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CIBIS II: Cardiac Insufficiency Bisoprolol Study II

CIBIS II: Cardiac Insufficiency Bisoprolol Study II. Purpose To determine whether bisoprolol, a β 1 -selective adrenoreceptor blocker, reduces all-cause mortality in chronic heart failure Reference

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CIBIS II: Cardiac Insufficiency Bisoprolol Study II

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  1. CIBIS II: Cardiac Insufficiency Bisoprolol Study II Purpose To determine whether bisoprolol, a β1-selective adrenoreceptor blocker, reduces all-cause mortality in chronic heart failure Reference CIBIS-II Investigators and Committees. The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II): a randomised trial. Lancet 1999;353:9–13.

  2. CIBIS II: Cardiac Insufficiency Bisoprolol Study II- TRIAL DESIGN - Design Multicenter, multinational, randomized, double-blind, placebo-controlled Patients 2647 patients, aged 18–80 years, with left ventricular ejection fraction <35% and NYHA class III or IV heart failure, receiving standard therapy (diuretic plus ACE inhibitor/other vasodilator) Follow up and primary end point Mean 1.3 years follow up. Primary endpoint all-cause mortality Treatment Placebo or bisoprolol 1.25 mg daily, increased stepwise over several weeks as tolerated to target dose 10 mg daily

  3. CIBIS II: Cardiac Insufficiency Bisoprolol Study II- RESULTS - • Study halted early because all-cause mortality significantly less in bisoprolol group than placebo group • Also significant reduction in: • Sudden deaths • All cardiovascular deaths • All-cause hospitalization, as well as hospitalization due to worsening heart failure • Treatment effects independent of severity or cause of heart failure • Drug well tolerated as defined by permanent early treatment withdrawals (15% in both groups, P=0.98)

  4. CIBIS II: Cardiac Insufficiency Bisoprolol Study II- RESULTS continued- All-cause mortality Survival 1.0 0.8 0.6 Placebo P<0.0001 Bisoprolol 0 200 400 600 800 Days after inclusion CIBIS-II Investigators and Committees. Lancet 1999; 353 :9 – 13.

  5. CIBIS II: Cardiac Insufficiency Bisoprolol Study II- RESULTS continued- Primary and secondary outcomes Placebo Bisoprolol Hazard ratio (n=1320) (n=1327) P (95% CI) (%) (%) Primary endpoint All-cause mortality 17 12 0.66 (0.54 – 0.81) <0.0001 Secondary endpoints All-cause hospital admission 39 33 0.80 (0.71 – 0.91) 0.0006 All cardiovascular deaths 12 9 0.71 (0.56 – 0.90) 0.0049 Combined endpoint 35 29 0.79 (0.69 – 0.90) 0.0004 Exploratory analyses Sudden death 6 4 0.56 (0.39 – 0.80) 0.0011 Hospital admission for 18 12 0.64 (0.53 – 0.79) 0.0001 worsening heart failure CIBIS-II Investigators and Committees. Lancet 1999; 353 :9 – 13.

  6. CIBIS II: Cardiac Insufficiency Bisoprolol Study II- RESULTS continued- Effect of bisoprolol on subgroups Baseline etiology/ Bisoprolol Placebo functional class (n/total) (n/total) Ischemia 75/662 121/654 Primary dilated 13/160 15/157 cardiomyopathy Undefined 68/505 92/509 NYHA III 116/1106 173/1096 NYHA IV 40/221 55/224 Total 0.4 0.6 0.8 1.0 1.2 1.4 1.6 1.8 Relative risk (and 95% CI) CIBIS-II Investigators and Committees. Lancet 1999; 353 :9 – 13.

  7. CIBIS II: Cardiac Insufficiency Bisoprolol Study II- SUMMARY - In patients with class III or IV heart failure, bisoprolol in addition to standard therapy reduced: • All-cause mortality • Sudden death and cardiovascular death • All-cause hospitalization and hospitalization due to worsening heart failure

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