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European Journal of Heart Failure Advance Access originally published online on August 1, 2009
European Journal of Heart Failure 2009 11(9):872-880; doi:10.1093/eurjhf/hfp104
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Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2009. For permissions please email: journals.permissions@oxfordjournals.org.
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Efficacy and safety of nebivolol in elderly heart failure patients with impaired renal function: insights from the SENIORS trial

Alain Cohen-Solal1, Dipak Kotecha2,3,*, Dirk J van Veldhuisen4, Daphne Babalis2, Michael Böhm5, Andrew J. Coats6, Michael Roughton2, Philip Poole-Wilson3,{dagger}, Luigi Tavazzi7, Marcus Flather2,3 on behalf of the SENIORS Investigators

1 Hôpital Lariboisiere, Assistance Publique-Hopitaux de Paris, Université Paris Diderot, INSERM U942, 2 Rue Ambroise Paré, 75475 Paris Cedex 10, France
2 Clinical Trials and Evaluation Unit, Royal Brompton Hospital, Sydney Street, London SW3 6NP, UK
3 National Heart and Lung Institute, Imperial College, London, UK
4 University Medical Center Groningen, University of Groningen, Groningen, The Netherlands
5 Klinik für Innere Medizin III, Universität des Saarlandes, Homburg/Saar, Germany
6 Faculty of Medicine, University of Sydney, Sydney, Australia
7 GVM Hospitals of Care and Research, Cotignola, Italy

* Corresponding author. Tel: +44 207 351 8827, Fax: +44 207 351 8829, Email: d.kotecha{at}rbht.nhs.uk


  Abstract

Aim: To determine the safety and efficacy of nebivolol in elderly heart failure (HF) patients with renal dysfunction.

Methods and results: SENIORS recruited patients aged 70 years or older with symptomatic HF, irrespective of ejection fraction, and randomized them to nebivolol or placebo. Patients (n = 2112) were divided by tertile of estimated glomerular filtration rate (eGFR). Mean age of patients was 76.1 years, 35% of patients had an ejection fraction of >35%, and 37% were women resulting in a unique cohort, far more representative of clinical practice than previous trials. eGFR was strongly associated with outcomes and nebivolol was similarly efficacious across eGFR tertiles. The primary outcome rate (all-cause mortality or cardiovascular hospital admission) and adjusted hazard ratio for nebivolol use in those with low eGFR was 40% and 0.84 (95% CI 0.67–1.07), 31% and 0.79 (0.60–1.04) in the middle tertile, and 29% and 0.86 (0.65–1.14) in the highest eGFR tertile. There was no interaction noted between renal function and the treatment effect (P = 0.442). Nebivolol use in patients with moderate renal impairment (eGFR <60) was not associated with major safety concerns, apart from higher rates of drug-discontinuation due to bradycardia.

Conclusion: Nebivolol is safe and has a similar effect in elderly HF patients with mild or moderate renal impairment.

Key Words: Heart failure • Renal impairment • Beta-blocker • Nebivolol

Received June 24, 2009; Accepted July 3, 2009

{dagger} In memoriam


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