[HTML][HTML] The cardiac insufficiency bisoprolol study II (CIBIS-II): a randomised trial
P Lechat, KW Brunhuber, R Hofmann, P Kuhn… - Lancet, 1999 - biblio.ugent.be
P Lechat, KW Brunhuber, R Hofmann, P Kuhn, HJ Nesser, J Slany, W Weihs, C Wiedermann…
Lancet, 1999•biblio.ugent.beBackground: In patients with heart failure, beta-blochade has improved morbidity and left-
ventricular function, but the impact on survival is uncertain. We investigated the efficacy of
bisoprolol, a beta (1) selective adrenoceptor blocker in decreasing all-cause mortality in
chronic heart failure. Methods: In a multicentre double-blind randomised placebo-controlled
trial in Europe, we enrolled 2647 symptomatic patients in New York Heart Association class
III or IV, with left-ventricular ejection fraction of 35% or less receiving standard therapy with …
ventricular function, but the impact on survival is uncertain. We investigated the efficacy of
bisoprolol, a beta (1) selective adrenoceptor blocker in decreasing all-cause mortality in
chronic heart failure. Methods: In a multicentre double-blind randomised placebo-controlled
trial in Europe, we enrolled 2647 symptomatic patients in New York Heart Association class
III or IV, with left-ventricular ejection fraction of 35% or less receiving standard therapy with …
Background
In patients with heart failure, beta-blochade has improved morbidity and left-ventricular function, but the impact on survival is uncertain. We investigated the efficacy of bisoprolol, a beta(1) selective adrenoceptor blocker in decreasing all-cause mortality in chronic heart failure.
Methods
In a multicentre double-blind randomised placebo-controlled trial in Europe, we enrolled 2647 symptomatic patients in New York Heart Association class III or IV, with left-ventricular ejection fraction of 35% or less receiving standard therapy with diuretics and inhibitors of angiotensin-converting enzyme. We randomly assigned patients bisoprolol 1.25 mg (n=1327) or placebo (n=1320) daily, the drug being progressively increased to a maximum of 10 mg per day. Patients were followed up for a mean of 1.3 years. Analysis was by intention to treat.
Findings
CIBIS-II was stopped early, after the second interim analysis, because bisoprolol showed a significant mortality benefit. All-cause mortality was significantly lower with bisoprolol than on placebo (156 [11.8%] vs 228 [17.3%] deaths with a hazard ratio of 0.66 (95% CI 0.54-0.81, p<0.0001). There were significantly fewer sudden deaths among patients on bisoprolol than in those on placebo (48 [3.6%] vs 83 [6.3%] deaths), with a hazard ratio of 0.56 (0.39-0.80, p=0.0011). Treatment effects were independent of the severity or cause of heart failure.
Interpretation
beta-blocker therapy had benefits for survival in stable heart-failure patients. Results should not, however, be extrapolated to patients with severe class IV symptoms and recent instability because safety and efficacy has not been established in these patients.
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