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CIBIS II

CIBIS II. Cardiac Insufficiency Bisoprolol Study. 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).

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CIBIS II

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  1. CIBIS II Cardiac Insufficiency Bisoprolol Study

  2. CIBIS IICardiac 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)

  3. CIBIS II - Study Objectives • Primary objective • All-cause mortality • Secondary objectives • Cardiovascular mortality • Hospital admissions • Cardiovascular mortality orcardiovascular hospital admissions • Permanent treatment withdrawal

  4. CIBIS II - Main inclusion criteria • Ambulatory patients with stable CHF of all aetiologies • NYHA functional class III or IV • Stable on ACE inhibitor and diuretic • Aged 18 – 80 years • Left ventricular ejection fraction £ 35%

  5. CIBIS II - Design Bisoprolol dose (mg) 10.00 7.50 5.00 3.75 2.50 1.25 W2 W3 W4 W8 W12 W1 W5 W6 W7 W9 W10 W11 W13 W14 W15 W16 Week • No run-in period • Dose increased according to tolerability

  6. CIBIS II - Characteristics (I) Placebo Bisoprolol (n=1320) (n=1327) Demographic data Mean (range) age (years) 61 (22–80) 61 (26–80) Sex (M/F) 1062 (80%) 1070 (81%) 258 (20%) 257 (19%) NYHA class III 1096 (83%) 1106 (83%) IV 224 (17%) 221 (17%) Heart failure Documented ischaemic heart disease 654 (50%) 662 (50%) Primary dilated cardiomyopathy 157 (12%) 160 (12%) Others* 509 (40%) 505 (38%) Mean (SD) left-ventricular ejection fraction 27.6 (5.5%) 27.5 (6.0%) *Coronary angiography unavailable or no history of myocardial infarction

  7. CIBIS II - Characteristics (II) Placebo Bisoprolol (n=1320) (n=1327) Concomitant medication Diuretic 1310 (99%) 1305 (98%) ACE inhibitor 1274 (96%) 1273 (96%) Dihydropyridine-type calcium antagonist 23 (2%) 23 (2%) Nitrate 762 (58%) 773 (58%) Digoxin 670 (51%) 697 (53%) Amiodarone 206 (16%) 185 (14%) Anticoagulant 413 (31%) 399 (30%) Antiplatelet agent 558 (42%) 537 (40%)

  8. CIBIS II - Survival 1.0 0.8 Survival Bisoprolol: 156 deaths (n = 1327) Placebo: 228 deaths (n = 1320) log rank test, p < 0.0001 0.6 0 0 200 400 600 800 Time after inclusion (days) • 34% reduction in all-cause mortality with bisoprolol

  9. CIBIS II - Analysis of time to death Patients 100 p=0.0011 80 83 6% Bisoprolol (n = 1327) 60 Placebo (n = 1320) p=0.0012 p=0.17 49 4% 48 4% 47 4% 40 p=0.58 36 3% p=0.41 28 2% 23 2% 23 2% 20 p=0.75 18 1% 14 1% 8 1% 7 1% 0 Sudden Pump Myocardial Other cardio- Non-cardio- Unknown cause death failure infarction vascular deaths vascular deaths of death Hazard ratio: (95% CI) 0.56 0.74 0.85 1.17 0.75 0.45 (0.39 – 0.80) (0.48 – 1.14) (0.31 – 2.34) (0.67 – 2.03) (0.37 – 1.50) (0.27 – 0.74)

  10. CIBIS II - Secondary endpoints Placebo Bisoprolol Hazard ratio p (log rank (n = 1320) (n = 1327) (95% Cl) test) All-cause hospital admissions 513 (39%) 440 (33%) 0.80 (0.71–0.91) 0.0006 All cardiovascular deaths 161 (12%) 119 (9%) 0.71 (0.56–0.90) 0.0049 Combined endpoint 463 (35%) 388 (29%) 0.79 (0.69–0.90) 0.0004 Permanent treatment 192 (15%) 194 (15%) 1.00 (0.82–1.22) 0.98withdrawals

  11. CIBIS II - Mortality by baseline findings Bisoprolol Placebo n/total n/total Ischaemia 75/662 121/654 Primary DCM 13/160 15/157 Undefined 68/505 92/509 NYHA III 116/1106 173/1096 NYHA IV 40/221 55/224 Total Relative risk: 0.4 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

  12. CIBIS II - Main results at a glance • In 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 by 36%(p<0.0001)

  13. CIBIS II - Conclusions • 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.

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