Comparison of two dosing methods for immediate administration of tolvaptan in acute decompensated heart failure

Abstract Background The clinical dosing method for tolvaptan in patients with acute heart failure (HF) is still unclear. We aimed to compare the differences in clinical effect between two dosing regimens: once-daily 7.5 mg and twice-daily 3.75 mg. Methods In this randomized trial, tolvaptan was administered within 12 h from hospital admission. The primary outcome was the serial change in congestion scores measured every day from enrollment until dosing day 7. Outcomes including safety parameters were also evaluated. Results The subjects were assigned to either the once-daily 7.5 mg dosing regimen ( N  = 15) or the twice-daily 3.75 mg dosing regimen ( N  = 16). The time-course changes in body weight, serum sodium and creatinine levels, systolic blood pressure, daily urine output, and congestion scores were similar between the two groups. In the twice-daily 3.75 mg dosing group, the serum sodium levels on days 3 and 4 were significantly ( p p Conclusions Our present results suggest that the early administration of tolvaptan within 12 h after hospital admission significantly improved congestion from the first day after administration by either dosing regimen, i.e. once-daily 7.5 mg or twice-daily 3.75 mg in patients with acute HF.