TNT研究PPT课件.pptVIP

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 A total of 18,469 patients were screened; lipid-lowering therapy was withdrawn, and all patients entered a wash-out phase. 15,464 patients with established CHD and an LDL-C level of 130 to 250 mg/dL (3.4 to 6.5 mmol/L) and with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 (3.4 mmol/L)—only those patients with a mean LDL-C 130 mg/dL (3.4 mmol/L) on 10 mg of open-label atorvastatin were entered into the randomized phase of the study. 10,001 patients were randomized to double-blind therapy with either atorvastatin 10 mg/day or 80 mg/day; 5006 patients remained on atorvastatin 10 mg daily and 4995 patients received 80 mg daily. Using the time of randomization as the baseline for the study, patients were then followed for a median of 4.9 years. Reference 1. LaRosa JC, et al. N Engl J Med. 2005;352. Patients were eligible for inclusion in the study if they satisfied the following criteria: Men and women aged 35-75 years. Clinically evident CHD, defined as previous MI, previous or present angina with objective evidence of atherosclerotic CHD, or patients who have undergone a coronary revascularization procedure. LDL-C 130-250 mg/dL (3.4-6.5 mmol/L) and triglycerides ?600 mg/dL (?6.8 mmol/L ) at the beginning of the open-label, run-in period. LDL-C 130 mg/dL (3.4 mmol/L) at the end of the open-label, run-in period. Reference 1. Waters DD, et al. Am J Cardiol. 2004;93:154-8. Major exclusion criteria included any of the following: Hypersensitivity to statins. Active liver disease or hepatic dysfunction, defined as ALT or AST 1.5 ? the upper limit of normal. Patients with nephrotic syndrome. Women who are pregnant or breastfee