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%.
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Medicine details
- Medicine name:
- eplerenone (Inspra)
- SMC ID:
- 793/12
- 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%)
- Pharmaceutical company
- Pfizer Ltd
- BNF chapter
- Cardiovascular system
- Submission type
- Full
- Status
- Accepted
- Date advice published
- 09 July 2012