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According to the World Health Report 2002, of an estimated 56
million deaths worldwide in 2001, more than 29% were due
to cardiovascular disease. Coronary artery disease (a condition
where the blood vessels supplying the heart become narrowed) – the
most common manifestation of cardiovascular disease – is
attributed with over 12% of deaths, making it one of the
principal causes of death worldwide.1 People with coronary
artery disease may experience chest pain, shortness of breath
and even heart attacks, although the condition can also be
present without any noticeable symptoms. Despite changes
in lifestyle and the use of modern medical and surgical techniques,
the burden of this disease is expected to increase over the
coming years. New strategies to tackle this worldwide threat
are therefore urgently needed.
Angiotensin converting enzyme (ACE) inhibitors, such as perindopril,
have a well-established role in the treatment of hypertension
(high blood pressure), heart failure
(a condition in which the heart has problems pumping
blood) and after a myocardial
infarction (heart attack). Importantly, evidence
also suggests that they have huge potential in the
treatment of coronary artery
disease. However, until the EUROPA study, no long-term
trial had ever investigated the effect of ACE inhibitors
in the overall
unselected population of patients who only have evidence
of coronary artery disease.
The EUROPA study – the eagerly awaited results of which
were presented at the European Society of Cardiology in Vienna,
August, 31, 2003 – investigated the effects of the ACE
inhibitor perindopril, added to optimal therapy, on cardiac events
in patients with stable coronary artery disease (e.g., patients
with a previous heart attack or with narrowing of a major artery),
but without heart failure. Perindopril was a particularly appropriate
choice of ACE inhibitor due to its proven efficacy and safety
profile, in the treatment of hypertension and heart failure,
which have been demonstrated through an extensive clinical trials
programme with more than 500 ongoing and completed trials involving
more than 100,000 patients.
The EUROPA study began recruiting patients from 1997 until June
2000, from 24 European countries and is the largest ever trial
to address the management of patients with coronary artery disease.
12,218 patients aged at least 18 years (mean age of 60 years)
were randomised from 424 centres and then randomly divided into
two treatment groups. One group received four years of treatment
with 8 mg once daily of perindopril in addition to their existing
medication(s) and the other group received placebo over the same
period.
The EUROPA study was designed primarily to determine whether adding
perindopril to optimal therapy decreased the rate of:
Cardiovascular death
Acute myocardial infarction (heart attack)
Cardiac arrest (a sudden cessation of heartbeat resulting
in the loss of circulation) with successful resuscitation
(recovery).
In addition, selected secondary end points of the study were:
cardiovascular mortality, myocardial infarction, heart failure,
total mortality, revascularisation (PTCA, CABG), stroke and unstable
angina.
The EUROPA study also includes five sub-studies, evaluating the
effect of perindopril on diabetes, endothelium dysfunction, atherosclerosis,
blood products associated with atherosclerosis. These sub-studies
have been designed to provide a better understanding of the exact
mechanism(s) via which perindopril exerts its effect in patients
with coronary artery disease.
Reference
1. The World Health Report 2002: Reducing risks,
promoting healthy life. World Health
Organization. http://www.who.int
2. Gomma AH, Fox KM. On behalf of the EUROPA investigators. The EUROPA trial:
design, baseline demography and status of the substudies. Cardiovasc Drugs Ther.
2001;15:169–179.
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