With the BEAUTIFUL Results, Procoralan* (ivabradine) is the First Antianginal Treatment Shown to Reduce Myocardial Infarction (Heart Attack) and Revascularisation in Stable Coronary Patients
31/08/2008 12:02
PR Newswire
MUNICH, Germany, August 31 /PRNewswire/ --
Press conference The BEAUTIFUL study: a step further in
title Coronary Artery Disease
ESC Hotline Title: The BEAUTIFUL study: efficacy of
session title ivabradine in reduction of cardiovascular
events among patients with stable coronary
artery disease and left ventricular
dysfunction
ESC Hotline 31st August 2008, 11:18 - 11:31 AM
session time
Press conference 9.00-10.00
Timing
Executive 31st August 2008: 9.00 - 10.30 AM
committee members
available for
interview
The results of the much awaited BEAUTIFUL (morBidity-mortality EvAlUaTion
of the IF inhibitor ivabradine in patients with CAD and left ventricULar
dysfunction) trial have shown that coronary artery disease (CAD) patients
with left ventricular dysfunction (LVD) and a heart rate more than 70 bpm
have a significantly higher risk of cardiovascular death and other
cardiovascular events and in these patients (heart rate above 70 bpm)
treatment with ivabradine further reduces the risk of the most important
coronary events such as fatal and non-fatal myocardial infarction and
coronary revascularisation by one third, even when these patients are already
receiving optimal therapy. Commenting after the results presentation, the
Chairman of the BEAUTIFUL Executive Committee, Prof Kim Fox said, "Ivabradine
was always known to relieve ischemia. With the BEAUTIFUL results, ivabradine
is the first antianginal treatment shown to reduce myocardial infarction and
revascularisation and to have a good tolerability profile even when used with
other drugs. This is the gold standard for any antianginal, anti-ischemic
drug."
The BEAUTIFUL trial was initiated in December 2004, under the guidance of
an independent Executive Committee with the first patient being enrolled in
early 2005. 10917 CAD patients with LVD, were recruited in 781 centres in 33
countries across 4 continents. The mean heart rate in these patients was 71
bpm and half of the patients had a heart rate more than 70 bpm. The results
of the BEAUTIFUL study have shown that these patients with heart rate greater
than or equal to 70 bpm are more likely to die or suffer from another
cardiovascular event. The increase in risk is 34% for cardiovascular death,
46% for myocardial infarction, 56% for heart failure and 38% for coronary
revascularisation.
In the overall study population treatment with ivabradine did not result
in a significant reduction of the primary composite end point (Cardiovascular
death, admission to hospital for acute MI and admission to hospital for heart
failure). However in patients with baseline heart rate more than 70 bpm,
ivabradine significantly reduced the risk of hospitalisation for fatal and
non-fatal myocardial infarction by 36% (p=0.001) and the risk of coronary
revascularisation by 30% (p=0.016). What is important to note is that most of
these patients were already receiving the guidelines-recommended
cardiovascular therapy: antiplatelet agents (94%), angiotensin-converting
enzyme inhibitors or angiotensin receptor blockers (91%), beta-blockers
(87%), as well as lipid-lowering agents (76%). Hence the results of BEAUTIFUL
constitute a step further in the management of these coronary patients with
heart rate above 70 bpm because, for the first time it has been shown that
pure heart rate reduction with ivabradine further reduces coronary events
even in patients receiving the current optimal cardiovascular therapy. This
study also confirms that ivabradine is safe and well tolerated and can be
used with all routinely prescribed cardiovascular drugs. Commenting on the
results the Chairman of the Steering Committee, Prof Roberto Ferrari said,
"Often a lot of investigations are performed in coronary patients but a
simple heart rate measurement is not done. BEAUTIFUL has reinforced the need
to measure heart rate in all CAD patients and if the heart rate is more than
70 bpm to reduce it by using ivabradine on top of background therapy."
BEAUTIFUL results with ivabradine can be explained by its well documented
ability to relieve myocardial ischemia in patients with chronic stable
angina.(1) New research has demonstrated that ivabradine improves endothelial
dysfunction(2) and prevents the progression of atherosclerosis.
Despite all the advances, the World Health Organisation reports that till
2030 coronary artery disease will remain the leading healthcare problem
worldwide(3). Ivabradine would help to reduce this burden because as shown by
the BEAUTIFUL study, ivabradine reduce the risk of myocardial infarction and
revascularisation. "Half of the CAD patients have a resting heart rate more
than 70 bpm. These patients can now benefit from a treatment that will
greatly reduce their chances of having another heart attack or needing
further surgery," concluded Professor Kim Fox, the Chairman of the BEAUTIFUL
Executive Committee.
For more information: http://www.beautiful-study.com
References:
(1). Tardif J-C, Ford I, Tendera M, et al. Eur Heart J. 2005;26:2529-
2536.
(2). Florian Custodis, MD*; Magnus Baumhakel, et al Circulation
2008;117:2377-2387.
(3). Projections of Global Mortality and Burden of Disease from 2002 to
2030 PLoS Med 3(11): e442. doi:10.1371/journal.pmed.0030442.
*Depending on the country, ivabradine is available as Procoralan(R),
Coralan(R), Coraxan(R), or Corlentor(R)
Media contact : Frederic Ville, MS? France, Health Practice, 13, rue Saint Ambroise, 75011 PARIS, Tel: +33(0)1-55-33-43-09, Mobile: +33(0)6-85-07-95-46, Fax : +33(0)1-55-33-43-44, frederic.ville@mslpr.com
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