Presentation is loading. Please wait.

Presentation is loading. Please wait.

Losartan Heart Failure Survival Study ELITE II Losartan Heart Failure Survival Study ELITE II A Multicenter, Double-Blind, Randomized, Parallel, Captopril-Controlled.

Similar presentations


Presentation on theme: "Losartan Heart Failure Survival Study ELITE II Losartan Heart Failure Survival Study ELITE II A Multicenter, Double-Blind, Randomized, Parallel, Captopril-Controlled."— Presentation transcript:

1 Losartan Heart Failure Survival Study ELITE II Losartan Heart Failure Survival Study ELITE II A Multicenter, Double-Blind, Randomized, Parallel, Captopril-Controlled Study to Evaluate the Effects of Losartan on Mortality in Patients with Symptomatic Heart Failure 46 Countries; 289 Sites; 3152 Patients Steering Committee Co-ChairsB. Pitt, P. Poole-Wilson Steering Committee Co-ChairsB. Pitt, P. Poole-Wilson Data and Safety Monitoring Committee ChairC. Furberg Data and Safety Monitoring Committee ChairC. Furberg Clinical Endpoint Classification CommitteeChairL. Frame Clinical Endpoint Classification CommitteeChairL. Frame Coordinating Center: Merck Research LabsStudy DirectorR. Segal Coordinating Center: Merck Research LabsStudy DirectorR. Segal

2 Losartan Heart Failure Survival Study ELITE II Primary Hypothesis: Treatment with losartan will reduce all-cause mortality compared to captopril Power: 90% to detect a 25% difference [p=0.043] intention-to-treat Secondary Hypothesis: Treatment with losartan will reduce the incidence of sudden death and/or resuscitated arrest compared to captopril Other Endpoints: All-cause mortality/hospitalizations Safety and tolerability

3 Study Design Losartan Heart Failure Survival Study ELITE II 60 yrs; NYHA II-IV; EF 40%  60 yrs; NYHA II-IV; EF  40% ACE-I/AIIA naive or <7 days in 3 months prior to entry ACE-I/AIIA naive or <7 days in 3 months prior to entry Standard Rx (± Dig/Diuretics), ß-blocker stratification Captopril 50 mg 3 times daily (N=1574) Primary Endpoint: All-Cause Mortality Secondary Endpoint: Sudden Cardiac Death and/or Resuscitated Arrest Other Endpoin: All-cause Mortality/Hospitalizations Safety and Tolerability Safety and Tolerability Event Driven (Target 510 Deaths) ~ 2 years Losartan 50 mg Daily (N=1578)

4 Age (mean, yrs) 71.4 71.5 Gender (male/female %) 70/30 69/31 Ejection Fraction (mean %) 31 31 NYHA Funct. Class II/III/IV (%) 49/45/6 49/45/6 Ischemic History (%) 80 79 Prior ACE Inhibitor 23 24 Beta Blocker (%) 24 23 Diuretic (%) 77 78 Cardiac Glycoside (%) 49 50 Aspirin/Salicylates (%) 59 59 Losartan (N=1578)Captopril(N=1574) p= NS losartan vs captopril Losartan Heart Failure Survival Study - ELITE II Baseline Characteristics

5 Losartan Heart Failure Survival Study - ELITE II Primary Endpoint: All-Cause Mortality 0100200300400500600700 Days of Follow-up 0.0 0.2 0.4 0.6 0.8 1.0 Probability of Survival Losartan (N=1578)280 Events Captopril(N=1574) 250 Events Captopril/Losartan Hazard Ratio (95% C.I.): 0.88 (0.75, 1.05) P=0.16

6 Losartan Heart Failure Survival Study - ELITE II Mortality by Cause (Adjudicated)

7 Losartan Heart Failure Survival Study - ELITE II Mortality by Subgroup Hazard Ratio Age Gender NYHA Class. % EF Beta Blockers Overall  71  71 Male Female III/IV II  32  32 With Without 731 846 1102 476 801 777 793 785 354 1224 1578 730 844 1083 491 798 776 783 790 325 1249 1574 0.93 0.84 0.89 0.87 0.93 0.80 1.02 0.71 0.56 0.95 0.88 NN Hazard Ratio LosartanCaptopril 1.00.80.60.42.0 Hazard Ratio of Death with 95% C.I.Subgroups at Baseline Favors CaptoprilFavors Losartan

8 Losartan Heart Failure Survival Study - ELITE II Secondary Endpoint: Sudden Death / Resuscitated Arrest 0100200300400500600700 Days of Follow-up 0.0 0.2 0.4 0.6 0.8 1.0 Event-Free Probability Losartan (N=1578)142 Events Captopril(N=1574) 115 Events Captopril/Losartan Hazard Ratio (95% C.I.): 0.80 (0.63, 1.03) P=0.08

9 Losartan Heart Failure Survival Study - ELITE II Hospitalization By Cause (Adjudicated) p=NS between groups # # CAD includes angina, unstable angina, revascularization, etc

10 Losartan Heart Failure Survival Study - ELITE II Tertiary Endpoint: All-Cause Mortality / Hospitalization 0100200300400500600700 Days of Follow-up 0.0 0.2 0.4 0.6 0.8 1.0 Event-Free Probability Losartan (N=1578)752 Events Captopril(N=1574) 707 Events Captopril/Losartan Hazard Ratio (95% C.I.): 0.94 (0.85, 1.04) P=0.21

11 Losartan Heart Failure Survival Study - ELITE II Withdrawal for Adverse Experience (Excluding Death) ** ** p  0.001 between groups **

12 Losartan Heart Failure Survival Study - ELITE II Study Endpoint Summary Crude Rate Losartan (N=1578) Captopril (N=1574) Adjusted Hazards Ratio (95%CI) All-cause Mortality 280 (17.7%)250 (15.9%) 0.88 (0.75, 1.05) All-cause Mortality/ Hospitalization 752 (47.7%)707 (44.9%) 0.94 (0.85, 1.04) Sudden Death/ Resusc. Arrest 142 (9.0%)115 (7.3%) 0.80 (0.63, 1.03) Primary Endpoint: Secondary Endpoint: Tertiary Endpoints: P-Value 0.16 0.21 0.08 Withdrawal for Adverse Experience 149 (9.4%)228 (14.5%) <0.001


Download ppt "Losartan Heart Failure Survival Study ELITE II Losartan Heart Failure Survival Study ELITE II A Multicenter, Double-Blind, Randomized, Parallel, Captopril-Controlled."

Similar presentations


Ads by Google