RANDOMIZED CONTROLLED DOUBLE-BLIND TRIAL OF THE CALCIUM-CHANNEL ANTAGONIST AMLODIPINE IN THE TREATMENT OF ACUTE ALCOHOLIC HEPATITIS

Background / Aims: Calcium channel blockers have a hepatoprotective ac tion in animal models of alcohol-induced liver injury but their effect in alcoholic liver disease in humans has not been previously investig ated. We have conducted a randomised, placebo-controlled trial to inve stigate the possible benefit of the calcium channel blocker amlodipine in term of 4-week survival in hospitalised patients with severe acute alcoholic hepatitis. Methods: Sixty-two patients with acute alcoholic hepatitis were randomised to receive 5-10 mg amlodipine each day for 1 year or an identical capsule containing placebo. In 36 (58%), acute alcoholic hepatitis was confirmed on biopsy and in the remainder on cl inical and laboratory criteria. There were no statistically significan t differences in clinical characteristics and disease severity in the treated and placebo groups. Results: Of the 32 patients receiving amlo dipine, there were six deaths (19%) in the first 4 weeks compared with seven (23%) of the placebo patients (p=0.329). Causes of death were s imilar in the amlodipine and control groups, with liver failure predom inant. Analysis by the Cox proportional hazards model after adjustment for other prognostic factors showed survival was not significantly in fluenced by active treatment (p=0.07). One patient in each group was w ithdrawn because of the development of hypotension, but this did not r ecur on reintroduction of the capsules. Conclusions: This study shows that calcium channel blockers are well tolerated with few side effects in advanced alcoholic liver disease, but there is no conclusive evide nce from this study that calcium channel blockers are helpful in the t reatment of alcoholic hepatitis.