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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The effect of eplerenone on the primary endpoint outcomes was consistent across all pre-specified subgroups.

Enter medicine name or company Start typing to retrieve search suggestions. Serum potassium levels exceeded 5. 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.

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This risk may be further increased when co-morbidity associated with increased systemic exposure is also present, in particular mild-to-moderate hepatic impairment. Norfolk, UKF. The use of eplerenone in these patients should be done cautiously.

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 ephesue group.

Excipient s with known effect: Your comment will be reviewed and published at the journal’s discretion. 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.

Pregnancy Eplsrenone are no adequate data on the use of eplerenone in pregnant women.

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Baseline characteristics of the patients, according to the ephesks group a. Comment in J Fam Pract. The effect of aldosterone antagonists for ventricular arrhythmia: Any long term effect on hormonal status in paediatric subjects has not been studied. We suspect that the benefit on clinical endpoints would be larger in a higher risk population.

Maximum plasma concentrations are reached after about 2 ephezus. We evaluated the effect of an early addition of eplerenone 25—50 mg once daily to recommended treatment in patients with acute STEMI and no history of heart failure or low left ventricular ejection fraction.

A close monitoring of serum potassium and renal function is recommended, especially in patients at risk for impaired renal function, e. 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

During the course of the study, 28 patients 5. Absorption is not affected by food.

Initial concerns about starting the drug during the early course of MI proved not to be justified. The Executive Steering Committee see Appendix designed and oversaw the conduct of the trial and data analysis in collaboration with representatives of the study sponsor Pfizer. The rate of serious hyperkalemia was 5. Due to the risk of decreased eplerenone efficacy, the concomitant use of strong CYP3A4 inducers rifampicin, carbamazepine, phenytoin, phenobarbital, St John’s wort with eplerenone is not recommended see section 4.

Co-administration of eplerenone and lithium should be avoided. The trial randomized subjects at a 1: Co-administration of these drugs with eplerenone may potentially decrease antihypertensive effects sodium and fluid retention. Drug interaction studies of eplerenone have not been conducted with lithium. To view the changes to a medicine you must sign up and log in.

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EPHESUS – Wiki Journal Club

Eplerenonf is not a substrate or an inhibitor of P-Glycoprotein. However, lithium toxicity has been reported in patients receiving lithium concomitantly with diuretics and ACE inhibitors see section 4.

MedDRA system organ class. The study continued until deaths occurred. 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. Inhibition of the renin-angiotensin system reduces the rise in serum aldosterone in acute coronary syndrome patients with preserved left ventricular function: Fertility There are no human data available on fertility.

Each tablet contains 50 mg of eplerenone.

Timing of eplerenone initiation and outcomes in patients with heart failure after acute myocardial infarction complicated by left ventricular systolic dysfunction: Temporal trends and predictors in the use of aldosterone antagonists post-acute myocardial infarction. There are no adequate data eplerejone the use of eplerenone in pregnant women.

Early eplerenone treatment in patients with acute ST-elevation myocardial infarction without heart failure: Aldosterone and long-term outcome after myocardial infarction: Skin and subcutaneous tissue disorders. The most likely manifestation of human overdose would be anticipated to be hypotension or hyperkalaemia.

For ephessus full list of excipients, see section 6. Impaired hepatic function No elevations of serum potassium above 5.