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

被引：226

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

关键词：

D O I：

暂无

中图分类号：

R5 [内科学];

学科分类号：

1002 [临床医学]; 100201 [内科学];

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.

引用

页码：9 / 13

页数：5

共 21 条

[1]

ANDERSON JL, 1995, AM J CARDIOL, V75, P1220

[2]

BRISTOW M, 1996, CIRCULATION, V4, P2807

[3]

*CIBIS 2 SCI COMM, 1997, FUND CLIN PHARM, V11, P38

[4]

Effects of beta-blockade with bisoprolol on heart rate variability in advanced heart failure: Analysis of scatterplots of R-R intervals at selected heart rates [J].

Copie, X ;

Pousset, F ;

Lechat, P ;

Jaillon, P ;

Guize, L ;

LeHeuzey, JY ;

Bernadet, P ;

Campricotti, R ;

Cohen, A ;

Dambrine, P ;

Hombach, V ;

Morelon, P ;

Quiret, JC ;

Gomes, RS ;

Silke, B .

AMERICAN HEART JOURNAL, 1996, 132 (02) :369-375

[5]

Doughty RN, 1997, EUR HEART J, V18, P560

[6]

GARG R, 1995, JAMA-J AM MED ASSOC, V273, P1450, DOI 10.1001/jama.273.18.1450

[7]

Effect of beta-blockade on mortality among high-risk and low-risk patients after myocardial infarction [J].

Gottlieb, SS ;

McCarter, RJ ;

Vogel, RA .

NEW ENGLAND JOURNAL OF MEDICINE, 1998, 339 (08) :489-497

[8]

HAEUSLER G, 1986, J CARDIOVASC PHARM, V8, pS2

[9]

Effect of beta-blockade on mortality in patients with heart failure: A meta-analysis of randomized clinical trials [J].

Heidenreich, PA ;

Lee, TT ;

Massie, BM .

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 1997, 30 (01) :27-34

[10]

Avoidable deaths from vehicle accidents in Modena, Italy [J].

Lauriola, P ;

Tosati, F ;

Fiandri, M ;

Frank, G ;

Zoli, A .

LANCET, 1998, 351 (9110) :1180-1180

← 1 2 3 →