DISCOVERY Asia - Crestor in Type IIa and IIb Hypercholesteremia

Inclusion criteria

• Visit 1:

• Written informed consent to participate in the trial (Appendix B)
• Male or female subjects, age > 18 years
• Primary hypercholesterolaemia with CV risk > 20%/10yrs, type 2 diabetes, a history of CHD or other established atherosclerotic disease (definition given in Appendix L).
• Subjects may be lipid-lowering therapy-naïve, but have completed 6-weeks dietary counselling before this visit OR Subjects may be treated with the 'start' dose of other lipid lowering therapy, which is ineffective, ie. The subject has not met LDL-C treatment goals.
• Subjects willing to follow all study procedures including attendance at clinics for scheduled study visits, fasting prior to blood draws and compliance with study treatment regimen

Visit 2:

• Subjects switched from start dose of a lipid lowering therapy (commonly accepted start dose) will have fasting LDL-C levels > 3.1 mmol (120 mg/dl)
• Newly treated subjects, after a six-weeks dietary counselling, will have fasting LDL-C levels > 3.5 mmol/L (135 mg/dL)
• Fasting triglycerides £ 4.52 mmol/L (400 mg/dL)
• Switched patients must stop current lipid lowering treatment at randomisation (Visit 2)

Exclusion criteria

• Known heterozygous or homozygous familial hypercholesterolaemia or known type III hyperlipoproteinaemia (familial dysbetalipoproteinaemia)
• Documented secondary hypercholesterolaemia of any cause other than named in inclusion criteria 3
• History of serious adverse effect or hypersensitivity reactions to other HMG-CoA reductase inhibitors, in particular any history of myopathy
• Unstable angina within three months prior to inclusion in the study
• Active liver disease or hepatic dysfunction as defined by elevations of AST or ALT ³ 1.5 times the ULN. In this case, a second determination of hepatic tests will be performed after one week. If the dysfunction is confirmed, the subject must not be included in the study
• Known uncontrolled diabetes
• Uncontrolled hypertension defined as either resting diastolic blood pressure of > 95mmHg or resting systolic blood pressure of > 200 mmHg
• Unexplained serum CK > 3 times ULN (eg not due to recent trauma, intramuscular injections, heavy exercise etc)
• Serum creatinine > 220 µmol/L (2.5mg/dL)