EPHESUS EPLERENONE PDF

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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Serum potassium should be assessed as needed periodically thereafter. The addition of eplerenone to optimal medical therapy reduces morbidity and mortality eohesus patients with acute myocardial infarction complicated by left ventricular dysfunction and heart failure.

The prognostic value of B-type natriuretic peptide in patients with acute coronary syndromes.

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The resulting increased plasma renin activity and aldosterone circulating levels do not overcome the effects of eplerenone. Sign In or Create an Account. The pharmacokinetics of eplerenone mg have been investigated in patients with moderate Child-Pugh Class B hepatic eplfrenone and compared with normal subjects.

The study continued until deaths occurred.

No cases of adverse events associated with overdose of eplerenone in humans have been reported. Randomization had to take place as early as possible following diagnosis and the first dose of study drug administered within 24 h of the onset of symptoms of acute MI and preferably within 12 h.

Eplerenone has relative selectivity in binding to recombinant human mineralocorticoid receptors compared to its binding to recombinant human glucocorticoid, progesterone and androgen receptors. Sudden unexpected infantile death due to undiagnosed ventricular septal defect-associated heart failure with single coronary artery.

The use of potassium supplements after initiation of eplerenone therapy is not recommended, due to an increased risk of hyperkalaemia. On the other hand, rates of hypokalaemia were low 1.

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Metabolism and nutrition disorders. View large Download slide. We conducted a double-blind, placebo-controlled study evaluating the effect of eplerenone, a selective aldosterone blocker, on morbidity and mortality among patients with acute myocardial infarction complicated by left ventricular dysfunction and heart failure.

EPHESUS – Wiki Journal Club

Breast-feeding It is unknown if eplerenone is excreted in human breast milk after oral administration. In this study and in a 1-year paediatric safety study in subjects, the safety profile was similar to that of adults. It is unknown if eplerenone is excreted in human breast milk after oral administration.

Eplerenone therapy should usually be started within days after an acute MI. The elimination half-life of eplerenone eplreenone approximately 3 to 5 hours. Inhibition of the renin-angiotensin system reduces the rise in serum aldosterone in acute coronary syndrome patients with preserved left ventricular function: Paediatric population Eplerenone has not been studied in pediatric subjects with heart failure.

Last updated on eMC: Hepatic Insufficiency The pharmacokinetics of eplerenone mg have been investigated in patients with moderate Child-Pugh Class B hepatic impairment and compared with normal subjects. Immediate administration of mineralocorticoid receptor antagonist eplerenine prevents post-infarct left ventricular remodeling associated with suppression of a marker of myocardial collagen synthesis in patients with first anterior acute myocardial infarction.

NYHA functional classification epgesus or remained stable for a statistically significant greater proportion of subjects receiving eplerenone compared to placebo. Not all pack sizes may be marketed. 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.

Between 28 September and 28 Octoberpatients at 65 centres in 11 countries were recruited. High plasma aldosterone levels on admission are associated with death in patients presenting with acute ST-elevation myocardial infarction. Back to top Consilient Health Ltd contact details.

For the individual adjustment of dose, the strengths of 25 mg eplerneone 50 mg are available. Each tablet contains 50 mg of eplerenone. No initial dose adjustment is required in the elderly. The rate of the other primary end point, death from cardiovascular causes or hospitalization for elperenone events, was reduced by eplerenone relative risk, 0.

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Eplerenone does not cause drowsiness or impairment of cognitive function but when driving vehicles or operating machines it should be taken into account that dizziness may occur during treatment.

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Each 50 mg tablet contains Co-administration of eplerenone and lithium should be avoided. Timing of eplerenone initiation and outcomes in patients with heart failure after acute myocardial infarction complicated by left ventricular systolic dysfunction: For post-MI heart failure patients: Consistent with its mechanism of action, hyperkalaemia may occur with eplerenone.

Baseline characteristics of the patients, according to the study group a. Renal impairment see sections 4. Steady state is reached within 2 days. 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.

A key value of this study is that it provides important new safety information about early treatment with eplerenone after myocardial infarction.

The safety and efficacy of eplerenone in children and adolescents have not been established. The effect of eplerenone on the primary endpoint outcomes was consistent across all pre-specified subgroups.

There was also a reduction in the rate of sudden death from cardiac causes relative risk, 0. The most likely manifestation of human overdose would be anticipated to be hypotension or hyperkalaemia. Consistent with these results, epphesus 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.

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