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Study of effects of nebivolol intervention on outcomes and rehospitalisation in seniors with heart failure - SENIORS
Description:
The goal of the SENIORS trial was to evaluate the effect of the beta-blocker nebivolol compared with placebo on morbidity and mortality in elderly heart failure patients.
Study Design
Study Design:
Patients Enrolled: 2,128
Mean Follow Up: Up to 40 months
Mean Patient Age: Mean age 76 years
Patient Populations:
Age ≥70 years, clinical diagnosis of chronic heart failure (LVEF ≤35% within prior six months or hospital admission for chronic heart failure within prior year)
Exclusions:
New drug therapy for heart failure, change in cardiovascular drug therapy in two weeks prior to randomization, heart failure due to valvular disease, contraindication to beta-blockers, heart rate <60 beats per minute, or systolic blood pressure <90 mm Hg
Primary Endpoints:
All-cause mortality or cardiovascular hospital admission
Secondary Endpoints:
All-cause mortality
Drug/Procedures Used:
Patients were randomized to the beta-blocker nebivolol (uptitrated to 10 mg; n=1,067) or placebo (n=1,061). Treatment was continued for up to 40 months.
Principal Findings:
Mean baseline ejection fraction (EF) was 36.0% in both groups, with 64% having an EF ≤35%. The majority of patients had New York Heart Association class II (56%) or class III (39%). ACE inhibitors were used in 83% of patients and diuretics in 86%. Mean dose was 7.7 mg in the nebivolol group and 8.5 mg in the placebo group, with 67.9% and 79.6% titrated to the maximum 10 mg dose, respectively.
The primary endpoint of all-cause mortality or rehospitalization for coronary events was lower in the nebivolol group compared with placebo (31.1% vs. 35.3%, hazard ratio [HR] 0.86, p=0.039). The secondary endpoint of all-cause mortality trended lower in the nebivolol group, but did not reach statistical significance (15.8% vs. 18.1%, HR 0.88, p=0.214). The primary endpoint favored nebivolol in the prespecified subgroups, including LVEF >35% (17.6% vs. 21.9%) and age >75 years (24.6% vs. 26.7%).
Study discontinuation was similar in both groups, with no difference in discontinuation due to development of contraindication (4.4% vs. 2.7%) or mandatory indication (1.6% vs. 3.0%).
Interpretation:
Among elderly heart failure patients, treatment with the beta-blocker nebivolol was associated with a reduction in the primary endpoint of all-cause mortality and admission for cardiovascular events compared with placebo.
Many earlier trials have shown a benefit of beta-blocker therapy over placebo in patients with heart failure, but most trials excluded elderly patients and patients with a preserved EF. Indeed, the average age in earlier beta-blocker trials was 61 years, compared with 76 years in the present trial. The presenter noted that survey data have shown many physicians considered elderly age a contraindication to beta-blocker therapy. However, the present trial demonstrates a benefit associated with beta-blocker therapy in elderly heart failure patients and do not support the notion of age as a contraindication.
References:
Flather MD, et al. Randomized trial to determine the effect of nebivolol on mortality and cardiovascular hospital admission in elderly patients with heart failure (SENIORS). European Heart Journal 2005;26:215-225.
Coats AJS. SENIORS: Study of effects of nebivolol intervention on outcomes and rehospitalisation in seniors with heart failure. Presented at the European Society of Cardiology Congress 2004, 29 August-1 September, Munich, Germany.
Keywords: Diuretics, Heart Failure, Benzopyrans, Vasodilator Agents, Ethanolamines, Adrenergic beta-1 Receptor Antagonists
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