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Search Results: 1 - 10 of 471347 matches for " S.N. Tolpygina "
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Acetylsalicylic acid in low doses for secondary prevention of cardio-vascular complications
N.A. Dmitrieva,Tolpygina S.N.
Rational Pharmacotherapy in Cardiology , 2009,
Abstract: Data of evidence based medicine which confirm efficacy of acetylsalicylic acid (ACA) in cardiologic practice are presented. The special attention is given to generic drugs of ACA. Their application has increased essentially recently. Some of generics are comparable with original drugs on clinical efficacy but have economic advantages.
Problem of generic replacement: advantages and disadvantages
S.N. Tolpygina,S.Yu. Martsevich
Rational Pharmacotherapy in Cardiology , 2009,
Abstract: The main differences between original and generic drugs as well as registration criteria for generics are described. Possible reasons of discrepancy in bioequivalence and therapeutic equivalence of original and generic drugs are reviewed. The examples of such a discrepancy as a result of comparative clinical trails (enalapril maleate) are discussed. Approaches to planning of comparative trails on drug therapeutic equivalence are presented.
Comparison of efficacy and tolerability of original and generic drugs of simvastatin in patients with hyperlipidaemia and high risk of ischemic heart disease complications
S.N. Tolpygina,S.Y. Martsevich
Rational Pharmacotherapy in Cardiology , 2008,
Abstract: Aim. To assess efficacy and safety of generic simvastatin, Simvahexal, in comparison with original drug of simvastatin, Zocor, in patients with hyperlipidaemia in short-term study.Material and methods. 30 patients (19 men and 11 women, 64,0 }1,8 y.o.) with low density lipoprotein (LDL) cholesterol ≥3,0 mmol/l and high cardiovascular risk were involved into the study. During 5 weeks before study including patients kept the hypolipidaemic diet and did not receive any hypolipidaemic drug. 28 patients completed study, 2 patients drop out: one patient because of nettle rash on Zocor therapy, another one – because of personal reason. Efficacy was assessed by dynamic of lipid profile and a number of patients who reached target level of LDL cholesterol (<3 mmol/l). Safety was assessed by side effect rate registration. Patients were randomized in 2 groups (G1 and G2): G1 patients (n=15) received Zocor 20 mg/day during 6 weeks, G2 patients (n=15) – Simvahexal 20 mg/day. After 6 weeks of therapy G1 patients were switched from Zocor to Simvahexal, G2 patients did not change their therapy. Simvahexal dose was increased to 30 mg/day, if the target level of LDL cholesterol had not been reached after first 6 weeks of therapy.Results. After switching therapy from Zocor to Simvahexal 11 patients increased the dose to 30 mg/day, 3 patients kept the dose of 20 mg/day, 1 patient drop out. At the beginning of the study 15 patients received Simvahexal 20 mg/day, after 6 weeks the dose was increased to 30 mg/day in 8 patients, 7 patients kept the dose of 20 mg/day. After 6 weeks of therapy with Zocor 20 mg/day levels of the total cholesterol (TC) and LDL cholesterol reduced on 25,2% and 33,6% (p<0,001), respectively. Next 6 weeks of therapy with Simvahexal in the average dose of 27,7 mg/day this reduction reached to 30,9% and 39,9% (p<0,001), respectively. After 6 weeks of therapy with Simvahexal 20mg/day levels of the TC and LDL cholesterol reduced on 28,2%and 38%(p<0,001), respectively. Next 6weeks of therapywith Simvahexal in the average dose of 25,3mg/day this reduction reached to 29,6%and 42,5%(p<0,001), respectively. In G1 patients Zocor 20mg/day reduced atherogenesis index (AI) from5,2 to 3,3 (p<0,001) after 6weeks of therapy. Next 6weeks of therapywith Simvahexal in the average dose of 27,7mg/day this reduction reached to 3,1. In G2 patients AIwas reduced from4,1 to 2,4 (p<0,001) after first 6 weeks of therapy with Simvahexal 20 mg/day and remained at the same level during next 6 weeks of therapy. Both drugs were comparable in rate (6 cases for each) and intensity of s
Comparison of the influence of long-term treatment based on carvedilol or bisoprolol on metabolic parameters in hypertensive patients with overweight or obesity Results of the randomized open-label parallel-groups steppped trial CABRIOLET (part I)
S.Y. Martsevich,S.N. Tolpygina
Rational Pharmacotherapy in Cardiology , 2012,
Abstract: Aim.To compare antihypertensive and metabolic effects of long-term treatment with carvedilol or bisoprolol in patients with arterial hypertension (HT) of 1-2 degree and overweight/obesity.Material and methods.A total of 105 patients were enrolled into open-label comparative stepped trial in two parallel groups. The patients were randomized into two groups: the group 1 (n=53) started treatment with carvedilol 25 mg daily and the group 2 (n=52) – with bisoprolol 5 mg daily. If the effect was insufficient a dose of a beta-blocker was doubled, then amlodipine was added in the dose of 5 mg daily with its further increase if necessary or indapamide in dose 1.5 mg daily. The follow-up for each patient was 24 weeks. At the start and then 12 and 24 weeks later the frequency of target blood pressure (BP) achievement, body mass index, biochemical indices, ECG and treatment safety were evaluated.Results.Significant distinctions in antihypertensive therapy effect between the groups were absent (ΔBP=-29.5±11.3/17.8±8.4 and -30.4±12.8/18.7±8 mm Hg for groups 1 and 2, respectively, p<0.001 for the both groups) as well as the necessity for additional therapy. All the patients completed the study had achieved target BP level. The patients of the both groups decreased body mass index after 6-month treatment (-0.57±1.1, p=0.001 and -0.53±0.8 kg/m2, p<0.001 for groups 1 and 2, respectively). Patients of the group 1 demonstrated significant reduction in fasting plasma glucose level (-0.45±1.2 mM/l, p=0.01), uric acid (-0.05±0.01 mM/l, p<0.001) and low-density lipoprotein cholesterol level (-0.28±0.9 mM/l, p<0.05) as well as a trend for HOMA index decrease. Serum creatinine level increased in patients of the group 2 (6.35±22.4 mcM/l, p=0.05) with no significant dynamics in metabolic indices. Glomerular filtration rate did not change significantly in the group 1, while there was significant decrease in the group 2 (Δ-3.8±15.2 ml/min/1,73m2, р=0.01). The groups did not differ in adverse events incidence and severity.Conclusion. The CABRIOLET study showed similar antihypertensive efficacy of carvedilol and bisoprolol in HT patients with abdominal obesity and confirmed favorable metabolic effects of long-term treatment with carvedilol, unlike bisoprolol.
Efficacy and safety of metoprolol succinate in high doses in patients with stable course of ischemic heart disease
S.N. Tolpygina,S.Y. Martsevich
Rational Pharmacotherapy in Cardiology , 2008,
Abstract: Aim. To compare two initial doses (50 or 100mg/day) ofmetoprolol succinate in control released presentation (Betaloc ZOK, AstraZeneca) for achievement of target level of heart rate (HR) in patients with stable course of ischemic heart disease (IHD).Material and methods. 50 patients (34 men and 16 women, aged 61,3 y.o., in average) with IHD were involved into the open randomized comparative study. IHD duration was from 1 to 22 years (8,3 years in average). 47 patients completed study, 3 patients drop out because of side effects. Previous therapy with β-blockers or other HR reducing drugs was replaced on metoprolol. Patients were randomized in 2 groups (G1 and G2). The initial metoprolol dose was 50 mg in G1 patients and 100 mg - in G2 patients. The dose was enlarged twice if necessary. Study duration was 6 weeks. The change of HR, blood pressure, electrocardiogram parameters was evaluated. Patients filled in Seattle angina questionnaire initially and after 6 weeks treatment. Therapy tolerability was also estimated.Results. In 6 weeks of therapy 61% of G1 patients and 87,5% of G2 patients (p<0,01) reached HR target. Dependence of achievement of target HR and dose of metoprolol was observed (r=0,3; p=0,056). Improvement of the HR control was accompanied by reduction of frequency of angina attacks and increase of life quality.Conclusion. Metoprolol (Betaloc ZOK) 200 mg/day provides more effective HR control in patients with IHD vs metoprolol 50-100 mg/day and has good tolerability.
Efficacy and safety of acetylsalicylic acid in primary and secondary prevention of cardiovascular diseases
S.N. Tolpygina,S.Yu. Martsevich,E.N. Khoseva,N.V. Kiseleva
Rational Pharmacotherapy in Cardiology , 2012,
Abstract: Acetylsalicylic acid (ASA) use in the primary and secondary prevention of cardiovascular diseases is focused. Mode of ASA disaggregation action is discussed. Data of randomized controlled trials on ASA efficacy and safety in primary and secondary prevention are presented. The main groups of patients who are required the ASA prevention according to current clinical guidelines are indicated. ASA benefit-risk ratio, as well as ways to improve the safety of antiplatelet therapy are presented, including use of enteric-soluble ASA forms.
Economic reasons for generic choice
N.P. Kutishenko,S.Y. Martsevich,S.N. Tolpygina,J.V. Lukina
Rational Pharmacotherapy in Cardiology , 2008,
Abstract: Many generic medicines appear in the pharmaceutical market now. However, they are not always completely comparable with original drugs on efficacy and safety. In this article pharmacoeconomical estimation of some generics and original drugs was performed on example of therapeutic equivalency studies.
Comparison of antiplatelet efficacy of original and generic enterosoluble acetylsalicylic acid in patients with high cardiovascular risk. Simple blind crossed randomized controlled study (IKAR)
S.Yu. Martsevich,S.N. Tolpygina,E. S. Boychenko,R.E. Dubinskaya
Rational Pharmacotherapy in Cardiology , 2010,
Abstract: Aim. To compare the antiplatelet efficacy of the original and generic enterosoluble tableted acetylsalicylic acid (ASA) in patients with high cardiovascular risk.Material and мethods. Patients (n=30) with high cardiovascular risk and indications for the ASA therapy were included in the study. Antiplatelet agents were withdrawn 3 weeks before study start (wash-out period). Study drugs were distributed at the start visit according to the randomization scheme. The first study drug course was 3 weeks, then next wash-out period lasting 3 weeks, and at last the second study drug course during 3 weeks occurred. Blood samples were taken; blood pressure and heart rate were recorded before and after therapies. ASA antiplatelet effect was evaluated by spontaneous and ADP-induced platelet aggregation assessment. Platelet aggregation was determined by the change turbidimetric translucent ability of the blood sample during the formation of aggregates after 2 minutes of exposure. ADP solution of three concentrations (0.5, 1 and 2 μMol) was used as an inductor of aggregation.Results. Significant differences between the compared drugs in effect on platelet aggregation, blood pressure and heart rate were not found. Signs of platelet desaggregation after 3 weeks of generic ASA therapy were found in 65, 34.5 and 31% of patients when aggregation was tested with ADP 0.5, 1 and 2 μMol respectively. Desaggregation was revealed in 65.4, 42.3 and 31% of patients treated with original ASA (p>0.05) in the same test and the same ADP inducing concentration.. Adverse events associated with study drugs were not registered.Conclusion. ASA generic TrombopolR 75 mg (Pharmaceutical Factory Polpharma SA, Poland) and ASA original AspirinR Cardio (Bayer AG, Germany) are equivalent in antiplatelet effect and tolerability.
Clinical and pharmacokinetic equivalence of original and generic amlodipine in patients with mild-to-moderate arterial hypertension
N.A. Belolipetskiy,S.N. Tolpygina,J.B. Zverkov,V.V. Pisarev
Rational Pharmacotherapy in Cardiology , 2007,
Abstract: 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 concentrationswith significant BP reduction. 96,6%and 90%of patients reached BP target level (<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.
A comparative study of the efficacy and tolerability of original and generic bisoprolol in monotherapy or in combination with S-amlodipine and indapamide in patients with arterial hypertension 1-2 degrees.
S.Yu. Martsevich,S.N. Tolpygina,V.P. Voronina,O.V. Lerman
Rational Pharmacotherapy in Cardiology , 2011,
Abstract: Aim. To study the clinical equivalence of original and generic drugs of bisoprolol in patients with arterial hypertension (HT) 1-2 degrees according to protocol recommended by the Society of Cardiology of the Russian Federation for comparative studies.Material and methods. 30 patients with HT 1-2 degrees were examined. Patients were randomized into group 1 (original bisoprolol 5 mg/day) or group 2 (generic bisoprolol 5 mg/day). In case of insufficient antihypertensive effect bisoprolol dose was increased or S-amlodipine and then indapamide were added. After the first treatment period (8 weeks) was completed 2-week wash-out period started and then the second period (8 weeks) of treatment (taking alternative medicine of bisoprolol) began. Blood pressure (BP), heart rate, ECG, adverse effects were recorded in patients.Results. After 8 weeks of therapy BP reduction was 27.2±12.2/12.0±6.1 mm Hg in group 1 and 29.9±10.5/12.5±7.2 mm Hg in group 2 (p<0.001 for both groups), intergroup differences were insignificant. Target BP levels were achieved in 79.3% of patients in both groups. Heart rate decrease was 11.1±12.9 in group 1 and 8.5±8.6 beats/min in group 2 (p<0.05 for both groups). Significant dynamics of PQ interval were not found in both groups. The groups were comparable in terms of treatment safety and tolerability.Conclusion. Therapeutic equivalence of original and generic bisoprolol is shown in patients with HT 1-2 degrees.
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