MEDIA RELEASE PR48044
Procoralan(R) Reduces Risk of Death and Hospitalisation for Heart Failure in Chronic Heart Failure Patients
by More Than a Quarter
STOCKHOLM, Sweden, Aug. 29 /PRNewswire-AsiaNet/ --
The largest-ever morbi-mortality study of treatments for
chronic heart failure has shown that adding the specific heart rate lowering
agent Procoralan(R) (ivabradine) to standard therapy significantly reduces
the risk of death and hospitalisation for heart failure.(1) Results from this
new study, SHIFT (Systolic Heart Failure Treatment with the I(f) Inhibitor
Ivabradine Trial), were presented today at the European Society of Cardiology
Congress(1) in Stockholm and published in The Lancet.(2)
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SHIFT involved over 6,500 patients from 37 countries with
moderate to severe heart failure and heart rate above 70 bpm who were
followed up for an average of 23 months. The results showed that
Procoralan(R) reduces the primary endpoint, a composite of cardiovascular
death or hospitalisation for worsening heart failure, by 18% (p<0.0001).
Procoralan(R) also reduced the likelihood of death from heart failure by over
a quarter (26%, p=0.014) and the risk of hospitalisation due to worsening
heart failure by the same amount (26%,p<0.0001). These benefits were evident
in just three months of treatment with Procoralan(R) and despite the fact
that patients were already receiving guideline recommended therapy
(beta-blockers, angiotensin converting enzyme (ACE) inhibitors, diuretics or
aldosterone antagonists). The study also confirmed that Procoralan(R) has a
good tolerability profile in these fragile patients.
"Twenty years after Angiostensin Converting Enzyme Inhibitors
and ten years after beta-blockers, we now have a new life-saving drug
available for our patients", pointed out SHIFT executive committee
co-chairman Professor Michel Komajda, Professor of Cardiology, University
Pierre et Marie Curie Paris 6, France.
Chronic heart failure is a common and growing problem
affecting 15 million patients in Europe (2% to 3% of the overall population).
It impairs the heart's ability to pump effectively and maintain sufficient
circulation to meet the body's needs. Heart failure presents a major
healthcare and economic burden. Heart failure represents 10% of all hospital
admissions and half of heart failure patients die within 4 years.
Procoralan(R) is an innovative treatment that is currently
used in angina patients as it relieves symptoms, myocardial ischemia and
reduces the risk of coronary events. The SHIFT study has now also
demonstrated the prognostic benefits of Procoralan(R) in chronic heart
failure patients.
The SHIFT study is also the first study to specifically
confirm that, due to Procoralan(R), isolated heart rate reduction reduces the
risk of death or hospitalisation for heart failure. This finding confirms
that heart rate plays a key role in the progression of disease.
SHIFT co-chairman, Professor Karl Swedberg from the Head of
the Department of Emergency and Cardiovascular Medicine at University of
Gothenburg, Sweden, said: "The SHIFT study has important implications for our
clinical practice. It tells us that having a high heart rate is bad for heart
failure patients. So we should routinely measure heart rate in all heart
failure patients and, if it is above 70 beats per minute, heart rate lowering
with Procoralan(R) should be considered, irrespective of their background
treatment".
SHIFT Trial Design
SHIFT is a randomised, double-blind study that compares
Procoralan(R) with placebo on outcomes in patients with moderate to severe
chronic heart failure (most commonly caused by ischaemia), poor
left-ventricular ejection function and heart rate above 70 bpm. The study was
designed to assess whether the I(f) inhibitor can improve cardiovascular
outcomes and symptoms and quality of life when added to standard therapy in
patients with CHF and systolic dysfunction.
Patients received Procoralan(R) or placebo in addition to
their standard chronic heart failure treatment. These included ACE inhibitors
and/or ARBs, beta-blockers, diuretics and aldosterone antagonists. A total of
89% of patients in the study received ACE inhibitors and beta-blockers, with
more than half of them who received at least 50% of the target dose.
SHIFT was funded by Servier, France's leading independent
pharmaceutical company with a long history of successful drug development for
cardiovascular diseases, and coordinated by the SHIFT executive committee, an
international group of heart failure experts.
Procoralan(R)* was developed by Servier and is indicated for
the treatment of angina. It is the first agent of a new therapeutic class
known as the selective and specific I(f) inhibitors.
*Depending on the country, ivabradine is available as
Procoralan(R), Coralan(R), Coraxan(R), or Corlentor(R)
References
1. 29th August 2010, Hotline 1, European Society of Cardiology
Congress, Stockholm
2. Swedberg K, et al. Beneficial effects of ivabradine on
outcomes in chronic heart failure. The Systolic Heart Failure Treatment with
the I(f) Inhibitor Ivabradine Trial (SHIFT). Lancet. Online 29th August 2010
SOURCE: SHIFT Executive Committee
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