negative endpoint study resulting in withdrawal of study drug

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.

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