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

GOTHENBURG, Sweden, May 22, 2011 /PRNewswire/ -- 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 Committee.

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

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References

[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