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.
RCT Entities:
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.