Procoralan(r) Reduces Risk Of Death And Hospitalisation For Heart Failure In Chronic Heart Failure P

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29th August 2010, 10:02pm - Views: 371





Business Company SHIFT Executive Committee 1 image

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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)


    To view the Multimedia News Release, please click:




    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


Business Company SHIFT Executive Committee 3 image

    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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