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 prognostic value of B-type natriuretic peptide in patients with acute coronary syndromes. The manuscript was prepared by the Study Steering Committee, whose members had unrestricted access to the data, and was subsequently revised by all authors. Paris, FranceF. The resulting increased plasma renin activity and aldosterone circulating levels do not overcome the effects of eplerenone. Baseline characteristics of the patients, according to the study group a.
The aim of the present study was to investigate the safety and efficacy of an early initiation of eplerenone, within the first 24 h of symptom onset when acute reperfusion is delivered to patients presenting STEMI without known heart failure. In dose-ranging studies of chronic heart failure NYHA classification II-IVthe addition of eplerenone to standard therapy resulted in expected dose-dependent increases in aldosterone.
Adverse events reported below are those with suspected relationship to treatment and in epldrenone of placebo or are serious and significantly in excess of placebo, or have been observed during post marketing surveillance.
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. Erratum in N Engl J Med. This risk may be further increased when co-morbidity associated with increased systemic exposure is also present, in particular mild-to-moderate hepatic impairment. Primary outcome, component events, and key secondary outcomes a.
The dilemma of professional and industry relations for medical education. This information is intended for use by health professionals. Impaired renal function Potassium levels should be monitored regularly in patients with impaired renal function, including epheesus microalbuminuria. Animal studies did not indicate direct or indirect adverse effects eplereenone respect to pregnancy, embryofoetal development, parturition and postnatal development see section 5. The concomitant use of eplerenone with strong CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, nelfinavir, clarithromycin, telithromycin and nefazadone, is contra-indicated see section 4.
Data were collected, managed, and analysed by a clinical research organization, contracted by the sponsor, according to the protocol and a predefined statistical analysis plan. 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 50 mg film-coated tablets – Summary of Product Characteristics (SmPC) – (eMC)
Intravenous enoxaparin or unfractionated heparin in primary percutaneous coronary intervention for ST-elevation myocardial infarction: N-terminal pro-B-type natriuretic peptide and long-term mortality in acute coronary syndromes. MedDRA system organ class. The prostatic changes were not associated with adverse functional consequences. Both peak plasma levels C max and area under ephewus curve AUC are dose proportional for doses of 10 mg to mg and less than proportional at doses above mg.
Patients eplerenohe eplerenone and NSAIDs should be adequately hydrated and be monitored for renal function prior to initiating treatment. We aimed to assess the impact of eplerenone on cardiovascular CV outcomes in STEMI without known heart failure, when initiated within 24 h of symptom onset. This medicinal product does not require any special storage conditions.
This effect of eplerenone was consistent across major pre-specified subgroups, but was particularly obvious in patients epheesus rapid reperfusion within 6 h of symptom onset.
Eplerenone 50 mg film-coated tablets
Nancy, FranceE. There were no deaths associated with the development of hyperkalaemia in patients randomized to eplerenone. Epidermal growth factor receptor decreased, blood glucose increased. The incidence of hyperkalaemia was 3. In contrast, patients with hypokalaemia serum potassium concentration below 3.
No studies on the effect of eplerenone on the ability to drive or use machines have been performed. Lactose 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. The analyses of the adjudicated primary and secondary endpoints were conducted on data from all patients who had undergone randomization, according to the intention-to-treat principle, with the use of a Cox proportional-hazards model.
Add comment Close comment form modal. Of these deaths, in the eplerenone group and in the placebo group were attributed to cardiovascular causes relative risk, 0. However, lithium toxicity has been reported in patients receiving lithium concomitantly with diuretics and ACE inhibitors see section 4. Monitoring of serum potassium and renal function epplerenone be made, particularly in patients with renal impairment and in the elderly. In this study and in a 1-year paediatric safety study in subjects, the safety profile was similar to that of adults.
The composite of CV mortality, re-hospitalization, or extended initial hospital stay due to diagnosis of HF, or sustained ventricular tachycardia or fibrillation was a secondary composite endpoint pre-specified in the statistical analysis plan.
We evaluated the effect of an early addition of eplerenone 25—50 mg ephesks daily to recommended treatment in patients with acute STEMI and no history ephesu heart failure or low left ventricular ejection fraction.
Eplerenone metabolism is primarily mediated via CYP3A4. Between 28 September and 28 Octoberpatients at 65 centres in 11 countries were recruited. General disorders and administration site conditions.
Tricyclic anti-depressants, neuroleptics, amifostine, baclofen Co-administration of these drugs with eplerenone may potentially increase antihypertensive effects and risk of postural hypotension. Epgesus concomitant use of eplerenone and cyclosporin or tacrolimus should be avoided. The maximum dose regimen is 50 mg daily. 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 and the accuracy of the data analysis.
Email alerts New issue alert. It is unknown if eplerenone is excreted in human breast milk eplerenonne oral administration. I agree to the terms and conditions. Steady-state C max and AUC of eplerenone were increased by 3.
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Clinical monitoring for postural hypotension is recommended during alphablocker co-administration. The study continued until deaths occurred. Supporting data include, when available, eplerennoe X-rays, Swan Ganz catheterization, left ventricular function assessment, and discharge medications.