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.
Division of Gastroenterology, Department of Internal Medicine, Nippon Medical School, 1-1-5 Sendagi, Bunkyo-ku, Tokyo 113-8603, Japan. y-nara@nms.ac.jp
Yoshiyuki
Y
Narahara
Hidenori
H
Kanazawa
Choitsu
C
Sakamoto
Hitoshi
H
Maruyama
Osamu
O
Yokosuka
Satoshi
S
Mochida
Masahito
M
Uemura
Hiroshi
H
Fukui
Yasukiyo
Y
Sumino
Yasushi
Y
Matsuzaki
Naohiko
N
Masaki
Shigehiro
S
Kokubu
Kiwamu
K
Okita
D000368:Aged; D000418:Albumins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003404:Creatinine / Q000097:blood; D004359:Drug Therapy, Combination; D005260:Female; D006530:Hepatorenal Syndrome / Q000188:drug therapy* / Q000209:etiology; D006801:Humans; D007564:Japan; D008103:Liver Cirrhosis / Q000150:complications; D008236:Lypressin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009638:Norepinephrine / Q000097:blood; D011446:Prospective Studies; D012083:Renin / Q000097:blood; D015996:Survival Rate; D000077585:Terlipressin; D016896:Treatment Outcome
D000418:Albumins; D000959:Antihypertensive Agents; D008236:Lypressin; D000077585:Terlipressin; D003404:Creatinine; D012083:Renin; D009638:Norepinephrine