Study of effects of nebivolol intervention on outcomes and rehospitalisation in seniors with heart failure - SENIORS
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.
Patients Enrolled: 2,128
Mean Follow Up: Up to 40 months
Mean Patient Age: Mean age 76 years
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)
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
All-cause mortality or cardiovascular hospital admission
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.
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%).
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.
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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