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Titolo:
The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II): a randomised trial
Autore:
Lechat, P; Brunhuber, KW; Hofmann, R; Kuhn, P; Nesser, HJ; Slany, J; Weihs, W; Wiedermann, C; Wimmer, H; van Mieghem, W; Boland, J; Chaudron, JM; Jordaens, L; Melchior, JP; Aschermann, M; Bruthansl, J; Hradec, M; Kolbel, F; Semrad, B; Haghfelt, T; Fischer-Hansen, J; Goetzsche, CO; Hildebrandt, P; Kassis, E; Rasmussen, V; Rokkedal, J; Thomassen, A; Groundstroem, K; Uusimaa, P; Le Heuzey, JY; Aumont, MC; Aupetit, JF; Baille, N; Baudouy, P; Belin, A; Bonneau, A; Bonneric, G; Bousser, JP; Citron, B; Dary, P; Decoulx, E; De Groote, P; Denolle, T; Dievart, F; Duriez, P; Eicher, JC; Enjuto, G; Ferriere, M; Fournier, E; Garandeau, M; Gauthier, J; Genest, M; Gerbe, A; Godenir, JP; Guillot, B; Guillot, JP; Guillot, P; Heno, P; dIvernois, C; Jean, M; Kacet, S; Kalle, R; Komajda, M; Lacroix, A; Lallemand, R; Lardoux, H; Marquet, M; Martin, M; Martin, O; Mery, D; Mossaz, R; Mothes, P; Olive, T; Ostorero, M; Paganelli, F; Page, E; Pauly-Laubry, C; Puel, J; Rousseau, JF; Roux, JJ; Schenowitz, A; Sourdais, K; Tremel, F; Verdun, A; Witchiz, S; Wolf, JE; Hombach, V; Assmann, I; Beyer, T; Bischoff, KO; Darius, H; Ertl, G; Fleck, E; Forster, K; Freytag, F; Gleichmann, U; Haasis, R; Henssge, R; Hey, D; Hesse, P; Hofs, T; Keck, M; Klein, H; Kromer, ET; Kruls-Munch, J; Luderitz, B; Maisch, B; Mitrovic, V; Neubauer, S; Osterziel, KJ; Simon, H; Spitzer, SG; Stohring, R; Taubert, G; Teichmann, W; Theisen, K; Wende, W; Wieser, H; Zotz, R; Preda, I; Csanady, M; Cserhalmi, L; Edes, I; Gesztesi, T; Karpati, P; Simon, K; Tarjan, J; Fogari, R; Tramarin, R; Galie, N; Giani, P; Milanese, U; Scalvini, S; Scrutinio, D; Sechi, LA; Tettamanti, F; De Vito, F; Crean, P; McCann, H; Mulcahy, D; Sugrue, D; van Hoogenhuyze, DCA; van der Burgh, PH; Ciampricotti, R; van Dantzig, JM; DenHartog, FR; Henneman, JA; van Kesteren, HAM; Kragten, JA; Liem, KL; Limburg, A; van der Linde, MR; Linssen, GCM; Pasteuning, H; Penn, HJAM; Van Rossum, P; Schaafsma, HJ; Schelling, A; Sloos, R; Wesdorp, JCL; Korewicki, J; Achremczyk, P; Czestockowska, E; Dowgird, M; Dyduszynski, A; Gorski, J; Ilmurzynska, K; Janicki, K; Kornacewicz-Jach, Z; Kraska, T; Krzeminska-Pakula, M; Kuch, J; Nartowicz, E; Petelenz, T; Piwowarska, W; Rawczynska-Englert, I; Ruzyllo, W; Swiatecka, G; Tendera, M; Wierzchowiecki, M; Wodniecki, J; Wojciechowoski, D; Wrabec, K; Wysocki, H; Gomes, RS; Ceia, MF; Lousada, N; Campos, JMM; Providencia, LA; de Moura, ALZC; Marejev, VJ; Aronov, DM; Arutjunov, GP; Bart, BJ; Basechikin, SS; Belenkov, JN; Beloussov, JB; Bokeria, OA; Charchogljan, RA; Doschytsin, V; Fedorova, TA; Glezer, MG; Gorbachenkov, A; Gorshkov, VA; Gospodarenko, AL; Ivashkin, VT; Ivleva, AJ; Kyrichenko, AA; Lavrov, AA; Lazebnik, LB; Marynov, A; Mazaev, VP; Polejev, NR; Shpektor, A; Sidorenko, BA; Sobolev, KE; Starodoubtsev, AK; Storozhakhov, GI; Syrkin, AL; Zodionchenko, VS; Zvereva, TV; Murin, J; Kaliska, G; Rybar, R; Valle, V; Artaza, M; Conthe, P; Cruz, JM; Garcia-Moll, M; Lopez-Sendon, JL; Martinez, A; Monzon, F; Ribas, M; Roig, E; Roldan, I; Hoglund, C; Ekdahl, S; Hjelmaeus, L; Lindberg, K; Lofdahl, P; Ulvenstam, G; Warselius, L; Follath, F; Anghern, W; Dubach, P; Erne, P; Gallino, A; Moccetti, T; Bridges, A; Adgey, J; Ambepitiya, G; Boon, N; Boyle, RM; Cowley, AJ; Cripps, T; Davies, MK; Dunn, F; Findlay, J; Forsey, P; Fyfe, T; Gould, B; Greenwood, TW; Hubner, P; Khan, S; Lewis, P; Mackay, A; Maltz, M; McArthur, J; McLeod, A; McLeod, D; Metcalfe, M; Millar-Craig, M; Mills, P; Nelson, JK; Nicholls, D; Oakley, GD; Patterson, DLH; Pohl, JEF; Ray, S; Silke, B; Wilkinson, PR; Jmouro, AV;
Indirizzi:
Hop La Pitie Salpetriere, AP HP, Dept Pharmacol, F-75013 Paris, France HopLa Pitie Salpetriere Paris France F-75013 col, F-75013 Paris, France
Titolo Testata:
LANCET
fascicolo: 9146, volume: 353, anno: 1999,
pagine: 9 - 13
SICI:
0140-6736(19990102)353:9146<9:TCIBSI>2.0.ZU;2-0
Fonte:
ISI
Lingua:
ENG
Soggetto:
HEART-RATE-VARIABILITY; BETA-BLOCKADE; CLINICAL-TRIALS; FAILURE; MORTALITY; MORBIDITY;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
21
Recensione:
Indirizzi per estratti:
Indirizzo: Lechat, P Hop La Pitie Salpetriere, AP HP, Dept Pharmacol, F-75013 Paris, France Hop La Pitie Salpetriere Paris France F-75013 13 Paris, France
Citazione:
P. Lechat et al., "The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II): a randomised trial", LANCET, 353(9146), 1999, pp. 9-13

Abstract

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 lessreceiving 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 theseverity 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 andefficacy has not been established in these patients.

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Documento generato il 30/09/20 alle ore 09:45:34