drugset / Trial / NCT03121521

The Effects of Melatonin on Elevated Liver Enzymes During Statins Treatment

NCT03121521

Phase 4 Completed 60 enrolled Medical University of Lodz
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2012-09-01
Primary completion
2016-09-30
Completion
2016-12-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Melatonin Small molecule 10 mg Oral

Indications