European Heart Journal Advance Access originally published online on January 9, 2005
European Heart Journal
2005 26(3):215-225; doi:10.1093/eurheartj/ehi115
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European Heart Journal vol. 26 no. 3 © The European Society of Cardiology 2005; all rights reserved.
Randomized trial to determine the effect of nebivolol on mortality and cardiovascular hospital admission in elderly patients with heart failure (SENIORS)
1Clinical Trials and Evaluation Unit, Royal Brompton and Harefield NHS Trust, London, UK
2National Heart and Lung Institute, Imperial College of Science Technology and Medicine, London, UK
3Division of Cardiology, University of Alberta, Edmonton, Canada
4Faculty of Medicine, University of Sydney, Sydney 2006, Australia
5Department of Cardiology, University Hospital, Groningen, The Netherlands
6Institute of Cardiology, Academy of Science of Ukraine, Kiev, Ukraine
7Hungarian Institute of Cardiology, Budapest, Hungary
8Service de Cardiologie, Hôpital Beaujon, Clichy, France
9University of Pharmacy and Medicine, Cluj Napoca, Romania
10Department of Cardiology, University of Ferrara, Ferrara, Italy
11Cardiovascular Research Centre, Salvatore Maugeri Foundation, IRCCS, Gussago, Italy
12Service de Pharmacologie, Hôpital Pitie-Salpetrière, Paris, France
13Cardiology Division, Hospital General Vall d'Hebron, Barcelona, Spain
14Department of Cardiology, IRCCS Policlinico San Matteo, Pavia, Italy
151st Department of Medicine, Masaryk University Hospital, Brno, Czech Republic
16Universitätskliniken des Saarlandes, Klinik für Innere Medizin III, Kardiologie, Angiologie und Internistische Intensivmedizin, Homburg/Saar, Germany
17Department of Cardiology, Charité Campus Virchow-Klinikum, Berlin, Germany
18Medical Research Council Biostatistics Unit, Cambridge, UK
Received 26 November 2004; revised 10 December 2004; accepted 15 December 2004; online publish-ahead-of-print 9 January 2005.
* Corresponding author. Tel: +61293514579; fax +61293516645. E-mail address: ajscoats{at}aol.com
See page 203 for the editorial comment on this article (doi:10.1093/eurheartj/ehi118)
Aims Large randomized trials have shown that beta-blockers reduce mortality and hospital admissions in patients with heart failure. The effects of beta-blockers in elderly patients with a broad range of left ventricular ejection fraction are uncertain. The SENIORS study was performed to assess effects of the beta-blocker, nebivolol, in patients 
70 years, regardless of ejection fraction.
Methods and results We randomly assigned 2128 patients aged 70 years with a history of heart failure (hospital admission for heart failure within the previous year or known ejection fraction 
35%), 1067 to nebivolol (titrated from 1.25 mg once daily to 10 mg once daily), and 1061 to placebo. The primary outcome was a composite of all cause mortality or cardiovascular hospital admission (time to first event). Analysis was by intention to treat. Mean duration of follow-up was 21 months. Mean age was 76 years (SD 4.7), 37% were female, mean ejection fraction was 36% (with 35% having ejection fraction >35%), and 68% had a prior history of coronary heart disease. The mean maintenance dose of nebivolol was 7.7 mg and of placebo 8.5 mg. The primary outcome occurred in 332 patients (31.1%) on nebivolol compared with 375 (35.3%) on placebo [hazard ratio (HR) 0.86, 95% CI 0.74–0.99; P=0.039]. There was no significant influence of age, gender, or ejection fraction on the effect of nebivolol on the primary outcome. Death (all causes) occurred in 169 (15.8%) on nebivolol and 192 (18.1%) on placebo (HR 0.88, 95% CI 0.71–1.08; P=0.21).
Conclusion Nebivolol, a beta-blocker with vasodilating properties, is an effective and well-tolerated treatment for heart failure in the elderly.
Key Words: Heart failure • Elderly • Beta-blocker • Nebivolol • Randomized trial • Ejection fraction
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P. C. Burger and H. B.-L. Rocca Pharmacotherapy of Congestive Heart Failure in Elderly Patients Journal of Cardiovascular Pharmacology and Therapeutics, April 1, 2005; 10(2): 85 - 94. [Abstract] [PDF]
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J. McMurray Making sense of SENIORS Eur. Heart J., February 1, 2005; 26(3): 203 - 206. [Full Text] [PDF]
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