Vitamin E Supplementation for Treatment of Statin Induced Hepatocellular Damage: A Randomized, Double-Blind, Placebo- Controlled Trial

Background: Statin treatment can cause elevation of the liver aminotransferase levels in 1-3% of the patients with hypercholesterolemia. Previous studies indicate that vitamin E plays a role in declining the increased levels of liver enzymes caused by fatty liver disease. Objectives: We conducted this study to determine the effect of vitamin E on liver aminotransferase levels in patients with elevated aminotransferase levels due to statin consumption. Materials and Methods: This study was a randomized, double-blind, placebo-controlled trials. Eligible patients were those who developed elevated aminotransferase levels after initiation of statin. They were randomized into the intervention group (vitamin E capsules, 400 units/day for one month) and placebo group. Randomization was done with permuted block sampling method with a 2:1 enrolment ratio. Study capsules were allocated in separate packs blinded and labeled using a four-digit code. Alanine aminotransferase (ALT) and asparate aminotransferase (AST) levels were checked in the beginning and one month after the intervention. Comparison of the levels before and after the intervention was done by paired sample T-test, and between group difference was checked by independent sample T-test. Results: A final number of 23 patients enrolled in this study (15 in the intervention and 8 in the control parallel groups). Baseline ALT and AST levels in both groups showed no difference (74.3 ± 9.1 vs. 77.6 ± 17.5, P = 0.9; and 50 ± 8.2 vs. 43.3 ± 9.3, P = 0.34, respectively). With consumption of vitamin E, ALT level was decreased from 77.6 ± 17.5 to 40.9 ± 13.4, showing a significant difference with placebo (treatment difference = -25.7, P = 0.04). However, the reduction of asparate aminotransferase level from 43.3 ± 9.3 to 29.8 ± 5.9 was not significant compared to placebo (treatment difference = -1.5, P = 0.12). Conclusions: Vitamin E therapy in patients with moderately elevated aminotransferase levels (1.5-3 times than basal levels) due to statin consumption may be beneficial and can reduce the asymptomatic hepatocellular damages