Background: The beneficial effects of the beta-blocker bisoprolol on mortality and rate of hospitalisation as well as its safety in patients with chronic heart failure has been proven. However, its efficacy in patients in whom beta-blockers have traditionally been contraindicated or caution has been advised has not been clearly determined. Therefore, analyses in high-risk subgroups of patients taking part in CIBIS II have been performed to investigate the effect of bisoprolol in elderly patients, in patients with type 2 diabetes, with renal failure, NYHA functional class IV or concomitantly treated with digitalis, aldosterone antagonists or amiodarone.
Methods: High-risk subgroups of patients with chronic heart failure taking part in the CIBIS II study were retrospectively analysed with respect to mortality, hospitalisation, combined endpoint of cardiovascular mortality or hospitalisation for cardiovascular reasons and treatment withdrawal as well as cause of death and hospitalisation. Analysis is based on intention-to-treat.
Results: It was demonstrated that in spite of the expected increase in the overall risk of death and hospitalisation, patients who are diabetic, have renal impairment, NYHA class IV symptoms, are elderly, are taking either digitalis, amiodarone or aldosterone antagonists as co-medication benefit equally from beta-blockade with bisoprolol as patients without these complications or drugs. Benefit was shown for the primary endpoint all cause mortality, as well as for the secondary endpoints.
Conclusions: Contrary to the hitherto prevailing doctrine of not using beta-blockers in high risk patient groups with chronic heart failure, retrospective analyses of the CIBIS II study justify the use of this drug class in patients regardless of age, NYHA functional class, the presence of diabetes, renal impairment or concomitant treatment with digitalis, amiodarone or aldosterone antagonists.