New Results From the Shift Study in Heart Failure Patients With Procoralan

Paris (ots/PRNewswire) -

- For The First Time: Direct Link Found Between Reducing Heart
Rate and Quality of Life

New results from SHIFT (Systolic Heart Failure Treatment with the
If Inhibitor Ivabradine Trial), the largest-ever morbi-mortality
study of treatments for chronic heart failure, reveal for the first
time a direct link between heart rate reduction and quality of life
in patients with heart failure.[1]

The new data from the SHIFT study with Procoralan(R)
(ivabradine), presented today at the European Society of Cardiology
congress, are clinically important as quality of life is greatly
impaired in patients with chronic heart failure and poor quality of
life in these patients is associated with worse disease outcomes.

"The main SHIFT results presented at last year's ESC congress
clearly told us that the If InhibitorProcoralan prevents the
progression of heart failure and improves survival," explained SHIFT
study co-chairman Prof Karl Swedberg, University of Gothenburg,
Sweden. "Our new analyses show that Procoralan also improves the
quality of life as reported by patients with heart failure and that
this improvement is directly proportional to heart rate reduction.
Put simply, we found that, the lower the heart rate, the better the
quality of life and the better the patient outcome."

The new SHIFT analysis set out to assess if quality of life in
heart failure patients was related to prognosis and changes in heart
rate. It involved 1944 patients with chronic heart failure from 24
countries who were randomised to receive either Procoralan or placebo
on top of standard heart failure therapy. Health related quality of
life was assessed using the Kansas City Cardiomyopathy Questionnaire
(KCCQ), a validated, disease-specific measure of functional status
and quality of life.[2] The 23 items of the questionnaire are divided
into 2 sets of scores, the clinical summary score assessing physical
limitation and symptoms and the overall summary score assessing
social limitation in chronic heart failure patients. The higher the
score, the better the quality of life.

By one year, the study showed that the risk of a cardiovascular
event increased in patients with lower KCCQ scores (equating to a
lower health related QoL). The reduction in heart rate achieved
through treatment with Procoralan was associated with almost double
the improvement in quality of life compared to the control group.
This improvement was observed in both the disease related component
and the social component of the scores. Practically speaking, this
means that patients who received Procoralan were able to participate
in a greater number of everyday activities, considerably changing
their day to day life. Thus, with these new results it is important
to note that heart rate reduction with Procoralan, unlike
beta-blockers, improves both survival and QOL in heart failure
patients.

SHIFT findings explained by new echocardiography data

An additional sub-study from SHIFT, also presented today at the
ESC congress, provides insight into why Procoralan achieves
improvements in the symptoms, prognosis, quality of life and survival
rates in heart failure patients.

The SHIFT echocardiography study was carried out in 411 patients.
Echocardiograms were performed at baseline and after eight months of
Procoralan treatment or placebo. The study showed that Procoralan
significantly reduced left ventricular volumes and improved left
ventricular ejection fraction.[3]

Left ventricular end-systolic volume -- the amount of blood in
the left ventricle at the end of contraction -- is a well-recognised
prognostic factor and increased end-systolic volume is a sign that
the heart is not pumping effectively.

"Our echocardiography study shows that Procoralan significantly
reduces the size of the left ventricle and improves the remodeling
and pumping function of the heart," says Professor Jean-Claude Tardif
from the Montreal Heart Institute at the University of Montreal in
Canada.

The results from these sub-studies 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.

"The objectives of treating heart failure are to improve
symptoms, quality of life, improve prognosis and prevent disease
progression. The SHIFT study and all the new analyses demonstrate
that Procoralan achieves these objectives over and above the best
possible recommended therapy," concludes Professor Michel Komajda,
co-chairman of the SHIFT Executive Committee from Pierre and Marie
Curie Paris 6 University, France.

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

1. Ekman I et al. Heart rate reduction with ivabradine and health
related quality of life in patients with chronic heart failure
Results from SHIFT. European Heart Journal, Published Online 29th
August 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. Tardif J-C et al. Effects of selective heart rate reduction
with ivabradine on left ventricular remodeling and function: results
from the SHIFT echocardiography substudy. European Heart Journal,
Published Online 29th August 2011

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