Incidence and risk factors for non-alcoholic steatohepatitis: Prospective study of 5408 women enrolled in Italian tamoxifen chemoprevention trial

Savino Bruno, Patrick Maisonneuve, Paola Castellana, Nicole Rotmensz, Sonia Rossi, Marco Maggioni, Marcello Persico, Alberto Colombo, Franco Monasterolo, Donata Casadei-Giunchi, Franco Desiderio, Tommaso Straffolini, Virgilio Sacchini, Andrea Decensi, Umberto Veronesi

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish
Pages (from-to)932-935
Number of pages4
JournalBritish Medical Journal
Volume330
Issue number7497
DOIs
Publication statusPublished - Apr 23 2005

ASJC Scopus subject areas

  • Medicine(all)

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