Prognostic value of calcific aortic stenosis in patients of the PROGNOZ IBS registry

Aim. To assess the impact of calcific aortic stenosis on long-term prognosis in patients with stable coronary artery disease (CAD) included in the PROGNOZ IBS registry.Material and methods. The analysis included data of patients (n=541; men, 432; women, 109) from the CHD PROGNOSIS registry, in whom diagnosis of CAD was confirmed using coronary angiography during reference hospitalization in the National Medical Research Center for the period from January 1, to December 31, 2007. The mean age of men was 57,5±0,4, women — 60,9±0,9 years. The survival analysis included 504 patients (93%). The mean follow-up period was 7,3±2,19 years. We assessed the presence of calcific aortic stenosis (CAS) according to echocardiography and data on endpoints after 4 and 7 years of follow-up.Results. CAS according to echocardiography during reference hospitalization was found in 29 patients (5,4%) with a confirmed CAD. After four-year followup, 7 patients (24,1%) died, after 7 years — 15 (51,7%). Fatal and non-fatal cardiovascular events (primary endpoint) after 4 years were revealed in 10 patients (34,5%), and after 7 years, all cardiovascular events were fatal (n=15; 51,7%). In the presence of aortic stenosis, the relative risk (RR) of all-cause death at 4-year follow-up increased by 2,9 times (p<0,01), while at 7-year follow-up — by 3,2 (p<0,0001). The RR for the primary endpoint at 4-year follow-up increased by 2,8 times (p<0,01), while at 7-year follow-up — by 2,3 times (p<0,001). The RR of death in CAS patients at 7-year follow-up was comparable to severe heart failure — 3,3 (p<0,01), stroke — 2,4 (p<0,05) and left main coronary artery stenosis — 2,5 (p<0,0001).Conclusion. The presence of calcific aortic stenosis had a pronounced negative effect on the long-term prognosis of CAD patients, comparable with those in left main coronary artery stenosis, severe heart failure and stroke

ESTIMATION OF CLINICAL AND PHARMACOKINETIC EQUIVALENCE OF ORIGINAL AND GENERIC CARVEDILOLS IN PATIENTS WITH HYPERTENSION OF 1-2 GRADES

Aim. To study clinical equivalence of original (DilatrendR, ≪Hoffmann-La Roche≫, Switzerland) and of generic (VedicardolR, ≪Synthesis≫, Russia) carvedilols with estimation of their serum level. And to study pharmacoeconomic advantages of their usage in patients with arterial hypertension (HT) of 1-2 stages.Material and methods. Study was double blind, randomized, crossed. 30 patients (8 men and 22 women, 57 y.o. average) with HT of 1 stage (3,3 %) and 2 stage (96,7 %) were included in the study. Original or generic carvedilols (12,5 mg twice a day) were prescribed to the patients. Hydrochlorothiazide was added followed carvedilol dose enlargement if initial antihypertensive effect had been insufficient. The second similar course of therapy with other carvedilol took place in 2 weeks after cancellation of the first carvedilol. Carvedilol serum level, blood pressure (BP), heart rate (HR) and side effects were registered on each visit.Results. 75 % of Vedikardol-group patients and 75 % of Dilatrend-group patients had reached target BP level (<140/90 mm Hg). Monotherapy was effective more than in a half of patients in both groups. Dilatrend had more expressed influence on HR in comparison with Vedikardol. Both drugs did not differ significantly in frequency and intensity of side effects.Conclusion. Generic carvedilol (VedicardolR) has clinical efficiency and pharmacokinetics similar to these of original carvedilol (DilatrendR). Generic carvedilol has lower cost of treatment than this in original carvedilol

Study of the Quality of Medical Therapy and Adherence in Patients with Chronic Heart Failure (According to the COMPLIANCE Study)

Aim. Assess the medical therapy quality in patients with chronic heart failure (CHF) and patients' adherence to the treatment depending on the previous observation in a specialized medical center as part of an of an outpatient registry.Materials and methods. An analysis of the medical therapy quality in patients with CHF was carried out as part of the COMPLIANCE prospective observational study (NCT04262583). 72 patients with CHF verified according to the protocol were included in the study. The average age of the patients was 69.1±9.5 years (31% of women and 69% of men). Patients were divided into groups: those who first applied to a specialized department during the period of the study inclusion, or those who were previously observed in a specialized department. The general adherence assessment to medical therapy was carried out using the original questionnaire «The adherence scale of the National Society for Evidence-Based Pharmacotherapy» which was supplemented with questions to assess the actual adherence to specific medical drugs recommended for patients with CHF.Results. According to the results of the study, beta-blockers were prescribed to 70 (97.2%) patients. Angiotensin converting enzyme inhibitors (ACEi)/angiotensin receptor blockers (ARBs) were recommended in 68 (94%) patients. Mineralocorticoid receptor antagonists were included in therapy in 6 out of 9 patients who were shown to be prescribed (66.6%). The choice of medical drugs within the group was not always adequate. For example, ACEi/ARBs with proven efficacy in patients with CHF were prescribed only in 72% of patients. Comparative analysis of adherence to medical therapy between patients of the selected groups demonstrated a higher adherence to the recommended therapy in patients who were previously observed in a specialized center.Conclusion. The medical therapy quality for patients with CHF doesn't always comply with current clinical guidelines. The choice of a medical drug within a group is not always adequate. Regular observation in a specialized center contributes to a higher adherence to the recommended therapy

Detection and Treatment of Hyperuricemia in Clinical Practice (According to the PROFILE Outpatient Registry)

Aim. To study the frequency of detection of hyperuricemia (HU) in patients with high and very high cardiovascular risk and the frequency of prescribing drugs that lower serum uric acid (sUA) levels in real clinical practice.Material and methods: The general information of the study was based on the data of 2457 patients who were consistently included in the «PROFILE» registry until November 30, 2020: 1250 men (50.9%) and 1207 (49.1%) women. All patients with HU were selected (UA level ≥360 pmol/l in women, ≥420 pmol/l in men). At the stage of inclusion of the patient, data on MC indicators were available in 1777 (72.3%), upon re-examination - only 262 (33.2%) out of 790 patients who returned to the appointment.Results: The most common study of the level of sUA was performed in patients with gout (65.2%), with arterial hypertension (AH) and dyslipemia in 29.1% of cases, with diabetes mellitus (DM) - 30.1%, with impaired tolerance to glucose (IGT) - 40.2%, with other diseases, the proportion of patients with a known UA was even less. A positive relationship was found between the presence of AH and IGT with the frequency of UA control (p<0.001). In patients with AH, an increase in the level of sUA was detected significantly more often than in patients without AH (p<0.001), and less frequently in patients with DM and IGT (p<0.001 and p<0.01, respectively). The frequency of allopurinol prescribing was low: 49 (2%) patients received therapy, while of the 284 patients with HU, only 20 (7%) were prescribed allopurinol.Conclusion: in real clinical practice, only 29.1% of patients with AH and 20-25% of patients with other CVDs were monitored for sUA levels, every third patient had data on sUA levels at a repeat visit. In the presence of gout, the proportion of patients with current UA was higher (65%). For those with AH and IGT, positive correlations were found between the presence of the disease and control of sUA levels. A low frequency of prescribing drugs for the correction of HU was revealed

Challenges of Statin Therapy in Clinical Practice (According to Outpatient Register «PROFILE» Data)

Aim. To identify the main problems of statin therapy in patients with high and very high cardiovascular (CV) risk in real clinical practice.Material and methods. The general information of the study was based on data from 2,457 patients who were included in the register before November 30, 2020: 1,250 men (50.9%) and 1,207 (49.1%) women. A more detailed analysis was performed for groups of patients with high          and very high CV risk who had indications for statin treatment at the time of inclusion in the register: out of 2457 patients, 1166 people had very high CV risk, 395 was at high CV risk (a total of 1561 people, the average age of patients was 64.4±11.0 years).Results. Information on the parameters of the lipidogram – the level of total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C) was available in 1918 (78.1%) and 1546 (62.9%) patients, respectively. Of 1561 patients with high and very high CV risk, TC and LDL-C levels were analyzed in 1221 (78.2%) and 956 (61.2%) cases, statistically significantly more often in patients with high CV risk (p<0.05). Statins were recommended only to 823 (52.7%) patients with high and very high CV risk. Patients with very high CV risk received such appointments 4 times more often than patients with high CV risk: odds ratio (OR) 4.2; 95% confidence interval (CI) 3.2-5.3 (p<0.001). Doctors preferred atorvastatin in prescriptions (n=456, 55.4%), rosuvastatin (n=244, 29.7%) and simvastatin (n=121, 14.7%) were in second and third places. The target level of LDLC was 2 times more often achieved in patients with high CVR, compared with patients with very high CV risk: OR = 2.0, 95% CI 1.4-3.0 (p<0.001).Conclusion. The main problems of statin treatment in real clinical practice remain the non-assignment of these drugs to patients who have indications for such therapy and the failure to achieve the target levels of lipidogram indicators, which may probably be due to the clinical inertia of doctors regarding titration of statin doses, and in some cases caused by the choice of drugs that are not the most effective in reducing LDL cholesterol. Patients with very high CV risk are 4 times more likely to receive a recommendation to take statins compared to patients with high CV risk, but the target level of LDL cholesterol is reached in them 2 times less often

Long-term survival of patients with cerebrovascular accident in different age groups in the REGION-M registry

Aim. To study the two-year survival rate of patients with cerebrovascular accident (CVA) in different age groups.Material and methods. The outpatient part of the REGION-M registry included 684 patients assigned to the City Polyclinic № 64 in Moscow, discharged from the F. I. Inozemtsev City Clinical Hospital (Moscow) in the period from January 1, 2012 to April 30, 2017 with a confirmed diagnosis of stroke or transient ischemic attack. All patients were divided into 5 age groups: group 1 — from 18 to 50 years old (n=72 (10,5%)), group 2 — from 51 to 60 years old (n=122 (17,8%)), group 3 — from 61 to 70 years old (n=156 (22,8%)), group 4 — from 71 to 80 years old (n=185 (27,0%)) and group 5 — 81 years and above (n=149 (21,8%)). Patient survival was assessed after 2 years of follow-up.Results. The mortality rate of patients during the follow-up period significantly increased with age as follows: in patients of 18-50 years old — 4%, 51-60 years old — 9,8%, 61-70 years old — 23,7%, 71-80 years old — 34%, 81-100 years old — 55% (p<0,0001). The relative death risk was 2,3 in group 2 (NA), 6,8 in group 3 (p<0,001), 9,8 in group 4 (p<0,0001) and 18,5 in group 5 (p<0,0001) compared with group 1. With increasing age in the study cohort, the proportion of women increased as follows: from 47,2% in group 1 to 77,9% in group 5 (p<0,0001). However, mortality among men and women in the groups did not differ. Patients in older age groups were more likely to have comorbidities and disability before the CVA. With increasing age, ischemic stroke was significantly more common and transient ischemic attack was less common (p<0,001).Conclusion. Mortality of patients who underwent stroke was significantly higher in older age groups and did not differ among men and women

Информационное управление качеством диспансерного наблюдения при ишемической болезни сердца

Highlights. Using the big data databases of provided medical services belonging to the Territorial Compulsory Medical Insurance Fund and the Unified State Healthcare Information System (USHIS), clinical and statistical analysis of ambulatory follow-up of patients with coronary artery disease was carried out, an algorithm was developed and the effectiveness of the presented information management technology was determined.Aim. To assess and justify the developed information management technology for the quality management of ambulatory follow-up of patients with coronary artery disease (CAD) based on monitoring and analyzing electronic personified data on medical services.Methods. In 2018 the Territorial Compulsory Medical Insurance Fund (TCMIF), the Medical Information and Analytical Center (MIAC) and healthcare organizations of the Orenburg Region implemented information management technology to assess the quality of ambulatory follow-up in patients with CAD, which is based on big data analysis of medical services and information integration “emergency medical services (EMS), hospital-TCMIF + MIAC-polyclinic”. To assess the effectiveness of the technology, the proportion of patients with myocardial infarction (MI), death from coronary artery disease, emergency hospitalizations and emergency calls for angina pectoris were compared. The study involved   two groups of patients: 13 208 ambulatory patients with angina pectoris and 4017 patients without follow-up, according to  the  TCMIF  reports  in  2017.  Out of the 13,208 patients with angina pectoris in 2019, 10,205 patients with continued follow-up presented with the same clinical endpoints. Patients with these unfavorable outcomes in proportion to the total number of patients in each group in 2017 and 2019 were compared as well.Results. The developed and implemented information management technology led to an increase in the number of ambulatory patients with angina pectoris from 63 to 69%, with MI from 78 to 87%, and a reduction of emergency calls and emergency hospitalizations of patients with angina pectoris in the region in 2017 and 2019.Conclusion. Information quality management of ambulatory follow-up of patients with coronary artery disease using electronic personalized data on medical services increases the number of ambulatory patients with angina pectoris and myocardial infarction, and decreases the number of unfavorable outcomes of patients with angina pectoris.Основные положения. По базам больших электронных данных о медицинских услугах – территориального фонда обязательного медицинского страхования и Единой государственной информационной системы в сфере здравоохранения – проведен клинико-статистический анализ диспансерного наблюдения при ишемической болезни сердца, построен алгоритм и определена результативность разработанной технологии информационного управления качеством такого наблюдения.Цель. Оценить и обосновать разработанную технологию информационного управления качеством диспансерного наблюдения при ишемической болезни сердца (ИБС) на основе мониторинга и анализа электронных персонифицированных данных о медицинских услугах.Материалы и методы. В 2018 г. в работу территориального фонда обязательного медицинского страхования (ТФОМС), медицинского информационно-аналитического центра (МИАЦ) и медицинских организаций Оренбургской области начато внедрение информационного управления качеством диспансерного наблюдения при ИБС. Технология такого управления разработана на основе анализа больших данных о медицинских услугах и информационной интеграции «скорая медицинская помощь (СМП), стационар-ТФОМС + МИАЦ-поликлиника». Для оценки эффективности разработанной технологии в двух группах пациентов со стенокардией из 13 208 больных с диспансерным наблюдением и 4 017 больных без него за 2017 г. по реестрам счетов ТФОМС сравнили доли больных инфарктом миокарда (ИМ), с летальным исходом от ИБС, экстренными госпитализациями и вызовами СМП по поводу стенокардии. Из 13 208 больных стенокардией в 2019 г. у 10 205 пациентов, находящихся по-прежнему на диспансерном наблюдении, определили такие же конечные клинические точки. Больных с данными неблагоприятными исходами в долях от общего числа каждой группы за 2017 и 2019 гг. сравнили между собой.Результаты. Результатом внедрения разработанной технологии информационного управления стало увеличение в регионе за 2017 и 2019 гг. доли пациентов с диспансерным наблюдением при стенокардии с 63 до 69%, при ИМ – с 78 до 87%, а также достоверное снижение доли больных стенокардией с вызовами СМП и экстренными госпитализациями среди пациентов, состоящих на диспансерном наблюдении.Заключение. Информационное управления качеством диспансерного наблюдения при ИБС по электронным персонифицированным данным о медицинских услугах приводит к увеличению доли больных с диспансерным наблюдением при стенокардии и ИМ и снижению неблагоприятных исходов стенокардии

Generic therapy: the problem of choice

The main differences between original and generic medications are discussed, and the criteria necessary for official generic registration are presented. The author describes possible reasons for bioequivalence and therapeutic equivalence discrepancy between original and generic medications, with enalapril maleate as an example of such discrepancies. Methodological approaches to designing comparative studies on medication therapeutic equivalence are presented

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 STEPPED TRIAL CABRIOLET (PART I)

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&lt;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&lt;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&lt;0.001) and low-density lipoprotein cholesterol level (-0.28±0.9 mM/l, p&lt;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.</p