Selective beta-blocker bisoprolol: effectiveness and safety in complex treatment of patients with chronic heart failure and Type 2 diabetes mellitus. RAMBO-DM CHF Study results

Aim. To assess effectiveness and safety of a selective beta-blocker bisoprolol in patients with chronic heart failure (CHF) and Type 2 diabetes mellitus (DM-2).

Material and methods. In total, 81 patients with mild to moderate CHF, NYHA Functional Class (FC) II-III, left ventricular ejection fraction (FV EF) <45 %, and DM-2 were examined. Bisoprolol group included 49 individuals (60 %), control group - 15 (18 %). Total length of therapy and follow-up was 12 months. Control examination was performed at baseline, after 6 months of the treatment, and at the end of the study. The examination included clinico-functional assessment of general status, renal function, neuro-hormonal profile, circadian heart rate variability, and carbohydrate metabolism (glycated hemoglobin level, standard breakfast test with fasting and 2- hour postprandial measurements of plasma glucose, insulin and C-peptide levels).

Results. Bisoprolol substantially improved CHF FC, physical stress tolerability and LV EF, reducing heart rate and LV end-systolic volume, comparing to controls. Bisoprolol therapy did not affect DM-2 clinical course and did not result in insulin resistance progression or a need for more aggressive glucose-lowering therapy even among patients with clinically manifested CHF.

Conclusion. Due to its demonstrated effectiveness and safety, bisoprolol could be recommended as a part of complex therapy in CHF and DM-2 patients.

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