Background: Statin drugs are known to cause dose-dependent abnormalities in liver function tests (LFTs), with elevations three times the upper limits of normal of the aminotransferase enzymes in up to 2.5% of patients on the highest prescribable doses. The Program on the Surgical Control of the Hyperlipidemias (POSCH) trial employed no hypocholesterolaemic drugs and used a surgical procedure, partial ileal bypass, as the intervention modality.
Methods: Serum total bilirubin, alkaline phosphatase and serum glutamic-oxaloacetic transaminase (SGOT) (equivalent to aspartate aminotransferase [AST]), were the LFTs obtained in POSCH at baseline, 3 months, annually for 5 years, and at 7 or 10 years postrandomization.
Results: Abnormal values were found for total bilirubin in seven of 416 control group (CG) patients (1.68%) and in 34 of 373 intervention group (IG) patients (9.16%) (P = 0.001); for alkaline phosphatase, in 28 of 378 (7.41%) and in 41 of 326 (12.58%) (P = 0.0214); and for SGOT, in 102 of 412 (24.76%) and in 161 of 372 (43.28%) (P = 0.001). Values twice the upper limit of normal occurred in 1 CG and 1 IG patient for total bilirubin and for alkaline phosphatase, and in 11 CG and 7 IG patients for SGOT (NS). Values three times the upper limit of normal did not occur in any patient for total bilirubin or alkaline phosphatase, and occurred in 3 CG and 5 IG patients for SGOT (NS).
Conclusions: In POSCH, the IG demonstrated statistically significant mild increases for total bilirubin, alkaline phosphatase and SGOT levels, with no significant increases in values twice or greater the upper limits of normal.