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

• Status: Terminated
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Ludwig-Maximilians - University of Munich
• Treatments: Niacin; Niacinamide; Nicotinic Acids

Criteria

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