ALDOSTERONE ANTAGONISTS FOR POST-MI HEART FAILURE  

A systematic review and economic evaluation of the clinical effectiveness and cost-effectiveness of aldosterone antagonists for postmyocardial infarction heart failure 

Background

Changes in the heart muscle following a myocardial infarction (MI) can lead to the development of heart failure, characterised by symptoms such as breathlessness, fluid retention and fatigue. Approximately 40% of people who experience an acute MI go on to develop heart failure. The hormone aldosterone is thought to play a crucial role in the changes in the heart muscle, leading to the progression of heart failure and its symptoms. Aldosterone antagonists, spironolactone and eplerenone, can be used in combination with other drugs for the treatment of heart failure. One clinical trial has demonstrated the beneficial effects of eplerenone in heart failure following MI but spironolactone has only been studied in more general heart failure patients. Although spironolactone is less expensive than eplerenone, eplerenone is thought to cause fewer side effects.

The aims of this project were to determine how precisely the relative clinical and cost-effectiveness of spironolactone and eplerenone in patients with heart failure following MI can be determined from the available evidence, to identify whether an RCT comparing spironolactone with eplerenone would be worthwhile, and to inform the design of a future trial.

Findings

An adequately powered, well-conducted RCT that directly compares spironolactone and eplerenone is required to provide more robust evidence on the optimal management of post-MI HF patients. Differences in mortality appear to be the major source of current uncertainty and hence the design and follow-up should reflect this. Non-fatal events requiring hospitalisation and side-effects would also be important outcomes given the limitations noted in existing studies. The estimates of EVPI appear sufficiently high to conclude that a head-to-head RCT is likely provide value for money. Should a future RCT be considered then a more formal assessment of the costs and benefits should be conducted using the cost-effectiveness model presented here to ensure that this is done efficiently.

Conducted by: C McKenna1, J Burch2, S Suekarran2, S Walker1, A Bakhai3, K Witte4, M Harden2, K Wright2, N Woolacott2, P Lorgelly5, L Fenwick5, S Palmer1

1 Centre for Health Economics, University of York; 2 Centre for Reviews and Dissemination, University of York; 3 Barnet General Hospital; 4 University of Leeds and Leeds General Infirmary; 5 Section of Health Policy and Public Health, University of Glasgow

Further details

Project page on the NIHR HTA Programme website

Publications

McKenna C, Burch J, Suekarran S, Walker S, Bakhai A, Witte K, Harden M, Wright K, Woolacott N, Lorgelly P, Fenwick L, Palmer S. A systematic review and economic evaluation of the clinical effectiveness and cost-effectiveness of aldosterone antagonists for postmyocardial infarction heart failure. Health Technol Assess. 2010; 14(24):1-162

Funding

Commissioned by the NIHR HTA Programme as part of the Technology Assessment Report (TAR) process