ELITE - II Study Design  60 yrs; NYHA II - IV; EF  40 % ACEI naive or  7 days in 3 months prior to entry Standard Rx ( ± Dig / Diuretics ), ß - blocker.

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Presentation transcript:

ELITE - II Study Design  60 yrs; NYHA II - IV; EF  40 % ACEI 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 Losartan 50 mg daily n = 1578 Event Driven Targeting 510 deaths estimate 2 yrs median follow-up 555 days Primary Endpoint : All-cause Mortality Secondary Endpoint : Sudden cardiac death and/or Resuscitated Arrest Other : All-cause Mortality / Hospitalizations Safety and Tolerability Lancet 2000; 355:

ELITE - II Baseline Characteristics Age ( mean, yrs. ) Gender ( male / female % ) Ejection Fraction ( mean % ) NYHA Functional Class II / III / IV ( % ) Ischemic History ( % ) Prior ACE – I ( % ) Beta Blocker ( % ) Diuretic ( % ) Cardiac Glycoside ( % ) Aspirin / Salicylates ( % ) Losartan n = / / 45 / Captopril n = / / 45 / P = NS losartan vs captopril Pitt, B. et al, Lancet 2000; 355: Limited to 25% by design but not reached

ELITE II - Primary Endpoint: All-Cause Mortality - Captopril (n-1574) 250 Events 15.9 % over 1.5 years Losartan (n-1578) 280 Events 17.7 % over 1.5 years p=0.16 Probability of Survival Days of Follow-up Pitt, B. et al, Lancet 2000; 355: Average Mean Mortality Rate = 11.0 % per year

ELITE II Withdrawal for Adverse Experience ( Excluding Death ) * * * * p = between groups Patients who died were excluded from any adverse effect and drug-related adverse effects. Pitt, B. et al, Lancet 2000; 355:

ELITE II Study Endpoint Summary P Value 1.13 ( )P = 0.16 NS 1.25 ( 0.98, 1.60 )P = 0.08 NS 1.07 ( 0.97, 1.19 )P = 0.18 NS 228 ( 14.5 ) P =  ( 9.4 ) Losartan n = 1578 number ( % ) Captopril n = 1574 number ( % ) 752 ( 47.7 )707 ( 44.9 ) 115 ( 7.3 )142 ( 9.0 ) 280 ( 17.7 )250 ( 15.9 ) Hazards Ratio ( 95% CI )* Withdrawal for Adverse Experiences Combined total mortality or hospitalizations for any reason Sudden death or/ resuscitated cardiac arrest All-cause mortality (primary endpoint) Pitt, B. et al, Lancet 2000; 355: