立普妥研究解读__更新版2015年4月.ppt

* Slide 16 ? The GREACE Study enrolled 1600 hypercholesterolemic patients with CHD and LDL cholesterol levels 100 mg/dL (2.59 mmol/L) after a6-week trial of lipid-lowering diet. CHD was defined as a history of prior MI or 70% stenosis of at least one coronary artery, as documented by a coronary angiogram. ? Eligible patients were provided study information and gave their informed consent to participate. If eligible after the diet phase, patients were randomized using a computer-generated list into one of 2 treatment groups (800 patients assigned to each group): (1) structured care, including atorvastatin 10 to 80 mg/d to achieve the NCEP goal for LDL cholesterol of 100 mg/dL, or (2) “usual” care. ? Recruitment for the study began in January 1998 and ended in November 1999. The study was terminated after 3 years in December 2001 because of the clear clinical benefit observed with structured care with atorvastatin compared with usual care. * Slide 24 ? The reductions in relative risk of primary end points for structured care compared with usual care after 3 years of treatment are highlighted in this slide. Total mortality was decreased by 43% (P=0.0021), coronary mortality by 47% (P=0.0017), nonfatal MI by 59% (P=0.0001), and stroke by 47% (P=0.034) in patients treated with structured care using atorvastatin compared with usual care. * The TNT hypothesis was tested in a double-blind, parallel-group design. A total of 18,469 patients were screened; lipid-lowering therapy was withdrawn, and all patients entered a wash-out phase. 15,464 patients with established CHD and an LDL-C level of 130 to 250 mg/dL (3.4 to 6.5 mmol/L) and with triglycerides ?600 mg/dL (?6.8 mmol/L) were then eligible to enter the 8-week, open-label, run-in period with atorvastatin 10 mg/day. In order that the 2 groups of patients would meet the LDL-C targets during the double-blind phase—and because it would have been unethical to under-treat patients whose LDL-C remained 130 mg/day (3.