CIBIS
Trial question
What is the role of β-blockade therapy with bisoprolol in patients with chronic HF of various etiologies and a LVEF of < 40% on diuretic and vasodilator therapy?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
17.0% female
83.0% male
N = 641
641 patients (112 female, 529 male).
Inclusion criteria: patients with chronic HF of various etiologies and an LVEF < 40% on diuretic and vasodilator therapy.
Key exclusion criteria: LV diastolic dysfunction, coronary artery disease awaiting bypass surgery or a recent history of MI < 3 months, insulin-dependent diabetes, asthma, renal insufficiency hypothyroidism or hyperthyroidism, or malignant disease.
Interventions
N=320 β-blockade therapy with bisoprolol (recommended dose increment or at one of the dose levels of 1.25, 2.5, 3.75, or 5 mg/d).
N=321 placebo (matching placebo).
Primary outcome
Death
16.6%
20.9%
20.9 %
15.7 %
10.4 %
5.2 %
0.0 %
Beta-blockade therapy with
bisoprolol
Placebo
No significant
difference ↔
No significant difference in death (16.6% vs. 20.9%; RR 0.8, 95% CI 0.56 to 1.15).
Secondary outcomes
Significant decrease in hospitalization for cardiac decompensation (19.1% vs. 28%; RR 0.68, 95% CI 0.16 to 1.2).
Significant increase in reduction by at least one NYHA functional class (21.3% vs. 15%; RR 1.42, 95% CI 0.06 to 2.78).
Safety outcomes
No significant difference in premature treatment withdrawals.
Conclusion
In patients with chronic HF of various etiologies and an LVEF < 40% on diuretic and vasodilator therapy, β-blockade therapy with bisoprolol was not superior to placebo with respect to death.
Reference
CIBIS Investigators. A randomized trial of beta-blockade in heart failure. The Cardiac Insufficiency Bisoprolol Study (CIBIS). CIBIS Investigators and Committees. Circulation. 1994 Oct;90(4):1765-73.
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