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	CIBIS-I 

Source: Circulation 1994 Oct;90(4):1765-73
Title: A randomized trial of beta-blockade in heart failure.
       The Cardiac Insufficiency Bisoprolol Study (CIBIS).
Authors: CIBIS Investigators and Committees.
Comment in: ACP J Club. 1995 May-Jun;122(3):62
            Circulation. 1994 Oct;90(4):2153-6

INTRODUCTION:

Beta-blockers have been shown to sometimes improve
physical functioning in heart failure from dilated
cardiomyopathy of unknown cause. Improvement in
survival has not been proven in a large-scale randomized
trial. This was the main objective of the Cardiac
Insufficiency Bisoprolol Study (CIBIS).

641 patients with chronic heart failure of various causes,
with EF less than 40% entered this placebo-controlled,
randomized, double-blind study. Patients were class 3
(95%) or class 4 (5%) at study start. All took standard
diuretic and ACE inhibitor therapy. A total of 320
patients took bisoprolol and 321 took placebo. Average
follow-up was 2 years.

FINDINGS:

Bisoprolol was well tolerated. The improvement in
mortality between groups was not significant:

A) 67 patients died on placebo
B) 53 patients died on bisoprolol

There was no difference in sudden death rate (17 on
placebo, 15 on bisoprolol) or death related to
arrhythmia (7 on placebo, 4 on bisoprolol).

Bisoprolol improved functional status of the patients.
Fewer bisoprolol patients required hospitalization for
CHF (90 on placebo versus 61 on bisoprolol). More
bisoprolol patients improved by at least one heart
class (48 on placebo versus 68 on bisoprolol) by end
of follow-up.

CONCLUSIONS:

These results confirm other trial results showing that a
progressively increasing dose of beta-blocker in severe
heart failure gives benefit. Further analysis suggested
that benefit from beta-blockers was greater for those
with non-ischemic cardiomyopathy.

PMID:7923660

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	CIBIS-II 

Source: Lancet 1999 Jan 2;353(9146):9-13
Title: The Cardiac Insufficiency Bisoprolol Study II
       (CIBIS-II): a randomized trial.
Comment in: ACP J Club. 1999 Jul-Aug;131(1):5
            Lancet. 1999 Apr 17;353(9161):1360-1
            Lancet. 1999 Apr 17;353(9161):1361
            Lancet. 1999 Jan 2;353(9146):2-3
            Lancet. 1999 Mar 20;353(9157):1011-2

INTRODUCTION:

In heart failure patients, beta-blockers have improved
symptoms and left ventricular function, but their impact
on survival is uncertain. We studied bisoprolol's effects
- a beta1-blocker - on all-cause mortality in chronic
CHF.

In a double-blind, randomized, placebo-controlled
trial in Europe, we enrolled 2647 patients with CHF
symptoms. All were in class 3 or 4, with ejection
fraction of 35% or less. All were taking standard
therapy of diuretics and ACE inhibitors. We
randomly assigned patients to take 1.25mg bisoprolol
(1327 patients) or placebo (1320 patients) daily. Drug
dose was progressively raised to 10mg per day.
Follow-up was an average of 1.3 years.

FINDINGS:

CIBIS-II was stopped early because bisoprolol
significantly decreased mortality. All-cause mortality
was significantly lower with bisoprolol than placebo.

A) 156 (12%) patients died on bisoprolol
b) 228 (17%) patients died on placebo

There were fewer sudden deaths among bisoprolol
patients than placebo patients (3.6% versus 6.3%).
Benefit was seen regardless of severity or cause of
heart failure.

CONCLUSIONS:

Bisoprolol therapy had a survival benefit in stable
CHF patients. Results should not, however, be
extended to patients with severe class 4 symptoms
and recent instability.

PMID: 10023943.