Extended Release Niacin and Fenofibrate for the Treatment of Atherogenic Dyslipidemia in Obese Females

• Status: Completed
• Trial end date: 2015-10-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lewai Sharki Abdulaziz, MSc PhD
• Collaborator: Al-Kindy College of Medicine
• Treatments: Fenofibrate; Niacin; Niacinamide; Nicotinic Acids

Criteria

Inclusion Criteria:

• BMI≥30 kg/m2.

• Conventional diagnosis of atherogenic dyslipidemia, confirmed by a fasting serum TG more than150 mg/dl coincide with an HDL-C of less than 50 mg/dl.

Exclusion Criteria:

• The use of any antilipidemic medication.

• Findings suggestive for renal dysfunction (eGFR˂60ml/min per 1.73 m2).

• Findings suggestive for hepatic insufficiency (ALT and/or AST˃2ULN).

• Clinical or laboratory findings suggestive for thyroid dysfunction.

• Established diagnosis of Diabetes Mellitus.

• History of gout, hyperuricemia, or on hypouricemic agents.

• Active peptic ulcer.

• Pregnancy, or nursing mothers.

• Alcohol or tobacco consumption.