drugset / Trial / NCT02548832

Bezafibrate Plus Berberine in Mixed Dyslipidemia

NCT02548832

Phase 3 Completed 36 enrolled University of Guadalajara
RandomizedParallel-groupDouble-blindTreatment

Summary

Dyslipidemia, is a cardiovascular risk factor of great importance whose prevalence has increased over the last decade. Part of the components of metabolic syndrome and consensus so far contemplated to increased triglycerides (TG) and reduced high-density lipoprotein cholesterol (HDL-C) as part of the elements for classification, which includes mixed dyslipidemia. Currently, fibrates, such as bezafibrate, are drugs used in treating hypertriglyceridemia, besides reducing the risk of coronary disease. However, although this treatment is safe, it is not without risks; with increased prevalence of adverse effects as the dose thereof is increased or joins combination with a statin drug for the treatment of mixed dyslipidemia long term. Among the alternative therapies is berberine, which to reduce cholesterol and triglycerides may be useful in combination with bezafibrate in the treatment of mixed dyslipidemia and as an option with lower cost and lower frequency of adverse events.

Timeline

Start
2013-04
Primary completion
2020-04-01
Completion
2020-04-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Berberine Traditional medicine (herbal / TCM) 1500 mg
Subject Bezafibrate Small molecule 400 mg