509.3 + 2788.2 ml vs. 975.5 + 1903.1 ml, p = 0.0059). The safety profile of tolvaptan was acceptable. Conclusion: Tolvaptan significantly reduced volume overload in hospitalized ADHF patients with volume overload despite the use of conventional diuretics.

原文English
頁(從 - 到)700-713
頁數14
期刊Acta Cardiologica Sinica
38
發行號6
DOIs
出版狀態Published - 2022 11月

All Science Journal Classification (ASJC) codes

  • 心臟病學與心血管醫學

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