The Effects of Melatonin on Elevated Liver Enzymes During Statins Treatment

• Status: Completed
• Trial end date: 2016-12-15
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Lodz; Medical Universtity of Lodz
• Treatments: Melatonin

Criteria

Inclusion Criteria:- hyperlipidemia treated with statins for minimum 6 months

• at least 2-fold increase in the level of aspartate and alanine aminotransferase found in two consecutive tests

• the persistence of increased aminotransferase levels despite the reduction in the statin dose At the time of the inclusion of patients in the study, 38 subjects were taking atorvastatin ( 20 mg), and 26 - rosuvastatin at the dose 40 mg (3 patients), - 20mg (19 patients) and 15 mg (4 patients).

Exclusion Criteria:- history of viral hepatitis

• cholelithiasis 4

• body mass index (BMI)>30kg/m2

• alcohol abuse

• familial hypercholesterolemia

• established hypertension

• thyroid diseases

• other organic, metabolic or mental diseases

• hormone replacement therapy

• taking other medications, especially analgesics and psychotropic drugs