Extended Release Niacin and Fenofibrate for the Treatment of Atherogenic Dyslipidemia in Obese Females
Status:
Completed
Trial end date:
2015-10-30
Target enrollment:
Participant gender:
Summary
Atherogenic Dyslipidemia (AD) is a risk-conferring lipid/lipoprotein profile that comprises a
higher proportion of small LDL particles, reduced HDL-C, and increased triglycerides. It is
characteristically seen in patients with obesity, metabolic syndrome, insulin resistance, and
type 2 diabetes mellitus and has emerged as an important marker for the increased
cardiovascular disease (CVD) risk observed in these populations.
Optimal cardiovascular risk reduction in patients exhibiting the lipid triad of AD requires
integrated pharmacotherapy to normalize HDL-C, Triglyceride (TG) and LDL-C levels. Recent
studies have focused on optimizing treatment for AD and compare the efficacy and tolerability
of combined lipid-altering drug based therapies, however, an optimal pharmacologic approach
has not yet been established.
The present study was intended to evaluate the restorative efficacy of Extended Release
Niacin (ER Niacin) and Fenofibrate as mono and combination therapies , as well as their
safety and tolerability in females with obesity-induced AD.