Nebivolol in heart failure patients ≥ 70 years of age, regardless of ejection fraction
Topic: Beta-blockers in heart failure with reduced ejection fraction
Aim:
- To assess outcomes of nebivolol in HF patients >70 years of age, regardless of ejection fraction
Design:
- Parallel group, randomized, double-blind, multi-center international trial
Treatment:
- Nebivolol 1.25 once daily; target dose: 10 mg
Control:
- Placebo
Cohort:
- 2,128 patients (1067 nebivolol; 1061 placebo)
Inclusion criteria:
- ≥ 70 years of age
- Chronic HF with at least one of following: (i) hospital admission within previous 1 year of CHF, or (ii) LVEF ≤35% within previous 6 months
Exclusion criteria:
- New drug therapy for heart failure in 6 weeks prior to randomization
- Any change in cardiovascular (CV) drug therapy in 2 weeks prior to randomization
- Heart failure due to primarily to uncorrected valvular disease
- Contraindication or previous intolerance to beta blockers
- Current use of beta blockers
- Significant hepatic or renal dysfunction
- Cerebrovascular accident within previous 3 months
- Being on wait list for PCI or cardiac surgery
Follow up:
- 21 months
Primary endpoint:
- Composite of all cause mortality or CV hospital admission (time to first event)
Secondary endpoint:
- All cause mortality
- Composite of all cause mortality or all cause hospital admissions
- All cause hospital admissions
- CV hospital admissions
- CV mortality
- Composite of CV mortality or CV hospital admissions
- NYHA class assessment and 6 min walk test at 6 months
Main results:
- Mean maintenance dose of nebivolol: 7.7 mg
- Primary outcome in 31.1% of nebivolol vs 35.3% placebo (HR 0.86, P = 0.039)
- No significant influence of age, gender, or ejection fraction on the effect of nebivolol on primary outcome
- Death (all cause) occurred in 15.8% on nebivolol and 18.1% on placebo (HR 0.88, P = 0.21)
TAKE AWAY: Nebivolol, a beta-blocker with vasodilating properties, is an effective and well-tolerated treatment for heart failure in the elderly.
