Pioglitazone reduced liver injury and improved fasting glucose in nonalcoholic steatohepatitis without diabetes

摘要

QuestionnnIn patients who have nonalcoholic steatohepatitis (NASH) without diabetes, is pioglitazone therapy effective?nnMethodsnnDesign: Randomized placebo-controlled trial. National Research Register N0192119052; ISRCTN 10319160.nnAllocation: Concealed.*nnBlinding: Blinded ({patients, clinicians, outcome assessors, safety committee}†, data collectors, and pathologist).*nnFollow-up period: 1 year.nnSetting: Queen's Medical Centre, Nottingham, and Derby City General Hospital, Derby, England, UK.nnPatients: 74 patients 27 to 73 years of age (mean age 54 y, 61% men) who had NASH without diabetes. Exclusion criteria were history of alcohol excess, use of weight-reduction drugs or drugs associated with fatty liver, current or previous heart failure, renal impairment, and pregnancy or lactation.nnIntervention: Standard diet and exercise with pioglitazone, 30 mg/d (n = 37), or matching placebo (n = 37) for 1 year.nnOutcomes: Reduction in liver injury and fibrosis, and change in biochemical parameters (included body weight, blood pressure, and hemoglobin [Hb] A1c, fasting glucose, cholesterol, triglyceride, C-peptide, and fasting insulin levels).nnPatient follow-up: 82%.