Rozšíření indikace pro použití betablokátorů: studie SENIOR

Cor Vasa 2005, 46(5)

Extending the indication for beta-blocker use: the SENIOR trial

Lenka Špinarová: I. interní-kardioangiologická klinika, Fakultní nemocnice u sv. Anny a Lékařská fakulta Masarykovy univerzity, Brno, Česká republika

The goal of the SENIOR (Study of the Effects of Nebivolol Intervention on Outcomes and Rehospitalisation in Seniors with Heart Failure) trial was to evaluate the effect of nebivolol on the morbidity and mortality of elderly patients with chronic heart failure regardless of ejection fraction.
The entry criterion was age over 70 years and heart failure defined as hospitalization for congestive heart failure over the past 12 months or a left ventricular ejection fraction below 35% at follow-up within the past six months.
The primary endpoint was a pooled parameter of total mortality or cardiovascular hospitalization. Secondary endpoints included total mortality and hospitalization for any cause, total hospitalization, or hospitalization for a cardiovascular cause, pooled parameter of cardiovascular mortality or hospitalization for a cardiovascular cause, NYHA Class and the 6-minute walk-test. Overall, 2,135 patients from 11 countries were enrolled.

Primary endpoint:
A combination of cardiovascular death or hospitalization in individual subgroups was 31.1% vs 35.3% in the nebivolol vs. placebo groups, respectively (p < 0.039). The reduction in absolute risk is 4.2%, resulting in treatment of 24 patients for 21 months to prevent a single event.

Primary endpoint outcomes:
Cardiovascular death or hospitalization were even demonstrated in individual subgroups - sex, age, ejection fraction, diabetes mellitus, or previous myocardial infarction. Overall, no differences were seen between the nebivolol and placebo groups: 15.8 vs. 18.1%; p < 0.21.

Relevance of the study:
The SENIOR study extends the use of beta-blockers to the population of patients over 70 years of age and is the first randomized prospective study furnishing beneficial data regarding beta-blocker use in patients with diastolic dysfunction.