Background and Aims: The aim of the present analysis of RENAISSANCE registry (Registry of patients with familial hypercholesterolemia (FH) and very high cardiovascular risk with lack of efficiency of lipid-lowering therapy) is the assessment of adherence and efficiency of the lipid-lowering therapy of patients with FH.

Цель. Целью исследования явилась оценка эффективности и приверженности гиполипидемической терапии, частоты развития сердечно<со< судистых осложнений в течение 3<летнего периода наблюдения в рамках регистра РЕНЕССАНС (Регистр пациентов с СГХС и пациентов очень высокого сЕрдечно<Сосудистого риска с недоСтАточной эффективНоСтью проводимой гиполипидемической терапии). Материал и методы. РЕНЕССАНС является открытым национальным наблюдательным исследованием и включает больных с семейной ги< перхолестеринемией (СГХС), а также пациентов очень высокого сердечно<сосудистого риска (ОВССР). Учитывали наличие факторов риска атеросклероза, анамнез сердечно<сосудистых заболеваний, гиполипидемическую терапию. В каждом центре выполняли определение концен< трации: общего холестерина (ОХС), триглицеридов (ТГ), холестерина липопротеидов высокой плотности (ХС ЛВП) в сыворотке крови. Содер< жание холестерина липопротеидов низкой плотности (ХС ЛНП) рассчитывали по формуле Фридвальда. Уровень липопротеида(а) измеряли методом иммуноферментного анализа в некоторых центрах. При оценке частоты конечной точки, включавшей фатальные и нефатальные сердечно<сосудистых осложнения (ССО), проводили анализ Каплана — Майера. Результаты. В регистр включено 1570 (средний возраст 54,0±14,6 лет) пациентов с СГХС и 121 (63,5±10,9 лет) больной с ОВССР. В группе СГХС динамическое наблюдение проведено у 594 пациентов (38%) в течение 23,6±14,6 месяцев, конечная точка зарегистрирована у 9% больных. Мужской пол (относительный риск 2,1; 95% доверительный интервал 1,13–3,66; p<0,01), гипертония (2,8; 1,4–5,2; p<0,01), ишеми< ческая болезнь сердца (6,8; 3,5–13,2; p<0,0001), отягощенный анамнез по сердечно<сосудистым заболеваниям (ССЗ) (2,1; 1,1–3,9; p<0,05) и концентрация липопротеида(а) ≥ 30 мг/дл (2,8; 1,1–7,7; p<0,05) явились предикторами развития ССО. В группе СГХС отмечено снижение уровня ОХС от исходного на 19%, ХС ЛНП на 25% (р<0,001 для обоих), целевых значений ХС ЛНП достигли 2% больных. В группе ОВССР динамическое наблюдение проведено у 72 (60%) пациентов в течение 19,7±5,8 месяцев. Ни один больной не достиг целевого уровня ХС ЛНП менее 1,4 ммоль/л. Заключение. Трехлетнее наблюдение за участниками регистра РЕНЕССАНС демонстрирует усиление приверженности гиполипидемической терапии. С увеличением риска развития сердечно<сосудистых осложнений при СГХС ассоциированы мужской пол, наличие гипертонии, ише< мической болезни сердца, отягощенного анамнеза по ССЗ и высокий уровень липопротеида(а). The aim of the study was to evaluate the effectiveness and adherence to hypolipidemic therapy, the frequency of cardiovascular events (CVE) during the 3!year follow!up in the RENAISSANCE registry (Registry of patients with familial hypercholesterolemia and very high cardiovascular risk with insufficient effect of hypolipidemic therapy). Methods. The RENAISSANCE registry is an open, national, observational study and includes patients with familial hypercholesterolemia (FH), as well as patients of very high cardiovascular risk (VHR). We took into consideration atherosclerosis risk factors and history of cardiovascular diseases (CVD), adherence to hypolipidemic therapy. Concentrations of total cholesterol (TC), triglycerides (TG), high density lipoprotein cholesterol (HDL!C) were measured in blood serum in all centers. Low density lipoprotein cholesterol (LDL!C) level was defined according to Friedewald formula. The concentration of lipoprotein(a) was measured by enzyme!linked immunosorbent assay in serum in some centers. Kaplan!Mayer analysis was performed to assess the frequency of fatal and nonfatal CVE. Results. The Registry consisted of 1570 (mean age 54.0±14.6 years) FH patients and 121 (63.5±10.9 years) VHR patients. Data of 594 patients (38%) who had follow!up visits were obtained in FH patients, follow!up duration 23.6±14.6 months, 54 (9%) patients experienced CVE. Male sex (hazard ratio 2.1; 95% confidence interval 1.13!3.66, p<0.01), hypertension (2.8;1.4–5.2; p<0.01), ischemic heart disease (6.8;3.5!13.2; p<0.0001), family history of CVD (2.1;1.1–3.9, p<0.05) and lipoprotein(a) level ≥30 mg/dl (2.8;1.1–7.7; p<0.05) were predictors of CVE. In FH patients the level of TC decreased by 19%, LDL!C by 25% (p<0.001 for both). Data on 72 VHR patients (60%) were obtained with follow!up duration of 19.7±5.8 months. No patient achieved the target LDL!C level of less than 1.4 mmol/L. Conclusion. Three!year follow!up of participants in the RENAISSANCE registry shows an enhanced adherence to hypolipidemic therapy. In FH patients the increased risk of new CVE is associated with male sex, hypertension, CHD, family history of CVD and lipoprotein(a) level ≥30 mg/dl

Aim. Russian multicenter register of familial hypercholesterolemia (FH) was transformed into Register of patients with FH and very high cardiovascular risk with insufficient effect of hypolipidemic therapy (RENESSANS Registry) in 2017 The aim of RENESSANS was maximal inclusion of patients not only with FH, but also those with atherosclerotic cardiovascular diseases (CVD), who did not achieve targeted level of low density lipoprotein cholesterol (LDL-C) using hypolipidemic drug therapy.Material and methods. The RENESSANS Registry is an open, national, observing study that includes patients with definite and probable (according to Dutch lipid clinic network and Simon Broome Registry criteria) heterozygous and homozygous FH, as well as patients of very high cardiovascular risk. There were designed two register forms: for patients with FH and for very high cardiovascular risk patients. Doctors filled out forms in paper and electronic variants. They took into consideration the risk factors of atherosclerosis and anamnesis of CVD, adherence to diet and hypolipidemic therapy. Concentrations of total cholesterol (TC), triglycerides (TG), high density lipoprotein cholesterol (HDL-C) were measured in blood serum in all centers. LDL-C level was defined according to Friedewald formula: LDL-C=TC-HDL-C-TG/2,2 (mmol/l).Results. The Registry consisted of 1208 FH patients and 497 patients with very high risk (average age 54±13 and 61±8, respectively, 37% men). Baseline levels of lipids were 9,4±2,3 and 6,9±1,5 mmol/l for TC, 6,6±2,1 and 4,5±1,3 mmol/l for LDL-C, respectively. The frequency of hypolipidemic therapy in both groups is 70%, while targeted level of LDL-C was achieved extremely rarely.Conclusion. The results show insufficient adherence and low effectiveness of standard hypolipidemic therapy both in patients with FH and very high cardiovascular risk. PCSK9 inhibitors are recommended for resistant hypercholesterolemia treatment. The RENESSANS Registry allows to improve FH diagnostics, to assess treatment effectiveness and choose patients who need treatment with PCSK9 inhibitors.

Aim. To assess rate of familiarity and specifics of treatment with statins among the citizens of economically active age with various cardiovascular risk by the data from epidemiological study ESSE-RF (Epidemiology of Cardiovascular Diseases in Different Russian Federation Regions). Material and methods. In the work the data from ESSE-RF study was used,  of representative  selection  of non-organized  male and  female inhabitants aged 25-64 y.o. from 13 regions, investigated during 2012-2014. Responded ~80%. The study included questionning by standard scale that included data on the anamnesis, etc. Lipid profile, including total cholesterol  (TC), cholesterol  of lipoproteids low and high density were measured at SSRCPM and RSPCC. Results. Analysis of the whole selection showed that 20% of men and 32% of women knew their TC, and 13,6% and 18,2% were even familiar having increased  level of TC. Part of those with high and very high risk was 31,3%, incl. men — 42,2%, women — 30,9%. Statins took ~7,0% of patients from this risk category. Effectiveness of treatment (target levels reached  of low density cholesterol) in these groups of men and women was 14,4% and 4,8%, respectively. Conclusion. The data obtained in populational study points on insufficient knowledge and low rate of statin treatment  of the persons with high and very high cardiovascular  risk in RF, which confirms the anxiety provoking data of registries and other studies. The data dictates necessity  of development  and implementation of specific educational programs for citizens, of physician improvement and availability of cheap but effective lipid-lowering medications.

Life quality (LQ) is an integrated parameter of the health, applied for integral characterization of population health, and as the parameter of healthcare interventions effectiveness.Aim. To assess LQ in Russian population at the age 25-64 y. o. in general and in various socio-economical groups using EQ-5D, by the results of ESSE-RF (2012-2013) study.Material and methods. LQ was assessed on representative selections of inhabitants of 13 Russian Federation regions, aged 25-64 (males 8327, females 13497) with response 80%. LQ was assessed via international questionnaire EUROQOL — EQ-5D: 1) no decline; 2) mild decline; 3) significant decline; scoring also performed with visualanalogue scale (VAS). Integral LQ by EUROQOL performed with Shaw JW et al. method (ranging from 0,0 (death) to 1,0 (perfect health)).Result. EQ-5D index of Russian population was 0,87 with no gender difference. By the increase of the age LQ declines. Educational gradient of LQ was significant only in VAS (p<0,05). Wealth level negatively associated with LQ. Most common (p<0,0005) were disorders by the components pain/discomfort and anxiety/depression. Part of those with lower LQ among males is lesser than in females, by all 5 factors of the LQ, and in all educational states. Regional specifics of LQ by EQ-5D index: from 0,82 in Vladikcaucas to 0,95 in Orenburg (p<0,0005). There was significant correlation of EQ-5D index with unemployment level (0,4) and consumer prices index (0,29) in regions.Conclusion. Monitoring of LQ is necessary condition for assessment of efficacy of population health improvement interventions, and the LQ values obtained will be useful as populational norms for health condition assessment in addition to morbidity and mortality factors.

Aim. To assess rate of familiarity and specifics of treatment with statins among the citizens of economically active age with various cardiovascular risk by the data from epidemiological study ESSE-RF (Epidemiology of Cardiovascular Diseases in Different Russian Federation Regions). Material and methods. In the work the data from ESSE-RF study was used, of representative selection of non-organized male and female inhabitants aged 25-64 y.o. from 13 regions, investigated during 2012-2014. Responded ~80%. The study included questionning by standard scale that included data on the anamnesis, etc. Lipid profile, including total cholesterol (TC), cholesterol of lipoproteids low and high density were measured at SSRCPM and RSPCC.Results. Analysis of the whole selection showed that 20% of men and 32% of women knew their TC, and 13,6% and 18,2% were even familiar having increased level of TC. Part of those with high and very high risk was 31,3%, incl. men — 42,2%, women — 30,9%. Statins took ~7,0% of patients from this risk category. Effectiveness of treatment (target levels reached of low density cholesterol) in these groups of men and women was 14,4% and 4,8%, respectively.Conclusion. The data obtained in populational study points on insufficient knowledge and low rate of statin treatment of the persons with high and very high cardiovascular risk in RF, which confirms the anxiety provoking data of registries and other studies. The data dictates necessity of development and implementation of specific educational programs for citizens, of physician improvement and availability of cheap but effective lipid-lowering medications.

Life quality (LQ) is an integrated parameter of the health, applied for integral characterization of population health, and as the parameter of healthcare interventions effectiveness. Aim. To assess LQ in Russian population at the age 25-64 y. o. in general and in various socio-economical groups using EQ-5D, by the results of ESSE-RF (2012-2013) study. Material and methods. LQ was assessed on representative selections of inhabitants of 13 Russian Federation regions, aged 25-64 (males 8327, females 13497) with response 80%. LQ was assessed via international questionnaire EUROQOL — EQ-5D: 1) no decline; 2) mild decline; 3) significant decline; scoring also performed with visualanalogue scale (VAS). Integral LQ by EUROQOL performed with Shaw JW et al. method (ranging from 0,0 (death) to 1,0 (perfect health)). Result. EQ-5D index of Russian population was 0,87 with no  gender difference. By the increase of the age LQ declines. Educational gradient of LQ was significant only in VAS (p<0,05). Wealth level negatively associated with LQ. Most common (p<0,0005) were disorders by the components pain/discomfort and anxiety/depression. Part of those with lower LQ among males is lesser than in females, by all 5 factors of the LQ, and in all educational states. Regional specifics of LQ by EQ-5D index: from 0,82 in Vladikcaucas to 0,95 in Orenburg (p<0,0005). There was significant correlation of EQ-5D index with unemployment level (0,4) and consumer prices index (0,29) in regions. Conclusion. Monitoring of LQ is necessary condition for assessment of efficacy of population health improvement interventions, and the LQ values obtained will be useful as populational norms for health condition assessment in addition to morbidity and mortality factors.

Aim. To study the prevalence of ischemic heart disease as one of the most common cardiovascular disorders, together with arterial hypertension (AH), diabetes mellitus (DM) and liver diseases (LD) in adult (25-64 y.o.) population of selected RF regions, the variance of those with gender and age, and association of cardiovascular risk factors (FR).Material and methods. Into analysis we included the results of representative selections studies from 13 RF regions, studied according to the program of multicenter study ESSE-RF during the years 2012­2014; totally 21923 patients studied. Investigation included standard questioning, including anamnesis. For statistics we used applied software SAS.Results. In men the prevalence of IHD is associated with the growth of comorbidity from 0 in the age group 25-34 y. to 77% in the age 55-64 y., almost duplicating every decade. For women there is analogic tendency, less prominent. In men there are significant associations only with AH, which increases the risk of IHD 2,5 times, though in women together with AH the associations are significant for LD. Comorbidities with DM do not influence the prevalence of IHD in men and women. At the same time, any association with two diseases increases the risk of IHD >304 times. The most negative is the association of all three diseases, with which IHD is 8,7 times more prevalent, than in their absence. Using multidimensional logistic regression after correction for the age and comorbidity in the patients with IHD of both genders, there are associations revealed of high density cholesterol lipoproteids (HDL) in blood and abdominal obesity. In men there are also positive associations with smoking and negative — with increased cholesterol.Conclusion. Comorbidities of IHD with AH, DM and LD in adult population are common, are associated with the general FR, are increasing with the age. Taking modern tendencies of population ageing, it is plausible to expect an increase of the prevalence of comorbidities, that requires a necessity of the healthcare services to these changes.

Aim. To study social and economic gradients — educational and occupational statuses, wealth level, behavioral risk factors (FR) in Russian population by the ESSE-RF data.Material and methods. The data for the analysis consisted of representative selections of 13 regions of RF (n=22906) participants of the study, incl. men (n=8353) and women (n=13553) of 25-64 y.o., with response 80%. We calculated the odds ratios for the presence of behavioral FR: smoking, excessive alcohol consumption, insufficient physical activity (IPA), nonrational food consumption, anxiety and depressive disorders, — in persons from different social and economic groups by education level, type of inhabitation, professional status, wealth level.Results. Higher education was associated with better FR profile, except IPA (negative association) and alcohol consumption (absence of association). "White in general had less FR probability than Blue, excl. IPA and psychoemotional deviations (in men). As for the wealth association with the FR there is backward gradient, i.e. lesser the income, higher the risk of FR presence, excl. IPA and excessive alcohol intake in women. For example, in very wealthy men the odds ratio for depressive states was 3,09 [95% CI 2,08-4,57] comparing to the persons with low income. The type of territory of inhabitance was associated with less behavioral FR in Russian population, as significant associations are found only for depression and excessive salt consumption in both genders and IPA in men. Conclusion. The significant social and economic gradients of behavioral FR prevalence are found, the direction of those is not necessary the same as in European countries. The analysis of association with social and economic parameters would help to develop the directed preventive interventions.

In the frame of Multicenter observational study ECVD-RF (Epidemiology of Cardiovascular Diseases and their Risk Factors in Regions of Russian Federation) by the unique protocol the investigation of representative selections of adult population at the age of 25-64 y.o. of 11 regions RF (n=18305, including males, n=6919 and females n=11386): Volgograd, Vologda, Voronezh, Ivanovo, Kemerovo, Orenburg, Samara, Tomsk, Tyumen, Saint-Petersburg and Northern Osetia-Alania. The prevalence of the following risk factors (RF) of cardiovascular diseases is evaluated: high blood pressure — 33,8%, obesity — 29,7%, high total cholesterol — 57,6%, high glucose level or diabetes — 4,6%, smoking (tobacco consumption) — 25,7%, insufficient (low) level of physical activity — 38,8%, excessive salt consumption — 49,9% and insufficient vegetables and fruits consumption — 41,9%. Gender differences and an increase with the age of the parameters mentioned are described.The absence of a epidemiologic monitoring system at the Federal level leads to an impossibility of clear conclusions on the RF dynamics in Russian population. While comparing the ECVD-RF study with previous epidemiological studies we can just cautiously suppose the existence in 21st age of negative dynamics of one RF (obesity, dyslipidemia) and positive dynamics of the others (smoking).

Aim. To study prevalence of arterial hypertension (AH), mean values of systolic and diastolic blood pressure (SBP, DBP), awareness of patients about their disease, medication consumption (MC) and efficacy of treatment in several regions of Russia.Material and methods. Representative selections were made in 9 regions of Russia: men (n=5563), women (n=9737) of 25–64 y.o., studied in 2012–2013 with the response 80%. Systematic stratified multilevel random selection was formed with localilty criteria (Kisch method). The Questionnaire on the presence of AH included: awareness of the patient about his disease, drug intake. BP measurement was performed on the right arm by automatic tonometer Omron in sitting position after 5 minutes resting. The mean value of two measurements was used. BP defined as SBP ≥140 mmHg, DBP ≥90 mmHg, or if the patient had taken antihypertensive therapy. Efficacy of treatment — the part of patients (in %) who reached target BP. Control group — part of patients (in %) with BP <140/90 mmHg. Statistic data calculation was done with computer-based statistic software — SAS with standardising by age stratification of Europe.Results. Mean SBP and DBP were 130,7±0,1 mmHg and 81,6±0,1 mmHg respectively. Prevalence of AH — 44%, higher in men (p<0,001). Prevalence of AH was higher in rural area citizens in men — 51,8% vs 47,5% (р<0,02) and in women — 42,9% vs 40,2% (р<0,05). Awareness was 67,5% in men, 78,9% in women. Medications were taken by 60,9% of women and 39,5% of men. Effectively treated were 53,5% of women and 41,4% of men. With the age the part of effectively treated decreases (p<0,0005). BP is under control only in 1/3 of women and 14,4% of men.Conclusion. The role of AH as one of the main modifiable risk factors of cardiovascular diseases is proved, however it is depressing that the percent of controlled AH is low. BP control is the main task of outpatient surveillance at every local outpatient department, where now less than a half of those affected are being observed.

Aim. To study prevalence of arterial hypertension (AH), mean values of systolic and diastolic blood pressure (SBP, DBP), awareness of patients about their disease, medication consumption (MC) and efficacy of treatment in several regions of Russia. Material and methods. Representative selections were made in 9 regions of Russia: men (n=5563), women (n=9737) of 25–64 y.o., studied in 2012–2013 with the response 80%. Systematic stratified multilevel random selection was formed with localilty criteria (Kisch method). The Questionnaire on the presence of AH included: awareness of the patient about his disease, drug intake. BP measurement was performed on the right arm by automatic tonometer Omron in sitting position after 5 minutes resting. The mean value of two measurements was used. BP defined as SBP ≥140 mmHg, DBP ≥90 mmHg, or if the patient had taken antihypertensive therapy. Efficacy of treatment — the part of patients (in %) who reached target BP. Control group — part of patients (in %) with BP <140/90 mmHg. Statistic data calculation was done with computer-based statistic software — SAS with standardising by age stratification of Europe. Results. Mean SBP and DBP were 130,7±0,1 mmHg and 81,6±0,1 mmHg respectively. Prevalence of AH — 44%, higher in men (p<0,001). Prevalence of AH was higher in rural area citizens in men — 51,8% vs 47,5% (р<0,02) and in women — 42,9% vs 40,2% (р<0,05). Awareness was 67,5% in men, 78,9% in women. Medications were taken by 60,9% of women and 39,5% of men. Effectively treated were 53,5% of women and 41,4% of men. With the age the part of effectively treated decreases (p<0,0005). BP is under control only in 1/3 of women and 14,4% of men. Conclusion. The role of AH as one of the main modifiable risk factors of cardiovascular diseases is proved, however it is depressing that the percent of controlled AH is low. BP control is the main task of outpatient surveillance at every local outpatient department, where now less than a half of those affected are being observed.

Aim. To study the prevalence of hyperuricemia in the Russian regions, depending on the climatic, geographical, socio-demographic characteristics and some cardiometabolic risk factors.Material and methods. Data from the ESSE-RF study from 10 regions of the Russian Federation are presented. All study participants were examined according to a uniform protocol. Measurements were standardized, biochemical tests were carried out in three Federal centers using the same methodology. The study was approved by independent Ethics committees, and all participants signed informed consent.Results. The prevalence of hyperuricemia was 16.8% (25.3% in men and 11.3% in women; p<0.0001). Hyperuricemia incidence increases with age, does not depend on education, significantly associates with place of residence, elevated blood pressure, obesity and abdominal obesity, alcohol consumption and diuretics taking. After adjustment for all factors included in the regression analysis, prevalence of hyperuricemia in the Ivanovo Region is 1.4 times higher than this in the reference region (Tyumen), while prevalence of hyperuricemia in the Samara Region and the Republic of North Ossetia-Alania is 30% and 40 % lower.Conclusion. Prevalence of hyperuricemia in Russia is defined; regions with the highest and lowest prevalence are identified. Associations of hyperuricemia with some social and demographic characteristics as well as cardiovascular risk factors are revealed.

The frequency of using autopsy to verify the cardiovascular causes of death was studied in typical regions of Russia. One thousand and sixty deaths from circulatory system diseases were analyzed among a representative sample of 285,736 subjects. Death occurred outside health care facilities in 88% of the analyzed cases; nevertheless, autopsy was made only in 28.3%. Moreover, autopsy was carried out in all cases of less than 40-year-old males and less than 50-year-old females who had died from suspected cardiovascular diseases. The proportion of notified cardiovascular mortality increased in the structure of overall mortality and the rate of autopsy-verified diagnosis decreased with advanced age. To obtain valid information on cardiovascular mortality rates is limited due to low autopsy rates primarily in cases of death outside health care facilities, particularly among elderly and senile persons, despite the fact that it is these fatal cases that constitute the bulk of registered cardiovascular mortality.

The study was aimed at assessing the incidence of sudden cardiac death (SCD) in patients with coronary heart disease (CHD) and evaluating the quality of SCD diagnostics and statistical registration in medical institutions (MI). In the population of 285736 patients with CHD (76,4% aged 18 years or older; 46% men), the incidence of SCD cases registered in MIs was compared to the study algorithm-based incidence of SCD. The latter was as high as 156 per 100 000 in men and 72 per 100 000 in women, which was 2,3 and 2,8 times higher, respectively, than the MI-registered levels (p<0,001). MI-based diagnostics and/or registration missed 55,6% and 66,5% of the SCD cases in men and women with CHD, respectively. The two main explanations were inadequate diagnostic search at death cause identification (45,4%) and mistakes made at completing medical documents (55,6%). Therefore, every second SCD case in men with CHD and two-thirds of SCD cases in women with CHD are not identified by MIs, which results in under-estimation of SCD incidence.

The study was aimed at assessing the incidence of sudden cardiac death (SCD) in patients with coronary heart disease (CHD) and evaluating the quality of SCD diagnostics and statistical registration in medical institutions (MI). In the population of 285736 patients with CHD (76,4% aged 18 years or older; 46% men), the incidence of SCD cases registered in MIs was compared to the study algorithm-based incidence of SCD. The latter was as high as 156 per 100 000 in men and 72 per 100 000 in women, which was 2,3 and 2,8 times higher, respectively, than the MI-registered levels (р<0,001). MI-based diagnostics and/or registration missed 55,6% and 66,5% of the SCD cases in men and women with CHD, respectively. The two main explanations were inadequate diagnostic search at death cause identification (45,4%) and mistakes made at completing medical documents (55,6%). Therefore, every second SCD case in men with CHD and two-thirds of SCD cases in women with CHD are not identified by MIs, which results in under-estimation of SCD incidence.