COMPARISON OF ANTIPLATELET EFFECT AND SAFETY OF ORIGINAL DRUG «ASPIRIN CARDIO» AND GENERIC«ACECARDOL» IN PATIENTS WITH ARTERIAL HYPERTENSION 1-2 GRADE

Aim. To compare antiplatelet effect of two acetylsalicylic acid medicines, Acecardol ("Synthesis Co. Ltd", Russia) and Aspirin cardio («Bayer AG», Germany), in patients with arterial hypertension (AH) 1-2 stage with increased risk of cardiovascular events.Material and methods. The study was double-blind, randomized, cross-over one. 32 hypertensive patients (12 men and 20 women) aged 59,4±14,4 y.o. were included in the study. They took investigated ASA medicines one after another during 4 weeks each. Antiplatelet efficacy of ASA medicines were estimated by effects on spontaneous and ADP-induced platelet aggregation at every visit.Results. 4-week therapy with both ASA medicines did not have significant effects on spontaneous platelet aggregation and the aggregation induced with low ADP concentrations (0,5 and 1,0 µM). However platelet aggregation induced with ADP in concentration of 2 µM was significantly reduced by therapies. There were not significant inter-group differences.Conclusion. ASA generic medicine Acecardol ("Synthesis Co.Ltd.", Russia) and original medicine Aspirin cardio («Bayer AG», Germany) are equivalent on antiplatelet effect

CLINICAL AND PHARMACOKINETIC EQUIVALENCE OF ORIGINAL AND GENERIC AMLODIPINE IN PATIENTS WITH MILD-TO-MODERATE ARTERIAL HYPERTENSION

Aim. To study clinical equivalence of two amlodipines under the control of their plasma levels and evaluate their pharmacoeconomical efficacy in patients with arterial hypertension (AH).Material and methods. 31 patient with AH were included in the study (14 men and 17 women). 21 (66 %) patients had AH of 1 stage and 10 (34 %) patients had AH of 2 stage. All patients were 39-81 y.o. (average - 60 y.o.) with AH duration 0,5-43 years (average - 17,9 years). Antihypertensive effect of Amlorus (Synthesis, Russia) and Norvasc (Pfizer, USA) was evaluated in the study. Blood pressure (BP), amlodipine plasma levels (by liquid chromatography with mass spectrometry) and side effects were registered before and after 2, 4 and 6 weeks of therapy. Hydrochlorothiazide 25 mg/d was added if the monotherapy with amlodipine10 mg/d had not been efficient. Therapy with the second studied amlodipine followed the therapy with the first drug.Results. Both drugs provided similar plasma amlodipine concentrations with significant BP reduction. 96,6 % and 90 % of patients reached BP target level (&lt;140/90 mm Hg) after 6 weeks of Amlorus and Norvasc therapy, respectively. Hydrochlorothiazide was needed in 23,3 % and 26,7 % of patients taking Amlorus and Norvasc, respectively. Cost of Amlorus therapy per patient was 221 rbl/month in comparison with cost of 727 rbl/month for Norvasc therapy.Conclusion. Generic Amlorus showed clinical and pharmacokinetic equivalency with an original amlodipine Norvasc and lower cost of therapy.</p