Eplerenone

Amber-G

Brand Name(s):Inspra

Indication:Heart failure

Rationale:

Considered:Nov-11

Review Date:Jan-25

Comments:
NICE CG 187 Acute Heart Failure, details at:http://www.nice.org.uk/guidance/cg187/resources/guidance-acute-heart-failure-pdf
Oct 2014
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Switching to eplerenone should take place under the supervision of a heat failure specialist such as a Consultant Cardiologst or Heart Failure Specialist Nurse
Ref: Doncaster & Bassetlaw Hospitals Foundation Trust Formulary – agreed by DCCG Prescribing Sub Group
July 2013
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Eplerenone is the second line formulary aldosterone antagonist for:

Heart failure patients who remain moderately to severely symptomatic despite already receiving a diuretic and appropriately titrated doses of an ACE inhibitor and a beta blocker

Post STEMI in patients already receiving therapeutic doses of ACE inhibitor with an ejection fraction of less than 40% and either symptomatic heart failure or diabetes
It should be used as an alternative to spironolactone in those patients intolerant to, or unsuitable for, spironolactone therapy (usually due to gynaecomastia – which is more common with spironolactone)
As with spironolactone patients with impaired renal function or those with potassium levels at the higher end of the usual range are at greater risk of developing hyperkalaemia. Indeed patients with hyperkalaemia (or with a creatinine clearance<50ml/min) should not be started on eplerenone. Treatment with eplerenone should be initiated at 25mg daily and titrated to the target dose of 50mg once daily within 4 weeks. Potassium levels must be monitored prior to starting therapy with eplerenone at baseline, after 1, 4, 8 and 12 weeks, then 3 monthly for the first year and 6 monthly thereafter. After initiation, the dose should be adjusted based on the serum potassium level as shown in the table below: Serum potassium (mmol/L) Action Dose adjustment < 5.0 Increase 25 mg on alternate days to 25 mg OD 25 mg OD to 50 mg OD 5.0 to 5.4 Maintain No dose adjustment 5.5 to 5.9 Decrease 50 mg OD to 25 mg OD 25 mg OD to 25 mg alternate days 25 mg on alternate days to withhold > 5.9 Withhold N/A

Eplerenone is licensed only in addition to standard therapy to reduce cardiovascular risk in stable patients with left ventricular dysfunction and clinical evidence of heart failure following recent myocardial Infarction.
Significant pharmacokinetic interaction can occur resulting in large increases in eplerenone concentration when eplerenone is co-administered with strong CYP3A4 inhibitors such e.g. clarithromycin or ketoconazole. Co-administration of these agents is contra-indicated.

Ref: Doncaster & Bassetlaw Hospitals NHS Foundation Trust Medicines Formulary