Randomized trial to determine the effect of nebivolol on mortality and cardiovascular hospital admission in elderly patients with heart failure (SENIORS)

Flather, Marcus D, Shibata, Marcelo C, Coats, Andrew J S, Van Veldhuisen, Dirk J, Parkhomenko, Aleksandr, Borbola, Joszef, Cohen-Solal, Alain, Dumitrascu, Dan, Ferrari, Roberto, Lechat, Philippe, Soler-Soler, Jordi, Tavazzi, Luigi, Spinarova, Lenka, Toman, Jiri, Böhm, Michael, Anker, Stefan D, Thompson, Simon G and Poole-Wilson, Philip A and SENIORS Investigators (2005) Randomized trial to determine the effect of nebivolol on mortality and cardiovascular hospital admission in elderly patients with heart failure (SENIORS). European Heart Journal, 26 (3). pp. 215-225. ISSN 1522-9645

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Abstract

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% Cl 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% Cl 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.

Item Type:	Article
Uncontrolled Keywords:	adrenergic beta-antagonists,aged,aged, 80 and over,benzopyrans,blood pressure,cause of death,double-blind method,ethanolamines,female,follow-up studies,heart failure,heart rate,humans,male,patient compliance,stroke volume,treatment outcome,vasodilator agents
Faculty \ School:	Faculty of Medicine and Health Sciences > Norwich Medical School
UEA Research Groups:	Faculty of Medicine and Health Sciences > Research Groups > Norwich Clinical Trials Unit Faculty of Medicine and Health Sciences > Research Groups > Cardiovascular and Metabolic Health Faculty of Medicine and Health Sciences > Research Groups > Public Health and Health Services Research (former - to 2023)
Depositing User:	EPrints Services
Date Deposited:	25 Nov 2010 11:13
Last Modified:	01 Mar 2023 11:30
URI:	https://ueaeprints.uea.ac.uk/id/eprint/15413
DOI:	10.1093/eurheartj/ehi115

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