FASTTRACK Randomized trial to determine the effect of nebivolol on mortality and cardiovascular hospital admission in elderly patients with heart failure (SENIORS)
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 ¼ 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 ¼ 0.21).
Conclusion Nebivolol, a beta-blocker with vasodilating properties, is an effective and
well-tolerated treatment for heart failure in the elderly