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Cholesteryl ester transfer protein (CETP) is a plasma protein that catalyzes the transfer of CE from HDL to apoB-containing lipoproteins (VLDL and LDL-C)in exchange for triglycerides that are transferred in the reverse direction. CETP inhibitors increase HDL-C and some also lower LDL-C, and therefore have the potential to reduce coronary events. HDL picks up free cholesterol (FC) from extrahepatic tissues. HDL FC is subsequently esterified by LCAT to form cholesteryl esters (CE) The HDL CE may then be delivered to the liver by either of two pathways: 1. A direct pathway following binding of HDL to hepatic SR-B1 2. An indirect pathway involving the CETP-mediated transfer of CE from HDL to VLDL and LDL with subsequent delivery to the liver following binding of LDL to the LDL receptor.&quot; After click: Inhibition of CETP prevents the transfer of CE from HDL to the VLDL/LDL fractions and results in an increase in concentration of HDL-C and a decrease in the cholesterol content of the VLDL/LDL.
ILLUMINATE is a multicenter, double-blind, parallel-group, clinical end point trial that is being conducted at 250 sites in 7 countries. Approximately 13,000 subjects with CHD or CHD risk equivalent will be randomized to treatment without regard to their baseline HDL-C levels. The primary end point is a composite of CHD death, nonfatal MI, or stroke. The study population includes men and women, 45 to 75 years of age, who have a prior history of CHD or a CHD risk equivalent and who are eligible for statin treatment. Baseline HDL-C level is not a feature of the inclusion or exclusion criteria. Subjects initially enter an atorvastatin run-in period during which atorvastatin treatment is initiated. Subjects previously treated with other statins are switched to an equivalent dose of atorvastatin. The atorvastatin dose is then titrated to a target LDL-C level of <100 mg/dL (2.6 mmol/L). Following attainment of the LDL-C goal, patients are randomized to either torcetrapib/atorvastatin or atorvastatin alone. In both treatment arms, the dose of atorvastatin is that established during the atorvastatin run-in phase. Follow-up is driven by end points (984 events) and estimated to last approximately 4.5 years. The primary end point is a composite of CHD death, nonfatal MI, or stroke.
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