© 2004 European Society of Cardiology
Comparison of treatment initiation with bisoprolol vs. enalapril in chronic heart failure patients: rationale and design of CIBIS-III
a Department of Cardiology, University Hospital S-205 02 Malmö, Sweden
b Medizinische Klinik III, University of Cologne Germany
c Medicine A, University Hospital Zürich Switzerland
d Departments of Epidemiology and Preventive Medicine and Medicine, Monash University, Alfred Hospital Melbourne, Australia
e Cardiology Department, Clinical Military Hospital Wroclaw, Poland
f Department of Pharmacology and Therapeutics, Trinity Centre, St James’ Hospital Dublin, Ireland
g Thoraxcenter, Department of Cardiology, University Hospital Groningen The Netherlands
h Merck KgaA Darmstadt, Germany
i Service de Pharmacologie, Hopital Pitié-Salpetriere Paris, France
* Corresponding author. Tel.: +46-40-33-10-00; fax: +46-40-33-62-09. E-mail address: ronnie.willenheimer{at}medforsk.mas.lu.se
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Abstract |
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Background: Angiotensin-converting-enzyme (ACE) inhibitors and β-blockers are standard therapy for chronic heart failure (CHF). β-blockers are recommended to be initiated after ACE-inhibitors, but this order is not evidence based. The initiation order may be important since many, especially elderly CHF patients cannot tolerate target doses of both. Data suggest that β-blockers may be more important to CHF patients than ACE-inhibitors, especially in early stages of CHF.
Aims: To compare the effect on combined death or hospitalisation of initial monotherapy with either bisoprolol or enalapril, followed by combination therapy.
Methods: One-thousand CHF patients without ACE-inhibitor, β-blocker or angiotensin-receptor-blocker therapy will be randomised 1:1 to monotherapy with either enalapril or bisoprolol for 6 months, followed by combined therapy for 6–18 months. The primary objective is to show non-inferiority for bisoprolol-first vs. enalapril-first regarding combined death or hospitalisation. If that is shown, superiority for bisoprolol-first will be tested.
Conclusions: If the trial shows non-inferiority for bisoprolol-first vs. enalapril-first, the first CHF therapy may be chosen based on individual judgement in each patient. If bisoprolol-first is superior to enalapril-first, a β-blocker should be given prior to an ACE-inhibitor in CHF, and the paradigm of testing CHF compounds against a background of ACE-inhibitor therapy will be challenged.
Key Words: Chronic heart failure • Therapy • β-blocker • ACE-inhibitor • Order of initiation
Received July 25, 2003; Revised November 4, 2003; Accepted December 11, 2003
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