立普妥研究解读更新版205年4月 ppt课件.ppt

* 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 A total of 18,469 patients were screened; lipid-lowering therapy was withdrawn, and all patients entered a wash-out phase. 15,464 patients with established CHD and an LDL-C level of 130 to 250 mg/dL (3.4 to 6.5 mmol/L) and with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 (3.4 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. * Over the course of the study, there was a highly significant reduction in the composite efficacy outcome of major cardiovascular events (death from CHD, nonfatal non–procedure-related MI, resuscitated cardiac arrest, or fatal or nonfatal stroke) in the atorvastatin 80 mg group compared with the atorvastatin 10 mg group. The Kaplan-Meier analysis demonstrated a hazard ratio of 0.78 (95% CI 0.69, 0.89; P0.001). This represente