Abstract
Aims: This study compared the efficacy of add-on low dose of tolvaptan (TLV) tofurosemide (FUR) with that of add-on high dose of TLV to FUR on heart failure (HF)patients with advanced kidney dysfunction (estimated glomerular filtration rate, eGFR; <45 mL/min/1.73 m2). Methods and Results: This study analyzed two clinical trial data from the Kanagawa Aquaresis Investigators Trial of TLV on HF patients with Renal Impairment (K-STAR) study and the pharmacokinetic/pharmacodynamic (PK/PD) study of TLV in HF patients with advanced kidney dysfunction. The K-STAR study was a multicenter, open-labeled, randomized and controlled prospective clinical study; the PK/PD study was a single center, open-label, single-dose study. The present study patients were divided into the TLV 7.5 mg (n = 32) or TLV 15 mg (n = 25) group. The urine volume significantly increased in the CKD stage 3 group (TLV 15 mg, 4572 mL; TLV 7.5 mg, 4114 ml) rather than the CKD stage 4,5 group(TLV 15 mg, 3557 mL; TLV 7.5 mg, 3030 ml; P = .01) . No significant differences in serum creatinine level or worsening renal function were observed at baseline and 48 hours after treatment. Conclusion: Add-on TLV 15 mg to FUR was effective to increase urine volume in congestive HF patients with CKD stage 4,5 group within 48 hours after administration. We recommend that TLV should be initiated at the lower doses (7.5 mg) in CKD stage 3 group.
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