A COMPARATIVE STUDY OF EFFICACY AND TOLERABILITY OF GENERIC AND ORIGINAL LOW-DOSE BISOPROLOL/HYDROCHLOROTHIAZIDE COMBINATION IN PATIENTS WITH ARTERIAL HYPERTENSION OF 1-2 DEGREES. RESULTS OF CLINICAL RANDOMIZED CROSSOVER STUDY

Abstract

Aim: To study the clinical equivalence of the two low‐dose combined drugs on the base of generic and original bisoprolol and hydrochlorothiazide (HCTZ): BISANGIL® (Ozon, Russia) and LODOZ® (NYCOMED, Merck KGaA, Germany) in patients with arterial hypertension (HT) of 1‐2 degrees. Material and methods: Patients with HT of 1‐2 degrees (n=30; 11 men and 19 women; aged 62.7±10.7 years) were included in open crossover randomized trial. Duration of the study for each patient was 18 weeks: two 6‐week courses of active treatment with each drug and two 2‐week washout periods prior to each treatment course. The sequence of treatment courses was determined by randomization. Increase in bisoprolol dose and/or amlodipine addition occurred when effect was not sufficient. Therapy effectiveness (office blood pressure (BP), heart rate) and safety was monitored at visits. Results: BP reduction after 6 weeks of therapy was ‐21.6±11.1/10.4±11.3 mm Hg in LODOZ® group and ‐22.9±9.7/11.7±13.5 mm Hg in BISANGIL® group (p<0.0001 for both), intergroup differences were insignificant. Target BP after 6 weeks of therapy was achieved in 26 (87%) and 28 (93%) patients, respectively. Conclusion: The therapeutic equivalence of the studied fixed combinations of bisoprolol/HCTZ was demonstrated in treatment of patients with HT of 1‐2 degrees.