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The Cardiac Insufficiency Bisoprolol Study II - CIBIS II
Description:
Bisoprolol vs. placebo for mortality in heart failure.
Hypothesis:
To test benefits of β-blockade (bisoprolol) in patients with heart failure.
Study Design
Study Design:
Patients Screened: Not given
Patients Enrolled: 2,647
Mean Follow Up: 1.4 years
Female: 0
Patient Populations:
Ambulatory NYHA Class III or IV patients with dyspnea on exertion, orthopnea or paroxysmal nocturnal dyspnea
Between 18 and 80 years of age
Stable on ACE I and diuretics
LVEF less than or equal to 35%
Primary Endpoints:
All cause mortality
Secondary Endpoints:
Cardiovascular mortality,
hospital admissions,
cardiovascular mortality and cardiovascular admissions,
permanent withdrawal from treatment.
Drug/Procedures Used:
Bisoprolol 1.25 mg. qd, titrated to 10 mg qd. over 6 months, vs placebo
Principal Findings:
Bisoprolol reduced all cause mortality by 32% (11.8% vs 17.3%, p=0.002). Sudden death was reduced by 45% (3.6% vs 6.4%, p=0.001).
Hospitalizations for heart failure was reduced by 30% (11.9% bisoprolol vs 17.6% placebo, p < 0.001), and all cause hospitalizations were reduced by 15% (33.6% vs 39.6%, p=0.002). The number of patients needed to treat for 1 year to save one life was 25
Bisoprolol was as well tolerated as the placebo (14.5% withdrawal rate in both groups).
Interpretation:
CIBIS-II was the first randomized controlled trial with sufficient power to address all cause mortality as a primary objective. The mortality benefit of low-dose beta blockade in congestive heart failure is encouraging.
References:
1. Presented at XXth Congress of the European Society of Cardiology, Vienna, 1998.
Keywords: Dyspnea, Paroxysmal, Diuretics, Heart Failure, Bisoprolol, Hospitalization, Death, Sudden, Cardiac
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