CIBIS II Cardiac Insufficiency Bisoprolol Study • Double-blind, placebo-controlled, randomised trial • 2,647 patients included (NYHA III + IV) • Bisoprolol administered on top of standard therapy (diuretic + ACE inhibitor) CIBIS II Investigators and Committees, Lancet 1999, 353: 9–13
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CIBIS II Cardiac Insufficiency Bisoprolol Study Double-blind, placebo-controlled, randomised trial 2,647 patients included (NYHA III + IV) Bisoprolol administered.
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CIBIS II – Cardiac Insufficiency Bisoprolol StudyMortality by baseline findings
CIBIS II – Cardiac Insufficiency Bisoprolol StudyMortality by baseline findings
CIB
IS II In
vest
igato
rs a
nd
Com
mit
tees,
Lan
cet
19
99
, 3
53
: 9
–13Ischaemia 75/662
Primary DCM 13/160
Undefined 68/505
NYHA III 116/1106
NYHA IV 40/221
121/654
Bisoprololn/total
Placebon/total
15/157
92/509
173/1096
55/224
Total
0.4Relative risk: 0.6 0.8 1.0 1.2 1.4 1.6 1.8
Mortality did not differ significantly between groupswhatever the aetiology or severity of heart failure
CIBIS II – Cardiac Insufficiency Bisoprolol StudyMain results at a glance
CIBIS II – Cardiac Insufficiency Bisoprolol StudyMain results at a glance
CIB
IS II In
vest
igato
rs a
nd
Com
mit
tees,
Lan
cet
19
99
, 3
53
: 9
–13In the bisoprolol-treated group of patients there was a
reduction in
• All-cause mortality (independent of aetiology) by 34% (p<0.0001)
• Sudden death by 44% (p<0.0011)
• All-cause hospital admissions by 20% (p<0.0006)
• Hospital admissions due to worsening heart failure by36%
(p<0.0001)
CIBIS II – Cardiac Insufficiency Bisoprolol StudyConclusions
CIBIS II – Cardiac Insufficiency Bisoprolol StudyConclusions
• CIBIS II successfully demonstrated that ß1-selective bisoprolol – given in addition to standard therapy –reduces significantly all-cause mortality andall-cause hospitalisation in CHF patients.
• Bisoprolol is the first ß-blocker which has provenits efficacy in a single large-scale CHF studywith all-cause mortality as primary objective.
• Bisoprolol was as well tolerated as placebowith a permanent treatment withdrawal rate of 15% in both groups.