Procoralan(R) Significantly Improves Quality of Life as Well as Survival in Chronic Heart Failure Patients

By Les Laboratoires Servier, PRNE
Saturday, May 21, 2011

GOTHENBURG, Sweden, May 22, 2011 -

Results of a new analysis from the largest-ever
morbi-mortality study of treatments for chronic heart failure show that the
heart rate lowering agent Procoralan(R) (ivabradine) significantly improves
health related quality of life.[1] The new data from SHIFT (Systolic Heart
Failure Treatment with the If Inhibitor Ivabradine Trial), presented for the
first time today at the Heart Failure Congress 2011, are particularly
important as quality of life is greatly impaired in patients with congestive
heart failure.

"Improving survival and alleviating patient suffering are the
major goals in the management of heart failure patients", points out SHIFT
co-chairman Professor Karl Swedberg from the University of Gothenburg.
"However, currently prescribed heart failure treatments that prolong life
such as beta-blockers only improve quality of life for heart failure patients
modestly, if at all, while therapies such as diuretics that significantly
improve quality of life have no demonstrable effect on survival. We need new
therapies such as ivabradine that improve quality of life and survival".

The SHIFT quality of life study involved 1944 patients with
chronic heart failure from 24 countries who were randomised to receive either
Procoralan(R) or placebo on top of standard heart failure therapy. Health
related quality of life was assessed for two years using the Kansas City
Cardiomyopathy Questionnaire (KCCQ), a validated, disease-specific measure of
functional status and quality of life.[2] The KCCQ is a self-administered
questionnaire, that quantifies various aspects of day-to-day life like
physical limitations, symptoms, self-efficacy, social interference in chronic
heart failure patients.

An improvement was observed in the Procoralan(R) group. In a
specific analysis that excluded patients who died, the increase, in clinical
summary score (CSS) reporting more on clinical symptoms and overall summary
score (OSS) including clinical and social aspects, was up to twice more in
the Procoralan group.

These new results complement the main findings of the SHIFT
study which showed that Procoralan(R) reduced the risk of hospitalisation due
to worsening heart failure by over a quarter (26%, p<0.0001) and the
likelihood of death from heart failure by the same amount (26%, p=0.014).
Despite the fact that patients were already well treated, these benefits were
seen in just three months of treatment with Procoralan.

Chronic heart failure affects 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 has an enormous impact on the prognosis and lifestyle of
patients and is a major healthcare and economic burden. Heart failure impacts
all aspects of patients' daily lives, but particularly their mobility and
usual activities such as housework and socialising. Sadly, half of all heart
failure patients die within four years.

When compared with other major chronic illnesses, patients with chronic
heart failure showed the same pattern of reduced quality of life as patients
on chronic haemodialysis, depression and hepatitis.[3]

Along with therapeutic advances that increase the longevity of
heart failure patients, it is essential that these patients are able to
perform routine day-to-day activities and have a better quality of life.

"These new results on quality of life further reinforce the
main SHIFT results suggesting a need to consider heart rate lowering with
ivabradine in heart failure patients in sinus rhythm and heart rate above 70
bpm", concludes Professor Michel Komajda, co-chairman of the SHIFT Executive

* Depending on the country, ivabradine is available as
Procoralan(R), Coralan(R), Coraxan(R), or Corlentor(R)



[1] Ekman I. Ivabradine is associated with improved health related
quality of life. Results from SHIFT, presented orally at a late breaking
trial session of the Heart Failure Congress 2011

[2] Green CP, Porter CB, Bresnahan DR, Spertus JA. Development and
evaluation of the Kansas City Cardiomyopathy Questionnaire: a new health
status measure for heart failure. J. Am. Coll. Cardiol. 2000;35;1245-1255

[3] Juenger J, et al. Health related quality of life in patients with
congestive heart failure: comparison with other chronic diseases and relation
to functional variables. Heart. 2002;87:235-241

For further information please contact: Media enquiries: Ben Stewart, Tonic Life Communications, Ben.stewart at , +44(0)207-798-9910; Laura Craggs, Tonic Life Communications, laura.craggs at , +44(0)207-798-9910.

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