Phase 4
N=57
Extended Release Niacin and Fenofibrate for the Treatment of Atherogenic Dyslipidemia in Obese Females
Atherogenic Dyslipidemia · Obesity Associated Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03615534 ↗Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcome: Primary: Changes Serum Triglyceride Levels — 223.1; 241.2; 227.0; 267.2 mg/dl — p=0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Therapeutic Lifestyle Changes (Other); Placebo (Other); Fenofibrate (Drug); Wax Matrix Extended Release Niacin (WMER Niacin) (Dietary_supplement)
- Age
- Adult · 20+ yrs
- Sex
- Female
- Sponsor
- Lewai Sharki Abdulaziz, MSc PhD
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes Serum Triglyceride Levels |
223.1; 241.2; 227.0; 267.2; 220.2; 133.7 | 0.0001 sig |
| PRIMARY Changes in Serum Lipoprotein Cholesterol Levels |
203.1; 190.7; 189.1; 219.5; 30.9; 32.1 | 0.060 |
| PRIMARY Changes in Serum Apolipoprotein Levels |
130.8; 143.8; 150.1; 150.0; 134.1; 141.8 | 0.058 |
| SECONDARY Changes in Serum Fasting Glucose Levels. |
93.5; 98.9; 94.6; 94.7; 91.3; 91.7 | 0.001 sig |
| SECONDARY Changes in Estimated Glomerular Filtration Rate (eGFR) |
89.8; 86.5; 91.0; 85.2; 83.1; 83.2 | 0.786 |
| SECONDARY Changes in Serum Uric Acid Levels |
4.45; 5.21; 4.87; 5.28; 4.80; 4.0 | 0.0001 sig |
| SECONDARY Changes in Serum Enzymes Levels |
17.1; 18.8; 17.0; 18.9; 13.1; 16.3 | 0.201 |
| SECONDARY Changes in Systolic and Diastolic Blood Pressure |
80.7; 83.5; 76.1; 77.3; 120.7; 125.4 | 0.434 |
| SECONDARY Adverse Events |
0; 0; 0; 1; 0; 0 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03615534). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.