Evaluation of Losartan in the Elderly - ELITE
Captopril vs losartan in congestive heart failure (CHF)
To compare the angiotensin II receptor blocker losaratan with captopril on creatinine clearance and major cardiac events in elderly heart failure patients.
Patients Screened: Not reported
Patients Enrolled: 722
NYHA Class: Class II: 64.8% , Class III: 33.5%, Class IV: 1.7%
Mean Follow Up: 48 weeks
Mean Patient Age: mean 73.5 years
Mean Ejection Fraction: average 51%
ACE inhibitor–naive patients in NYHA class II–IV and with EF ≤40%.
SBP <90 mm Hg or uncontrolled HTN (DBP >95 mmHg), significant obstructive valvular disease, symptomatic arrhythmias, contrictive pericarditis or active myocarditis, acute MI or coronary angioplasty in prior 72 hours, bypass surgery in prior 2 weeks (or planned induring study period), ICD placement in prior 2 weeks, unstable angina requiring admission in prior 3 months or angina requiring 5 NTG tablets/week within 6 weeks, stroke or transient ischemic attack in prior 3 months, digitalis toxicity, uncontrolled diabetes, chronic cough of any etiology, untrated thyrotoxicosis, or hypothroidism, renal artery stenosis, angioedema of any etiology, hematuria of unknown etiology, condition that would contraindicate a vasodilator, unlikely survival for length of study or risk to patient, other investigational drugs in prior 4 weeks, previous treatment with losartan or other angiotensin II antagonist Lab exclusions: serum creatinine >2.5 mg/dL, serum potassium <3.5 or >5.5, magnesium <0.7 mmol/L, transaminases >2X ULN, hemoglobin <10 gm/dL or Hct <30%, platelets <100K
Increase in creatinine clearance of 0.3 mg/dL.
All-cause mortality, hospital admission for heart failure, death plus hospital admission for heart failure
Losartan 12.5–50 mg daily or captopril 6.25–50 mg three times daily for 48 weeks
The captopril and losartan groups had a similar incidence of increased creatinine (bothj 10.5%). Fewer losartan patients stopped therapy (12.2% vs. 20.8%; p = 0.002); of note, no losartan patients stopped therapy due to cough versus 14 captopril patients. The losartan group did have a 45% lower overall mortality rate (4.8% vs. 8.7%, p = 0.035; sudden cardiac death: 5 vs. 14 patients). This mortality benefit present in all evaluated subgroups except women (240 patients, 7.6% vs. 6.6%).
Losartan did not have a lower incidence of creatinine impairment than captopril. Losartan was better tolerated and the losartan group had a signficantly lower mortality and hospitalization rate.
Lancet 1997;349:747–752. Related trial: ELITE II (Lancet 2000;355:1582-7)
Keywords: Angiotensin Receptor Antagonists, Losartan, Heart Failure, Creatinine, Cough, Hospitalization, Captopril, Death, Sudden, Cardiac
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