COPERNICUS研究课件（PPT 6页）.ppt

COPERNICUS: Carvedilol Prospective Randomized Cumulative Survival trial Purpose To assess the effect of carvedilol, a β1-, β2- and α1-receptor blocker, on mortality in patients with severe chronic heart failure Reference Packer M, Coats AJS, Fowler M et al. for the COPERNICUS Study Group. Effect of carvedilol on survival in severe chronic heart failure. N Engl J Med 2001;344:1651–8. COPERNICUS: Carvedilol Prospective Randomized Cumulative Survival trial- TRIAL DESIGN - Design Multicenter, multinational, randomized, double-blind, placebo-controlled Patients 2289 patients with symptoms of heart failure at rest or on minimal exertion and left ventricular ejection fraction 25%, receiving standard therapy (diuretic plus ACE inhibitor/angiotensin II-receptor antagonist) Follow up and primary end point Mean 10.4 months follow up. Primary endpoint all-cause mortality Treatment Placebo or carvedilol 3.125 mg twice daily for 2 weeks, increased stepwise over several weeks as tolerated to target dose 25 mg twice daily COPERNICUS: Carvedilol Prospective Randomized Cumulative Survival trial- RESULTS - Study halted early on recommendation of data and safety monitoring board because beneficial effect of carvedilol exceeded prespecified interim monitoring boundaries Significant reduction in all-cause mortality in carvedilol group (130 deaths vs. 190 in placebo group, 35% relative risk reduction, P=0.0014), equating to 11.4% cumulative risk of death at 1 year vs. 18.4% with placebo Significant reduction in combined endpoint of death or hospitalization for any reason (425 vs. 507, 24% relative RR, P0.001) These beneficial effects seen in all subgroups examined, including patients at highest risk Permanent discontinuation of treatment 23% lower in carvedilol group than placebo group at 1 year (14.8 vs. 18.5%, P=0.02) COPERNICUS: Carvedilol Prospective Randomized Cumulative Survival trial- RESULTS continued - COPERNICUS: Carvedilol Prospective Ran