PRESS RELEASE

Heart failure: results of the SENIORS study presented at Munich

Munich (Germany), 29 August 2004 - Is heart failure the problem of the future? According to estimates of the European Heart Society, it is; in Europe at least 10 million people suffer from heart failure and 50% of patients with ascertained diagnosis will die within the next 4 years. A contribution towards overcoming this failure may be arriving from Italy.

It is called SENIORS (Study of Effects of Nebivolol Intervention on Outcomes and Rehospitalisation in Seniors with Heart Failure) and was presented today at the European Heart Convention currently being held in Munich.

This study has clearly demonstrated the tolerability and efficacy of Nebivolol, compared to placebo, reducing mortality and morbility (hospitalisation) by 14% in patients over 70 suffering from heart failure who are already being treated with classical therapies (diuretics, ace-inhibitors, etc.). These are important results in view of the fact that all patients were subjected to maximum pharmacological protection (and despite this Nebivolol demonstrated to be an additional and significant therapeutic aid).

This result is even more outstanding considering that the “very elderly” (older than 80 years old) were also included, for whom the efficacy of any treatment is greatly lower compared to the rest of the population. Infact, the further results are going to confirm a 20% reduction in mortality among the less old population.

The study also demonstrated how the benefits were already evident after very short periods (6 months of treatment). Moreover, for the first time SENIORS photographs the “real scenario” of the population suffering from heart failure, constituting a fundamental reference point for overcoming this pathology.

In fact this is the first great international study on heart failure in elderly patients using a new drug, Nebivolol (the first beta-blocker with a vasodilating action mediated by nitric oxide) developed in the research centres of the Menarini Group.

With a duration of three and a half years under the supervision of three independent Scientific Committees, SENIORS is a study that has been carried out in 200 hospital centres in 11 European countries (Italy, Germany, France, United Kingdom, Hungary, The Netherlands, Rumania, Ukraine, the Czech Republic, Spain and Switzerland), with over 2000 patients enrolled.
SENIORS has stirred enormous interest in the scientific world as it is the first study on heart failure targeting the section of the population at highest risk, the over-70 age group, which up until now was only marginally considered in studies. SENIORS is also the first study on heart failure to have enrolled a large number of women (about 40%), until now erroneously ignored in this pathology. In fact, with increased life expectancy, the patients most prone to heart failure in the future will be precisely those women who from a certain age range (starting with menopause due to the lack of oestrogen protection) will catch up to men in the incidence of cardiovascular diseases.

Contrary to other cardiovascular diseases which are diminishing, heart failure, with its huge burden of mortality and invalidity, is a chronic pathology that is dramatically increasing as it is correlated to a higher life expectancy: the longer one lives, the greater the probability of heart failure being the cause of death, a probability that touches 45% in the over-70 age group.

Stressing the key role of this study, Prof. Philip Poole-Wilson of the Imperial College School of Medicine in London explained how “SENIORS has extended the indications for use of beta-blockers in the treatment of heart failure”.
Andrew Coats, President of the Faculty of Medicine at the University of Sydney stated during the press conference that “SENIORS is a reference point as it is the first important study on mortality and morbility in heart failure in a population that represents the average age for this pathology”.

While Prof. Alberto Zanchetti, Director of the Clinical Physiology and Hypertension Clinic of the University of Milan declared that “Nebivolol is a unique drug for its characteristic mechanism of action, a part from belonging to the well-known class of beta-blockers, it also carries out direct vasodilating activity thanks to nitric oxide. Louis Ignarro, Nobel Prize-winner for Medicine in 1998, contributed towards revealing this effect which not only endows Nebivolol with an important role in hypertension therapy, and as demonstrated in the SENIORS study, in that of heart failure, and it also has the capacity to correct the endothelial dysfunction that is at the basis of atherosclerosis and its cardiovascular complications.”

SENIORS Control Committee:
Steering Committee (chaired by Prof. Philip Poole-Wilson -Imperial College of Science Technology and Medicine and Royal Brompton Hospital of London and Prof. Andrew Coats - University of Sydney).
Data and Safety Monitoring Committee (chaired by Prof. Alberto Zanchetti- University of Milan)
Clinical Events Adjudication Committee (chaired by Prof. Kristian Thygesen-Aahrus University Hospital, Denmark)