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The widespread use of statins in clinical practice necessitates a systematic approach to the risk and safety assessment. The aim of the study was to analyze information about adverse reactions to statins and their specific causes in patients with hypercholesterolemia accompanied by diabetes and hypothyroidism. The paper compares statin products (simvastatin, atorvastatin, pravastatin, rosuvastatin, and fluvastatin) in terms of the frequency of the most significant adverse reactions—statin-induced myopathy, liver damage, secondary hyperglycemia. It dis­cusses specific causes of adverse reactions to statins in patients with hypothyroidism and dia­betes. It was demonstrated that the use of statins in patients with compensated hypothyroid­ism, who have CC and TC allelic variants of the SLCO1B1*5 gene ( c.521T>C ), is associated with a higher risk of developing statin-induced myopathies. The adjustment of statin doses, especially in patients with hypothyroidism and diabetes, should be made based on the results of pharmaco­genetic testing for SLCO1B1*5 ( c.521T>C ) allelic variants. The results of dynamic clinical and laboratory control of the hepatic transaminase level, as well as the levels of glucose, glycated hemoglobin, and thyroid-stimulating hormone should be the key factors to be taken into account when adjusting treatment plans in this group of patients. The paper analyses polymorphisms of genes which are associated with resistance to statin therapy in patients with diabetes. Thus, the use of statins for primary prevention and treatment of cardiovascular diseases in patients with hypercholesterolemia accompanied by diabetes and/or hypothyroidism, requires a comprehen­sive assessment of the risk/benefit ratio.

Hypertension is one of the most important risk factors for cardiovascular diseases (CVD) in the world, including Russia. Current Guidelines for the management of arterial hypertension do not include different theatment strategies for men and women. Gender and age analysis of antihypertensive treatmen in men and women could reveal unreasonable and non - optimal treatment in each group. The purpose of this study was to identify the gender features of antihypertensive therapy used by primary care physicians in patients with hypertension. Materials and methods. The study is based on the Arterial Hypertension Registry established in 2012. The methodology of it has been described previously [1]. Medical data from outpatient cards were entered by doctors of 53 city primary care medical centers and 5 cardiology clinics from 22 regions of the Russian Federation. The study included the data of 33 564 patients from 18 years and older with diagnosis of arterial hypertension. Gender, age, height, body weight, smoking status, office blood pressure (BP), laboratory and instrumental examination methods, diagnosed cardiovascular and cerebrovascular diseases and comorbidities in accordance with the International Classification of Diseases of the 10th revision [ICD-10], as well as the treatment (antihypertensive and lipid - lowering therapy) were listed. Results and conclusion. Gender differences in the prescription antihypertensive therapy (AHT) in men and women with hypertension were revealed. Apparently, one of the reasons for these differences is the earlier and more frequent development of cardiovascular and cerebrovascular complications of hypertension in men than in women. Beta - blockers (BB) and angiotensin - converting enzyme inhibitors (ACEi) are more often prescribed to men with hypertension and with coronary artery disease (CAD), myocardial infarction (MI) and chronic heart failure (CHF). Women with hypertension are more often prescribed angiotensin receptor blockers (ARB), thiazide and thiazide - like diuretics. The study also showed non - optimal treatment of patients with hypertension. Insufficient prescription of medication which could improve the prognosis of the disease (ACE inhibitors /ARB, BB, mineralocorticoid receptor antagonist) have been identified in patients with hypertension and CAD, MI, CHF. It is noteworthy that in the some outpatient cards of patients with AH there is no record of AHT prescription: at a young age - in 9.6%, at old age in 15.1% of cards. Despite the fact of high and very high cardiovascular risk of the majority of patients, lipid - lowering therapy (statins) was prescribed insufficiently. The most statin administration was observed in hypertensive patients with coronary artery disease (50.1%) and myocardial infarction (62.7%).Артериальная гипертония (АГ) - один из ведущих факторов, определяющих высокую смертность населения от сердечно - сосудистых заболеваний (ССЗ) во многих странах мира, включая Россию. Современные клинические рекомендации по диагностике и лечению АГ не предусматривают различные стратегии медикаментозной терапии для мужчин и женщин с АГ. Анализ гендерных и возрастных особенностей медикаментозной терапии у мужчин и женщин с АГ может выявить необоснованное и неоптимальное лечение больных АГ. Целью данного исследования было изучение гендерных особенностей медикаментозной терапии больных АГ, применяемой врачами первичного звена здравоохранения. Материалы и методы. Исследование проводилось методом регистра АГ, который функционирует с 2012 г. Методика его проведения описана ранее [1]. Медицинские данные из амбулаторных карт вводились врачами 53 городских поликлиник и 5 кардиологических диспансеров из 22 регионов Российской Федерации. Из базы данных регистра АГ в исследование вошли данные 33 564 больных старше 18 лет с диагнозом «артериальная гипертония». В регистре АГ использовалась единая компьютеризованная карта, в которую врачи вносили данные пациентов о половой принадлежности, возрасте, росте, массе тела, статусе курения, клиническом уровне артериального давления (АД), лабораторных и инструментальных методов обследования, диагностированных сердечно - сосудистых и цереброваскулярных заболеваниях и коморбидности в соответствии с Международной классификацией болезней 10-го пересмотра [ICD-10], а также о проводимом лечении (антигипертензивная и гиполипидемическая терапия). Результаты и заключение. Выявлены гендерные различия в назначении врачами медикаментозной антигипертензивной терапии (АГТ) у мужчин и женщин с АГ. Одной из причин этих различий, по - видимому, являются особенности клинического течения, связанного с более частым и ранним развитием сердечно - сосудистых и цереброваскулярных осложнений АГ у мужчин, чем у женщин. Так, бета - адреноблокаторы (БАБ) и ингибиторы ангиотензинпревращающего фермента (ИАПФ) чаще назначаются мужчинам с АГ с ишемической болезнью сердца (ИБС), перенесенным инфарктом миокарда (ИМ) и хронической сердечной недостаточностью (ХСН). Женщинам с АГ чаще назначают блокаторы к ангиотензину II (БРА), тиазидные и тиазидоподобные диуретики. Исследование показало неоптимальность лечения больных АГ. В частности, у больных с АГ и ИБС, перенесенным ИМ и ХСН выявлено недостаточное назначение препаратов [ИАПФ/БРА, БАБ, антагонистов минералокортикоидных рецепторов], улучшающих прогноз заболевания. Обращает на себя внимание отсутствие записей в амбулаторных картах о проводимой АГТ у больных АГ всех возрастных категорий: в молодом возрасте - у 9,6%, в старческом возрасте - у 15,1%. Недостаточно назначается гиполипидемическая терапия (статины), несмотря на то, что большинство больных, наблюдаемых в первичном звене здравоохранения, относятся к высокому и очень высокому сердечно - сосудистому риску. Максимально большее назначение статинов наблюдалось у больных АГ с ИБС (50,1%) и перенесенным ИМ (62,7%).

Aim. To analyze changes in the pattern of lipid-lowering therapy (LLT) in outpatients with stable coronary artery disease (SCAD) over the 7-year period.Material and methods. This pharmacoepidemiological, retrospective, cross-sectional, two-stage study was conducted on the basis of primary care facility of Moscow. We analyzed 1,834 and 805 medical records of patients with SCAD at the first (2011) and second (2018) stages, respectively. Data on demography, medical history, lipid profile, and administrated LLT were collected. Statistical analysis was performed using SPSS Statistics V16.0 and MS Excel. Differences were considered significant at pResults. Overall LLT prescription rate in outpatients with SCAD increased from 48,5 up to 86,4% (pConclusion. The results demonstrated significant improvements in the LLT pattern over the 7-year period in outpatients with SCAD. Number of patients receiving statins doubled, and the cases of prescribing lowintensity LLT have become very rare. However, control of blood lipids in the target group remained inadequate.

Aim. To analyze the efficacy and safety of statin therapy in multimorbid outpatients with very high cardiovascular risk in actual clinical practice.Material and methods. The study included 131 patients with an established very high cardiovascular risk. History and anthropometric data were collected. The Charlson Comorbidity Index (CCI) was calculated; patients were divided into groups of moderate (№ 1, ≤6 points) and high (№ 2,> 6 points) multimorbidity. The frequency of prescribing statins, the range of doses used, the achievement of lipid metabolism targets, and the incidence of adverse effects were evaluated.Results. The median of the CCI was 6 (5÷8) points. Group 1 included 72 patients, group 2 — 59 patients. Statins received 87 (66,4%) patients, more often in group 1 (n=54) than 2 (n=33), p=0,026. The minimum doses were taken by 17 patients, the mean — 66, the maximum — 4. Patients of group 2 received higher dosages (χ2 =9,3, p=0,010). The target level of total cholesterol was achieved in 8 (6,1%) patients, low-density lipoprotein cholesterol — no one (0,0%). Of the 106 patients ever taking statins, they were withdrawn in 19 (17,9%) patients. The reason for discontinuation in 7 patients were adverse effects, in 5 — the high cost of therapy; in 7 patients, the reason was identified. Adverse effects were recorded in 12 (11,3%) patients; there were no differences between groups (p=0,118).Conclusion. Patients with a very high cardiovascular risk are characterized by high multimorbidity. Statins are less commonly prescribed for patients with severe polymorbidity, but at higher doses. Despite the sufficient prescribing statins and the use of mean doses, target lipid levels were not achieved. The presence of multimorbidity was not associated with an increase in the incidence of statin adverse effects.

Aim. To evaluate a complex clinical efficacy, tolerability and safety of statin drugs — simvastatin, atorvastatin, rosuvastatin in patients with hyperlipidemia (HL).Material and methods. The assessment of clinical efficacy was done in 90 patients with HL and arterial hypertension of the grades 1 and 2, age 40-75 y.o.; some of them had coronary heart disease.Results. In 90 patients with cardiac pathology and HL, selected to 3 groups by 30 persons, the clinical efficacy of the listed statins was assessed. A significant hypolipidemic effect was noted as a decline of atherogenicity of the blood, with slight more prominent effect of rosuvastatin.Conclusion. The data makes it to conclude the simvastatin, atorvastatin and rosuvastatin are equally effective hypolipidemic drugs in HL type IIA and IIB patients. The time frame, type and grade of positive changes in lipid profile are almost the same, and in rosuvastatin just slightly more prominent.

Aim. To evaluate the influence of nicotinic acid (NA) on subfractional spectrum of proand antiatherogenic lipoproteides in hyperlipoproteidemia (a) patients.Material and methods. Totally, 78 patients included, with Lp(a) level more than 20 mg/dL, taking either combinational statin and NA therapy (n=43), or on monotherapy by statins (n=13), or monotherapy by NA (n=22). Lipid profile parameters were analyzed with the assays “Biocon/Analyticon” (Germany), quantitative subfractional contents were assessed with the system Lipoprint® (Quantimetrix,USA), Lp(a) concentriation — with immune enzyme assay.Results. Results. In combinational therapy and monotherapy groups of NA the baseline Lp(a) levels were 98,0±44,8 and 71,3±21,8 mg/dL, respectively, р

The review article highlights the views reflected in the recent clinical guidelines related to high-intensity statin treatment and non statin cholesterol lowering drugs in patients with very high cardiovascular risk after myocardial infarction and the purpose of therapy. The article tells about the approaches to controlling lipidogramic parameters after high-intensity statin therapy was prescribed and to the prescription of PCSK9 inhibitors (Alirocumab) after an acute coronary event. The report was compiled on the basis of the available materials from the national and foreign databases (e-Library, Library’s MEDLINE/PubMed database).

Results of randomized clinical studies and meta-analyses on evaluation of the role of statins high dosages before and after coronary bypassing and stending are analyzed. The maximum evidence basis is provided in studies with use of atorvastatin. Considerable risk reduction of early and late cardiovascular complications is demonstrated with use of high statin dosages in patients with various forms of the ischemic heart disease.

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.

In article possibility of an assessment of efficiency of therapy by the reproduced drug Mertenil of production of JSC Gideon Richter (Hungary) appointed for the purpose of primary prevention of the cardiovascular diseases. Increase of level of lipoproteid of the low density is one of the most powerful risk factors of death. Today therapy of a statin is carried out both for secondary and for primary prevention of cardiovascular diseases. For an assessment of dynamics of atherosclerotic processat patients with the diagnosis: CHD hypercholesterolemia without visual verification of defeat of the proximal coronary course possibility of use of a multispiral computer tomography of coronary arteries with calculation of a coronary calcic index is considered.

Dyslipidemia is a frequent condition in patients with hypothyroidism which determines possible need for statin use in treatement. However, both hypothyroidism and statin use can lead to myopathy and rhabdomyolysis so safety concerns are important for clinical decision. Current article is a review of publications, clinical guidelines and drug labels which are related to the problem of statin safety in patients with hypothyroidism. Recommendations are given for use of statin in patients with compensated and decompensated hypothyroidism based on review of data.

High morbidity and mortality from ischemic heart disease (CHD) in RF presupposes the significance of individual prognosis of cardiovascular risk and of primary prevention.Aim.To analyze the level of risk that could be calculated in patients with CHD debut just before the manifest of the disease and therefore to evaluate the opportunities for the CHD debut by standard scores; to evaluate the relation of a real volume of primary prevention events to current Guidelines.Material and methods.In 122 patients hospitalized with CHD debut as an acute coronary syndrome, a retrospective cardiovascular risk evaluation, which could be found just before the onset of the disease.Results.The prevalence of traditional risk factors among persons with CHD onset was high: 88% patients had ≥3 risk factors. However, before the onset of acute coronary syndrome 68% patients at Framingham scale and 47% by SCORE could have been under the low and moderate calculated risk that shows low sensitivity for the real CHD risk. Calculated risk by the scores has not correlated with the severity of coronary vessels lesion. In analysis of primary prevention events in was found that in the studied group drug therapy of dyslipidemia was not being performed as primary prevention, though it is indicated by the standards for at least 82% patients.Conclusion.The data shows that the use of the main risk scores underestimates real chance of CHD development in the exact patient. Also even for the patients, who require statin prescription for the aim of primary prevention, this therapy is not prescribed.

Collagen type II (Col II) is among the proposed candidate autoantigens initiaiting rheumatoid arthritis (RA). Statins have been shown to have anti-inflammatory and immunomodulating properties. Mechanisms of statin effects upon the autoantigen-induced T lymphocyte activation in RA patients are still unknown. The aim of present study was to evaluate the effects of mevastatin upon Col II- and anti-CD3-induced (PBMC) activation of peripheral blood mononuclear cells (PBMC) from RA patients. PBMC from active RA patients (DAS28 – 6.6±0.64) were stimulated with antibodies specific for either anti-CD3 or anti-Col II. The cultured cells were treated with mevastatin at different concentrations. Mevalonic acid, geranylgeranyl pyrophosphate (GGpp) and farnesyl pyrophosphate (Fpp) were added to cultures. Mevastatin at concentration of 10 μM caused significant reduction of Col II-induced PBMC proliferation and of IFNγ production. These mevastatin effects were partially reversible by addition of mevalonic acid, GGpp, and Fpp. Mevastatin did not influence the anti-CD3 induced PBMC activation. In conclusion, mevastatin is able to suppress antigen-specific T-cell stimulation in RA patients, due to decreased production of mevalonic acid metabolites.

Aim of this study was to investigate efficiency and safety of OctreotidLong FS in patients with acromegaly. Materials and methods. 41 patients with acromegaly (8 – de novo and 33 patients after different somato statin analogs treatment) was treated OctreotidLong FS one injection in 28 days. Growth hormone (GH), Insulin like Growth Factor 1 (IFG1), fasting glucose (FG) and HbA1c were assess after 3, 6 and 12 month of therapy. Results. We found out the decreasing of GH and IGF1 from 12,8 (8,0–82,7) mU/ml to 3,8 (1,6–13,8) mU/ml ( p < 0,05) and %IGF1 increasing (% IGF1) from 231 (150–286)% to 9,5 (−26–111)% ( p < 0,05) in 8 de novo acromegalic patients. We also revealed that IGF1 didn’t change and GH decreased after 3 month (33 patients), 6 month (22 patients) and 12 month (8 patients) of OctreotidLong FS treatment. We didn’t observed negative effect of OctreotidLong FS treatment to carbohydrate metabolism in patients with acromegaly. Conclusion. The therapy of OctreotidLong FS leads to induce successful control of GH and IGFI in 50% de novo patients and didn’t change the number of patients with control of acromegaly after another somato statin analogs treatment. Carbohydrate metabolism also didn’t change after OctreotidLong FS treatment.

Aim.To assess the effectiveness of a complex programme of primary cardiovascular prevention, including statin therapy (Liptonorm), among men from an occupational sample who have high coronary risk levels.Material and methods.The occupational sample included male train drivers and train driver assistants, aged 40–55 yeas. The primary prevention programme included the assessment of the risk factors (RFs) and SCORE risk levels; the development of an individual prevention plan; the Workplace Health School, with Self-Control Diary distribution; and the 6-month administration of Liptonorm (mean dose 14,7±5,1 mg/d) in the high-risk group.Results.In 2010–2011, 224 men participated in the primary prevention programme. The high-risk group, as assessed by the SCORE scale, comprised 14,3%. The results of preventive measures, including the 6-month Liptonorm therapy, are presented for the high-risk group. In particular, 29,4% of the men stopped smoking. The daily number of cigarettes smoked at workplace decreased by 5,1. Consumption of >2 drinks per day, overweight, and abdominal obesity prevalence decreased by 12,5%. The prevalence of insufficient rest time and night sleep Conclusion.The workplace administration of the complex preventive programme, including statin administration, facilitates modification of behavioural RFs, achievement of target blood lipid levels, and total coronary risk reduction.

Aim. To assess the effects of original statins as monotherapy or in combination with ezetimibe on the levels of proinflammatory cytokines and high-sensitive C-reactive protein (hsCRP) in patients with coronary heart disease (CHD) and hyperlipidemia (HLP). Material and methods. The study included 60 male and female patients with CHD, primary polygenic HLP, and the levels of low-density lipoprotein cholesterol (LDL-CH) of 2,9-4,9 mmol/l. Monotherapy with original statins or ezetimibe lasted for 6 months, while the combination therapy lasted for 3 months. In all randomised patients, the levels of hsCRP, interleukin 6 (IL-6), and monocyte chemotactic protein-1 (MCP-1) were measured at baseline, 12 and 24 weeks after the therapy started. Results. At baseline, median hsCRP levels in the groups of Ezetrol, Zocor, Liprimar, and Crestor monotherapy were 0,5-0,88 mg/l, with no significant dynamics after 3 months of the treatment. Baseline IL-6 levels across the monotherapy groups were 1,94-2,54 pg/ml; at 3 months, there was a non-significant reduction by 7-32 %. After 3 months of the therapy, the decrease in MCP-1 levels was not statistically significant (-1,3-7,7 %). The combined therapy did not result in a significant dynamics of hsCRP concentrations, with the exception of the group receiving Ezetrol and Liprimar. Although the combined therapy further reduced MCP-1 levels (by 30-78 pg/ml), these changes were not statistically significant. No significant difference was observed across statin and Ezetrol groups in terms of their effects on IL-6 and MCP-1 levels. Conclusion. The comparison of the three treatment schemes demonstrated similar, but not statistically significant reduction on the levels of hsCRP, IL-6, and MCP-1. No marked benefits were observed for either monotherapy or combination therapy over 12-24 weeks of the follow-up.

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Statins reduce adverse cardiovascular outcomes and slow the progression of coronary atherosclerosis in proportion to their ability to reduce low-density lipoprotein (LDL) cholesterol. However, few studies have either assessed the ability of intensive statin treatments to achieve disease regression or compared alternative approaches to maximal statin administration.We performed serial intravascular ultrasonography in 1039 patients with coronary disease, at baseline and after 104 weeks of treatment with either atorvastatin, 80 mg daily, or rosuvastatin, 40 mg daily, to compare the effect of these two intensive statin regimens on the progression of coronary atherosclerosis, as well as to assess their safety and side-effect profiles.After 104 weeks of therapy, the rosuvastatin group had lower levels of LDL cholesterol than the atorvastatin group (62.6 vs. 70.2 mg per deciliter [1.62 vs. 1.82 mmol per liter], P0.001), and higher levels of high-density lipoprotein (HDL) cholesterol (50.4 vs. 48.6 mg per deciliter [1.30 vs. 1.26 mmol per liter], P=0.01). The primary efficacy end point, percent atheroma volume (PAV), decreased by 0.99% (95% confidence interval [CI], -1.19 to -0.63) with atorvastatin and by 1.22% (95% CI, -1.52 to -0.90) with rosuvastatin (P=0.17). The effect on the secondary efficacy end point, normalized total atheroma volume (TAV), was more favorable with rosuvastatin than with atorvastatin: -6.39 mm(3) (95% CI, -7.52 to -5.12), as compared with -4.42 mm(3) (95% CI, -5.98 to -3.26) (P=0.01). Both agents induced regression in the majority of patients: 63.2% with atorvastatin and 68.5% with rosuvastatin for PAV (P=0.07) and 64.7% and 71.3%, respectively, for TAV (P=0.02). Both agents had acceptable side-effect profiles, with a low incidence of laboratory abnormalities and cardiovascular events.Maximal doses of rosuvastatin and atorvastatin resulted in significant regression of coronary atherosclerosis. Despite the lower level of LDL cholesterol and the higher level of HDL cholesterol achieved with rosuvastatin, a similar degree of regression of PAV was observed in the two treatment groups. (Funded by AstraZeneca Pharmaceuticals; ClinicalTrials.gov number, NCT000620542.).