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INSPRA

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Opinions on drugs - Posted on Sep 10 2014

Reason for request

Re-assessment of the actual benefit at the Committee’s request

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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).