Effect of Homocysteine-lowering Therapy With Folic Acid, Vitamin B12, and Vitamin B6 on Endothelium-dependent Vasodilatation of Forearm Resistance Vessels in Patients With Coronary Heart Disease

Effect of Homocysteine-lowering Therapy With Folic Acid, Vitamin B12, and Vitamin B6 on Endothelium-dependent Vasodilatation of Forearm Resistance Vessels in Patients With Coronary Heart Disease

Endothelial dysfunction is an early marker of atherosclerosis and is found in patients (pts) with coronary (CAD) and peripheral artery disease (PAD). Statin-therapy has been shown to improve endothelial function in pts with CAD or PAD by reducing LDL-cholesterol and inflammatory markers. B-group vitamin-supplements have variable been reported to have positive or neutral effects on endothelial function. Therefore, we want to compare the effect of rosuvastatin and B-group vitamin supplementation on endothelial function of the forearm resistance vessels in pts with cardiovascular disease.

Study design: 36 pts with CAD or PAD are randomly assigned to either rosuvastatin 10mg/d or vitamin supplementation with folic acid 1mg, vitamin B12 0.4mg and B6 10mg/d for 6 weeks in a double-blinded design. After 6 weeks all pts receive rosuvastatin and vitamin supplementation in combination for additional 6 weeks.

Inclusion Criteria:

• CAD or PAD (>50% luminal stenosis), previous myocardial infarction or bypass surgery >3 month ago
• history of percutaneous coronary intervention (PTCA or stenting)
• confirmed consent

Exclusion Criteria:

• myocardial infarction or acute coronary syndrome or bypass surgery <3 month ago
• ongoing treatment with statins
• ongoing vitamin supplementation with folic acid and B vitamins
• <18 years
• active smokers
• uncontrolled arterial hypertension
• renal insufficiency
• atrial fibrillation
• liver disease
• NYHA class >2
• familial hypercholesterolemia