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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No active metabolites of eplerenone have been identified in human plasma. The pharmacokinetics of eplerenone were evaluated in patients with varying degrees of renal insufficiency and in patients undergoing haemodialysis.
Eplerenone 50 mg film-coated tablets
The effect of eplerenone on the primary endpoint outcomes was consistent across all pre-specified subgroups. Published on behalf of the European Society of Cardiology. After a mean follow-up of Drug interaction studies of eplerenone have not been conducted with lithium.
In contrast, patients with hypokalaemia serum potassium concentration below 3. No consistent effects of eplerenone on heart rate, QRS duration, or PR or QT interval were observed in normal subjects evaluated for electrocardiographic changes during pharmacokinetic studies.
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.
Lithium, cyclosporin, tacrolimus should be avoided during treatment with eplerenone see section 4.
Inhibition of the renin-angiotensin system reduces the rise in serum aldosterone in acute coronary syndrome patients with preserved left ventricular function: This effect of eplerenone was consistent across major pre-specified subgroups, but was particularly obvious in patients undergoing rapid reperfusion within 6 h of symptom onset. These results confirm the blockade of the mineralocorticoid receptor in these populations.
To view the changes to a medicine you must sign up and log in. Bad Nauheim, GermanyM. This effect was consistent at months 6, 12, and All patients provided written informed consent.
Juan Ramon Rey Blas. Due to an increased systemic exposure to eplerenone in patients with mild-to-moderate hepatic impairment, frequent and regular monitoring of serum potassium is recommended in these patients, especially when elderly see section 4.
Eplerenone 50 mg film-coated tablets – Summary of Product Characteristics (SmPC) – (eMC)
Steady-state C max and AUC of eplerenone were increased by 3. There was however no statistical significant difference between the occurrence of stroke in the eplerenone 30 vs placebo ephsus groups. Close mobile search navigation Article navigation.
The use of eplerenone in these patients should be done cautiously. It should also be emphasized that there were no deaths associated with the development of hyperkalaemia in patients randomized to eplerenone.
High plasma aldosterone levels on admission are associated with death in patients presenting with acute ST-elevation myocardial infarction. The elimination half-life of eplerenone is approximately 3 to 5 hours.
EPHESUS – Wiki Journal Club
If this combination appears necessary, lithium plasma concentrations should be monitored see section 4. Eplerenone has been shown to bind extensively to charcoal.
For post-MI heart failure patients: Initial concerns about starting the drug during the early course of MI proved not elhesus be justified. Percentages may not total because of rounding. Eplerenone cannot be removed by haemodialysis. One patient in each group did not start study medication and was not included in the safety analysis. Last updated on eMC: Arterial thrombosis limb, orthostatic hypotension.
The pharmacokinetics of eplerenone did not differ significantly between males and females. View large Download slide. Impaired hepatic function No elevations of serum potassium above 5. Eplerenone is not removed by haemodialysis.