Evaluation of Losartan in the Elderly - ELITE

Feb 25, 2002
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Date Presented:
01/01/1997
Date Published:
01/01/1997
Date Updated:
02/25/2002
Original Posted Date:
02/25/2002
References

Description:

Captopril vs losartan in congestive heart failure (CHF)

Hypothesis:

To compare the angiotensin II receptor blocker losaratan with captopril on creatinine clearance and major cardiac events in elderly heart failure patients.

Study Design

Study Design:

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
Female: 33%
Mean Ejection Fraction: average 51%

Patient Populations:

ACE inhibitor–naive patients in NYHA class II–IV and with EF ≤40%.

Exclusions:

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

Primary Endpoints:

Increase in creatinine clearance of 0.3 mg/dL.

Secondary Endpoints:

All-cause mortality, hospital admission for heart failure, death plus hospital admission for heart failure

Drug/Procedures Used:

Losartan 12.5–50 mg daily or captopril 6.25–50 mg three times daily for 48 weeks

Principal Findings:

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%).

Interpretation:

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.

References:

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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