Drug products: Eplerenon Accord, Eplerenon Actavis, Eplerenon Bluefish, Eplerenon Krka, Eplerenon Medical Valley, Eplerenon STADA, Eplerenone Sandoz, Eplerenone Teva, Inspra, Inspra®
ATC code: C03DA04
Eplerenone as supplement treatment during serious heart failure reduces mortality and hospitalization equally in men and women.
Hormonal side effects can occur during long treatment with eplerenone, but they are less common than for spironolactone.
Following administration of single or multiple doses of eplerenone (12.5-100 mg) , no differences in pharmacokinetics parameters were found between men and women [1-4]. Black participants had 19% lower Cmax and 26% lower AUC than White participants at steady state [3, 4].
No sex differences in blood pressure reduction, regardless of dose regimens, have been found, and no sex differentiation in dosing is recommended .
In the major clinical trial of eplerenone in patients with acute myocardial infarction and left ventricular dysfunction, the EPHESUS trial (4714 men, 1918 women), mortality hazard ratios were similar for both sexes [5, 6].
The effects of eplerenone on clinical outcomes in patients with systolic heart failure and mild symptoms were investigated in the EMPHASIS-HF trial (2127 men, 610 women). Hazard ratios for hospitalization for heart failure or death from cardiovascular causes with eplerenone versus placebo were similar for men and women .
Eplerenone is more specific than spironolactone in the effect on the mineralocorticoid receptor with minimal effects at other steroid receptors, thereby minimizing many of the hormonal adverse effects . However, sex hormone-related adverse events that have been seen with eplerenone in clinical trials of hypertension. These are gynecomastia in men and abnormal vaginal bleeding in women. These adverse events increased marginally with longer duration of therapy .
In the EPHESUS trial mentioned above, adverse events occurred at a similar rate in both sexes [3, 5].
Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
Date of litterature search: 2019-03-04
Reviewed by: Mia von Euler
Approved by: Karin Schenck-Gustafsson