Rosuvastatin and Renal Endothelial Function

Inclusion Criteria:

• Female and male patients aged between 18 and 75 years
• fasting LDL C concentrations >=160 and < 250mg/dl
• fasting TG concentrations =< 350mg/dl

Exclusion Criteria:

• History of statin induced myopathy, or serious hypersensitivity reaction to other HMG-CoA reductase inhibitors (statins).
• History of hypersensitivity reaction to inulin.
• Lipid-lowering drugs (including lipid lowering dietary supplements of food additives) within the last 4 weeks.
• Diabetes mellitus, defined as glycosylated hemoglobin (HbA1C) above the upper limit of normal (ULN).
• Uncontrolled arterial hypertension (>160/100mm Hg).
• Subjects considered to be unstable (event within 12 weeks) by the investigator after the following events: a myocardial infarction, unstable angina, myocardial revascularisation (PTCA, CABG surgery or another revascularisation procedure) or a transient ischaemic attack (TIA) or stroke.
• Significant arrythmias or conduction disturbances.
• Congestive heart failure (NYHA classes III or IV).
• Pregnant women, women who are breast feeding, and women of childbearing potential who are not using chemical or mechanical contraception or have positive serum pregnancy test (a serum beta-human chorionic gonadotropin analysis).
• History of homozygous familial hypercholesterolaemia or known type III hyperlipoproteinemia (familial dysbetalipoproteinemia).
• Use of concomitant medications.
• Current active liver disease(SGPT > 2xULN) or severe hepatic impairment.
• Unexplained serum CK > 3 times ULN (e.g. not due to recent trauma, intramuscular injections, heavy exercise etc.).
• Serum creatinine > 2,0 mg/dl and creatinine clearance <80ml/min.
• History of nephrolithiasis with calcium oxalate aggregation.
• Uncontrolled hypothyroidism defined as a thyroid stimulating hormone (TSH) > 1,5 times the UL or subjects whose thyroid replacement therapy was initiated within the last 3 month.
• Severe disorders of the gastrointestinal tract or other diseases which interfere with the pharmacodynamics and pharmacokinetics of the study drug.
• History of malignancy(unless a documented disease-free period exceeding 10 years is present) with the exception of basal cell or squamous cell carcinoma of the skin. Women with a history of cervical dysplasia would be permitted to enter the study provided they have 3 consecutive clear Papanicolaou (Pap) smears.
• History of organ allografts.
• Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subjects´s safety or successful participation in the trial.
• Participation in a clinical study within 4 weeks preceding treatment start.
• Past or present alcohol or drug abuse.
• Suspected or confirmed poor compliance.
• Previous enrolment in this study.