Pitt B(1), Remme W, Zannad F, Neaton J, Martinez F, Roniker B, Bittman R, Hurley S, Kleiman J, Gatlin M; Eplerenone Post-Acute Myocardial. Insights from an EPHESUS (Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study) substudy. Rossignol P(1), MĂ©nard J, Fay R. Eur J Heart Fail. May;8(3) Epub Feb Evaluation of eplerenone in the subgroup of EPHESUS patients with baseline left ventricular.

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Close mobile search navigation Article navigation. Each 50 mg tablet contains The effect of eplerenone on the primary endpoint outcomes was consistent ephesuss all pre-specified subgroups.

Eplerenone 50 mg film-coated tablets – Summary of Product Characteristics (SmPC) – (eMC)

Eplerenone therapy should usually be started within days after an acute MI. Results of pharmacokinetic studies with Eplerenon probe-substrates, i. Dosing should not exceed 25 mg OD see section 4.

On day 2, the majority of patients If hyperkalaemia develops, standard treatment should be initiated. The rate of the other primary end point, death from cardiovascular causes or hospitalization for cardiovascular events, was reduced by eplerenone relative risk, 0. Eplerenone has been shown to produce sustained increases in plasma renin and serum aldosterone, consistent with inhibition of the negative regulatory feedback of aldosterone on renin secretion.

Aldosterone promotes a number of deleterious short- and long-term effects eplrenone sodium retention and potential arrhythmogenesis possibly due to potassium and magnesium depletion, as well as endothelial dysfunction, increased vascular tone, inhibition of neuronal re-uptake of catecholamines, cardiac myocyte necrosis, collagen deposition, and cardiac remodelling.

There were numerically more cases of hyperkalaemia serum potassium concentration above 5. Any long term effect on hormonal status in paediatric subjects has not been studied. There were no other clinically significant differences between the two groups with respect to changes in laboratory variables, reported adverse events, or adverse events leading to permanent withdrawal of the study drug.


Adverse events reported below are those with suspected relationship to treatment and in excess of placebo or are serious and significantly in excess of placebo, or have been observed during post marketing surveillance. Impaired renal function Potassium levels should be monitored regularly in patients with impaired renal function, including diabetic microalbuminuria. Receive exclusive offers and updates from Oxford Academic. The complete author group had full access to all of the data in this study and take complete responsibility for the integrity of the data ephesux the accuracy eplerdnone the data analysis.

Trimethoprim The concomitant administration of trimethoprim with eplerenone increases the risk of hyperkalaemia. Because of the unknown potential for adverse effects on the breast fed infant, a decision should be made whether to discontinue breast-feeding or discontinue the drug, taking into account the importance of the drug to the ephesys.

The Executive Steering Committee see Appendix designed and oversaw the conduct of the trial and data analysis in collaboration with representatives of the study rphesus Pfizer. You must accept the terms and conditions. Co-administration of these drugs with eplereonne may potentially decrease antihypertensive effects sodium and wplerenone retention.

Eplerenone is not removed by haemodialysis see section 4. Usefulness of biomarker strategy to improve GRACE score’s prediction performance in patients with non-ST-segment elevation acute coronary syndrome and low event rates. To email a medicine you must sign up and log in. This is important because low serum potassium has been associated with an increased risk of arrhythmia and mortality.

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You have entered an invalid code. General ephess and administration site conditions. Enter medicine name or company Start typing to retrieve search suggestions. Nancy, FranceE. Cumulative Kaplan—Meier estimates of rates of the primary outcome according to study group. Paediatric population A population pharmacokinetic model for eplerenone concentrations from two studies in 51 paediatric hypertensive subjects of ages 4 to 16 years identified that patient body weight had a statistically significant effect on eplerenone volume of distribution but not on its clearance.


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Heart failure was adjudicated by a epjesus endpoint committee. Posology For the individual adjustment of dose, the strengths of 25 mg and 50 mg are available.

Animal studies did not indicate direct or indirect adverse effects with respect to pregnancy, embryofoetal development, parturition and postnatal development see section 5. Epidermal epheaus factor receptor decreased, blood glucose increased. Adverse events were tabulated according to randomized group assignment and analysed by means of Fisher’s exact test. Eplerenone is not removed by haemodialysis. Metabolism and nutrition disorders.

Eplerenone 50 mg film-coated tablets

The trial randomized subjects at a 1: No correlation was observed between plasma clearance of eplerenone and creatinine clearance. Currently available data are described in section 5. Electrolyte levels should be monitored in patients with mild to moderate hepatic impairment.

Eplerenone is not a substrate or an inhibitor of P-Glycoprotein. For chronic heart failure NYHA class E;hesus patients, treatment should be initiated at a dose of 25 mg once daily and titrated to the target dose of 50 mg once daily preferably within 4 weeks; taking into account the serum potassium level see Table 1 and section 4.

Serum potassium levels should be monitored in all patients at initiation of treatment and with a change in dosage. Madrid, SpainC. The recommended maintenance dose of eplerenone is 50 mg once daily OD. Latest Most Read Most Cited Transcatheter aortic valve replacement in patients with concomitant mitral stenosis.

Potassium levels should be monitored regularly in patients with impaired renal function, including diabetic microalbuminuria. N Engl J Eplreenone. There was also a reduction in the rate of sudden death from cardiac causes relative risk, 0. No initial dose adjustment is required in patients with mild renal impairment.