The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II):: a randomised trial

被引:0
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作者
Lechat, P [1 ]
Brunhuber, KW [1 ]
Hofmann, R [1 ]
Kühn, P [1 ]
Nesser, HJ [1 ]
Slany, J [1 ]
Weihs, W [1 ]
Wiedermann, C [1 ]
Wimmer, H [1 ]
van Mieghem, W [1 ]
Boland, J [1 ]
Chaudron, JM [1 ]
Jordaens, L [1 ]
Melchior, JP [1 ]
Aschermann, M [1 ]
Bruthansl, J [1 ]
Hradec, M [1 ]
Kölbel, F [1 ]
Semrád, B [1 ]
Haghfelt, T [1 ]
Fischer-Hansen, J [1 ]
Goetzsche, CO [1 ]
Hildebrandt, P [1 ]
Kassis, E [1 ]
Rasmussen, V [1 ]
Rokkedal, J [1 ]
Thomassen, A [1 ]
Groundstroem, K [1 ]
Uusimaa, P [1 ]
Le Heuzey, JY [1 ]
Aumont, MC [1 ]
Aupetit, JF [1 ]
Baille, N [1 ]
Baudouy, P [1 ]
Belin, A [1 ]
Bonneau, A [1 ]
Bonneric, G [1 ]
Bousser, JP [1 ]
Citron, B [1 ]
Dary, P [1 ]
Decoulx, E [1 ]
De Groote, P [1 ]
Denolle, T [1 ]
Dievart, F [1 ]
Duriez, P [1 ]
Eicher, JC [1 ]
Enjuto, G [1 ]
Ferrière, M [1 ]
Fournier, E [1 ]
Garandeau, M [1 ]
机构
[1] Hop La Pitie Salpetriere, AP HP, Dept Pharmacol, F-75013 Paris, France
来源
LANCET | 1999年 / 353卷 / 9146期
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中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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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页码:9 / 13
页数:5
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