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Eplerenone, a selective aldosterone blocker, in

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Eplerenone, a selective aldosterone blocker, in

  1. 1. Eplerenone, a Selective Aldosterone Blocker, in Patients with Left Ventricular Dysfunction after Myocardial Infarction (EPHEUSIS Trial) By Dr Salman Ahmed
  2. 2. Introduction  Aim to evaluate the effect of epleronone in pts with acute MI complicated by LVD.  It is a selective potassium channel inhibitor thought to improve ventricular remodelling,redues coronary vascular inflamation and attenuate the platelete aggregasion  RALES trial and REMINDER were also trial to evaluate the efficacy of potassium channel inhibitors
  3. 3. Study design  Drug Given: Eplirenone 50 mg od  Included  Within 3 -14 days post MI  LVD EF<40 % by either echo. LV angio  Presnce of evidence of LVD Rales on auscultation Cxr findings 3rd heart sound Diabetic pts included donot have the symptoms Excluded  Potassium conc: > 5.0 meq/dl  Creatinine > 2.5 mg/dl
  4. 4. Eplerenone (n = 3,313) Placebo (n = 3,319) Endpoints (at mean of 16 month follow-up):  Primary – 1) death from any cause and 2) death or hospitalization from CV causes EPHESUS Trial N Engl J Med 2003;348:1309- Optimal medical therapy (ACE inhibitors, angiotensin-receptor blockers, diuretics, and beta- blockers, coronary reperfusion therapy) 6,632 patients with acute MI complicated by heart failure and systolic left ventricular dysfunction  Acute MI in prior 3-14 days  Left ventricular dysfunction (EF <40%)  symptoms (in non-diabetics but not required for diabetics)
  5. 5. Results  Reduces all cause mortality (14.4 v/s 16.7%) NT=50  Reduces mortality from CV cause(NT=33) or hospitalization from CV cause  15% relative reduction of hospitalization due to Heart failure in Eplerenone group V/s Placebo  Risk of seroius hyperkalemia was inc: when cr:cl< 50
  6. 6. EPHESUS Trial: Primary Endpoints 14.4% 16.7% 0% 5% 10% 15% 20% All-cause Mortality RR 0.85 p=0.008 26.7% 30.0% 0% 10% 20% 30% 40% CV Death or Hospitalization RR 0.83 p=0.005 Eplerenone Placebo N Engl J Med 2003;348:1309- Eplerenone Placebo
  7. 7. EPHESUS Trial: Secondary Endpoint 12.3% 14.6% 0% 5% 10% 15% 20% CV Death RR 0.87 p=0.002 N Engl J Med 2003;348:1309- Eplerenone Placebo
  8. 8. EPHESUS Trial: Serious Adverse Events 5.5% 3.9% 0% 2% 4% 6% 8% Serious hyperkalemia p=0.002 0.5% 0.6% 0.0% 0.5% 1.0% 1.5% Gynecomastia p=0.70 Eplerenone Placebo N Engl J Med 2003;348:1309- Eplerenone Placebo
  9. 9. Conclusion  Addition of Eplirinone to Maximal therapy reduces all cause mortality and mortality from CVD and rehospitalization from CVD in Pts with MI complicated by LVD.  Eplirinone reduces CVD mortality by 15%  Majority of them were due dec: in sudden death  Risk of serious hypokalemia was twicwe greater in placebo than risk of hyperkalemia ineplirenone group

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