Reason for request
-
Clinical Benefit
Substantial |
Substantial |
Clinical Added Value
no clinical added value |
In view of : - the efficacy results in terms of mortality and morbidity shown only versus placebo in the EPHESUS study, - the absence of comparative data versus spironolactone, - the absence of differentiation in the role of two mineralocorticoid receptor antagonists (spironolactone and eplerenone) in the therapeutic strategy according to current guidelines (ESC 2011 and 2012), - the adverse effects most commonly observed in real life with eplerenone (in particular hyperkalaemia), the Committee considers that in addition to standard therapy including beta-blockers, to reduce the risk of cardiovascular mortality and morbidity in stable patients with left ventricular dysfunction (LVEF ≤ 40 %) and clinical evidence of heart failure after recent myocardial infarction, INSPRA does not provide an improvement in actual benefit (IAB V, non-existent) in the therapeutic strategy of care, particularly including spironolactone (ALDACTONE and generic drugs). |