THERAPEUTIC EQUIVALENCE OF ORIGINAL CLOPIDOGREL (PLAVIX) AND ITS GENERIC (EGITROMB). RESULTS OF COMPARATIVE RANDOMIZED CROSS-OVER BLIND STUDY

Aim. To study therapeutic equivalence (efficacy, safety and tolerability) of original clopidogrel (Plavix) and its generic (Egitromb) in patients of high cardiovascular risk. Material and methods. Thirty one patients with coronary heart disease and indications for clopidogrel therapy were involved into the randomized cross-over blind study. Half of the patients received original clopidogrel (75 mg daily) during the first 2 weeks and then they received generic clopidogrel in the same dose during next 2 weeks. Another half of the patients received the drugs in reverse order. Antiplatelet activity of Plavix and Egitromb was estimated by effects on ADP-induced platelet aggregation initially and after 2 weeks of treatment with each drug. Study blinding was provided by the following approach: doctors of cardiology clinic performed clinical monitoring and drug distribution; coded blood samples for platelet aggregation assessment were studied in independent laboratory of thrombosis; statistical data analysis was performed by biostatistics expert in other research center. Results. 2-week therapy with each drug led to a significant decrease of ADP-induced platelet aggregation which remained low after switching from original drug to generic and vice versa. Aggregation dynamics did not depend on the first administered drug. There were no significant differences between aggregation changes as a result of treatment with original or generic drug. No one adverse event was observed in association with both drugs therapy. Conclusion. Generic drug Egitromb (Egis, Hungary) and original clopidogrel Plavix (Sanofi-Aventis, France) have equivalent antiplatelet effect

Hypertension control during the COVID-19 pandemic: results of the MMM2021 in Russia

Repetitive quarantines and social restrictions during the coronavirus disease 2019 (COVID-19) pandemic have negatively affected the population health in general, and the control of hypertension (HTN) in particular.Aim. To evaluate the control of HTN in the Russian population during the COVID-19 period based on the results of screening for HTN May Measurement Month 2021 (MMM2021).Material and methods. During May-August 2021, 2491 participants from 11 Russian regions took part in the screening. Participation was voluntary without restrictions on sex. All participants were over 18 years of age. During the screening, blood pressure (BP) was measured three times using automatic and mechanical BP monitors. In addition, a questionnaire was filled out on behavioral risk factors, comorbidities and therapy. HTN was diagnosed with systolic BP ≥140 mmHg and/ or diastolic blood pressure ≥90 mmHg and/or taking antihypertensive therapy. The questionnaire included questions about prior COVID-19, vaccinations and their impact on the intake of antihypertensive drugs.Results. The analysis included data from 2461 respondents aged 18 to 92, of which 963 were men (39,1%). The proportion of hypertensive patients was 41,0%, while among them 59,0% took antihypertensives and 30,9% were effectively treated. In comparison with pre-pandemic period according to MMM2018-2019, the higher proportion of HTN patients in the Russian sample was revealed during MMM2021 (41,0% vs 31,3%, p<0,001) with a comparable proportion of patients receiving antihypertensive therapy (60,7% vs 59,0%, p=0,05) and treatment efficacy (28,7% vs 30,9%, p=0,36). Monotherapy was received in 44,7% of cases, while dual and triple combination therapy — in 30,9% and 14,1%, respectively. The majority of respondents (~90%) did not adjust their antihypertensive therapy during the COVID-19 pandemic.Conclusion. According to HTN screening in Russia, there is persistent ineffective control of HTN, which may be due to both the worsening pattern of behavioral risk factors, limited access to healthcare during COVID-19, and the inertia of physicians and low adherence of patients due to the asymptomatic HTN course in the majority

CARDIOVASCULAR EVENTS IN SYSTEMIC LUPUS ERYTHEMATOSUS: MECHANISMS FOR THE ACCELERATED DEVELOPMENT OF ATHEROSCLEROSIS, DIAGNOSIS, CORRECTION CAPABILITIES

Atherosclerosis and its complications are the major cause of late mortality among patients with systemic lupus erythematosus (SLE). SLE and coronary heart disease share common pathophysiological mechanisms associated with systemic and chronic inflammation. At the same time, traditional risk factors, such as hypertension, elderly age, smoking, hypercholesterolemia, obesity, and male sex, cannot fully explain the mechanism for the accelerated development of atherosclerosis in patients with SLE. Specific risk factors, such as its duration, glucocorticoid use, anti-doublestranded (native) DNA autoantibodies and antiphospholipid antibodies, create conditions for the accelerated development of atherosclerosis in this group of patients.The available facts indicate that a rheumatologist can reduce the risk of cardiovascular disease (CVD), by controlling the activity of SLE. Traditional CVD risk factors should be also modified with smoking cessation, weight loss, and blood pressure control. It is necessary to keep in mind the role of anti-inflammatory therapy, in particular the positive effect of drugs, such as anti-malarial drugs and mycophenolate mofetil, and the adverse prognostic effect of prolonged glucocorticoid use. Further studies should assist in elaborating effective risk scales and specific therapeutic programs for the prevention and treatment of CVD in patients with SLE

THERAPEUTIC EQUIVALENCE OF ORIGINAL CLOPIDOGREL (PLAVIX) AND ITS GENERIC (EGITROMB). RESULTS OF COMPARATIVE RANDOMIZED CROSS-OVER BLIND STUDY

Aim. To study therapeutic equivalence (efficacy, safety and tolerability) of original clopidogrel (Plavix) and its generic (Egitromb) in patients of high cardiovascular risk. Material and methods. Thirty one patients with coronary heart disease and indications for clopidogrel therapy were involved into the randomized cross-over blind study. Half of the patients received original clopidogrel (75 mg daily) during the first 2 weeks and then they received generic clopidogrel in the same dose during next 2 weeks. Another half of the patients received the drugs in reverse order. Antiplatelet activity of Plavix and Egitromb was estimated by effects on ADP-induced platelet aggregation initially and after 2 weeks of treatment with each drug. Study blinding was provided by the following approach: doctors of cardiology clinic performed clinical monitoring and drug distribution; coded blood samples for platelet aggregation assessment were studied in independent laboratory of thrombosis; statistical data analysis was performed by biostatistics expert in other research center. Results. 2-week therapy with each drug led to a significant decrease of ADP-induced platelet aggregation which remained low after switching from original drug to generic and vice versa. Aggregation dynamics did not depend on the first administered drug. There were no significant differences between aggregation changes as a result of treatment with original or generic drug. No one adverse event was observed in association with both drugs therapy. Conclusion. Generic drug Egitromb (Egis, Hungary) and original clopidogrel Plavix (Sanofi-Aventis, France) have equivalent antiplatelet effect

ANTIPLATELET ACTIVITY OF ORIGINAL CLOPIDOGREL AND ITS GENERIC: RESULTS OF RANDOMIZED COMPARATIVE CROSS-OVER STUDY

Objective — to study therapeutic equivalence (efficacy, safety and tolerability) and hemorheological activity of original clopidogrel and itsgeneric in patients of high cardiovascular risk.Materials and methods. 50 patients with stable angina pectoris were randomized into 2 groups of consecutive 2-week treatment by original(plavix) and generic (plagril) clopidogrel and vice versa. ADP-induced platelet aggregation was measured at baseline and after treatment byeach of the drugs. Physical examination and adverse events were evaluated at visits.Results. After the first treatment period a significant decrease of platelet aggregation was determined in both groups. After switching to anotherdrug the decrease continued but not significantly in both groups. There were registered no adverse events associated with antiplatelet therapy.Conclusion. Equal antiplatelet activity established for plavix and plagril demonstrates their therapeutic equivalence.</p