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CIBIS II: Cardiac Insufficiency Bisoprolol Study II

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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 ß1-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-

    5. CIBIS II: Cardiac Insufficiency Bisoprolol Study II - RESULTS continued-

    6. CIBIS II: Cardiac Insufficiency Bisoprolol Study II - RESULTS continued-

    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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