Results from post-hoc analyses of the CIBIS II trial: effect of bisoprololin high-risk patient groups with chronic heart failure

Background: The beneficial effects of the beta -blocker bisoprolol on morta lity and rate of hospitalisation as well as its safety in patients with chr onic heart failure has been proven. However, its efficacy in patients in wh om P-blockers have traditionally been contraindicated or caution has been a dvised has not been clearly determined. Therefore, analyses in high-risk su bgroups of patients taking part in CIBIS II have been performed to investig ate the effect of bisoprolol in elderly patients, in patients with type 2 d iabetes, with renal failure, NYHA functional class IV or concomitantly trea ted with digitalis, aldosterone antagonists or amiodarone. Methods: High-ri sk subgroups of patients with chronic heart failure taking part in the CIBI S II study were retrospectively analysed with respect to mortality, hospita lisation, combined endpoint of cardiovascular mortality or hospitalisation for cardiovascular reasons and treatment withdrawal as well as cause of dea th and hospitalisation. Analysis is based on intention-to-treat. Results: I t was demonstrated that in spite of the expected increase in the overall ri sk of death and hospitalisation, patients who are diabetic, have renal impa irment, NYHA class IV symptoms, are elderly, are taking either digitalis, a miodarone or aldosterone antagonists as co-medication benefit equally from P-blockade with bisoprolol as patients without these complications or drugs . Benefit was shown for the primary endpoint all cause mortality, as well a s for the secondary endpoints. Conclusions: Contrary to the hitherto prevai ling doctrine of not using beta-blockers in high risk patient groups with c hronic heart failure, retrospective analyses of the CIBIS II study justify the use of this drug class in patients regardless of age, NYHA functional c lass, the presence of diabetes, renal impairment or concomitant treatment w ith digitalis, amiodarone or aldosterone antagonists. (C) 2001 European Soc iety of Cardiology. All rights reserved.