Effect of Niacin/Laropiprant on Postprandial Lipoprotein Metabolism in Patients With Dyslipoproteinemia

Study Overview
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Brief Summary
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The study is designed to evaluate the effect of Niacin/Laropiprant on postprandial lipoprotein metabolism, postprandial glucose metabolism, postprandial monocyte function, and postprandial biomarkers of endothelial dysfunction and inflammation.

Official Title
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Effect of Niacin/Laropiprant on Postprandial Lipoprotein and Glucose Metabolism in Patients With Severe Dyslipoproteinemia

Conditions
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Hyperlipoproteinemia, Metabolic Syndrome

Intervention / Treatment
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* Drug: Niacin/ Laropiprant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male subjects or postmenopausal female subjects aged between 19-70 years High risk patients (PROCAM risk ≥20%) on a stable statin-therapy, but at least simvastatin 20 mg/d HDL-cholesterol ≤50 mg/dl and /or triglycerides 150-400 mg/dl and/or LDL-cholesterol 70 - 150 mg/dl Lipoprotein (a) < 30 mg/dl Patients may have normal glucose metabolism (normal HOMA), be insulin resistant (abnormal HOMA), have impaired fasting glucose or impaired glucose tolerance but not diabetes mellitus. Without niacin therapy for at least 6 months Dosage of any concomitant medication has been stable for at least 3 weeks If female, postmenopausal (absence of menstruation for at least 12 months or absence of menstruation > 6 months with FSH > 40 ng/ml respectively oestrogen < 20 pg/ml) Exclusion Criteria: Subjects with additional causes for hyperlipoproteinemia Diabetes mellitus or antidiabetic medication Subject has history of cardiovascular ischemia in previous 3 months or acute myocardial infarction or unstable angina History of psychiatric disorder or cognitive impairment that would interfere with participation in the study History of alcoholism Contraindication against niacin and/or laropiprant Subject has participated in an investigational study within 30 days prior to study initiation Fasting triglycerides >400 mg/dl Life-threatening disease (e.g. cancer) Renal insufficiency (GFR ≤ 30 ml/min ) Major hepatic impairment Known allergic reaction/intolerance against niacin and/or laropiprant Active peptic ulcer disease

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Niacin/ Laropiprant<br> | Drug: Niacin/ Laropiprant<br>* 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily<br>* Other names: EU/1/08/459/001;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incremental Area Under the Plasma Triglyceride Curve Over 8 Hours Following a Standardized Oral Fat Tolerance Test | Percent change of incremental AUC at 12 weeks compared to baseline. | baseline and 12 weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HDL Cholesterol | Percent change of HDL-cholesterol at 12 weeks compared to baseline. | baseline and 12 weeks after treatment | 
| Fasting Triglycerides | Percent change of fasting triglycerides at 12 weeks compared to baseline | baseline and 12 weeks after treatment |