title: Clinical comparison of branched-chain amino acid (l-Leucine, l-Isoleucine, l-Valine) granules and oral nutrition for hepatic insufficiency in patients with decompensated liver cirrhosis (LIV-EN study).
abstract: This multicenter study compared the effects of branched-chain amino acid granules (Livact((R)) Granules, LIV) and an enteral nutrient for chronic hepatic failure (Aminoleban((R)) EN, EN) on serum albumin in patients with decompensated liver cirrhosis. This study enrolled "patients with decompensated liver cirrhosis associated with hepatic encephalopathy who were suffering from hypoalbuminemia in spite of adequate food intake," a condition for which both drugs are indicated. Enrolled patients were randomized to the two groups according to the central registration method. This study continued for 24 weeks. Selected foods were supplied to each patient in principle so that caloric and protein intakes were standardized between the two groups. A total of 281 patients were enrolled. LIV was not inferior to EN concerning the primary efficacy endpoint changes in serum albumin.
authors.affiliation: Iwate Medical University, 19-1 Uchimaru, Morioka 020-8505, Japan.
authors.forename: Shunichi
authors.initials: S
authors.lastname: Sato
authors.forename: Akiharu
authors.initials: A
authors.lastname: Watanabe
authors.forename: Yasutoshi
authors.initials: Y
authors.lastname: Muto
authors.forename: Kazuyuki
authors.initials: K
authors.lastname: Suzuki
authors.forename: Akinobu
authors.initials: A
authors.lastname: Kato
authors.forename: Hisataka
authors.initials: H
authors.lastname: Moriwaki
authors.forename: Masahiko
authors.initials: M
authors.lastname: Kato
authors.forename: Teiji
authors.initials: T
authors.lastname: Nakamura