PREAMI Study Shows Significant Benefit of Coversyl® in Elderly Post-Heart Attack Patients
(I-Newswire) - Results from the PREAMI ( Perindopril Remodelling in Elderly with Acute Myocardial Infarction ) study announced today at the European Society of Cardiology ( ESC ) Congress show that the ACE inhibitor Coversyl® ( perindopril ) significantly reduces the risk of death, hospitalisation for heart failure and cardiac remodelling in elderly post-heart attack patients with preserved left ventricular ( LV ) function.1
PREAMI is a landmark study, marking the first time that an ACE inhibitor has been evaluated in this elderly population with preserved left ventricular function, which is widely represented in clinical practice.
The beneficial effect of perindopril was due to a highly significant reduction ( 46%, p<0.001 ) in cardiac remodelling when compared to placebo. Acute myocardial infarction ( heart attack, MI ) leads to progressive changes of heart ventricle size, shape and function. This process is known as remodelling and is a silent sign of cardiac decline towards heart failure. Previous studies demonstrated the beneficial effect of ACE inhibitors, although in younger patients with altered left ventricular function.
“The PREAMI findings fill a gap in our knowledge of the effect of ACE inhibitors in post-myocardial infarction patients”, says Professor R Ferrari from S Anna Hospital, University of Ferrara, Italy, and lead investigator of the PREAMI study. “PREAMI demonstrated that, even in patients who survived a heart attack and who have normal left ventricular function more than 10 days after acute phase, progressive cardiac remodelling silently appears. The good news is that perindopril can significantly prevent this cardiac decline and could be of benefit to millions of post-MI elderly patients.”
PREAMI, a multinational, double-blind, randomised, parallel, multi-centre study compared Coversyl ( 8 mg / day ) vs. placebo in elderly post-MI patients with a LV ejection fraction _40%.
The trial involved 1,252 elderly patients with an average age of 73 years and was carried out at 109 centres spanning five European countries.* After myocardial infarction patients received recommended usual therapy ( antithrombotics, b-blockers, ACE inhibitors ). 1,252 patients with preserved LVEF were randomised 11+/-4 day after MI and received either 4 mg / day of perindopril or placebo for the first month of treatment, followed by 8 mg / day perindopril or placebo for the remaining 11 months of the trial. Study treatment was given in addition to recommended conventional therapy.
Highly Significant Relative Results
Coversyl treatment was associated with a highly significant relative risk reduction ( RRR ) of 38% ( p<0.001 ) in the combined primary end point ( death, hospitalisation for heart failure and cardiac remodelling ). This considerable overall reduction in the combined study endpoint was driven by the highly significant benefit of perindopril in cardiac remodelling. The results showed significantly less LV remodelling in the perindopril group compared to the placebo group ( 28% vs. 51%, p<0.001 ).
Perindopril was found to be well tolerated at a dose of 8 mg per day despite the advanced age of PREAMI patients. In addition, there was no interaction with any of the concomitant treatments.
Coversyl
Coversyl, discovered and developed by Servier, is licensed worldwide for hypertension and heart failure at the dosages of 4 to 8 mg. In the EU, the EMEA has given the go-ahead for a new indication for Coversyl in stable coronary artery disease to reduce the risk of cardiac events in patients with a history of MI and/or revascularisation. In the US, the FDA has just approved a label extension for perindopril for a similar indication.
Perindopril is marketed in 118 countries under the trade names COVERSYL®, COVEREX®, ACERTIL®, PRESTARIUM®, PREXANIL®, PREXUM®, COVERENE®, COVERSUM®, PROCAPTAN® and marketed by Solvay Pharmaceutical and CV Therapeutics under the trade name of ACEON® in the US.
* The five countries involved in the PREAMI study are Greece, Hungary, Italy, Romania and Spain
References 1 R Ferrari. PREAMI:perindopril and remodelling in elderly with acute myocardial infarction, ESC Hotline Session 2005
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