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Cardiac Insufficiency Bisoprolol Study (CIBIS III) Trial CIBIS III Trial Presented at The European Society of Cardiology Hot Line Session 2005 Presented.

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Presentation on theme: "Cardiac Insufficiency Bisoprolol Study (CIBIS III) Trial CIBIS III Trial Presented at The European Society of Cardiology Hot Line Session 2005 Presented."— Presentation transcript:

1 Cardiac Insufficiency Bisoprolol Study (CIBIS III) Trial CIBIS III Trial Presented at The European Society of Cardiology Hot Line Session 2005 Presented by Dr. Ronnie Willenheimer

2 www. Clinical trial results.org Monotherapy with beta-blocker bisoprolol (first 6 mos) 10mg O.D. n=505 Monotherapy with beta-blocker bisoprolol (first 6 mos) 10mg O.D. n=505  Primary Endpoint: Time-to-the-first-event of combined all-cause mortality and all-cause hospitalization throughout study.  Secondary Endpoint: Combined primary endpoint at end of monotherapy phase; individual components of primary endpoint at study end and at end of monotherapy phase.  Primary Endpoint: Time-to-the-first-event of combined all-cause mortality and all-cause hospitalization throughout study.  Secondary Endpoint: Combined primary endpoint at end of monotherapy phase; individual components of primary endpoint at study end and at end of monotherapy phase. CIBIS III Trial Presented at ESC 2005 Monotherapy with ACE-inhibitor enalapril (first 6 mos) 10mg B.I.D. n=505 Monotherapy with ACE-inhibitor enalapril (first 6 mos) 10mg B.I.D. n= patients > 65 years with mild to moderate CHF (NYHA class II or III) and LV ejection fraction < 35% in 3 months prior to randomization, clinically stable CHF for 7 days Randomized 32% female, mean age 72 years, mean follow-up 1.22 years 13% received aldosterone-receptor blocker and 84% diuretic 1010 patients > 65 years with mild to moderate CHF (NYHA class II or III) and LV ejection fraction < 35% in 3 months prior to randomization, clinically stable CHF for 7 days Randomized 32% female, mean age 72 years, mean follow-up 1.22 years 13% received aldosterone-receptor blocker and 84% diuretic Combination beta-blocker and ACE-inhibitor therapy (6-24 mos)

3 www. Clinical trial results.org CIBIS III Trial: Per-Protocol (PP) Primary Endpoint PP Analysis of death or rehospitalization (%) p = for non-inferiority Presented at ESC 2005 The per-protocol primary endpoint of death or rehospitalization did not differ by treatment group (HR 0.97, 95% CL ), and In the per-protocol group, non-inferiority criteria, trended to be significant, but significance was not met Baseline characteristics were similar between the two treatment groups: Ischemic heart disease present in 62% of patients Mean LVEF of 28.8% NYHA heart failure classification was evenly divided by class II and III Adverse even rate was similar between two treatment groups

4 www. Clinical trial results.org CIBIS III Trial: Intent-to-Treat (ITT) ITT Analysis of death or rehospitalization Presented at ESC 2005 In the intent-to-treat group, non- inferiority criteria was met (HR 0.94, 95% CL , p=0.019) There was no difference in the individual components of death (n=65 vs n=73, HR 0.88) or hospitalization (n=151 vs n=157, HR 0.97) among the intent-to-treat group At the end of the monotherapy phase, there was no difference in the primary endpoint (HR 1.02, p=0.90) p=0.44 p=0.86 n=65 n=73 n=151 n=157

5 www. Clinical trial results.org CIBIS III Trial Worsening CHF requiring hospitalization or occuring in-hospital p = 0.23 Presented at ESC 2005 Worsening CHF requiring hospitalization or occurring in- hospital was non-significantly higher in the bisoprolol group (HR 1.25) Study drug discontinuation during the monotherapy arm occurred in 6.9% of the bisoprolol-first strategy and 9.7% of the enalapril-first strategy n=63 n=51

6 www. Clinical trial results.org CIBIS III Trial Summary Among patients with newly diagnosed mild to moderate heart failure, a strategy of initial treatment with the beta- blocker bisoprolol did not meet the criteria for non-inferiority in the per-protocol population for death or hospitalization compared with a strategy of initial treatment with the ACE- inhibitor enalapril. Non-inferiority was met in the intent-to-treat population. Current guidelines recommend first-line therapy with an ACE-inhibitor after initial heart failure diagnosis, followed by addition of beta-blocker. Among patients with newly diagnosed mild to moderate heart failure, a strategy of initial treatment with the beta- blocker bisoprolol did not meet the criteria for non-inferiority in the per-protocol population for death or hospitalization compared with a strategy of initial treatment with the ACE- inhibitor enalapril. Non-inferiority was met in the intent-to-treat population. Current guidelines recommend first-line therapy with an ACE-inhibitor after initial heart failure diagnosis, followed by addition of beta-blocker. Presented at ESC 2005


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