Cost-effectiveness analysis of aldosterone blockade with eplerenone in patients with heart failure after acute myocardial infarction in the French context: the EPHESUS study.
BACKGROUND
The Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study (EPHESUS) randomized clinical trial demonstrated the efficacy of eplerenone, a new aldosterone antagonist diuretic, with standard treatment versus standard treatment alone in the reduction of cardiovascular mortality and cardiovascular-related hospital readmissions for patients with heart failure after an acute myocardial infarction.


OBJECTIVE
We assessed the incremental cost per life-year saved of eplerenone in the French context versus standard treatment.


METHODS
A within-trial study was designed. A piecewise regression model yielded death rates and survival gains adjusted for patients' characteristics, based on the extraction of comparable patients from the Saskatchewan Health database. Resource use was collected alongside the clinical trial data. Only direct medical costs were considered. All costs were in 2003 euros. Costs and outcomes were discounted at 5%.


RESULTS
The overall mortality rate was 14.4% in the treatment group versus 16.7% in the placebo group (p=0.008). Combined cardiovascular deaths and hospitalization rates were 26.7% in the treatment group versus 30.3% in the placebo group (p=0.002). The discounted survival gain was 3.2 weeks. The incremental cost per life-year saved was euro15,382 (95% confidence interval 8274-42,723). Seventy-four per cent of the values of the incremental cost-effectiveness ratio fell under a euro15,000 per life-year saved threshold.


CONCLUSIONS
The cost of eplerenone leads to an acceptable level of incremental cost per life-year saved when compared with existing treatments in the cardiovascular domain for the prevention of cardiovascular death and morbidity in patients with heart failure after an acute myocardial infarction.
de Pouvourville
Gérard
G
Health Economics, ESSEC, avenue Bernard-Hirsch, BP 50105, 95021 Cergy-Pontoise cedex, France. pouvourville@essec.fr
Solesse
Anne
A
Beillat
Maud
M
D003362:Cost-Benefit Analysis; D016527:Drug Costs; D004359:Drug Therapy, Combination; D000077545:Eplerenone; D017048:Health Care Costs; D006333:Heart Failure / Q000188:drug therapy* / Q000191:economics / Q000209:etiology / Q000401:mortality; D006760:Hospitalization / Q000191:economics; D006801:Humans; D000451:Mineralocorticoid Receptor Antagonists / Q000191:economics* / Q000627:therapeutic use*; D009203:Myocardial Infarction / Q000150:complications / Q000188:drug therapy* / Q000191:economics / Q000401:mortality; D016016:Proportional Hazards Models; D018570:Risk Assessment; D055502:Secondary Prevention / Q000191:economics; D013148:Spironolactone / Q000031:analogs & derivatives* / Q000191:economics / Q000627:therapeutic use; D013269:Stochastic Processes; D013997:Time Factors; D016896:Treatment Outcome
D000451:Mineralocorticoid Receptor Antagonists; D013148:Spironolactone; D000077545:Eplerenone