Clinical effects of initial 6 months monotherapy with bisoprolol versus enalapril in the treatment of patients with mild to moderate chronic heart failure. Data from the CIBIS III Trial.
OBJECTIVE
To assess the clinical effects and safety profile of initial monotherapy with either bisoprolol or enalapril in elderly patients with heart failure (HF).


METHODS
In CIBIS III, 1010 patients with mild to moderate HF and age>or=65 years were randomized to monotherapy with either bisoprolol or enalapril for 6 months.


RESULTS
Bisoprolol had a similar effect as enalapril on the combined end-point of all-cause mortality or hospitalization (HR 1.02; p=0.90), as well as on each of the individual end-points. A trend towards fewer sudden deaths was observed with bisoprolol (NS). On the other hand, more cases of worsening HF requiring hospitalization or occurring while in hospital were observed in the bisoprolol group (HR 1.67; p=0.03). The two groups were similar with regard to treatment cessations and early introduction of the second drug.


CONCLUSIONS
Bisoprolol and enalapril had a similar effect on the combined end-point of mortality or hospitalization during 6 months monotherapy. However, more worsening HF events were observed in the bisoprolol group.
Department of Clinical Pharmacology, University Medical Centre Groningen, University of Groningen, Antonius Deusinglaan 1, 9713 AV, Groningen, The Netherlands. d.dobre@med.umcg.nl
Daniela
D
Dobre
Dirk J
DJ
van Veldhuisen
Michael A
MA
Goulder
Henry
H
Krum
Ronnie
R
Willenheimer
D000368:Aged; D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D017298:Bisoprolol / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects; D001919:Bradycardia / Q000139:chemically induced; D002908:Chronic Disease; D003371:Cough / Q000139:chemically induced; D004334:Drug Administration Schedule; D004656:Enalapril / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006333:Heart Failure / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D007022:Hypotension / Q000139:chemically induced; D053208:Kaplan-Meier Estimate; D008297:Male; D011446:Prospective Studies; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D028761:Withholding Treatment
D000959:Antihypertensive Agents; D004656:Enalapril; D017298:Bisoprolol