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Original article
β-blockade with nebivolol for prevention of acute ischaemic events in elderly patients with heart failure
  1. Giuseppe Ambrosio1,
  2. Marcus D Flather2,
  3. Michael Böhm3,
  4. Alain Cohen-Solal4,
  5. Adriano Murrone1,
  6. Flavio Mascagni5,
  7. Giulio Spinucci1,
  8. Maria Giovanna Conti1,
  9. Dirk J van Veldhuisen6,
  10. Luigi Tavazzi7,
  11. Andrew J S Coats8
  1. 1Division of Cardiology, University of Perugia School of Medicine, Perugia, Italy
  2. 2Clinical Trials and Investigation Unit, Royal Brompton and Harefield NHS Trust, London, UK
  3. 3Klinik für Innere Medizin III, Universität des Saarlandes, Homburg/Saar, Germany
  4. 4INSERM U942; Faculté Paris 7 Paris Diderot; Hopital Lariboisiere, Paris, France
  5. 5Data Management & Biometry Unit, CAST and TRIAL, Pozzo della Chiana, Italy
  6. 6Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands
  7. 7Department of Cardiology, IRCCS Policlinico San Matteo, Pavia, Italy
  8. 8Faculty of Medicine, University of Sydney, Australia
  1. Correspondence to Professor Giuseppe Ambrosio, Cardiology. University of Perugia School of Medicine, Ospedale Silvestrini, Via S. Andrea delle Fratte, 06156 Perugia, Italy; giuseppe.ambrosio{at}ospedale.perugia.it

Abstract

Objectives This subanalysis of the Study of the Effects of Nebivolol Intervention on Outcomes and Hospitalisation in Seniors with Heart Failure (SENIORS) investigates whether treatment with nebivolol, a β-blocker with nitric oxide-releasing properties, can provide additional benefits besides its effects on heart failure (HF), by reducing cardiac ischaemic events in patients with HF of ischaemic aetiology.

Design A double-blind, randomised, placebo-controlled, multicentre trial of nebivolol in 2128 elderly patients.

Patients and interventions For this analysis, data were extracted for 2128 elderly (≥70 years) HF patients in whom coronary artery disease (CAD) was the underlying aetiology (68.2%; 717 placebo-treated patients and 735 assigned to nebivolol).

Main outcome measures The main endpoint was the composite of cardiac ischaemic events at 2 year follow-up: death/hospitalisation for myocardial infarction, unstable angina or sudden death, as originally identified in the case report form.

Results At follow-up, nebivolol treatment was associated with a one-third reduction in the risk of ischaemic events, the composite endpoint occurring in 15.9% of placebo and 10.7% of nebivolol-treated patients (HR 0.68; 95% CI 0.51 to 0.90; p=0.008). This effect was independent of age, gender and ejection fraction. No difference in this composite endpoint was observed in the subgroup of patients of non-ischaemic aetiology.

Conclusions Nebivolol was effective in reducing cardiac ischaemic events in patients with HF of ischaemic aetiology. The prevention of ischaemic events can be an additional beneficial effect of β-blockade in HF patients with underlying CAD.

  • Acute coronary syndrome
  • β-blocker
  • coronary artery disease
  • heart failure
  • ischaemic events
  • nebivolol
  • nitric oxide

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Footnotes

  • Funding The original SENIORS trial was sponsored by Menarini. GA has received honoraria and speaker fees from Menarini. MDF has received research grants and honoraria from Menarini. MB has received speaker honoraria from Berlin Chemie and Menarini. DJV has received lecture fees from Menarini. AJSC and AC-S have received honoraria and speaker fees from Menarini.

  • Competing interests None.

  • Ethics approval This is a spin off of a multicentre trial that had been originally approved by the ethics committees for each participating site.

  • Provenance and peer review Not commissioned; externally peer reviewed.