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Perindopril new indication
The ACE inhibitor Perindopril received a positive opinion from
the EMEA (European Medical Evaluation Agency) recommending the extension of its
licence indication for the treatment of patients with stable coronary artery
disease (CAD) to reduce the risk of cardiac events in patients with a history
of MI and / or revascularisation. The FDA has now also approved a label
extension for Perindopril for a similar indication in the US. This new
indication is in addition to Perindopril's well-established position as an
effective antihypertensive agent.
The EMEA gave the green light to approve the new indication for Perindopril based
on the results of EUROPA (The European Trial on Reduction of Cardiac Events
with Perindopril in Stable Coronary Artery Disease), the landmark trial involving
12,218 patients with stable CAD and without heart failure which showed that
Perindopril significantly cuts the risk of cardiovascular mortality and non-fatal
MI by 20% compared to placebo (p=0.0003).1 In the EUROPA study, patient
received 8 mg of Perindopril in addition to standard preventive therapy.
New EUROPA data
Further features of Perindopril's cardiovascular protective properties were
confirmed by new data from EUROPA presented at this year's ESC meeting. In a
subgroup of EUROPA patients (n=7,096) who had a precisely-measured left
ventricular ejection fraction (mean LVEF=57%), Coversyl reduces the risk of CV
death, non fatal MI and cardiac arrest by 16% (p<0.03). Additional analysis
demonstrates that the beneficial effect of Perindopril 8 mg was independent of
cardiovascular risk level, baseline blood pressure, concomitant treatments
(betablockers, lipid lowering drugs) or history of previous revascularisation,
reinforcing the specificity of EUROPA results in comparison with HOPE, ACTION
and PEACE.2-4
"The results from the EUROPA trial have extremely important clinical
implications and the new indication for Perindopril in CAD will help doctors
improve prognosis in CAD patients, even in those with relatively low risk,
beyond that achievable with existing standard therapy", points out Professor K
Fox, M.D, Royal Brompton Hospital, London, UK and chairman of the EUROPA trial.
"Perindopril therapy should be considered in addition to other preventive
treatments, even in the absence of heart failure, marked reduction in LV
function or risk factors for all CAD patients."
Reference
 1. Fox KM; European trial on reduction of cardiac events with perindopril in
stable coronary artery disease investigators. Efficacy of perindopril in
reduction of cardiovascular events among patients with stable coronary artery
diseased: randomized, double-blind, placebo-controlled, multicentre trial (the
EUROPA study). Lancet 2003;362:782-8
2. Bertrand ME et al. Effects of Perindopril on long-term outcome of patients with coronary artery disease and preserved left ventricular function – the EUROPA study. Poster. ESC 2005
3. Deckers JW et al. Treatment benefit by perindopril in patients with stable coronary artery disease at different levels of risk. Abstract n°3663, ESC 2005
4. Ceconi C et al. Effect of perindopril in patients with stable coronary disease: results on inflammatory and thrombosis markers of the pertinent study. Abstract n°3665, ESC 2005
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ESC 2003 Hotline - video
