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), Ménard 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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The treatment-by-subgroup interaction was evaluated by means of a Cox proportional-hazards model with terms for treatment, subgroup, and their interaction.
Eplerenone is not removed by haemodialysis. Show table of contents Hide table of contents 1. Adverse events are listed by body system and absolute frequency. At these doses, the highest observed eplerenone concentrations in paediatric subjects were not substantially higher than those in adults initiated at 50 mg once daily. Of these deaths, in the eplerenone group and in the ephezus group were attributed to cardiovascular causes relative risk, 0.
Eplerenone 50 mg film-coated tablets
Serum potassium should be assessed as needed periodically thereafter. Musculoskeletal and connective tissue disorders. The rate of the other primary end point, death from cardiovascular causes or hospitalization for cardiovascular events, was reduced by eplerenone relative risk, 0.
Related articles in Web of Science Google Scholar. Arterial thrombosis limb, orthostatic hypotension. Eplerenone treatment was initiated at 25 mg once daily in paediatric patients and increased to 25 mg twice daily after 2 weeks and eventually to 50 mg twice daily, if clinically indicated.
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Preclinical studies on safety pharmacology, genotoxicity, carcinogenic potential and reproductive toxicity revealed no special hazard for humans. Patients received the first dose of eplerenone after a mean duration of Excipient s with known effect: Steady-state C max and AUC of eplerenone were increased by 3.
It should epjesus be emphasized that there were no deaths associated with the development of hyperkalaemia in patients randomized to eplerenone. To view the changes to a medicine you must sign up and log in.
The primary end points were death from any cause and death from cardiovascular causes or hospitalization for heart epleenone, acute myocardial infarction, stroke, or ventricular arrhythmia.
In case of concomitant treatment with mild to moderate CYP3A4 inhibitors, e. There was however no statistical significant difference between the occurrence of stroke in the eplerenone 30 epgesus placebo 22 groups. I agree to the terms and conditions.
Efficacy and safety assessments were performed at weeks 1 and 4 as well as at months 6, 12, 18, and the end of study visit. There was also a reduction in the rate of sudden death from cardiac causes relative risk, 0. Change from baseline in vital signs and clinically relevant laboratory values such as serum creatinine, serum potassium, and eGFR were assessed by analysis of covariance, with the corresponding baseline value as a covariate.
EPHESUS – Wiki Journal Club
Hyperkalaemia see sections 4. Sign In or Create an Account.
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. Eplerenone is not a substrate or an inhibitor of P-Glycoprotein. Consistent with these results, a population pharmacokinetic analysis of eplerenone based on a subset of patients from EPHESUS indicates that clearance of eplerenone in patients with heart failure was similar to that in healthy elderly subjects.
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 mother.
Electrolyte levels should be monitored in patients with mild to moderate hepatic impairment. The trial randomized subjects at a 1: Aldosterone receptor antagonist use after myocardial infarction. During a mean follow-up of 16 months, there were deaths in the eplerenone group and deaths in the placebo group relative risk, 0. Eplerenone therapy should usually be started within days after an acute MI.
No initial dose adjustment is necessary for patients with mild-to-moderate hepatic impairment.