43 results on '"V. V. Yakusevich"'
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2. Patients with atrial fibrillation in outpatient practice: clinical characteristics and outcomes over a 10-year observation period (data from the REQUAZA AF registrу — Yaroslavl)
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V. V. Yakusevich, V. Vl. Yakusevich, S. Yu. Martsevich, M. M. Lukyanov, and O. M. Drapkina
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atrial fibrillation ,course ,complications ,mortality ,Therapeutics. Pharmacology ,RM1-950 ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Aim. To present clinical characteristics and assess serious adverse outcomes (death, acute cardiovascular events) in outpatients with atrial fibrillation (AF) in one of the Yaroslavl clinics for 10 years.Material and methods. A total of 212 patients with AF aged from 23 to 94 years were included in the REQUAZA AF registrу — Yaroslavl at the first visit to the clinic in 2013. Their health status was monitored over 10,5 years through in-person visits, phone contacts with patients, their relatives, and treating physicians. Recorded data included the AF type, comorbid conditions, extent and quality of examinations and treatments, development of serious adverse events, and mortality. Statistical processing was carried out using the Microsoft Office 365 application software package.Results. Most patients (66,5%) were diagnosed with persistent AF. Paroxysmal, persistent, and newly detected forms were observed in 26,4%, 3,8%, and 3,3% of patients, respectively. Most AF patients had concomitant cardiovascular diseases, most frequently hypertension (96,7%), heart failure (91,6%), and coronary artery disease (91,2%). A total of 54 patients (25,5%) had prior stroke or transient ischemic attack. Complete information was obtained for 203 patients (95,8%), of which 164 (78,5%) passed away during the follow-up period. The leading death cause was cardiovascular disease, particularly cerebrovascular events (n=111; 67,7%). The highest mortality was recorded within the first two years of follow-up, during which more than a quarter (25,1%) of the registered patients had died. The COVID-19 pandemic did not significantly affect the mortality rates. The most common AF complications were stroke and transient ischemic attack, with a total of 74 episodes in the history and follow-up period, including 7 recurrences.Conclusion. Ambulatory AF patients represent a group with a high frequency of cardiovascular events and fatal outcomes. In the observed group of ambulatory AF patients, annual mortality exceeded 10%, and over 3/4 of patients died within 10 years. The leading death cause was cardiovascular disease, primarily cerebrovascular events.
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- 2023
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3. Patients with a Combination of Atrial Fibrillation and Chronic Heart Failure in Clinical Practice: Comorbidities, Drug Treatment and Outcomes
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M. M. Loukianov, S. Yu. Martsevich, Yu. V. Mareev, S. S. Yakushin, E. Yu. Andreenko, A. N. Vorobiev, K. G. Pereverzeva, A. V. Zagrebelny, E. Yu. Okshina, V. V. Yakusevich, Vl. Vl. Yakusevich, E. M. Pozdnyakova, T. A. Gomova, E. E. Fedotova, M. N. Valiakhmetov, V. P. Mikhin, Yu. V. Maslennikova, E. N. Belova, V. G. Klyashtorny, E. V. Kudryashov, A. N. Makoveeva, Yu. E. Tatsiy, S. A. Boytsov, and O. M. Drapkina
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atrial fibrillation ,chronic heart failure ,outpatient and hospital registries ,concomitant diseases ,multimorbidity ,pharmacotherapy ,outcomes ,mortality ,Therapeutics. Pharmacology ,RM1-950 ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Aim. To assess in clinical practice the structure of multimorbidity, cardiovascular pharmacotherapy and outcomes in patients with a combination of atrial fibrillation (AF) and chronic heart failure (CHF) based on prospective registries of patients with cardiovascular diseases (CVD).Materials and Methods. The data of 3795 patients with atrial fibrillation (AF) were analyzed within the registries RECVASA (Ryazan), RECVASA FP (Moscow, Kursk, Tula, Yaroslavl), REGION-PO and REGION-LD (Ryazan), REGION-Moscow, REGATA (Ryazan). The comparison groups consisted of 3016 (79.5%) patients with AF in combination with CHF and 779 (29.5%) patients with AF without CHF. The duration of prospective observation is from 2 to 6 years.Results. Patients with a combination of AF and CHF (n=3016, age was 72.0±10.3 years; 41.8% of men) compared with patients with AF without CHF (n=779, age was 70.3±12.0 years; 43.5% of men) had a higher risk of thromboembolic complications (CHA2DS2-VASc – 4.68±1.59 and 3.10±1.50; p
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- 2022
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4. Combination of Atrial Fibrillation and Coronary Heart Disease in Patients in Clinical Practice: Comorbidities, Pharmacotherapy and Outcomes (Data from the REСVASA Registries)
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M. M. Loukianov, S. Yu. Martsevich, E. Yu. Andrenko, S. S. Yakushin, A. N. Vorobiev, K. G. Pereverzeva, A. V. Zagrebelny, Е. Yu. Okshina, V. V. Yakusevich, Vl. Vl. Yakusevich, E. M. Pozdnyakova, T. A. Gomova, E. E. Fedotova, M. M. Valiakhmetov, V. P. Mikhin, Yu. V. Maslennikova, E. N. Belova, V. G. Klyashtorny, E. V. Kudryashov, A. N. Makoveeva, Ju. E. Tatsii, S. A. Boytsov, and O. M. Drapkina
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atrial fibrillation ,coronary artery disease ,myocardial infarction ,outpatient and hospital registries ,concomitant diseases ,multimorbidity ,pharmacotherapy ,outcomes ,mortality ,Therapeutics. Pharmacology ,RM1-950 ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Aim. Assess the structure of comorbid conditions, cardiovascular pharmacotherapy and outcomes in patients with atrial fibrillation (AF) and concomitant coronary artery disease (CAD) included in the outpatient and hospital RECVASA registries.Materials and methods. 3169 patients with AF were enrolled in outpatient RECVASA (Ryazan), RECVASA AF-Yaroslavl registries and hospital RECVASA AF (Moscow, Kursk, Tula). 2497 (78.8%) registries of patients with AF had CAD and 703 (28.2%) of them had a previous myocardial infarction (MI).Results. There were 2,497 patients with a combination of AF and CAD (age was 72.2±9.9 years; 43.1% of men; CHA2DS2-VASc – 4.57±1.61 points; HAS-BLED – 1.60±0,75 points), and the group with AF without CAD included 672 patients (age was 66.0±12.3 years; 43.2% of men; CHA2DS2-VASc – 3.26±1.67 points; HAS-BLED – 1,11±0.74 points). Patients with CAD were on average 6.2 years older and had a higher risk of thromboembolic and hemorrhagic complications (p
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- 2021
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5. Patients with Atrial Fibrillation in Clinical Practice: Comorbidity, Drug Treatment and Outcomes (Data from RECVASA Registries)
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M. M. Loukianov, E. Yu. Andreenko, S. Yu. Martsevich, S. S. Yakushin, A. N. Vorobyev, K. G. Pereverzeva, A. V. Zagrebelnyy, E. Yu. Okshina, V. V. Yakusevich, V. Vl. Yakusevich, E. M. Pozdnyakova, T. A. Gomova, E. E. Fedotova, M. N. Valiakhmetov, V. P. Mikhin, Yu. V. Maslennikova, V. G. Klyashtorny, E. V. Kudryashov, Ju. E. Tatsii, S. A. Boytsov, and O. M. Drapkina
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atrial fibrillation ,outpatient and hospital registries ,comorbidity ,drug treatment ,prospective monitoring ,outcomes ,mortality ,Therapeutics. Pharmacology ,RM1-950 ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Aim. To study comorbidity, drug therapy and outcomes in patients with atrial fibrillation (AF) included in the outpatient and hospital RECVASA registries.Material and methods. Patients with AF (n=3169; age 70.9±10.7 years; 43.1% of men) in whom comorbidity, drug therapy, short-term and longterm outcomes (follow-up period from 2 to 6 years) were included in hospital registers RECVASA AF (Moscow, Kursk, Tula), as well as outpatient registers RECVASA (Ryazan) and RECVASA AF-Yaroslavl.Results. Outpatient registries (n=934), as compared to hospital registries (n=2235), had a higher average age of patients (73.4±10.9 vs 69.9±10.5; p80 bpm, systolic blood pressure 80 bpm (RR=1.50). Anticoagulant prescription in women was associated with a lower risk of ACVA (if adjusted for age: RR=0.54; p=0.04), in contrast to men (RR=1.11; p=0.79).Conclusion. The majority of patients with AF registries in 5 regions of Russia had a combination of three or more cardiovascular diseases (73.9%), as well as chronic non-cardiac diseases (68.8%). The frequency of proper cardiovascular pharmacotherapy was insufficient (68.6%), especially at the outpatient stage (55.6%). Over the observation period (2-6 years), the average mortality per year was 10.3%, but at the same time it differed significantly in the regions (from 3.7% in Moscow to 9.7-12.5% in Yaroslavl, Ryazan and Kursk). Cardiovascular causes of deaths occurred in 62%. A higher risk of death (1.5-2.7 times) was associated with a history of stroke and MI, diabetes mellitus, COPD, heart rate>80 bpm, systolic blood pressure
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- 2020
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6. Modern antihypertensive therapy: the effectiveness of a unique Russian fixed-dose combination of ramipril and indapamide
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A. O. Konradi, S. V. Nedogoda, A. O. Nedoshivin, L. G. Ratova, R. A. Libis, G. P. Arutyunov, N. Yu. Borovkova, A. S. Galyavich, Yu. I. Grinshteyn, D. V. Duplyakov, V. V. Kashtalap, Yu. M. Lopatin, N. P. Lyamina, S. V. Malchikova, V. P. Mikhin, G. I. Nechaeva, O. D. Ostroumova, T. M. Ripp, G. A. Chumakova, I. I. Shaposhnik, and V. V. Yakusevich
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hypertension ,fixed-dose combination ,ramipril ,indapamide ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Experts consensus of the Russian Cardiology Society (RSC)
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- 2020
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7. SAFARI - RANDOMISED TRIAL ON COMPLEX THERAPY OF ARTERIAL HYPERTENSION AND DISLIPIDEMY. THE MAIN RESULTS
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S. Y. Martsevich, N. P. Kutishenko, V. V. Yakusevich, A. D. Deev, A. A. Serazhim, T. V. Bobkova, L. P. Volkonskaya, V. P. Voronina, N. A. Dmitrieva, O. V. Lerman, J. V. Lukina, M. A. Maksimova, S. N. Tolpygina, and E. V. Shilova
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сердечно-сосудистый риск ,артериальная гипертония ,гиперхолестеринемия ,Therapeutics. Pharmacology ,RM1-950 ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Aim. To evaluate possibility of complex pharmaceutical effect simultaneously on 2 risk factors – arterial hypertension (HT) and hypercholesterolemia (HH) in patients with high risk of cardiovascular complications (CVC).Material and methods. 101 patients with HT of 1-2 stage, HH and high risk of CVC (SCORE>5) were included in the study. Patients were randomized in 2 groups: active therapy group (ATG) and control group (CG). ATG patients were actively treated for HT and HH control. The long-acting nifedipine (Nifecard XL, LEK) 30 mg once daily (OD) was prescribed as start antihypertensive drug. Hydrochlorothiazide 12,5 mg/day OD and bisiprolol 5 mg OD was added if antihypertensive effect was insufficient. Atorvastatin (Tulip, LEK) 20-40 mg OD was prescribed for HH control. Management of CG patients was performed by doctors of out-patient clinics. The study duration was 12 weeks.Results. Systolic and diastolic blood pressure (BP) levels in ATG patients were lower than these in CG patients. Target BP level was reached in 88,4% of ATG patients and only in 48,9% of CG patients. Cholesterol of low density lipoprotein (CH LPLD) level was also lower in ATG patients than this in CG patients. Target CH LPLD level was reached in 37,2 % of ATG patients and in 8,3 % of CG patients. Relative risk of CVC was significantly lower in ATG patients than this in CG patients.Conclusion. SAFARI trial shows that effective pharmaceutical simultaneous control of 2 key risk factors, HT and HH, results in risk reduction of CVC.
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- 2016
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8. THE CHOICE OF THE DRUG AMLODIPINE FOR THE HYPERTENSION TREATMENT FROM THE STANDPOINT OF ECONOMIC FEASIBILITY
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S. Yu. Martsevich, N. A. Dmitrieva, A. D. Deev, Yu. V. Lukina, L. A. Sokolova, and V. V. Yakusevich
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артериальная гипертензия ,амлодипин ,дженерический препарат ,фармакоэкономический анализ ,Therapeutics. Pharmacology ,RM1-950 ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Aim. Тo compare the cost-effectiveness of antihypertensive therapy based on a generic and original drugs of amlodipine in patients with arterial hypertension (HT) degree 1-2 in NORST study. Material and methods. Patients (n=60) with HT degree 1-2 were involved in NORST study. After wash-out period they were randomized to receive generic (Group 1) or original (Group 2) amlodipine in the initial dose of 5 mg daily. In case of insufficient antihypertensive effect dose of amlodipine was increased to 10 mg per day and then successively lisinopril 10 mg daily and hydrochlorothiazide 12.5 mg one time per day were added. The total duration of treatment was 10 weeks (70 days). Achieving target blood pressure (BP) (
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- 2016
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9. THERAPEUTIC EQUIVALENCE OF ORIGINAL CLOPIDOGREL (PLAVIX) AND ITS GENERIC (EGITROMB). RESULTS OF COMPARATIVE RANDOMIZED CROSS-OVER BLIND STUDY
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V. V. Yakusevich, A. S. Petrochenko, V. A. Simonov, N. Yu. Levshin, and A. D. Deev
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клопидогрел ,агрегация тромбоцитов ,оригинальный препарат ,дженерик ,Therapeutics. Pharmacology ,RM1-950 ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
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.
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- 2016
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10. COMPARISON OF THERAPIES BASED ON CARVEDILOL AND METOPROLOL IN HYPERTENSIVE PATIENTS WITH OVERWEIGHT OR OBESITY. THE FIRST RESULTS OF CAMELLIA TRIAL
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S. Y. Martsevich, N. P. Kutishenko, E. V. Shilova, A. D. Deev, S. A. Shalnova, R. G. Oganov, I. A. Velishanina, E. G. Volkova, Yu. E. Voskanjan, L. I. Gapon, P. Ya. Dovgalevskij, V. Ya. Ermolina, E. M. Idrisova, N. N. Ilov, A. R. Kiseleva, S Yu. Levashov, V. A. Nevsorova, G. I. Nechaeva, T. N. Panova, I. I. Reznik, V. V. Skibickij, L. A. Sokolova, V. P. Terentev, N. V. Hailo, A. V. Shabalin, T. V. Shnyukova, V. V. Yakusevich, E. N. Akulina, V. A. Budanova, T. S. Bondarenko, V. P. Voronina, I. N. Gozhaja, I. I. Igricenco, A. V. Drogan, N. A. Dmitrieva, F. M. Dyshekova, A. I. Zaiceva, A. N. Ikovnikova, G. A. Ilicheva, I. S. Irhina, L. A. Kovaleva, O. N. Kutkina, E. A. Kudrjashev, A. Z. Leonidova, E. N. Loginova, M. P. Marganjan, O. V. Nastradin, A. N. Nikitina, I. N. Nikolskaja, I. E. Pashinceva, A. S. Petrochenko, O. M. Pasnenkova, E. S. Potapova, A. A. Serazhim, M. N. Sergeev, V. V. Sidorenko, V. A. Simonov, D. V. Sirotenko, I. N. Spanderashvili, A. N. Strunina, E. S. Timoschenko, S. N. Tolpygina, and M. R. Redkina
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артериальная гипертония ,избыточная масса тела ,ожирение ,бета-блокаторы ,карведилол ,метопролол ,Therapeutics. Pharmacology ,RM1-950 ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Aim. To evaluate antihypertensive and metabolic effects of the therapy based on carvedilol (C) in comparison with metoprolol (M) in hypertensive patients with overweight or obesity.Material and methods. 320 patients were involved in multicenter, randomized open parallel study. One part of the patients received C 12,5 mg BID (Vedicardol, “Sintez”), another part – M 25 mg/day BID. Doubling dose of β-blockers (BB) and switching patients to combined therapy with AML 5-10 mg OD (Amlorus, “Sintez”) and hydrochlorothiazide (HCT) 12,5-25 mg OD was performed if necessary. The study duration was 24 weeks.Results. Significant reduction of systolic and diastolic blood pressure was revealed in both groups, there was no difference between groups (р=0,88 and p=0,61 respectively). Switching patients to combined therapy with AML and HCT was made more often in M group than in C group (p>0,05). Prescription of BB resulted in significant reduction of the heart rate, there was no difference between groups (p=0,61). 96,2% patients of group C and 95,5% of group M reached target levels of BP. Significant reduction of glucose (p0.05), half of them were not related to BB taking.Conclusion: Controlled antihypertensive therapy, based on С and M, allows reaching target levels of BP in majority of patients with overweight or obesity. Switching to combined therapy was made more seldom in group of С than in M group. Both drugs demonstrated metabolic neutrality, however significant lowering of glucose and uric acid levels and tendency to lowering of TC an LDLC levels was observed only in group С.
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- 2016
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11. COMPARISON OF THE METABOLIC EFFECTS OF CARVEDILOL AND METОPROLOL IN HYPERTENSIVE PATIENTS WITH OVERWEIGHT AND OBESITY. THE CAMELLIA TRIAL
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S. Y. Martsevich, N. P. Kutishenko, E. V. Shilova, A. D. Deev, S. A. Shalnova, R. G. Oganov, I. A. Veliganina, E. G. Volkova, Yu. E. Voskanjan, L. I. Gapon, P Ya. Dovgalevskij, V. Ya. Ermolina, E. M. Idrisova, N. N. Ilov, A. R. Kiselev, S. Yu. Levashov, V. A. Nevzorova, G. I. Nechaeva, T. N. Panova, I. I. Reznik, V. V. Skibickij, L. A. Sokolova, V. P. Terentev, N. V. Hailo, A. V. Shabalin, T. V. Shnjukova, and V. V. Yakusevich
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артериальная гипертония ,избыточная масса тела ,ожирение ,бета-адреноблокаторы ,карведилол ,метопролол ,Therapeutics. Pharmacology ,RM1-950 ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Aim. To compare two therapies based on carvedilol or metoprolol in hypertensive patients with overweight and obesity.Material and methods. 320 patients with arterial hypertension (1-2 degree) were involved in the study. 160 patients received carvedilol and 160 patients – metoprolol. Both randomized groups were comparable on the main clinical characteristics.Results. By the end of the study both systolic and diastolic blood pressure (SBP, DBP) reduced in both groups рConclusion. The results of open, randomized CAMELLIA trial confirmed antihypertensive effect and good tolerability of carvedilol in common clinical practice as well as demonstrated some its advantages in patients with metabolic syndrome. Carvedilol has positive metabolic effects on lipid, glucose and uric acid levels. Carvedilol therapy is more preferable in patients with arterial hypertension and metabolic risk factors.
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- 2016
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12. COMMENTS ON GUIDELINES OF THE TASK FORCE FOR DIAGNOSIS AND TREATMENT OF CHRONIC HEART FAILURE OF THE EUROPEAN SOCIETY OF CARDIOLOGY (2005)
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V. V. Yakusevich
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Therapeutics. Pharmacology ,RM1-950 ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Published
- 2016
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13. EFFECTS OF BETAHISTINE DIHYDROCHLORIDE AS ADJUVANT TO ENALAPRIL THERAPY OF PATIENTS WITH CHRONIC HEART FAILURE CLASS II-II (NYHA) SUFFERING FROM GIDDINESS
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S. Y. Martsevich, J. V. Lukina, V. V. Yakusevich, D. A. Anichkov, A. D. Deev, O. V. Lerman, S. N. Tolpygina, N. A. Dmitrieva, A. A. Serazhim, M. A. Maksimova, V. P. Voronina, E. V. Shilova, G. F. Andreeva, A. V. Zaharova, I. V. Novikov, А. А. Platonova, Т. А. Kazakovtseva, T. V. Babkova, and L. P. Volhonskaya
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chronic heart failure ,giddiness ,betahistine dihydrochloride ,Therapeutics. Pharmacology ,RM1-950 ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Aim. To study adjuvant effect of betahistine dihydrochloride to ACE inhibitors in patients with chronic heart failure (CHF) class II-III suffering from giddiness.Material and methods. 61 patients with CHF class II-III, ejection fraction ≤45% (Simpson) suffering from giddiness were involved into randomized open parallel study. Patients were randomized to Betahistine dihydrochloride plus basic CHF therapy or only basic therapy groups. Enalapril dose titration was performed in all patients. Quality of life and giddiness severity evaluation, electrocardiogram was performed initially and after treatment. Clinical examination results, drug therapy and adverse event were registered at each visit.Results. The target ACE inhibitor dose (≥20 mg daily) was reached in 97 % of patients. It led to significant reduction of dyspnea, edemas, CHF class reduction and life quality increase. Significant differences between investigated groups were not found. Reduction of giddiness severity was shown in both groups. There was a trend to more prominent improvement of life quality (р=0,08) and more frequent achievement of target ACE inhibitor dose in patients treated with betahistine dihydrochloride.Conclusion. The target ACE inhibitor dose can be achieved more than in 90% of patients with CHF class II-III without hypotension symptoms. Adjuvant usage of betahistine dihydrochloride is necessary in patients with CHF still suffering from giddiness after achievement of target ACE inhibitor dose.
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- 2016
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14. ASSESSMENT OF QUALITY OF GENERICS IN CARDIOLOGY: REALITY AND POSSIBILITIES
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V. V. Yakusevich
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дженерики ,оригинальные препараты ,фармацевтическая ,армакокинетическая ,фармакотерапевтическая эквивалентность ,Therapeutics. Pharmacology ,RM1-950 ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Wide presence of original drugs’ copies, the so-called “generics”, on the pharmaceutical market is analyzed. The positive side of this expansion is connected with the lower price of generics, which makes it possible to decrease the costs of treatment. From the other side with the advent of big number of copies of the original drugs it becomes more difficult to assess the quality of each particular generic. Russian legislation in the field of registration allows selling in the country almost all drugs, which have at least minimal similarity to the original. The problem of pre-registration studies of bioequivalency of original and analogue drugs, therapeutical equivalency is widely observed. Concrete proposals of how to prevent the overflow of the Russian market with the generics with the unproved efficacy and safety are considered.
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- 2015
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15. ASSESSMENT OF THERAPEUTICAL EQUIVALENCY OF ORIGINAL AND GENERIC INDAPAMIDE IN HYPERTENSIVE PATIENTS BY RANDOMIZED CROSS-OVER STUDY
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N. P. Kutishenko, V. V. Yakusevich, A. D. Deev, and S. Y. Martsevich
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индапамид ,оригинальный препарат ,дженерик ,артериальная гипертония ,Therapeutics. Pharmacology ,RM1-950 ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Aim. To develop a protocol for comparison of efficacy and safety of original drugs with generic ones and to apply this protocol for comparison of generic indapamide (Indap) with original indapamide in two presentations: short acting (Arifon) and long acting (Arifon Retard).Materials and methods: 64 patients with arterial hypertension of 1-2 degree took part in open cross-over randomized study. All patients were treated with Indap as well as with Arifon (half of patients) or Arifon Retard (another half) for comparison. Each kind of therapy lasted for 6 weeks; sequence of drug administration was randomized. The effect of treatment was assessed by resting blood pressure (BP) dynamics. If antihypertensive effect was not sufficient after 3 weeks of treatment, lisinopryl (Dapril) 10 mg/d was added.Results. There were no differences between basic clinical characteristics in groups of patients initially treated with different indapamide medications. Systolic and diastolic BP significantly reduced after 3 weeks of treatment without difference between tested indapamide medications. Combined therapy led to additional decrease in BP without significant difference between the patients groups. There was no significant difference in groups on the rates of side effects caused by therapy with tested indapamide medications.Conclusion. The proposed protocol of study showed that there were no significant differences in efficacy and safety of two presentations of original indapamide and tested generic indapamide in hypertension treatment.
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- 2015
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16. ARTERIAL HYPERTENSION IN RUSSIA: PROLOG STUDY AS A PROOF METHOD OF CONTEMPORARY THERAPY OPPORTUNITIES
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S. A. Shalnova, S. Y. Martsevich, A. D. Deev, N. P. Kutishenko, P. G. Oganov, A. N. Britov, E. G. Volkova, K. I. Ivanov, A. M. Kalinina, L. I. Katelnitskaya, G. D. Kobalava, E. V. Kokurina, A. O. Conradi, S. K. Kukushkin, Yu. M. Lopatin, N. I. Maksimov, V. Y. Mareev, I. S. Petelin, D. V. Nebieridze, G. I. Nechayev, L. A. Sokolova, A. V. Suslikov, I. G. Fomina, A. V. Shabalin, V. A. Shulman, V. V. Yakusevich, and S. S. Jakushin
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артериальная гипертония ,целевое АД ,ингибиторы АПФ ,ступенчатая терапия гипертонии ,Therapeutics. Pharmacology ,RM1-950 ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Aim. To prove the advantage of the long-term controlled antihypertensive therapy compared with the real usual standard therapy in patients with mild to moderate arterial hypertension.Material and methods. It was multicenter, randomized, prospective parallel-group study in patients with mild to moderate hypertension. One part of patients (treatment group) received the strongly regulated stepped antihypertensive therapy based on ACE-inhibitor spirapril, the second one (control group) continued their usual standard therapy prescribed by doctors of polyclinics or other patient care institutions. The study lasted one year.Results. 1742 patients were enrolled in the study, 854 patients were included in the treatment group and 888 – in the control group. 220 patients dropped out of the study by different reasons, and 1552 patients finished the study. There were 651 (37,6%) men and 1081 (62,4%) women. It was substantial decrease in blood pressure in both group, but distinctions between systolic and diastolic blood pressure in the treatment and control group during the study were significant.The target levels of blood pressure (systolic < 140 mm Hg and diastolic < 90 mm Hg) were registered substantially more frequent in the patients of treatment group than in control group (69,4% и 39,3% after three months and 83,6% и 66,9% after 12 months of the treatment correspondingly).Conclusion. Controlled stepped antihypertensive therapy resulted into more significant decrease in systolic and diastolic blood pressure and more frequent achievement of target levels of blood pressure in comparison with control group. It supposes better prognosis of patients.
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- 2015
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17. THE EFFICACY OF HIGH-DOSE SIMVASTATIN IN ACUTE PERIOD OF ISCHEMIC STROKE
- Author
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V. V. Yakusevich, A. Yu. Malygin, S. V. Lychenko, A. S. Petrochenko, and A. V. Kabanov
- Subjects
ишемический инсульт ,симвастатин ,высокая доза ,эндотелиальная дисфункция ,сердечно-сосудистые события ,Therapeutics. Pharmacology ,RM1-950 ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Aim. To estimate in a 12-month study mortality and frequency of recurrent cardiovascular events, dynamics of neurological deficit and endothelial dysfunction in patients with the first-time ischemic stroke treated with simvastatin 40 mg/day in acute period of the disease. Materials and methods. The efficacy of high-dose simvastatin (40 mg/day) therapy initiated in acute stage of ischemic stroke was evaluated in 12-month comparative randomized study. Patients of the first group (n=97) received standard stroke therapy , and patients of the second group (n=86) also received standard treatment and simvastatin additionally. Combined endpoint (cardiovascular death + recurrent cardiovascular events + necessity of readmission), dynamics of neurological status and endothelial function were considered. Results. Primary combined endpoint was achieved in 66 cases in the first group (68.04%) and in 47 (54.65%) in the second one (p=0.043). Neurological status evaluated by National Institutes of Health Stroke Scale (NIHSS), Mini-Mental State Examination (MMSE) scale, and Scandinavian scales had a faster positive dynamics in patients receiving simvastatin. The same patients revealed more intense and quick decrease in desquamated plasma endotheliocytes. Conclusion. Simvastatin 40 mg/day prescribed along with neuroprotective and antihypertensive treatment in acute stage of ischemic stroke leads to lowering of recurrent cardiovascular events number, positive dynamics of neurological status, regression of endothelial dysfunction reflected by significant decrease in number of circulating desquamated endotheliocytes.
- Published
- 2015
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- View/download PDF
18. PHARMACOLOGICAL CORRECTION OF CEREBRAL BLOOD FLOW DISTURBANCES IN WOMEN WITH ARTERIAL HYPERTENSION IN POSTMENOPAUSE
- Author
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V. V. Yakusevich, M. E. Mozheiko, N. V. Sudareva, and N. E. Semyonova
- Subjects
артериальная гипертония ,постменопаузальный период ,церебральный кровоток ,моэксиприл ,аторвастатин ,Therapeutics. Pharmacology ,RM1-950 ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Aim: to study cerebral blood flow and cholesterol metabolism in menopausal women with arterial hypertension (AH); to evaluate dynamics of cerebral blood flow parameters and plasma lipid concentrations in these patients during 6-month antihypertensive and hypolipidemic therapy.Material and methods: 24 women with AH of I and II grade were examined. They were in postmenopausal period of life during 7,1±0,5 years. At the beginning of the study all women were prescribed moexipril as monotherapy, daily dose 7,5 – 15 mg. Patients with initial dislipidemia were prescribed lipid reducing drug atorvastatin in 10mg daily dose additionally to the antihypertensive therapy. Therefore all the patients were divided into two groups: I – monoteraphy with moexipril (13 people), II – combined therapy with moexipril and atorvastatin (11 people). At the beginning of the study and after 6 months all the patients passed through ultrasonic Dopplerography of vessels of head and neck, rheoencephalography, their lipoproteidogrammes were studied.Results: During 6-month therapy all the patients showed proved decrease in systolic and diastolic blood pressure, also positive dynamics of neuropsychological status, improvement in cerebral blood flow according to the results of Dopplerography of vessels and rheoencephalography. Normalization of plasma lipid spectrum was noted. More significant positive changes in cerebral hemodynamic parameters and plasma lipid spectrum were observed in patients, who received combined therapy with antihypertensive and lipid reducing drugs.Conclusion: Deterioration of cerebral hemodynamics is typical for women with long-lasting AH. The most positive influence on cerebral perfusion was received due to combined therapy with moexipril and atorvastatin.
- Published
- 2015
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19. EFFECT OF SIMVASTATIN ON THE PROGNOSIS AND THE CHANGES OF THE CLINICAL STATUS IN PATIENTS WITH ACUTE ISCHEMIC STROKE. THE RESULTS OF THE 12 MONTH RANDOMIZED, OPEN COMPARATIVE STUDY
- Author
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V. V. Yakusevich, A. Yu. Malygin, and A. V. Kabanov
- Subjects
ишемический инсульт ,симвастатин ,прогноз ,неврологический статус ,эндотелиальная дисфункция ,Therapeutics. Pharmacology ,RM1-950 ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Aim. To evaluate in open 12 month prospective, randomized study the mortality and recurrent cardiovascular events rate, dynamics of neurological deficit, endothelial dysfunc- tion and renal function in patients with the first ischemic stroke of hemispheric localization after prescription of simvastatin 40 mg daily in the acute stage of the disease. Material and methods. Patients (n=210) above 18 years of age (95 men and 115 women) with acute ischemic stroke were included into the study. Patients were randomized into two groups. Patients of the group 1 (n=105) received standard treatment for ischemic stroke. Patients of the group 2 (n=105) received simvastatin 40 mg/day additional- ly to standard therapy of stroke. Follow-up duration was 12 months. The lipid profile, a number of desquamated epithelial cells circulating in the blood, glomerular filtration rate (GFR) according to MDRD, as well as neurological patient status (Scandinavian Scale, MMSE, NIHSS) were monitored.Results. During the follow-up period mortality was 18.1% and 15.2% in group 1 and 2, respectively. Composite end point was achieved in 60.9% and 46.6% of patients, re- spectively (p=0.037). Lipid profile did not change significantly in group 1 while patients in group 2 showed a significant decrease in lipid levels. The positive dynamics of neuro- logical status was observed in both groups, however, the most significant - in group 2. Reduction in a number of endothelial desquamated cells was 45.7% in group 2 and 13.3% in group 1 (p=0.00001). GFR increased significantly in patients of group 2.Conclusion. The long-term treatment with simvastatin in combination with neuroprotective and antihypertensive therapy in patients with acute ischemic stroke leads to decrease in the incidence rate of clinically relevant events, improvement of endothelial function, neurological status and prognosis.
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- 2015
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20. AN OUTPATIENT WITH ATRIAL FIBRILLATION: KEY FEATURES. THE FIRST DATA OF REKVAZA FP - YAROSLAVL REGISTER
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V. V. Yakusevich, E. M. Pozdnyakova, Vl. .V. Yakusevich, V. A. Simonov, S. Yu. Martsevich, M. M. Loukianov, A. V. Zagrebelnyy, and S. A. Boytsov
- Subjects
фибрилляция предсердий ,амбулаторная практика ,мониторинг событий ,Therapeutics. Pharmacology ,RM1-950 ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Aim. To study the clinical forms of atrial fibrillation (AF), cardiovascular risk factors and comorbidities in these patients; to perform monitoring of complications and mortality in AF; to assess the quality of diagnosis and treatment of AF in real outpatient practice.Material and methods. The register of patients with AF, visited an outpatient clinic of Yaroslavl from 01 January to 31 December 2013, was created. Quality of AF patient examination in the outpatient clinic was assessed. Morbidity and mortality of these patients were monitoring during 12 months by the contacts with patients, their relatives and doctors in charge.Results. The typical patient with AF has advanced age, mainly permanent AF and compromised history of cardiovascular diseases. 12-month monitoring of 212 outpatients with AF showed high mortality and the need for hospitalization due to cardiovascular diseases in this group. A total number of these patients was 99 or 46.7% of patients included into the register.Conclusion. The irregularity of observation and the lack of examination of patients with AF may be the reasons of the increased rates of mortality and complications in this group of outpatients.
- Published
- 2015
- Full Text
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21. ROLE OF THE ANTIPLATELET DRUGS IN TREATMENT OF STABLE ANGINA: COMMON SENSE AND NON-RESOLVED ISSUES
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V. V. Yakusevich, V. Vl. Yakusevich, and E. M. Pozdnyakova
- Subjects
ihd ,angina ,aspirin ,clopidogrel ,generics ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Stable angina pectoris is the most prevalent type of ischemic heart disease. In its treatment, the main role play drugs that block adhesion and aggreagation of platelets — antiaggregants. Their role in prevention of cardiovascular complications in this kind of patients was confirmed by multiple large clinical trials. However, there is a plenty of antiaggregants with various mechanisms of effect, only two of them: acetylsalicylic acid and clopidogrel currently are recommended for continuous use for patients with stable IHD. Acetylsalicylic acid is in priority, and clopidogrel as an alternative in its intolerance. At the same time, lower prevalence of side effects, common for clopidogrel, makes the use of the drug more attractive. Many generics of the both drugs, invented recently, actualizes the comparative studies of these forms with the originals.
- Published
- 2015
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- View/download PDF
22. HEMORHEOLOGICAL PROFILE AND LIPID SPECTRUM IN PATIENTS IN THE ACUTE PHASE OF ISCHEMIC STROKE
- Author
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V. V. Yakusevich, S. V. Lychenko, and A. Yu. Malygin
- Subjects
ischemic stroke ,atherosclerosis ,hemorheological profile ,lipid spectrum ,Medicine - Abstract
Objective: to assess the specific features of the hemorheological profile and lipid spectrum in patients in the acute phase of ischemic stroke inthe presence of arterial hypertension (AH). Subjects and methods. Fifty patients divided into 2 groups were examined. Group 1 included 30 patients (mean age 67 .0± 10.1 years) with acute ischemic stroke. They all were diagnosed as having grade 2 AH as evidenced by medical records. Group 2 comprised 20 apparentlyhealthy individuals (50 ± 48 years) without AH. The parameters of the hemorheological profile and lipid spectrum were determined in allthe enrolled patients.Results. Among the blood macrorheological characteristics, there was a rise in plasma viscosity in the study group, which was 17 % greaterthan in group 2 (2.10 ± 0.25 and 1.80 ± 0.23 mPas, respectively; p < 0.01). The most important results were obtained in the study of bloodmicrorheological characteristics. All the study parameters were considerably higher in the patients with acute ischemic stroke than those in the apparently healthy individuals. Thus, the formation rate for aggregates (0.50 ± 0.24 and 0.32 ± 0.20 relative units in Groups 1 and 2, respectively; p < 0.01) and their sizes (7.30 ± 1.02 and 6.20 ± 0.63 relative units, respectively; p < 0.01) were more in the study group thanthose in the control one. At the same time, in the study group the integral aggregation index was 80 % higher (p < 0.01) than that in the control. However, in the patients with acute ischemic stroke, the erythrocyte rigidity index was lower than that in apparently healthy patients (0.71 ± 0.07 and 0.76 ± 0.09 relative units, respectively; p < 0.05). In Group 1 patients, impairments of the hemorheological profile were accompanied by changes in the lipid spectrum. Despite the fact that no differences in total cholesterol levels were recorded in the study groups (4.7 ± 1.5 and 5.20 ± 1.02 mmole/l in Groups 1 and 2, respectively), there was a substantial change in the other parameters of the lipid spectrum. Thus, in the patients with acute ischemic stroke, the levels of high-density lipoprotein cholesterol were 62 % lower than in the control group (p < 0.01) and the atherogenicity coefficient was 1.5-fold higher in the study group than in the control one (p < 0.01). At the same time, there were increases in triglycerides in Groups 1 and 2 (1.33 ± 0.74 and 0.96 ± 0.55 mmol/l, respectively; p < 0.05) and low-density lipoprotein cholesterol in these groups (3.10 ± 0.78 and 1.96 ± 0.60 mmol/l, respectively; p < 0.01).Conclusion. The changes in the lipid spectrum and hemorheological profile can provide a more detailed insight into the pathogenic processesoccurring in the patients in the acute phase of ischemic stroke.
- Published
- 2014
23. ANTIPLATELET ACTIVITY OF ORIGINAL CLOPIDOGREL AND ITS GENERIC: RESULTS OF RANDOMIZED COMPARATIVE CROSS-OVER STUDY
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V. V. Yakusevich, A. S. Petrochenko, V. S. Simonov, N. Yu. Levshin, and A. D. Deev
- Subjects
clopidogrel ,equivalence ,plavix ,plagril ,Medicine - Abstract
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.
- Published
- 2014
24. CHARACTERISTICS OF BLOOD RHEOLOGICAL PARAMETERS IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE
- Author
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M. M. Egorova, O. A. Ovchinnikova, E. P. Petrochenko, A. O. Oslyakova, and V. V. Yakusevich
- Subjects
human immunodeficiency virus ,dilated cardiomyopathy ,pericardial effusion ,antiretroviral therapy ,Medicine - Abstract
Aim – to evaluate macro-and microrheology hemorheological characteristics parameters in patients with COPD, and their dependence on the severity of COPD.Materials and methods. The study included 107 people, 80 patients with chronic obstructive pulmonary disease I, II, III, IV degree and 27 persons as a control group. Rheological examination included determination of the viscosity of whole blood and erythrocyte suspensions with a hematocrit (HT) 40 % in plasma and nonggregating environment, the plasma viscosity. Measuring the effectiveness of oxygen delivery to tissues produced by the formula: TO2 = Ht/η, where η — viscosity of blood. The degree of erythrocyte aggregation was evaluated by microscopy with video recording of diluted blood, and computer image analysis. Indices of rigidity of the red blood cells were calculated, indicators of internal viscosity of red blood cell content and efficiency of transport of oxygen to the tissues.Results. In patients with COPD were identified expressed disturbances of macro-and microrheology of blood parameters were identified. Blood viscosity at all shear stresses were increased by 23–27% compared with the control group, plasma viscosity – 21.5 % (p < 0.001). Indicators of hemoglobin and hematocrit (by 9.7 % and 8.8 % respectively, p < 0,001) were Significantly higher in patients with COPD. The viscosity of erythrocyte suspension to a standard hematocrit of 40 % in saline and in autologous plasma at different shear stresses were increased by 19,5–25,3 % (p < 0,001) and 22–24 % (p < 0,001), respectively. Revealed significant changes in properties of the blood stream, which in turn led to a marked reduction in oxygen-function of the blood in 27.5 % (p < 0.001).Conclusions. In patients with COPD, there are marked disturbances of macro-and microrheology of blood parameters, the viscosity of whole blood and plasma increases greatly, red blood cell deformability is reduced, and changing of the properties of the blood stream leads to decrease in its oxygenfunction. However, with increasing severity of COPD, there is no corresponding worsening of blood rheology.
- Published
- 2014
25. MAXIMAL REDUCTION OF CARDIOVASCULAR COMPLICATIONS RISK – THE MAIN TASK OF MODERN THERAPY FOR HIGH RISK PATIENTS. RANDOMIZED STUDY ON COMPREHENSIVE CONTROL ON ARTERIAL HYPERTENSION AND DYSLIPIDAEMIA
- Author
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N. P. Kutishenko, V. V. Yakusevich, A. A. Seragzim, A. D. Deev, and S. Y. Martsevich
- Subjects
Therapeutics. Pharmacology ,RM1-950 ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Maximal reduction of cardiovascular complications risk – the main task of modern therapy for high risk patients. Randomized study on comprehensive control on arterial hypertension and dyslipidaemia.
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- 2015
- Full Text
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26. ON ETHICS OF SCIENTIFIC PUBLICATION
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V. V. Yakusevich
- Subjects
Therapeutics. Pharmacology ,RM1-950 ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
On ethics of scientific publication.
- Published
- 2015
- Full Text
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27. PROLOG study: main results and guidance for further action
- Author
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S. Yu. Martsevich, S. A. Shalnova, A. D. Deev, N. P. Kutishenko, and V. V. Yakusevich
- Subjects
arterial hypertension ,antihypertensive drugs ,cardiovascular event risk reduction ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
The article contains main results of PROLOG study, that compared effectiveness of controlled arterial hypertension therapy in step-wise antihypertensive treatment scheme: ACE inhibitor, spirapril, with addiction, if necessary, of diuretic hydrochlorthiazide, and beta-adrenoblocker atenolol (intervention group), vs standard treatment, prescribed by out-patient clinic doctors (control group). The follow-up period lasted for one year. Throughout the study period, systolic and diastolic blood pressure levels were significantly lower in intervention group than in control one. Cardiovascular event risk reduction was more pronounced in intervention group: 33% vs 22% in control group. PROLOG study results coincide with data from other large-scale, randomized, controlled studies.
- Published
- 2006
28. Indap effectiveness and tolerability, in comparison to arifon and arifon retard, as monotherapy or in combination with ACE inhibitors, among patients with mild to moderate arterial hypertension. Multi-center, open, randomized, cross-over study
- Author
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S. Yu. Martsevich, N. P. Kutishenko, A. D. Deev, and V. V. Yakusevich
- Subjects
Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Published
- 2006
29. Conceptual approaches to cerebral blood flow correction in postmenopausal women with arterial hypertension
- Author
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V. V. Yakusevich, M. E. Mozeyko, and N. V. Sudareva
- Subjects
arterial hypertension ,postmenopause ,cerebral blood flow ,moexipril ,fosinopril ,atorvastatin ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Aim. To assess cerebral blood flow and cholesterol (CH) metabolism in postmenopausal women with arterial hypertension (AH); to evaluate dynamics of cerebral blood flow and lipid profile during 6-month antihypertensive and hypolipidemic therapy. Material and methods. Postmenopausal women (n=47) with Stage I-II AH were examined. Leading clinical symptoms were explained by cerebrovascular pathology. All participants were divided into two groups: moexipril monotherapy (7.5-15 mg/d; n=15) and fosinopril monotherapy (10-20 mg/d; n=15). Women with dyslipidemia were administered atorvastatin, 10 mg/d: 10 patients in moexipril group, and 7 in fosinopril group. At baseline and 6 months later, Doppler ultrasound and lipoprotein profile assessment were performed in all participants. Results. At baseline, increased systolic blood flow velocity (S), decreased pulse index (PI), and increased cerebral vascular resistance index (RI) were observed in hypertensive women, comparing to age-specific normal levels. Six-month antihypertensive therapy was associated with S decrease, PI increase, and RI reduction, without any significant difference in cerebral hemodynamics parameters between two groups. At the same time, positive dynamics was more manifested in combined antihypertensive and hypolipidemic treatment. In these patients, cerebral hemodynamics improvement was combined with improvements in lipid profile and quality of life. Conclusion. In women with long-term AH duration, cerebral hemodynamics is typically disturbed. Combined antihypertensive and hypolipidemic therapy has the greatest beneficial effect on cerebral perfusion.
- Published
- 2005
30. A STUDY OF CLINIC EQUIVALENCE OF TWO DRUG FORMS OF ENALAPRIL IN PATIENTS WITH ARTERIAL HYPERTENSION
- Author
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N. P. Kutishenko, S. Yu. Martsevich, S. A. Shalnova, A. D. Deyev, and V. V. Yakusevich
- Subjects
arterial hypertension ,cost of therapy ,enalapril drug forms (renitec® and enam®) ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
In a randomized open crossover study clinic equivalence of two drug forms of enalapril (Renitec®and Епат® in patients with arterial hypertension (AH) was compared. 46 patients with mild to moderate AH (mean age 57, 0 ± 12, 5years) have been studied. All underwent courses of treatment with Renitec® and Enam® 4 weeks each. Every drug's initial daily dose was 10 mg and increased to 20 mg daily in case of insufficient antihypertensive effect. The effect of treatment was evaluated by daily BP dynamics. After 4 weeks therapy Enam® and Renitec® resulted in reliable indices reduction both systolic BP (SBP) and diastolic BP (DBP). At the end of a course of treatment with Enam® SBP decreased to 16, 8 mm Hg, DBP to 8, 2 mm Hg (in both cases p < 0,001). Under the influence of Renitec® SBP decreased to 19, 1 mm Hg, DBP to 9, 6 mm Hg (in both cases the tendency to more marked effect of Renitec® was noted, but differences between two medications were not statistically significant. During the course of both medications insignificant inauthentic increase of HR was observed. The dose-effect analysis showed that for achieving the equal level of SBP reduction the dose of Enam® should be slightly higher, at the same time the cost of therapy with much as Renitec® BP reduction was less in treatmentwith Enam®, then with Renitec®. Two drugforms of enalapril Enam® and Renitec® are clinically equivalent, at the same time the daily therapy of AH in treatment with Enam® prove to be significantly inexpensive.
- Published
- 2003
31. SYMPOSIUM 'THIAZIDE-LIKE DIURETICS IN THE THERAPY OF ARTERIAL HYPERTENSION' (OCTOBER 11, 2007. MOSCOW)
- Author
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V. V. Yakusevich
- Subjects
Therapeutics. Pharmacology ,RM1-950 ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Published
- 2016
- Full Text
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32. Patients with Atrial Fibrillation in Clinical Practice: Comorbidity, Drug Treatment and Outcomes (Data from RECVASA Registries)
- Author
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V. P. Mikhin, A. N. Vorobyev, Yu. V. Maslennikova, E. V. Kudryashov, E. E. Fedotova, Sergey Boytsov, V. V. Yakusevich, Oxana Drapkina, E. Yu. Andreenko, Ju. E. Tatsii, S. S. Yakushin, V. G. Klyashtorny, E. M. Pozdnyakova, M. M. Loukianov, E. Yu. Okshina, S. Yu. Martsevich, T. A. Gomova, K. G. Pereverzeva, A. V. Zagrebelnyy, and M. N. Valiakhmetov
- Subjects
medicine.medical_specialty ,medicine.drug_class ,RM1-950 ,Lower risk ,outcomes ,Pharmacotherapy ,Diabetes mellitus ,Internal medicine ,medicine ,Diseases of the circulatory (Cardiovascular) system ,Pharmacology (medical) ,atrial fibrillation ,Stroke ,outpatient and hospital registries ,prospective monitoring ,business.industry ,Anticoagulant ,drug treatment ,Atrial fibrillation ,medicine.disease ,Comorbidity ,mortality ,comorbidity ,Blood pressure ,RC666-701 ,Therapeutics. Pharmacology ,Cardiology and Cardiovascular Medicine ,business - Abstract
Aim. To study comorbidity, drug therapy and outcomes in patients with atrial fibrillation (AF) included in the outpatient and hospital RECVASA registries.Material and methods. Patients with AF (n=3169; age 70.9±10.7 years; 43.1% of men) in whom comorbidity, drug therapy, short-term and longterm outcomes (follow-up period from 2 to 6 years) were included in hospital registers RECVASA AF (Moscow, Kursk, Tula), as well as outpatient registers RECVASA (Ryazan) and RECVASA AF-Yaroslavl.Results. Outpatient registries (n=934), as compared to hospital registries (n=2235), had a higher average age of patients (73.4±10.9 vs 69.9±10.5; p2DS2-VASc 4.65±1.58 vs 4.15±1.71; p80 bpm, systolic blood pressure 80 bpm (RR=1.50). Anticoagulant prescription in women was associated with a lower risk of ACVA (if adjusted for age: RR=0.54; p=0.04), in contrast to men (RR=1.11; p=0.79).Conclusion. The majority of patients with AF registries in 5 regions of Russia had a combination of three or more cardiovascular diseases (73.9%), as well as chronic non-cardiac diseases (68.8%). The frequency of proper cardiovascular pharmacotherapy was insufficient (68.6%), especially at the outpatient stage (55.6%). Over the observation period (2-6 years), the average mortality per year was 10.3%, but at the same time it differed significantly in the regions (from 3.7% in Moscow to 9.7-12.5% in Yaroslavl, Ryazan and Kursk). Cardiovascular causes of deaths occurred in 62%. A higher risk of death (1.5-2.7 times) was associated with a history of stroke and MI, diabetes mellitus, COPD, heart rate>80 bpm, systolic blood pressure
- Published
- 2020
33. The Therapy with Oral Anticoagulants in Patients with Atrial Fibrillation in Outpatient and Hospital Settings (Data from RECVASA Registries)
- Author
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V. V. Yakusevich, Oxana Drapkina, E. Y. Andreenko, M. A. Panagopulu, A. V. Zagrebelnyy, K. G. Pereverzeva, Sergey Boytsov, E. V. Kudryashov, E. E. Fedotova, V. P. Mikhin, E. Yu. Okshina, A. N. Vorobyev, S. Yu. Martsevich, T. A. Gomova, S. S. Yakushin, V. G. Klyashtorny, M. N. Valiakhmetov, E. M. Pozdnyakova, M. M. Loukianov, and Yu. V. Maslennikova
- Subjects
medicine.medical_specialty ,RM1-950 ,non-vitamin k antagonist oral anticoagulant ,Internal medicine ,follow-up ,Medicine ,Outpatient clinic ,Diseases of the circulatory (Cardiovascular) system ,Pharmacology (medical) ,In patient ,atrial fibrillation ,Stroke ,therapy with oral anticoagulants ,business.industry ,Incidence (epidemiology) ,Warfarin ,registries ,Atrial fibrillation ,medicine.disease ,outpatient and hospital settings ,Thromboembolic risk ,warfarin ,Hospital treatment ,RC666-701 ,Therapeutics. Pharmacology ,Cardiology and Cardiovascular Medicine ,business ,medicine.drug - Abstract
Aim. To evaluate an incidence of oral anticoagulants (OAC) administration during longterm follow-up period in patients with atrial fibrillation (AF) enrolled in outpatient and hospital RECVASA registries.Material and methods. 3169 patients with AF were enrolled in outpatient registries RECVASA (Ryazan), RECVASA AF-Yaroslavl and hospital registries RECVASA AF (Moscow, Kursk, Tula), age 70.9±10.7 years, 43.1% men. The incidence of OAC administration was evaluated in hospital and outpatient settings, including longterm follow-up period (2-6 years).Results. OAC were administrated only in 42.2% of cases (1335 from 3169 patients; age 69.1±10.4 years, 43% men), including warfarin (817 patients; 26%) and non-vitamin K antagonist oral anticoagulants (NOAC) – 518 (16%). Patients with permanent and persistant types of AF had lower incidence of OAC administration (43% and 40%) than in cases of paroxysmal type (47.6%, p0.05) contrary to the pronounced difference of thromboembolic risk in these groups (6.14±1.34 and 3.77±1.39; рConclusions. RECVASA registries in 5 regions of Russia revealed low incidence of OAC administration. The risk of thromboembolic events was higher in patients with AF and no OAC administration compared with patients who received OAC. Patients with paroxysmal type of AF received OAC more often than those with permanent type. There were no significant differences of incidence of OAC therapy in patients with and without history of stroke. Both questioning of patients with AF and analysis of medical cards in outpatient clinics revealed higher incidence of OAC administration after 4-6 years of follow-up compared with the stage of enrollment in registries.
- Published
- 2019
34. THE CONTROL OF INTERNATIONAL NORMALISED RATIO IN PATIENTS WITH ATRIAL FIBRILLATION TREATED WITH WARFARIN IN OUTPATIENT AND HOSPITAL SETTINGS: DATA FROM RECVASA REGISTRIES
- Author
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V. P. Mikhin, L. A. Matskevich, M. N. Valiakhmetov, V. V. Yakusevich, A. N. Vorobyev, E. N. Belova, S. S. Yakushin, E. V. Kudryashov, A. D. Deev, O. M. Drapkina, Sergey Boytsov, S. Yu. Martsevich, T. A. Gomova, M. M. Loukianov, A. V. Zagrebelnyy, V. G. Klyashtorny, K. G. Pereverzeva, M. A. Bichurina, and Yu. V. Maslennikova
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medicine.medical_specialty ,achievement of target inr values ,international normalized ratio (inr) ,Warfarin therapy ,RM1-950 ,Internal medicine ,medicine ,Diseases of the circulatory (Cardiovascular) system ,atrial fibrillation ,heterocyclic compounds ,Pharmacology (medical) ,In patient ,registers ,cardiovascular diseases ,Cardioembolic stroke ,anticoagulant therapy ,business.industry ,Warfarin ,outpatient and hospital stages of treatment ,Atrial fibrillation ,After discharge ,medicine.disease ,warfarin ,adherence to inr control ,Anticoagulant therapy ,RC666-701 ,International normalised ratio ,Therapeutics. Pharmacology ,Cardiology and Cardiovascular Medicine ,business ,medicine.drug - Abstract
Am. To study in the RECVASA registers the availability of data about the international normalized ratio (INR) indicator and achievement of its target values in outpatient and hospital practice in patients with atrial fibrillation (AF) receiving anticoagulant therapy with warfarin. Material and methods . Data about the INR control and the frequency of achievement of its target values at the outpatient and hospital stages were analyzed in RECVASA (Ryazan) and RECVASA FP – Yaroslavl outpatient registries, as well as in the hospital registers RECVASA FP (Moscow, Kursk, Tula) in 817 patients (46.9% of men, age 68.5±9.6 years) with AF and the prescribed anticoagulant therapy with warfarin. Results . INR was determined in 689 (84.3%) of 817 patients. The values of INR were monitored during therapy with warfarin in RECVASA (Ryazan) and RECVASA FP –Yaroslavl outpatient registries in 73.7% and 77.7% of patients, respectively, and in RECVASA FP hospital registers: 95.8% (Moscow); 81.3% (Tula) and 93.5% (Kursk). The target level of INR (2.0-3.0) was achieved in a minority of patients with AF during treatment with warfarin: inRyazan – in 26.3% of cases;Yaroslavl – 38.3%;Kursk – 34.8%;Moscow – 39.5%; Tule – 26.3%. Control of INR in hospital registries during warfarin therapy in patients with AF significantly more often (p
- Published
- 2018
- Full Text
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35. THERAPEUTIC EQUIVALENCE OF ORIGINAL CLOPIDOGREL (PLAVIX) AND ITS GENERIC (EGITROMB). RESULTS OF COMPARATIVE RANDOMIZED CROSS-OVER BLIND STUDY
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N. Yu. Levshin, A. D. Deev, V. V. Yakusevich, A. S. Petrochenko, and V. A. Simonov
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Drug ,medicine.medical_specialty ,lcsh:Diseases of the circulatory (Cardiovascular) system ,Blinding ,агрегация тромбоцитов ,media_common.quotation_subject ,дженерик ,RM1-950 ,Blind study ,Internal medicine ,Generic drug ,medicine ,Diseases of the circulatory (Cardiovascular) system ,Pharmacology (medical) ,оригинальный препарат ,Adverse effect ,media_common ,clopidogrel ,business.industry ,lcsh:RM1-950 ,medicine.disease ,Clopidogrel ,Thrombosis ,Surgery ,lcsh:Therapeutics. Pharmacology ,Tolerability ,клопидогрел ,platelet aggregation ,lcsh:RC666-701 ,RC666-701 ,original drug ,generic drug ,Therapeutics. Pharmacology ,Cardiology and Cardiovascular Medicine ,business ,medicine.drug - Abstract
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.
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- 2016
36. THE CHOICE OF THE DRUG AMLODIPINE FOR THE HYPERTENSION TREATMENT FROM THE STANDPOINT OF ECONOMIC FEASIBILITY
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N. A. Dmitrieva, Yu. V. Lukina, V. V. Yakusevich, S. Yu. Martsevich, L. A. Sokolova, and A. D. Deev
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Drug ,фармакоэкономический анализ ,lcsh:Diseases of the circulatory (Cardiovascular) system ,medicine.medical_specialty ,arterial hypertension ,media_common.quotation_subject ,дженерический препарат ,Urology ,RM1-950 ,amlodipine ,pharmacoeconomic analysis ,Indirect costs ,Hydrochlorothiazide ,Generic drug ,medicine ,Diseases of the circulatory (Cardiovascular) system ,Pharmacology (medical) ,Amlodipine ,media_common ,business.industry ,lcsh:RM1-950 ,Lisinopril ,амлодипин ,Economic feasibility ,артериальная гипертензия ,Surgery ,lcsh:Therapeutics. Pharmacology ,Blood pressure ,lcsh:RC666-701 ,RC666-701 ,generic drug ,Therapeutics. Pharmacology ,Cardiology and Cardiovascular Medicine ,business ,medicine.drug - Abstract
Aim. Тo compare the cost-effectiveness of antihypertensive therapy based on a generic and original drugs of amlodipine in patients with arterial hypertension (HT) degree 1-2 in NORST study. Material and methods. Patients (n=60) with HT degree 1-2 were involved in NORST study. After wash-out period they were randomized to receive generic (Group 1) or original (Group 2) amlodipine in the initial dose of 5 mg daily. In case of insufficient antihypertensive effect dose of amlodipine was increased to 10 mg per day and then successively lisinopril 10 mg daily and hydrochlorothiazide 12.5 mg one time per day were added. The total duration of treatment was 10 weeks (70 days). Achieving target blood pressure (BP) (
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- 2016
37. COMPARISON OF THE METABOLIC EFFECTS OF CARVEDILOL AND METОPROLOL IN HYPERTENSIVE PATIENTS WITH OVERWEIGHT AND OBESITY. THE CAMELLIA TRIAL
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V. V. Skibickij, S. Yu. Levashov, V. Ya. Ermolina, A. R. Kiselev, E. M. Idrisova, A. V. Shabalin, T. N. Panova, I. A. Veliganina, S. Y. Martsevich, V. A. Nevzorova, L. A. Sokolova, T. V. Shnjukova, E. G. Volkova, V. V. Yakusevich, Rafael G. Oganov, V. P. Terentev, N. V. Hailo, A. D. Deev, E. V. Shilova, P. Ya. Dovgalevskij, Yu. E. Voskanjan, I. I. Reznik, L. I Gapon, N. P. Kutishenko, N. N. Ilov, S. A. Shalnova, and G. I. Nechaeva
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medicine.medical_specialty ,arterial hypertension ,obesity ,lcsh:Diseases of the circulatory (Cardiovascular) system ,RM1-950 ,метопролол ,carvedilol ,артериальная гипертония ,chemistry.chemical_compound ,beta-blockers ,ожирение ,Internal medicine ,избыточная масса тела ,medicine ,overweight ,Diseases of the circulatory (Cardiovascular) system ,Pharmacology (medical) ,Adverse effect ,Carvedilol ,Metoprolol ,Creatinine ,business.industry ,lcsh:RM1-950 ,бета-адреноблокаторы ,medicine.disease ,metoprolol ,карведилол ,Blood pressure ,Endocrinology ,lcsh:Therapeutics. Pharmacology ,chemistry ,Tolerability ,lcsh:RC666-701 ,RC666-701 ,Cardiology ,Uric acid ,Therapeutics. Pharmacology ,Metabolic syndrome ,Cardiology and Cardiovascular Medicine ,business ,medicine.drug - Abstract
Aim. To compare two therapies based on carvedilol or metoprolol in hypertensive patients with overweight and obesity.Material and methods. 320 patients with arterial hypertension (1-2 degree) were involved in the study. 160 patients received carvedilol and 160 patients – metoprolol. Both randomized groups were comparable on the main clinical characteristics.Results. By the end of the study both systolic and diastolic blood pressure (SBP, DBP) reduced in both groups рConclusion. The results of open, randomized CAMELLIA trial confirmed antihypertensive effect and good tolerability of carvedilol in common clinical practice as well as demonstrated some its advantages in patients with metabolic syndrome. Carvedilol has positive metabolic effects on lipid, glucose and uric acid levels. Carvedilol therapy is more preferable in patients with arterial hypertension and metabolic risk factors.
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- 2016
38. THE EFFICACY OF HIGH-DOSE SIMVASTATIN IN ACUTE PERIOD OF ISCHEMIC STROKE
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A. V. Kabanov, A. Yu. Malygin, A. S. Petrochenko, S. V. Lychenko, and V. V. Yakusevich
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lcsh:Diseases of the circulatory (Cardiovascular) system ,medicine.medical_specialty ,сердечно-сосудистые события ,Disease ,RM1-950 ,Neuroprotection ,endothelial dysfunction ,law.invention ,cardiovascular events ,Randomized controlled trial ,law ,высокая доза ,Internal medicine ,high dose ,medicine ,ischemic stroke ,simvastatin ,Diseases of the circulatory (Cardiovascular) system ,Pharmacology (medical) ,cardiovascular diseases ,Endothelial dysfunction ,Stroke ,ишемический инсульт ,business.industry ,Standard treatment ,lcsh:RM1-950 ,симвастатин ,эндотелиальная дисфункция ,medicine.disease ,lcsh:Therapeutics. Pharmacology ,lcsh:RC666-701 ,Simvastatin ,RC666-701 ,Ischemic stroke ,Cardiology ,Physical therapy ,Therapeutics. Pharmacology ,Cardiology and Cardiovascular Medicine ,business ,medicine.drug - Abstract
Aim. To estimate in a 12-month study mortality and frequency of recurrent cardiovascular events, dynamics of neurological deficit and endothelial dysfunction in patients with the first-time ischemic stroke treated with simvastatin 40 mg/day in acute period of the disease. Materials and methods. The efficacy of high-dose simvastatin (40 mg/day) therapy initiated in acute stage of ischemic stroke was evaluated in 12-month comparative randomized study. Patients of the first group (n=97) received standard stroke therapy , and patients of the second group (n=86) also received standard treatment and simvastatin additionally. Combined endpoint (cardiovascular death + recurrent cardiovascular events + necessity of readmission), dynamics of neurological status and endothelial function were considered. Results. Primary combined endpoint was achieved in 66 cases in the first group (68.04%) and in 47 (54.65%) in the second one (p=0.043). Neurological status evaluated by National Institutes of Health Stroke Scale (NIHSS), Mini-Mental State Examination (MMSE) scale, and Scandinavian scales had a faster positive dynamics in patients receiving simvastatin. The same patients revealed more intense and quick decrease in desquamated plasma endotheliocytes. Conclusion. Simvastatin 40 mg/day prescribed along with neuroprotective and antihypertensive treatment in acute stage of ischemic stroke leads to lowering of recurrent cardiovascular events number, positive dynamics of neurological status, regression of endothelial dysfunction reflected by significant decrease in number of circulating desquamated endotheliocytes.
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- 2015
39. ARTERIAL HYPERTENSION IN RUSSIA: PROLOG STUDY AS A PROOF METHOD OF CONTEMPORARY THERAPY OPPORTUNITIES
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A. V. Shabalin, L. I. Katelnitskaya, D. V. Nebieridze, E. G. Volkova, A. D. Deev, Yu. M. Lopatin, I. G. Fomina, A. O. Conradi, G. D. Kobalava, Anna Kalinina, A. N. Britov, S. S. Jakushin, A. V. Suslikov, P. G. Oganov, N. P. Kutishenko, Viacheslav Mareev, N. I. Maksimov, V. V. Yakusevich, G. I. Nechayev, V. A. Shulman, S. K. Kukushkin, E. V. Kokurina, K. I. Ivanov, S. Y. Martsevich, I. S. Petelin, L. A. Sokolova, and Svetlana A. Shalnova
- Subjects
medicine.medical_specialty ,arterial hypertension ,lcsh:Diseases of the circulatory (Cardiovascular) system ,Diastole ,RM1-950 ,Patient care ,Prehypertension ,Treatment and control groups ,артериальная гипертония ,Internal medicine ,Medicine ,Diseases of the circulatory (Cardiovascular) system ,Pharmacology (medical) ,In patient ,Spirapril ,target blood pressure levels ,stepped antihypertensive therapy ,ступенчатая терапия гипертонии ,business.industry ,lcsh:RM1-950 ,Surgery ,Blood pressure ,lcsh:Therapeutics. Pharmacology ,ace inhibitors ,lcsh:RC666-701 ,RC666-701 ,Therapeutics. Pharmacology ,Cardiology and Cardiovascular Medicine ,business ,Standard therapy ,целевое АД ,ингибиторы АПФ ,medicine.drug - Abstract
Aim. To prove the advantage of the long-term controlled antihypertensive therapy compared with the real usual standard therapy in patients with mild to moderate arterial hypertension.Material and methods. It was multicenter, randomized, prospective parallel-group study in patients with mild to moderate hypertension. One part of patients (treatment group) received the strongly regulated stepped antihypertensive therapy based on ACE-inhibitor spirapril, the second one (control group) continued their usual standard therapy prescribed by doctors of polyclinics or other patient care institutions. The study lasted one year.Results. 1742 patients were enrolled in the study, 854 patients were included in the treatment group and 888 – in the control group. 220 patients dropped out of the study by different reasons, and 1552 patients finished the study. There were 651 (37,6%) men and 1081 (62,4%) women. It was substantial decrease in blood pressure in both group, but distinctions between systolic and diastolic blood pressure in the treatment and control group during the study were significant.The target levels of blood pressure (systolic < 140 mm Hg and diastolic < 90 mm Hg) were registered substantially more frequent in the patients of treatment group than in control group (69,4% и 39,3% after three months and 83,6% и 66,9% after 12 months of the treatment correspondingly).Conclusion. Controlled stepped antihypertensive therapy resulted into more significant decrease in systolic and diastolic blood pressure and more frequent achievement of target levels of blood pressure in comparison with control group. It supposes better prognosis of patients.
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- 2015
40. Effects of Ramipril and Isradipin on hemorheological profiles in patients with arterial hypertension
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A V, Muravyov, L G, Zaitsev, A A, Muravyov, V V, Yakusevich, and A M, Sirotkina
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Ramipril ,Hypertension ,Humans ,Angiotensin-Converting Enzyme Inhibitors ,Blood Pressure ,Female ,Isradipine ,Middle Aged ,Blood Viscosity ,Calcium Channel Blockers - Abstract
In this study, the effect of the angiotensin-converting-enzyme inhibitor (ACE inhibitor) Ramipril (5 mg/day) and calcium antagonist Isradipin (5 mg/day) treatment of two groups of hypertensive patients (n = 22 in each of group) was evaluated. The parameters of the hemorheological profile (blood and plasma viscosity, red blood cell aggregation and deformation, plasma protein concentration and its osmolality, hematocrit and ratio of Hct/blood viscosity) were measured in basal conditions (before treatment) and after 3 weeks of treatment. The patients showed some increased blood, plasma viscosity, RBC aggregability and fibrinogen concentration in basal conditions. In both groups of patients, three main parameters of the hemorheological profile (plasma viscosity, Hct and RBC aggregation) decreased after treatment. No significant changes in red cell deformability was found. In conclusion, ACE inhibition with Ramipril and calcium channel blocking with Isradipin lead to a moderate improvement of blood rheology in patients with hypertension. This may be explained by the pronounced vasodilatatory effect of ACE inhibitor and calcium antagonist, though their acting mechanism is different.
- Published
- 1998
41. BRAIN BIOELECTRICAL ACTIVITY IN HYPERTENSIVE PATIENTS UNDER SPIRAPRIL TREATMENT
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M. E. Mojeiko, E. A. Ryabihina, V. V. Yakusevich, L. Yu. Galimskaya, and O. S. Patrunova
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medicine.medical_specialty ,Physiology ,business.industry ,Internal medicine ,Internal Medicine ,medicine ,Cardiology ,Spirapril ,Cardiology and Cardiovascular Medicine ,business ,medicine.drug - Published
- 2000
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42. Long-term safety and efficacy of acotiamide in functional dyspepsia (postprandial distress syndrome)-results from the European phase 3 open-label safety trial.
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Tack J, Pokrotnieks J, Urbonas G, Banciu C, Yakusevich V, Bunganic I, Törnblom H, Kleban Y, Eavis P, Tsuchikawa M, and Miyagawa T
- Subjects
- Adult, Benzamides pharmacology, Dyspepsia physiopathology, Europe epidemiology, Female, Gastrointestinal Agents pharmacology, Humans, Male, Middle Aged, Postprandial Period physiology, Thiazoles pharmacology, Time Factors, Treatment Outcome, Benzamides therapeutic use, Dyspepsia drug therapy, Dyspepsia epidemiology, Gastrointestinal Agents therapeutic use, Postprandial Period drug effects, Thiazoles therapeutic use
- Abstract
Backgrounds: Acotiamide is a novel acetylcholinesterase inhibitor for treatment of postprandial distress syndrome (PDS) symptoms of functional dyspepsia (FD). This European phase 3 open-label safety trial has been conducted to evaluate the long-term safety of acotiamide and explore the efficacy of acotiamide on PDS symptoms using the validated LPDS, quality of life using SF-36 and SF-NDI, and work productivity using WPAI., Methods: FD-PDS patients (defined by ROME III criteria) aged ≥18 years with active PDS symptoms and without predominant overlapping symptoms of epigastric pain syndrome and related disorders were enrolled to receive 100 mg acotiamide three times daily for 1 year. Patients' safety profile and efficacy of acotiamide were monitored., Key Results: The majority of patients (81.6%) maintained exposure to acotiamide for >50 weeks, with a mean duration of 320.3 days. No specific clinically significant safety concerns have been shown, with no deaths, treatment-related severe/serious adverse events, or any clinically significant laboratory test results. Although being an open-label trial, acotiamide showed a change in severity larger than the minimum clinically important difference at weeks 1 and 2 for postprandial fullness and early satiation (meal-related symptoms), and showed improvement of quality of life and work productivity from the first measurement (at week 12) up to 1 year., Conclusions & Inferences: The long-term safety of acotiamide treatment was confirmed. A clinically important change for PDS symptoms, QoL, and work productivity was suggested; however a controlled trial is required to confirm this hypothetic efficacy of acotiamide. (NCT01973790)., (© 2018 The Authors. Neurogastroenterology & Motility Published by John Wiley & Sons Ltd.)
- Published
- 2018
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43. An exploratory dose-escalating study investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of intravenous atacicept in patients with systemic lupus erythematosus.
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Pena-Rossi C, Nasonov E, Stanislav M, Yakusevich V, Ershova O, Lomareva N, Saunders H, Hill J, and Nestorov I
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- Adult, Aged, B-Lymphocytes drug effects, B-Lymphocytes immunology, Dose-Response Relationship, Drug, Double-Blind Method, Female, Follow-Up Studies, Humans, Immunity, Cellular drug effects, Injections, Intravenous, Lupus Erythematosus, Systemic blood, Lupus Erythematosus, Systemic immunology, Male, Middle Aged, Russia, Treatment Outcome, Young Adult, Lupus Erythematosus, Systemic drug therapy, Recombinant Fusion Proteins administration & dosage, Recombinant Fusion Proteins pharmacokinetics
- Abstract
Atacicept, a recombinant fusion protein containing the extracellular, ligand-binding portion of the transmembrane activator and calcium modulator and cyclophilin-ligand interactor receptor, and the Fc portion of human immunoglobulin (Ig) G, is designed to block the activity of B-lymphocyte stimulator and a proliferation-inducing ligand, and may have utility as a treatment for B-cell-mediated diseases, such as systemic lupus erythematosus (SLE). This Phase Ib study investigated the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of intravenous (i.v.) atacicept in patients with mild-to-moderate SLE. Patients (n = 24) were randomised (5:1) to receive atacicept (single dose: 3, 9 or 18 mg/kg; or multiple dose: 2 x 9 mg/kg) or matching placebo. Patients were followed for 6 weeks after dosing (9 weeks in the 2 x 9 mg/kg cohort). Local tolerability of atacicept was comparable with that of placebo, with only mild injection-site reactions reported with atacicept. Atacicept i.v. was generally well tolerated, both systemically and locally, in patients with mild-to-moderate SLE. Atacicept displayed non-linear PK, which was predictable across doses and between single and repeat doses. The biological activity of atacicept was demonstrated by its marked effect in reducing B-cells and Ig levels in patients with SLE. This supports the utility of this therapeutic approach in the treatment of autoimmune diseases, such as SLE.
- Published
- 2009
- Full Text
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