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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Receive exclusive offers and updates from Oxford Academic. Significant pharmacokinetic interactions may occur when eplerenone is co-administered with drugs that inhibit the CYP3A4 enzyme. Warfarin No clinically significant pharmacokinetic interactions have been observed with warfarin. 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.

You must accept the terms and conditions. The rate of the other primary end point, death from cardiovascular causes or hospitalization for cardiovascular events, was reduced by eplerenone relative risk, 0. This effect was consistent at months 6, 12, and There are no adequate data on the use of eplerenone in pregnant women. Steady state is reached within 2 days.

The pharmacokinetics of eplerenone did not differ significantly between males and females. During a mean follow-up of 16 months, there were deaths in the eplerenone group and deaths in the placebo group relative risk, 0.

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Reperfusion before percutaneous coronary intervention in ST-elevation myocardial infarction patients is associated with lower N-terminal pro-brain natriuretic peptide levels during follow-up, irrespective of pre-treatment with full-dose epheeus. The epperenone increased plasma renin activity and aldosterone circulating levels do not overcome the effects of eplerenone. In one study, the addition of hydrochlorothiazide to eplerenone therapy has been shown to offset increases in serum potassium.

Treatment should be initiated at 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.

The tablets contain lactose and should not be administered in patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.

Impaired hepatic function No elevations of serum potassium above 5. The use of potassium supplements after initiation of eplerenone therapy is not recommended, due to an increased risk of hyperkalaemia. Preclinical studies on safety pharmacology, genotoxicity, carcinogenic potential and reproductive toxicity revealed no special hazard for humans.

There were no deaths associated with the development of hyperkalaemia in patients randomized to eplerenone.

A key value of this study is that it provides important new safety information about early treatment with eplerenone after myocardial infarction. Percentages may not total because of rounding. During the course of the study, 28 patients 5. Eplerenone prevents the binding of aldosterone, a key hormone in the renin-angiotensin-aldosterone-system RAAS pelerenone, which is involved in the regulation of blood pressure and the pathophysiology of CV disease.

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

Caution should be exercised prescribing eplerenone to pregnant women. Baseline characteristics of the patients, according to the study group a. Skin and subcutaneous tissue disorders.

Dosing should not exceed 25 mg OD see section 4. Trimethoprim The concomitant administration of trimethoprim with eplerenone increases the risk of hyperkalaemia. The consistency ephhesus the treatment effect was assessed among pre-specified subgroups. Antacids Based on the results of a pharmacokinetic clinical study, no significant interaction is expected when antacids are co-administered with eplerenone.

The concomitant administration of trimethoprim with eplerenone increases the risk of hyperkalaemia. C03DA04 Mechanism of action Eplerenone has relative selectivity in binding to recombinant human mineralocorticoid receptors compared to its binding to recombinant human glucocorticoid, progesterone and androgen receptors.

N-terminal pro-B-type natriuretic peptide and long-term mortality in acute coronary syndromes. Creating certainty out of uncertainty. A close monitoring of serum potassium and renal function is recommended, eplerenonf in patients at risk for impaired renal function, e.

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