TREATMENT EFFECTIVENESS AND SAFETY OF THE ORIGINAL AND GENERIC BISOPROLOL IN PATIENTS WITH ISCHEMIC HEART DISEASE

Abstract

Aim. To compare the clinical efficacy and safety of original and generic bisoprolol compounds in patients with normal ejection fraction after acute coronary syndrome (ACS) with the outcome to stable angina. Material and methods. Totally, 60 ACS with the outcome to stable angina patients included, that had not reached target heart rate 55-60 bpm at rest, with mean age — 60,28±8,03 y.o. All patients were randomized to groups A and B. Patients from A group were taking original bisoprolol, B group were taking generic. Follow-up duration was 6 weeks. The dynamics of heart rate was assessed. For the factual drug intake there was calculation performed of the setting doses summation for pulse-decreasing drugs in each group using ATC/DDD-method. Results. In quantitative expression, in both groups there was significant reducing of HR by the end of observation. However, it was found that original bisoprolol decreases HR deeper, comparing to generic. The sum of setting doses for pulse-reducing drugs in A group in mean for 1 person was 33,5 mg by 6 weeks of therapy, in B group — 44,2 mg. To reduce HR by 10 bpm in A group, 28,15 mg needed of the sum of setting pulse-reducing drugs for 6 weeks, and in group B — 48,0 mg. Conclusion. Comparing two beta-blockers— original and generic bisoprolol, in ACS patients, it was shown, that original drug was significantly better than generic within pulse-reducing effect. Safety of the drugs did not differ.