The Effects of Melatonin on Elevated Liver Enzymes During Statins Treatment
Status:
Completed
Trial end date:
2016-12-15
Target enrollment:
Participant gender:
Summary
Introduction. Statins are generally well tolerated but not devoid of side effects. Quite
often it is manifested by asymptomatic increase in the level of aspartate and alanine
aminotransferase. In such cases patients to administer hepatoprotective drugs, but most of
them used for this purpose are ineffective. The aim of this study was assess the usefulness
of melatonin in counteracting the adverse hepatic events from statins. Methods. The research
program included 60 patients(aged 47-65 years, 41 women and 23 men)with hyperlipidemia taking
atorvastatin or rosuvastatin in dose 20-40 mg daily. The patients were randomly allocated in
two groups. Group I (n=30) was recommended to take the same statin at a standardized daily
dose of 20 mg together with melatonin at a dose 2 x 5 mg, at 7:00 and 21:00. In group II
(n=30) patients took statins with placebo at the same time of the day. Follow-up laboratory
tests (AST, ALT, GGT, ALP, cholesterol, triglycerides) were evaluated after 2,4 and 6 mounts
of treatment.
Phase:
Phase 4
Details
Lead Sponsor:
Medical University of Lodz Medical Universtity of Lodz