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EPHESUS TRIAL |
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| Problem | LV dysfunction post-MI |
| Format | Double-blinded multi-center RCT |
| Treatment | Eplerenone |
| Control | Placebo |
| Population | 6452 patients |
| Inclusion criteria | Patients in whom the following criteria were met were eligible for randomization 3 to 14 days after acute myocardial infarction: Acute myocardial infarction as documented according to standard criteria Left ventricular dysfunction as documented by a left ventricular ejection fraction of 40 percent or lower on echocardiography, radionuclide angiography, or angiography of the left ventricle after the index acute myocardial infarction and before randomization Heart failure as documented by the presence of pulmonary rales, chest radiography showing pulmonary venous congestion, or the presence of a third heart sound. In patients with diabetes who met the criteria for left ventricular dysfunction after acute myocardial infarction, symptoms of heart failure did not have to be demonstrated, since such patients have an increased risk of cardiovascular events similar to that of nondiabetic patients with symptoms of heart failure. |
| Exclusion criteria | Use of potassium-sparing diuretics Serum creatinine concentration of more than 2.5 mg per deciliter (220 Î_mol per liter) Serum potassium concentration of more than 5.0 mmol per liter before randomization |
| Follow-up | Mean 16 months |
| Primary endpoint | Time to death from any cause Time to death from cardiovascular causes or first hospitalization for a cardiovascular event, including heart failure, recurrent acute myocardial infarction, stroke, or ventricular arrhythmia |
| Secondary endpoint(s) | Death from cardiovascular causes and death from any cause or any hospitalization |
| Details | Patients received optimal medical therapy, which could include ACE inhibitors, angiotensin-receptor blockers, diuretics, and beta-blockers, as well as coronary reperfusion therapy. |
| Brief summary: | First trial to show benefits of aldosterone antagonists after acute MI with CCF |
| PAPER: Eplerenone, a Selective Aldosterone Blocker, in Patients with Left Ventricular Dysfunction after Myocardial Infarction | |
|---|---|
| Date | 3 Apr 2003 |
| Journal | N Engl J Med. 2003 Apr 3;348(14):1309-21. |
| Information | Eplerenone vs. placebo -15% RRR in deaths -16% RRR in CV death or hospitalization for CV events -8% RRR in death from any cause or any hospitalization -21% RRR in sudden death from cardiac causes -Increased risk of serious hyperkalaemia |