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eplerenone (Inspra)

Advice

following a full submission:

eplerenone (Inspra®) is accepted for use within NHS Scotland.

Indication under review: in addition to standard optimal therapy, to reduce the risk of cardiovascular mortality and morbidity in adult patients with NYHA class II (chronic) heart failure and left ventricular systolic dysfunction (LVEF ≤30%).

In the pivotal phase IIIb study, addition of eplerenone to standard optimal therapy significantly reduced the composite of death from cardiovascular causes or hospitalisation for heart failure (primary outcome) and both the risk of cardiovascular death and the risk of hospitalisation (secondary outcomes) in patients with mild heart failure (NYHA class II) and LVEF ≤30%.

Drug Details

Drug Name: eplerenone (Inspra)
SMC Drug ID: 793/12
Manufacturer: Pfizer Ltd
Indication: For the new indication in Chronic Heart Failure in addition to standard optimal therapy, to reduce the risk of cardiovascular mortality and morbidity in adult patients with NYHA class II (chronic) heart failure and left ventricular systolic dysfunction (LVEF ≤30%)
BNF Category:
Sub Category: 2.2 Diuretics
Submission Type: Full submission
Status: Accepted
Date Advice Published: 9 July 2012

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