Inspra (eplerenone) is a new medicinal product approved as add-on treatment to standard therapy including betablockers for reduction of cardiovascular mortality and morbidity in stable patients with clinical signs of cardiac insufficiency and left ventricular dysfunction (EF<40%) after recent myocardial infarction. Inspra is a selective aldosterone antagonist and the mechanism of action is equal to that of the unselective antagonist spironolactone, except that eplerenone binds significantly less to androgen-, progesterone- and glucocorticoid receptors, resulting in substantially less gynaecomasty and menstruation disturbances than with spironolactone.
Overall, the indication is based on one clinical study, which displayed a reduction in mortality compared to placebo from 16.7% to 14.4% and an equal reduction in cardiovascular death or hospitalizations (sic!) from 30.0% to 26,7%. Since eplerenone may not be given simultaneously with spironolactone, a choice between the two drugs has to be made for patients recently recovered from myocardial infarction and EF<40%. In spite of the fact that for the time being recommendations cannot be given with certainty, eplerenone should be the drug of choice in general to patients with determined cardiac insufficiency, which – with modern interventions – only applies to a minority of patients. If the recommendations are complied with, it is - in case of continued insufficiency - rational to switch to spironolactone after approx. one year. Spironolactone seems to be equally efficacious and a lot cheaper. If new studies should appear, these recommendations can easily be changed.
The cost of a daily dose of Inspra (50 mg) is DKK 22 per day, compared to DKK 0.5 for the cheapest medicinal product with spironolactone (25 mg daily).
Inspra was marketed on November 22th 2004.
Last modified: November 30th 2005