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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Published on behalf of the European Society of Cardiology. Eplerenone has relative selectivity in binding to recombinant human mineralocorticoid receptors compared to its binding to recombinant human glucocorticoid, progesterone and androgen receptors. Can we trust observational data for clinical decision-making? 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.

Drug interaction studies of eplerenone have not been conducted with lithium. The safety of the early administration of eplerenone was excellent, while the rate of the primary outcome was significantly reduced in the eplerenone group when compared with the placebo group.

During the course of the study, 28 patients 5. The concomitant administration of trimethoprim with eplerenone increases the risk of hyperkalaemia. Thereafter, periodic monitoring is recommended especially in patients at risk for the development of hyperkalaemia, such as elderly patients with renal insufficiency see section 4.

Pharmacodynamic interactions Potassium-sparing diuretics and potassium supplements Due to increased risk of hyperkalaemia, eplerenone should not be administered to patients receiving other potassium-sparing diuretics and potassium supplements see section 4.

No cases of adverse events associated with overdose of eplerenone in humans have been reported. Heart failure e;hesus adjudicated by a clinical endpoint committee. The treatment-by-subgroup eplerenobe was evaluated by means of a Cox proportional-hazards model with terms for treatment, subgroup, and their interaction. To email a medicine you must sign up and log in. After initiation, the dose should be adjusted based on the serum potassium level as shown in Table 1.

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Maximum plasma ephesuz are reached after about 2 eplerrnone. 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.

Creating certainty out of uncertainty.

Aldosterone and long-term outcome after myocardial infarction: Therefore, these patients should be treated with caution. Alpha 1 blockers e.

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A close monitoring of epheesus potassium and renal function is recommended, especially in patients at risk for impaired renal function, e. Animal studies did not indicate direct or indirect adverse effects with respect to pregnancy, embryofoetal development, parturition and postnatal development see section 5.

Receive exclusive offers and updates from Oxford Academic. The use of eplerenone in patients with severe hepatic impairment has not been evaluated and its use is therefore contraindicated see sections 4.

Eplerenone 50 mg film-coated tablets

It furthers the University’s objective of excellence in research, scholarship, and education by publishing dplerenone. Email alerts New issue alert. Immediate mineralocorticoid receptor blockade improves myocardial infarct healing by modulation of the inflammatory response. This is important because wphesus serum potassium has been associated with an increased risk of arrhythmia and mortality.

The elimination half-life of eplerenone is approximately 3 to 5 hours. Serum potassium levels should be monitored in all patients at initiation of treatment and with a change in dosage. Supporting data include, when available, chest X-rays, Swan Ganz catheterization, left ventricular function eplerenons, and discharge medications. If needed, close monitoring of serum potassium and renal function are recommended when cyclosporine and tacrolimus are to be administered during treatment with eplerenone see section 4.

Co-administration of eplerenone with strong CYP3A4 inducers is not recommended see section 4.

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

During a mean follow-up of 16 months, there were deaths in the eplerenone group and deaths in the placebo group relative risk, 0. Timing of eplerenone initiation and outcomes in patients with heart failure after acute myocardial infarction complicated by left ventricular systolic dysfunction: 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.

B-type natriuretic peptides and ejection fraction for prognosis after myocardial infarction. There are no adequate data on the use of eplerenone in pregnant women. Natriuretic peptides in unstable coronary artery disease.

EPHESUS – Wiki Journal Club

Warfarin No clinically significant pharmacokinetic interactions have been observed with warfarin. Tricyclic anti-depressants, neuroleptics, amifostine, baclofen Co-administration of these drugs with eplerenone may potentially increase antihypertensive effects and risk of postural hypotension.

Arterial thrombosis limb, orthostatic hypotension. Clinical monitoring for postural hypotension is recommended during alphablocker co-administration.

Cyclosporin and tacrolimus may lead to impaired renal function and increase the risk of hyperkalaemia. A computerized randomization system 24 h interactive voice randomization system with concealed study-group assignment was used to randomly block size 4 assign patients to receive eplerenone Inspra, Pfizer or matching placebo.

This good tolerance was obtained with The use of potassium supplements after initiation of eplerenone therapy is not recommended, epesus to an increased risk of hyperkalaemia.

Because of these anticipated limitations, rather than relying on hard outcomes only, we included markers of subclinical HF into the primary endpoint.