The efficacy and safety of terlipressin and albumin in patients with type 1 hepatorenal syndrome: a multicenter, open-label, explorative study.

BACKGROUND: Treatment with terlipressin and albumin has been reported recently to be effective in improving renal function in the treatment of cirrhotic patients with hepatorenal syndrome (HRS). The aim of this prospective, multicenter study was to investigate the efficacy and safety of treatment with terlipressin and albumin in Japanese cirrhotic patients with type 1 HRS.

METHODS: Eight cirrhotic patients with type 1 HRS were included in the study. Terlipressin (2.8 ± 0.4 mg/day) and albumin (25.7 ± 2.8 g/day) were given simultaneously for 6.3 ± 4.2 days.

RESULTS: Urine volume was significantly increased (p < 0.05) at the end of treatment compared with baseline. Serum creatinine levels were significantly decreased from 2.84 ± 0.45 to 1.08 ± 0.33 mg/dl (-61.9 ± 9.9%, p < 0.05) after terlipressin and albumin administration. Creatinine clearance was significantly increased (p < 0.05) after treatment. Plasma renin activity and norepinephrine were significantly decreased (p < 0.05) after therapy. Six of the 8 patients (75%) showed a complete response (reduction of serum creatinine to 1.5 mg/dl or less). The cumulative probabilities of survival at 4 and 12 weeks were 63 and 13%, respectively. Complication of congestive heart failure possibly related to this regimen was seen in 1 patient, but ischemic adverse events were not observed during the treatment.

CONCLUSIONS: Treatment with terlipressin and albumin improves renal function in cirrhotic patients with type 1 HRS. However, the survival of cirrhotic patients with type 1 HRS remains poor, although it may be improved by this specific therapy.