Biomarker Sub-study to the VYTUL Study

INTERVENTION: Oral administration of Vytorin 10/40 (Ezetimibe 10 mg and Simvastatin 40 mg) intervention group CONDITION: Hypercholesterolaemia PRIMARY OUTCOME: To determine and compare the effects of Vytorin 10/40 to Atorvastatin 80 daily on cardiovascular risk profile as indicated by changes to the levels of each of the following risk biomarkers: B‐Type Natriuretic Peptide (BNP) To determine and compare the effects of Vytorin 10/40 to Atorvastatin 80 daily on cardiovascular risk profile as indicated by changes to the levels of each of the following risk biomarkers: C Reactive Protein (CRP) To determine and compare the effects of Vytorin 10/40 to Atorvastatin 80 daily on cardiovascular risk profile as indicated by changes to the levels of each of the following risk biomarkers: Lipoprotein‐associated phospholipase A2 (Lp‐PLA2) To determine and compare the effects of Vytorin 10/40 to Atorvastatin 80 daily on cardiovascular risk profile as indicated by changes to the levels of each of the following risk biomarkers: Matrix Metalloproteinase (MMP) To determine and compare the effects of Vytorin 10/40 to Atorvastatin 80 daily on cardiovascular risk profile as indicated by changes to the levels of each of the following risk biomarkers: Oxidised low density lipoprotein (oxLDL) To determine and compare the effects of Vytorin 10/40 to Atorvastatin 80 daily on cardiovascular risk profile as indicated by changes to the levels of each of the following risk biomarkers: Tumour Necrosis Factor alpha (TNFa). SECONDARY OUTCOME: To explore non‐physiological external issues such as participant awareness of their health and its management and any perceived barriers to health care that may contribute to ineffective risk factor modification. INCLUSION CRITERIA: Participation in the VYTUL study‐ Capable of and willing to sign written informed consent‐ Has been treated for at least the last 3 months with a daily dose of atorvastatin40 mg‐ Existing coronary heart disease and has cholesterol > 4.0 mmol/L measured at Visit 1 OR diabetes mellitus and has measured at Visit 1• cholesterol > 6.5 mmol/L OR• cholesterol > 5.5 mmol/L and HDL < 1 mmol/L‐ Free of any clinically significant diseases, other than hyperlipidaemia, that would interfere with study evaluations and willing and able to attend all study visits.