TY - JOUR
T1 - Incidence and risk factors for non-alcoholic steatohepatitis
T2 - Prospective study of 5408 women enrolled in Italian tamoxifen chemoprevention trial
AU - Bruno, Savino
AU - Maisonneuve, Patrick
AU - Castellana, Paola
AU - Rotmensz, Nicole
AU - Rossi, Sonia
AU - Maggioni, Marco
AU - Persico, Marcello
AU - Colombo, Alberto
AU - Monasterolo, Franco
AU - Casadei-Giunchi, Donata
AU - Desiderio, Franco
AU - Straffolini, Tommaso
AU - Sacchini, Virgilio
AU - Decensi, Andrea
AU - Veronesi, Umberto
PY - 2005/4/23
Y1 - 2005/4/23
N2 - Objective: To assess the incidence, cofactors, and excess risk of development of non-alcoholic fatty liver disease, including non-alcoholic steatohepatitis, attributable to tamoxifen in women. Design: Prospective, randomised, double blind, placebo controlled trial. Setting and participants: 5408 healthy women who had had hysterectomies recruited into the Italian tamoxifen chemoprevention trial from 58 centres in Italy. Intervention: Women were randomly assigned to receive tamoxifen (20 mg daily) or placebo for five years. Main outcome measure: Development of non-alcoholic fatty liver disease in all women with normal baseline liver function who showed at least two elevations of alanine aminotransferase (≥ 1.5 times upper limit of normal) over a six month period. Results: During follow up, 64 women met the predefined criteria: 12 tested positive for hepatitis C virus, and the remaining 52 were suspected of having developed non-alcoholic fatty liver disease (34 tamoxifen, 18 placebo) - hazard ratio = 2.0 (95% confidence interval 1.1 to 3.5; P=0.04). In all 52 women ultrasonography confirmed the presence of fatty liver. Other factors associated with the development of non-alcoholic fatty liver disease.
AB - Objective: To assess the incidence, cofactors, and excess risk of development of non-alcoholic fatty liver disease, including non-alcoholic steatohepatitis, attributable to tamoxifen in women. Design: Prospective, randomised, double blind, placebo controlled trial. Setting and participants: 5408 healthy women who had had hysterectomies recruited into the Italian tamoxifen chemoprevention trial from 58 centres in Italy. Intervention: Women were randomly assigned to receive tamoxifen (20 mg daily) or placebo for five years. Main outcome measure: Development of non-alcoholic fatty liver disease in all women with normal baseline liver function who showed at least two elevations of alanine aminotransferase (≥ 1.5 times upper limit of normal) over a six month period. Results: During follow up, 64 women met the predefined criteria: 12 tested positive for hepatitis C virus, and the remaining 52 were suspected of having developed non-alcoholic fatty liver disease (34 tamoxifen, 18 placebo) - hazard ratio = 2.0 (95% confidence interval 1.1 to 3.5; P=0.04). In all 52 women ultrasonography confirmed the presence of fatty liver. Other factors associated with the development of non-alcoholic fatty liver disease.
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U2 - 10.1136/bmj.38391.663287.E0
DO - 10.1136/bmj.38391.663287.E0
M3 - Article
C2 - 15746106
AN - SCOPUS:20244370881
VL - 330
SP - 932
EP - 935
JO - British Medical Journal
JF - British Medical Journal
SN - 0959-8146
IS - 7497
ER -