CONSENSUS研究课件（PPT 7页）.ppt

CONSENSUS: Cooperative North Scandinavian Enalapril Survival Study Purpose To determine whether the ACE inhibitor enalapril reduces mortality in patients with severe congestive heart failure Reference The CONSENSUS Trial Study Group. Effects of enalapril on mortality in severe congestive heart failure. Results of the Cooperative North Scandinavian Enalapril Survival Study (CONSENSUS). N Engl J Med 1987; 316:1429–35. CONSENSUS: Cooperative North Scandinavian Enalapril Survival Study- TRIAL DESIGN - Design Multicenter, multinational, randomized, double-blind, placebo-controlled Patients 253 patients with severe congestive heart failure (NYHA class IV) and heart size 600 (men) or 500 mL/m2 (women), and receiving a diuretic and digoxin; patients with MI in previous 2 months excluded Follow up and primary endpoint Primary endpoint: all-cause mortality. Mean 188 days follow up Treatment Placebo or enalapril initiated at 5 mg twice daily; increased to 10 mg twice daily after 1 week if no side effects, then to maximum 20 mg twice daily according to clinical response CONSENSUS: Cooperative North Scandinavian Enalapril Survival Study- RESULTS - Trial halted early on recommendation of Ethical Review Committee because of evident benefit of enalapril Significant reduction in all-cause mortality in enalapril group at 6 months and 1 year, with overall relative risk reduction of 27% (39 vs. 54%, P=0.003) Reduction in mortality entirely attributed to reduction in death due to progression of heart failure No difference in incidence of sudden cardiac death within the two groups NYHA class improved in significantly higher proportion of enalapril group (42 vs. 22%, P0.001) Withdrawal due to hypotension higher in enalapril group, but overall withdrawal rate similar in the two groups CONSENSUS: Cooperative North Scandinavian Enalapril Survival Study- RESULTS continued - CONSENSUS: Cooperative North Scandinavian Enalapril Survival Study- RESULTS contin