After 36 weeks of treatment, the cumulative proportion of patients who reached the primary safety endpoint was lower in the
pravastatin group than in the placebo group (8%
vs 13%; 95% confidence interval [CI], −11.6 to 1.6; P = .1379). In fact, the mean ALT values declined from baseline in the pravastatin group, whereas the mean ALT and AST were increased from baseline in the placebo group. None of the subjects in either treatment group had an elevation of total bilirubin >2 times the ULN.