Bisoprolol vs. carvedilol in elderly patients with heart failure:: rationale and design of the CIBIS-ELD trial

被引:47
作者
Duengen, Hans-Dirk [1 ]
Apostolovic, Svetlana [2 ]
Inkrot, Simone [1 ]
Tahirovic, Elvis [1 ]
Krackhardt, Florian [1 ]
Pavlovic, Milan [2 ]
Putnikovic, Biljana [3 ]
Lainscak, Mitja [4 ]
Gelbrich, Goetz [5 ]
Edelmann, Frank [6 ]
Wachter, Rolf [6 ]
Eschenhagen, Thomas [9 ]
Waagstein, Finn [7 ]
Follath, Ferenc [8 ]
Rauchhaus, Mathias [1 ]
Haverkamp, Wilhelm [1 ]
Osterziel, Karl-Josef
Dietz, Rainer [1 ]
机构
[1] Charite, Dept Cardiol, Campus Virchow Klinkum, Competence Network Heart Failure, D-13353 Berlin, Germany
[2] Clin Ctr Nis, Dept Cardiol, Nish 18000, Serbia
[3] Univ Hosp Zemun, Dept Cardiol, Belgrade 11080, Serbia
[4] Univ Clin Pulm & Allerg Dis Golnik, Golnik 4204, Slovenia
[5] Coordinat Ctr Clin Trials, D-04107 Leipzig, Germany
[6] Univ Gottingen, Dept Cardiol, D-37075 Gottingen, Germany
[7] Gothenburg Univ, Sahlgrenska Acad, Wallenberg Lab Cardiovasc Res, Dept Mol & Clin Med Cardiol, S-41345 Gothenburg, Sweden
[8] Univ Zurich Hosp, Dept Internal Med, CH-8006 Zurich, Switzerland
[9] Univ Hamburg Hosp, Inst Expt & Clin Pharmacol, D-20146 Hamburg, Germany
关键词
chronic heart failure; bisoprolol; carvedilol; tolerance; head-to-head;
D O I
10.1007/s00392-008-0681-6
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Chronic heart failure (CHF) is a widespread disease with severe quality of life impairment and a poor prognosis. Beta-blockers are the mainstay of CHF therapy; yet they are under-prescribed and under-dosed in clinical practice. This is particularly evident in elderly patients, which may be due to a fear of side-effects or intolerance. Beta-blockers have further not been adequately tested in patients with diastolic CHF, which is particularly common in elderly patients. Finally, comparative data on the use of different beta-blockers in patients with CHF is scarce. To compare the tolerance of bisoprolol and carvedilol in elderly patients with CHF. CIBIS-ELD is an investigator-initiated, multi-centre, 1:1 randomised, double-blind, phase III trial comparing bisoprolol and carvedilol in patients >= 65 years with systolic or diastolic CHF. Recruitment started in April 2005 and is anticipated to be completed by April 2008 with at least 800 patients enrolled. This is the first large scale head to head beta-blockers trial in an elderly population with CHF. Besides determining which of two standard beta-blockers is best tolerated in elderly patients with systolic or diastolic CHF, we expect to gain further insight into the treatment of the particular population of patients with diastolic CHF.
引用
收藏
页码:578 / 586
页数:9
相关论文
共 29 条
[1]   Effects of digoxin on morbidity and mortality in diastolic heart failure: The ancillary Digitalis Investigation Group trial [J].
Ahmed, Ali ;
Rich, Michael W. ;
Fleg, Jerome L. ;
Zile, Michael R. ;
Young, James B. ;
Kitzman, Dalane W. ;
Love, Thomas E. ;
Aronow, Wilbert S. ;
Adams, Kirkwood F., Jr. ;
Gheorghiade, Mihai .
CIRCULATION, 2006, 114 (05) :397-403
[2]   β blockers in older persons with heart failure:: tolerability and impact on quality of life [J].
Baxter, AJ ;
Spensley, A ;
Hildreth, A ;
Karimova, G ;
O'Connell, JE ;
Gray, CS .
HEART, 2002, 88 (06) :611-614
[3]  
Böhm M, 2006, CLIN RES CARDIOL, V95, P36, DOI 10.1007/s00392-006-2008-9
[4]   Systolic and diastolic heart failure in the community [J].
Bursi, Francesca ;
Weston, Susan A. ;
Redfield, Margaret M. ;
Jacobsen, Steven J. ;
Pakhomov, Serguei ;
Nkomo, Vuyisile T. ;
Meverden, Ryan A. ;
Roger, Veronique L. .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2006, 296 (18) :2209-2216
[5]  
*CIBIS 2 INV COMM, 1988, LANCET, V242, P8
[6]   A comparison of the effects of carvedilol and metoprolol on well-being, morbidity, and mortality (the "patient journey") in patients with heart failure - A report from the Carvedilol or Metoprolol European Trial (COMET) [J].
Cleland, JGF ;
Charlesworth, A ;
Lubsen, J ;
Swedberg, K ;
Remme, WJ ;
Erhardt, L ;
Di Lenarda, A ;
Komajda, M ;
Metra, M ;
Torp-Pedersen, C ;
Poole-Wilson, PA .
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2006, 47 (08) :1603-1611
[7]   Management of heart failure in primary care (the IMPROVEMENT of Heart Failure Programme): an international survey [J].
Cleland, JGF ;
Cohen-Solal, A ;
Aguilar, JC ;
Dietz, R ;
Eastaugh, J ;
Follath, F ;
Freemantle, N ;
Gavazzi, A ;
van Gilst, WH ;
Hobbs, FDR ;
Korewicki, J ;
Madeira, HC ;
Preda, I ;
Swedberg, K ;
Widimsky, J .
LANCET, 2002, 360 (9346) :1631-1639
[8]   Tolerability and dose-related effects of nebivolol in elderly patients with heart failure: Data from the Study of the Effects of Nebivolol Intervention on Outcomes and Rehospitalisation in Seniors with Heart Failure (SENIORS) trial [J].
Dobre, Daniela ;
van Veldhuisen, Dirk J. ;
Mordenti, Giacomo ;
Vintila, Marius ;
Haaijer-Ruskamp, Flora M. ;
Coats, Andrew J. S. ;
Poole-Wilson, Philip A. ;
Flather, Marcus D. .
AMERICAN HEART JOURNAL, 2007, 154 (01) :109-115
[9]   Do elderly systolic heart failure patients benefit from beta blockers to the same extent as the non-elderly?: Meta-analysis of >12,000 patients in large-scale clinical trials [J].
Dulin, BR ;
Haas, SJ ;
Abraham, WT ;
Krum, H .
AMERICAN JOURNAL OF CARDIOLOGY, 2005, 95 (07) :896-898
[10]   FASTTRACK Randomized trial to determine the effect of nebivolol on mortality and cardiovascular hospital admission in elderly patients with heart failure (SENIORS) [J].
Flather, MD ;
Shibata, MC ;
Coats, AJS ;
Van Veldhuisen, DJ ;
Parkhomenko, A ;
Borbola, J ;
Cohen-Solal, A ;
Dumitrascu, D ;
Ferrari, R ;
Lechat, P ;
Soler-Soler, J ;
Tavazzi, L ;
Spinarova, L ;
Toman, J ;
Böhm, M ;
Anker, SD ;
Thompson, SG ;
Poole-Wilson, PA .
EUROPEAN HEART JOURNAL, 2005, 26 (03) :215-225