Cost-Effectiveness of Eplerenone Compared With Placebo in Patients With Myocardial Infarction Complicated by Left Ventricular Dysfunction and Heart Failure

Background—In the Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study (EPHESUS), aldosterone blockade with eplerenone decreased mortality in patients with left ventricular systolic dysfunction and heart failure after acute myocardial infarction. The present study was performed to evaluate the cost-effectiveness of eplerenone compared with placebo in these patients. Methods and Results—A total of 6632 patients with left ventricular systolic dysfunction and heart failure after acute myocardial infarction were randomized to eplerenone or placebo and followed up for a mean of 16 months. The coprimary end points were all-cause mortality and the composite of cardiovascular mortality/cardiovascular hospitalization. The evaluation of resource use included hospitalizations, outpatient services, and medications. Eplerenone was priced at the average wholesale price, $3.60 per day. Survival beyond the trial period was estimated from data from the Framingham Heart Study, the Saskatchewan Health database, and the Worcester Heart Attack Registry. The incremental cost-effectiveness of eplerenone in cost per life-year and quality-adjusted life-year gained compared with placebo was estimated. The number of life-years gained with eplerenone was 0.1014 based on Framingham (95% CI, 0.0306 to 0.1740), 0.0636 with Saskatchewan (95% CI, 0.0229 to 0.1038), and 0.1337 with Worcester (95% CI, 0.0438 to 0.2252) data. Cost was $1391 higher over the trial period in the eplerenone arm (95% CI, 656 to 2165) because of drug cost. The incremental cost-effectiveness ratio was $13 718 per life-year gained with Framingham (96.7% under $50 000 per life-year gained), $21 876 with Saskatchewan, and $10 402 with Worcester. Conclusions—Eplerenone compared with placebo in the treatment of heart failure after acute myocardial infarction is effective in reducing mortality and is cost-effective in increasing years of life by commonly used criteria.

[1]  M. Kenward,et al.  An Introduction to the Bootstrap , 2007 .

[2]  M. Flather,et al.  One year comparison of costs of coronary surgery versus percutaneous coronary intervention in the stent or surgery trial , 2004, Heart.

[3]  S. Yusuf,et al.  Cost‐effectiveness of clopidogrel in acute coronary syndromes in Sweden: a long‐term model based on the cure trial , 2004, Journal of internal medicine.

[4]  A. Cohen-Solal,et al.  Determinants and Prognostic Impact of Heart Failure Complicating Acute Coronary Syndromes: Observations From the Global Registry of Acute Coronary Events (GRACE) , 2004, Circulation.

[5]  M. Ridao-López,et al.  Using clopidogrel in non-ST-segment elevation acute coronary syndrome patients: a cost-utility analysis in Spain. , 2004, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[6]  B. Pitt,et al.  Eplerenone , a Selective Aldosterone Blocker , in Patients with Left Ventricular Dysfunction after Myocardial Infarction , 2003 .

[7]  E. Mahoney,et al.  Cost-Effectiveness Analysis Alongside Clinical Trials: Statistical and Methodological Issues , 2003 .

[8]  W. Weintraub Cardiovascular health care economics , 2003 .

[9]  B. Pitt,et al.  EPLERENONE POST-ACUTE MYOCARDIAL INFARCTION HEART FAILURE EFFICACY AND SURVIVAL STUDY INVESTIGATORS. EPLERENONE, A SELECTIVE ALDOSTERONE BLOCKER, IN PATIENTS WITH LEFT VENTRICULAR DYSFUNCTION AFTER MYOCARDIAL INFARCTION , 2003 .

[10]  C. O'connor,et al.  Frequency, patient characteristics, and outcomes of mild-to-moderate heart failure complicating ST-segment elevation acute myocardial infarction: lessons from 4 international fibrinolytic therapy trials. , 2003, American heart journal.

[11]  C. Cannon,et al.  Cost and cost-effectiveness of an early invasive vs conservative strategy for the treatment of unstable angina and non-ST-segment elevation myocardial infarction. , 2002, JAMA.

[12]  L. Parsons,et al.  Hospital outcomes in patients presenting with congestive heart failure complicating acute myocardial infarction: a report from the Second National Registry of Myocardial Infarction (NRMI-2). , 2002, Journal of the American College of Cardiology.

[13]  P. Beck,et al.  Health Databases in Saskatchewan , 2002 .

[14]  W. Weintraub,et al.  Cost and cost-effectiveness studies in heart failure research. , 2002, American heart journal.

[15]  J. Spertus,et al.  Expanding the outcomes in clinical trials of heart failure: the quality of life and economic components of EPHESUS (EPlerenone's neuroHormonal Efficacy and SUrvival Study). , 2002, American heart journal.

[16]  Abdullah Al Mamun,et al.  A cardiovascular life history. A life course analysis of the original Framingham Heart Study cohort. , 2002, European heart journal.

[17]  R. Rabin,et al.  EQ-SD: a measure of health status from the EuroQol Group , 2001, Annals of medicine.

[18]  B. Pitt,et al.  The Effect of Spironolactone on Morbidity and Mortality in Patients with Severe Heart Failure , 2000 .

[19]  J. Gore,et al.  Twenty year trends (1975-1995) in the incidence, in-hospital and long-term death rates associated with heart failure complicating acute myocardial infarction: a community-wide perspective. , 1999, Journal of the American College of Cardiology.

[20]  B. Pitt,et al.  The effect of spironolactone on morbidity and mortality in patients with severe heart failure. Randomized Aldactone Evaluation Study Investigators. , 1999, The New England journal of medicine.

[21]  J. Gore,et al.  A two-decades (1975 to 1995) long experience in the incidence, in-hospital and long-term case-fatality rates of acute myocardial infarction: a community-wide perspective. , 1999, Journal of the American College of Cardiology.

[22]  D. Meltzer,et al.  Accounting for Future Costs in Medical Cost-Effectiveness Analysis , 1997, Journal of health economics.

[23]  G. Sanders,et al.  Cost-Effectiveness of Implantable Cardioverter Defibrillators Relative to Amiodarone for Prevention of Sudden Cardiac Death , 1997, Annals of Internal Medicine.

[24]  M. Gold Cost-effectiveness in health and medicine , 2016 .

[25]  L. Goldman,et al.  Cost-effectiveness of captopril therapy after myocardial infarction. , 1995, Journal of the American College of Cardiology.

[26]  Tammy O. Tengs,et al.  Five-hundred life-saving interventions and their cost-effectiveness. , 1995, Risk analysis : an official publication of the Society for Risk Analysis.

[27]  S. Wilson Methods for the economic evaluation of health care programmes , 1987 .

[28]  Malcolm E. Turner,et al.  The Decomposition of Time-Varying Hazard into Phases, Each Incorporating a Separate Stream of Concomitant Information , 1986 .