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How to begin treatment in chronic heart failure? Results of CIBISIII

Willenheimer, Ronnie LU (2006) In European Heart Journal Supplements 8(C). p.43-50
Abstract
Aims To compare the effect of initial monotherapy with either bisoprolot or enalapril, followed by their combination, on mortality and hospitalization in patients with mild-to-moderate CHF. Methods and results One thousand and ten patients with mild-to-moderate CHF and left ventricular ejection fraction <= 35%, without ACE-inhibitor, beta-blocker, or angiotensin-receptor-blocker therapy were randomized to open-label monotherapy with either bisoprolot (target dose 10 mg od, n = 505) or enalapril (target dose 10 mg bid, n = 505) for 6 months, followed by their combination for 6-24 months. The combined primary endpoint was all-cause mortality or hospitalization; bisoprolol-first was considered non-inferior to enalapril-first if the upper... (More)
Aims To compare the effect of initial monotherapy with either bisoprolot or enalapril, followed by their combination, on mortality and hospitalization in patients with mild-to-moderate CHF. Methods and results One thousand and ten patients with mild-to-moderate CHF and left ventricular ejection fraction <= 35%, without ACE-inhibitor, beta-blocker, or angiotensin-receptor-blocker therapy were randomized to open-label monotherapy with either bisoprolot (target dose 10 mg od, n = 505) or enalapril (target dose 10 mg bid, n = 505) for 6 months, followed by their combination for 6-24 months. The combined primary endpoint was all-cause mortality or hospitalization; bisoprolol-first was considered non-inferior to enalapril-first if the upper limit of the 95% Cl for the absolute between-group difference was below +5%, corresponding to HR 1.17. In the intention-to-treat population, the primary endpoint occurred in 178 patients allocated bisoprotol-first vs. 186 allocated enalapril-first: absolute difference, -1.6%; 95% Cl, -7.6 to +4.4%; HR, 0.94; 95% Cl, 0.77-1.16. Thus, non-inferiority was demonstrated in the intention-to-treat population. In the per-protocol population, the primary endpoint occurred in 163 patients in the bisoprolol-first group vs. 165 in the enalapril-first group: absolute difference, -0.7%; 95% Cl, -6.6 to +5.1%; HR, 0.97; 95% Cl, 0.78-1.21. With bisoprolol-first, 65 patients died vs. 73 with enalapril-first (HR, 0.88; 95% Cl, 0.63-1.22; between-group difference P = 0.44), and 151 vs. 157 patients were hospitalized (HR, 0.95; 95% Cl, 0.76-1.19; between-group difference P = 0.66). Post hoc analysis of data from the first year indicated that a bisoprolol-first strategy reduced mortality by 31%, compared with an enalapril-first strategy (HR, 0.69; 95% CI, 0.46-1.02; between-group difference P = 0.065). Conclusion Initiating treatment with bisoprolot is as effective and well-tolerated as initiating treatment with enalapril. Post hoc analysis suggests that starting treatment with enalapril may reduce the risk of death, especially in the first year of treatment. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
sequence of drug initiation, enzyme inhibitor, angiotensin-converting, beta-blocker, congestive heart failure, therapy
in
European Heart Journal Supplements
volume
8
issue
C
pages
43 - 50
publisher
Oxford University Press
external identifiers
  • wos:000238679500008
  • scopus:33750124513
ISSN
1520-765X
DOI
10.1093/eurheartj/sul013
language
English
LU publication?
yes
id
8a0d2a95-f197-4b86-ad2c-fdc180c2fa82 (old id 404552)
alternative location
http://eurheartjsupp.oxfordjournals.org/cgi/content/abstract/8/suppl_C/C43
date added to LUP
2016-04-01 15:51:41
date last changed
2021-02-17 06:54:16
@article{8a0d2a95-f197-4b86-ad2c-fdc180c2fa82,
  abstract     = {Aims To compare the effect of initial monotherapy with either bisoprolot or enalapril, followed by their combination, on mortality and hospitalization in patients with mild-to-moderate CHF. Methods and results One thousand and ten patients with mild-to-moderate CHF and left ventricular ejection fraction &lt;= 35%, without ACE-inhibitor, beta-blocker, or angiotensin-receptor-blocker therapy were randomized to open-label monotherapy with either bisoprolot (target dose 10 mg od, n = 505) or enalapril (target dose 10 mg bid, n = 505) for 6 months, followed by their combination for 6-24 months. The combined primary endpoint was all-cause mortality or hospitalization; bisoprolol-first was considered non-inferior to enalapril-first if the upper limit of the 95% Cl for the absolute between-group difference was below +5%, corresponding to HR 1.17. In the intention-to-treat population, the primary endpoint occurred in 178 patients allocated bisoprotol-first vs. 186 allocated enalapril-first: absolute difference, -1.6%; 95% Cl, -7.6 to +4.4%; HR, 0.94; 95% Cl, 0.77-1.16. Thus, non-inferiority was demonstrated in the intention-to-treat population. In the per-protocol population, the primary endpoint occurred in 163 patients in the bisoprolol-first group vs. 165 in the enalapril-first group: absolute difference, -0.7%; 95% Cl, -6.6 to +5.1%; HR, 0.97; 95% Cl, 0.78-1.21. With bisoprolol-first, 65 patients died vs. 73 with enalapril-first (HR, 0.88; 95% Cl, 0.63-1.22; between-group difference P = 0.44), and 151 vs. 157 patients were hospitalized (HR, 0.95; 95% Cl, 0.76-1.19; between-group difference P = 0.66). Post hoc analysis of data from the first year indicated that a bisoprolol-first strategy reduced mortality by 31%, compared with an enalapril-first strategy (HR, 0.69; 95% CI, 0.46-1.02; between-group difference P = 0.065). Conclusion Initiating treatment with bisoprolot is as effective and well-tolerated as initiating treatment with enalapril. Post hoc analysis suggests that starting treatment with enalapril may reduce the risk of death, especially in the first year of treatment.},
  author       = {Willenheimer, Ronnie},
  issn         = {1520-765X},
  language     = {eng},
  number       = {C},
  pages        = {43--50},
  publisher    = {Oxford University Press},
  series       = {European Heart Journal Supplements},
  title        = {How to begin treatment in chronic heart failure? Results of CIBISIII},
  url          = {http://dx.doi.org/10.1093/eurheartj/sul013},
  doi          = {10.1093/eurheartj/sul013},
  volume       = {8},
  year         = {2006},
}