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

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.

Conditions

• Atherogenic Dyslipidemia
• Obesity Associated Disorder

Interventions

OTHER

Therapeutic Lifestyle Changes

Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

OTHER

Placebo

DRUG

Fenofibrate

DIETARY_SUPPLEMENT

Wax Matrix Extended Release Niacin (WMER Niacin)

Sponsors & Collaborators

• Al-Kindy College of Medicine

  collaborator OTHER

• Lewai Sharki Abdulaziz, MSc PhD

  lead OTHER

Principal Investigators

• Lewai S Abdulaziz, MSc PhD · Al-Kindy college of Medicine, University of Baghdad

• May S Al-Sabbagh, MSc · College of Pharmacy, University of Baghdad

• Marwah S Attar, MSc · College of Pharmacy, University of Baghdad

• Faris A Khazaal, FRCP · Al-Kindy college of Medicine, University of Baghdad

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

FACTORIAL

Eligibility

Min Age

20 Years

Max Age

60 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-10-01

Primary Completion

2015-06-30

Completion

2015-10-30

FDA Drug

Yes

Countries

• Iraq

Study Locations