Abstract 19103: Tolvaptan Increases Urine Output Without Hemodynamic Impairment in Heart Failure Patients With Renal Dysfunction

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Introduction: There has been scant clinical evidence on whether the aquaretic effect of tolvaptan (TLV) contributes to decongestion without further renal impairment compared with furosemide (FUR). Methods: The Kanagawa Aquaresis Investigators Trial of TLV on Heart Failure Patients with Renal Impairment (K-STAR) is a multicenter, open-labeled, randomized, controlled prospective clinical study of 81 patients with heart failure (HF) in Japan. Patients with residual signs of congestion despite treatment with oral FUR at a dose of ≥40 mg/day with baseline estimated glomerular filtration rates of <45 mL/min were randomly assigned to two groups for 7-day treatments with either ≤15 mg/day of additive TLV or ≤40 mg/day of FUR. Results: During the treatment period, a more significant increase from baseline in urine volume (%ΔUV) was seen in the TLV group than in the FUR group (+42 ± 43% in the TLV group vs. +15 ± 39% in the FUR group, p < 0.01). Renal function was better preserved in the TLV group than in the FUR group [increase in serum creatinine (%ΔCr): +3 ± 13% in the TLV group vs. +10 ± 14% in the FUR group, p = 0.015]. Increases in the ratio of blood urea nitrogen to %ΔCr and %ΔUV were positively correlated in the FUR group (r = 0.33, p = 0.03) but were not significantly correlated in the TLV group (r = -0.15, p = 0.34). Moreover, an increase in pulse rate (%ΔPR: r = 0.31, p = 0.04) and decrease in stroke volume (%ΔSV: r = –0.35, p = 0.04) were positively correlated to the %ΔUV in the FUR group but not in the TLV group (%ΔPR: r = 0.10, p = 0.51; %ΔSV: r = –0.08, p = 0.65; respectively). Conclusions: TLV increases UV with less hemodynamic and renal impairment by maintaining adequate intravascular volume compared with FUR in HF patients with renal dysfunction.