Author + information
- Received November 12, 2008
- Revision received January 27, 2009
- Accepted February 3, 2009
- Published online June 9, 2009.
- Dirk J. van Veldhuisen, MD⁎,⁎ (, )
- Alain Cohen-Solal, MD†,
- Michael Böhm, MD‡,
- Stefan D. Anker, MD§,
- Daphne Babalis, MSc∥,
- Michael Roughton, PhD∥,
- Andrew J.S. Coats, MD¶,
- Philip A. Poole-Wilson, MD∥,
- Marcus D. Flather, MBBS∥,
- SENIORS Investigators
- ↵⁎Reprint requests and correspondence:
Dr. Dirk J. van Veldhuisen, Department of Cardiology, University Medical Center Groningen, University of Groningen, P.O. Box 30.001, 9700RB Groningen, the Netherlands
Objectives In this pre-specified subanalysis of the SENIORS (Study of Effects of Nebivolol Intervention on Outcomes and Rehospitalization in Seniors With Heart Failure) trial, which examined the effects of nebivolol in elderly heart failure (HF) patients, we explored the effects of left ventricular ejection fraction (EF) on outcomes, including the subgroups impaired EF (≤35%) and preserved EF (>35%).
Background Beta-blockers are established drugs in patients with HF and impaired EF, but their value in preserved EF is unclear.
Methods We studied 2,111 patients; 1,359 (64%) had impaired (≤35%) EF (mean 28.7%) and 752 (36%) had preserved (>35%) EF (mean 49.2%). The effect of nebivolol was investigated in these 2 groups, and it was compared to explore the interaction of EF with outcome. Follow-up was 21 months; the primary end point was all-cause mortality or cardiovascular hospitalizations.
Results Patients with preserved EF were more often women (49.9% vs. 29.8%) and had less advanced HF, more hypertension, and fewer prior myocardial infarctions (all p < 0.001). During follow-up, the primary end point occurred in 465 patients (34.2%) with impaired EF and in 235 patients (31.2%) with preserved EF. The effect of nebivolol on the primary end point (hazard ratio [HR] of nebivolol vs. placebo) was 0.86 (95% confidence interval: 0.72 to 1.04) in patients with impaired EF and 0.81 (95% confidence interval: 0.63 to 1.04) in preserved EF (p = 0.720 for subgroup interaction). Effects on all secondary end points were similar between groups (HR for all-cause mortality 0.84 and 0.91, respectively), and no p value for interaction was <0.48.
Conclusions The effect of beta-blockade with nebivolol in elderly patients with HF in this study was similar in those with preserved and impaired EF.
Dr. van Veldhuisen has received lecture fees from Menarini and was a member of the steering committee of the SENIORS trial. Dr. Cohen-Solal has received lecture and consultancy fees from Menarini, and was a member of the steering committee for the SENIORS trial and received lecture fees. Dr. Böhm has received speaker fees from Menarini. Dr. Anker has received speaking honoraria from Menarini Ricerche SpA, Roche, Merck, and Tanabe. Dr. Babalis's department has received a grant from Menarini. Dr. Coats has received honoraria from Menarini. Dr. Poole-Wilson has received honoraria from Menarini for speaking about the SENIORS trial. Dr. Flather has received research grant funding to his institution from Menarini and speaker fees from Menarini for lectures at scientific meetings and symposia. The original SENIORS trial was supported by Menarini Ricerche SpA, Italy. Funding for additional statistical analyses for the present study to the Clinical Trials and Evaluation Unit in London were obtained. All members of the Steering Committee of the SENIORS trial have received honoraria for speaking on aspects of heart failure and beta-blockers at meetings funded by companies in the pharmaceutical industry.
- Received November 12, 2008.
- Revision received January 27, 2009.
- Accepted February 3, 2009.
- American College of Cardiology Foundation