The High Density Lipoprotein and Endothelial Function, Niacin and Nitric Oxide Study (The High-Ennd Study)

Inclusion Criteria:

• Statin treatment for at least 3 weeks
• Reduced HDL: < 40 mg/dL (1.03 mmol/L) in men or < 50 mg/dL (1.29 mmol/L) in women
• Plus TWO of the following (thereby defining the patients to have metabolic syndrome (Grundy et al.; Circulation 2005)):
• Elevated waist circumference: ≥ 102 cm (≥ 40 inches) in men or ≥ 88 cm (≥ 35 inches) in women
• Elevated triglycerides: ≥ 150 mg/dL (1.7 mmol/L
• Elevated blood pressure: ≥ 130 mmHg systolic blood pressure or ≥ 80 mmHg diastolic blood pressure or anti-hypertensive treatment
• Elevated fasting glucose: ≥ 100 mg/dL or on drug treatment for elevated fasting glucose

Exclusion Criteria:

• Hypersensitivity to niacin
• Active liver disease or impaired liver function
• Persistent elevation of transaminases
• Cholestasis
• Gastric ulcer
• Acute coronary syndrome
• Gout
• Pregnancy, lactation
• Active infections
• Cancer
• Untreated concomitant diseases
• Renal insufficiency or renal failure
• Hypothyreosis
• Alcoholism
• Myopathies
• Muscle pain under therapy with fibrates or statins
• Hereditary muscle diseases in family history