LIPID-LOWERING THERAPY IN OUTPATIENT PRACTICE (ACCORDING TO THE ARGO-2 STUDY)

Aim. To study the features of lipid-lowering therapy with rosuvastatin in high and very high cardiovascular risk patients in real outpatient practice.Material and methods. Patients ≥30 years, visited internists or cardiologists of district outpatient clinics in the period from October 2013 to July 2014 were included into the study. Each patient fill in questionnaire. Determination of total cholesterol (TC) level was performed without special preparation of the patient using a portable photometric blood analyzer. Doctors prescribed rosuvastatin therapy when indicated, in accordance with the Guidelines, choosing the dose on their own. Repeated TC level was determined after 1 month.Results. TC level was initially determined in 10547 patients. Rosuvastatin treatment was recommended for all patients. Repeated TC level determination was performed in 7897 patients in an average after 33 days. Baseline TC level in them was 6.37±0.89 mmol/l, and after 1 month while taking rosuvastatin – 4.89±0.81 mmol/l (p<0.001). The change of TC level was -22% (p<0.001). The average prescribed dose of rosuvastatin was 11.88±5.1 mg per day. The most often (62.8%) rosuvastatin was prescribed in a dose of 10 mg per day, in 27.3% of patients – 20 mg per day, in 9.2% – 5 mg per day, and only 0.5% of patients took it in the maximal dose.Conclusion. In real clinical practice, rosuvastatin for treatment of patients with high or very high cardiovascular risk is often prescribed in moderate doses and rarely in the maximum dose despite the proven lipid-lowering effect

Роль иммунных реакций в патогенезе оптической нейропатии при нормотензивной глаукоме

PURPOSE: To analyze molecular and immunological mechanisms of optic neuropathy development in patients with normal tension glaucoma. METHODS: We have been studying serologic indicators of autoantibodies (AB) in patients with normal tension glaucoma (NTG, n=31), which were compared to corresponding parameters in patients with primary open-angle glaucoma (POAG, n=30). The control group consisted of 25 somatically healthy individuals without ophthalmic pathology and clinical symptoms of systemic autoimmune diseases. For the immunological part of the research we used a wide range of antigens: ENO-1, MBP, NSE, Tβ4, α-crystallin, rhodopsin, GAPDH, actin, α-fodrin. The antibody formation in blood serum was determined with the use of the enzyme-linked immunosorbent assay (ELISA). Antibodies concentration in the blood serum was reflected in a spectrophotometric indicator measured in standard units of optical density. RESULTS: Systemic immune disorders in patients with both forms of glaucoma were revealed. In the NTG group the level of AB to rhodopsin decreased from 1.13±0.13 (Mean±SD) to 0.91±0.19 (p=0.00002, pЦЕЛЬ. Изучение роли иммунных реакций в механизмах оптической нейропатии при нормотензивной глаукоме. МЕТОДЫ. Изучали серологические показатели аутоантител (АТ) в крови пациентов с нормотензивной глаукомой (НТГ, n=31); которые сопоставляли с данными при первичной открытоугольной глаукоме (ПОУГ, n=30). Контрольную группу составили 25 соматически здоровых лиц без офтальмопатологии и клинических признаков системных аутоиммунных заболеваний. Для иммунологических исследований использовали широкий спектр аутоантигенов: ENO-1, MBP, NSE, Tβ4, α-кристаллин, родопсин, GAPDH, актин, α-фодрин. Реакции антителообразования в сыворотке крови оценивали методом иммуноферментного анализа. Концентрацию антител в сыворотке отражал спектрофотометрический показатель, который выражался в условных единицах оптической плотности. РЕЗУЛЬТАТЫ. Выявили нарушения системного иммунитета при обеих формах глаукомы. При НТГ снижался уровень АТ к родопсину с 1,13±0,13 (Mean±SD) до 0,91±0,19 (p=0,00002,

Гемодинамические нарушения в магистральных сосудах глаза и орбиты при эндокринной офтальмопатии как фактор риска развития оптической нейропатии

PURPOSE: The search and identification of factor revealing the hemodynamic disturbances in magistral ocular and orbital blood vessels in endocrine ophthalmopathy (EOP) increasing the risk of the optic neuropathy development. METHODS: 86 patients with EOP were examined. EOP was associated with Graves' disease (GD, n=72, 144 orbits) and autoimmune thyroiditis (AIT, n=14, 28 orbits). All patients were examined by an ophthalmologist and an endo-crinologist. The diagnostic of GD and AIT was based on the medical history, examination, the level of thyroid hormones (free T4, free T3), thyroid-stimulating hormone (TSH), rTSH antibodies and thyroid sonography. Normal range for TSH levels was 0.25-3.5 mlU/l; free Т4 - 9.0-20.0 pmol/L; free ТЗ - 4.26-8.1 pmol/L. Patients with EOP were evaluated using the EUGOGO protocol. Every orbit was assessed separately. Ophthalmic examination included patients history and clinical assessment of EOP. All patients underwent similar eye examination (visometry, perimetry, biomicroscopy, tono-metry, ophthalmoscopy, Hertel exophthalmometry). Orbit pathology was verified by multispiral computed tomography. Orbit echography was carried out for all patients. Eyeball, retrobulbar space and magistral vessels were the anatomic objects of investigation. Blood flow was examined by ultrasound diagnostic system Voluson 730 PRO («Kretz», Austria) in regimen of triplexic screening (B-regimen, CDK in combination with impulse value dopplrography). Hemodynamic indices were analysed in a. ophthalmica, a. et v. retinae centralis, a. ciliaris posterior brevis et longae. Thyroid dysfunction type, endocrine disease duration, patient's age, orbital inflammation and the compressive factor were considered as factors of hemodynamic orbit disturbances. RESULTS: Different hemodynamic disturbances were present in all patients with EOP (100%). Statistic correlative analysis showed, that thyroid dysfunction is one of the most important factors, determining hemodynamic disturbances of orbit blood flow. The severity of these disturbances depended on the type of thyroid dysfunction. The obtained data showed that the age of the patient and the duration of the endocrine disease is the important factor of the hemodynamic disturbances of orbit blood flow in EOP. The age (over 50) and the duration of the disease result in hemodynamic disturbances, reaching the value of «chronic eye ischemic syndrome». The intensity of autoimmune inflammation was revealed to determine the depth of hemodynamic disturbances in orbit. At the same time the severity of EOP reflected intraorbital pressure that may cause hemodynamic disturbances changing the blood flow in the orbit. CONCLUSION: Factors determining the character of hemo-dynamic disturbances in main vessels of the eye and orbit in EOP are found and identified such as thyroid dysfunction type, orbital inflammation intensity, compressive factor, endocrine disease duration and the age of the patient.ЦЕЛЬ. Поиск и идентификация факторов, определяющих гемодинамические нарушения в магистральных сосудах глаза и орбиты при эндокринной офтальмопатии (ЭОП), повышающие риск развития оптической нейропатии. МЕТОДЫ. Обследованы 86 пациентов с ЭОП, ассоциированной с диффузным токсическим зобом (ДТЗ, 72 человека, 144 орбиты) и аутоиммунным тиреоидитом (АИТ, 14 человек, 28 орбит). Все пациенты были осмотрены офтальмологом и эндокринологом. Диагноз ДТЗ и АИТ устанавливали на основании анамнеза, осмотра, уровня тиреоидных гормонов (св.Т4, св.ТЗ), тирео- тропного гормона (ПТ), показателей АТ к рТТГ, АТ-ТПО, АТ-ТГ, эхографии щитовидной железы. Границы нормы для базального уровня ТТГ - 0,25-3,5 мЕд/л; св.Т4 - 9,0-20,0 пмоль/л; св.ТЗ - 4,26-8,1 пмоль/л. ЭОП верифицировали по протоколу EUG0G0. Каждую орбиту оценивали отдельно. Офтальмологический осмотр включал: сбор жалоб, анамнез, клиническую оценку ЭОП. Всем пациентам проводили: визометрию, периметрию, биомикроскопию, тонометрию, офтальмоскопию, экзофтальмометрию по Гертелю. Структуры орбиты исследовали мультиспиральной компьютерной томографией. Всем пациентам проводили эхографию орбиты. Анатомическими объектами исследования служили: глазное яблоко, ретробульбарное пространство и его магистральные сосуды. Кровоток исследовали на ультразвуковой диагностической системе Voluson 730 PRO («Kretz», Австрия) в режиме триплексного сканирования (В-режим, ЦДК в комбинации с импульсно-волновой допплерографией). Анализировали гемодинамические показатели в a. ophthalmica, a. etv. retinae centralis, a. ciliaris posterior brevis et longae. В качестве факторов, определяющих гемодинамические нарушения в орбите, рассматривали: уровень тиреоидных гормонов и ТТГ, длительность заболевания щитовидной железы, возраст пациента, орбитальное воспаление, компрессионный фактор. РЕЗУЛЬТАТЫ. У всех пациентов с ЭОП (100%) присутствовали различные гемодинамические нарушения. Статистический корреляционный анализ показал, что отклонение уровня тиреоидных гормонов и ТТГ от нормы - один из наиболее значимых факторов, определяющих гемодинамические нарушения орбитального кровотока. Выраженность этих нарушений зависит от вида дисфункции щитовидной железы. Полученные результаты свидетельствовали о том, что возраст и длительность заболевания щитовидной железы являются важными факторами, определяющими гемодинамические нарушения орбитального кровотока при ЭОП. С увеличением возраста (после 50 лет) и длительности заболевания гемодинамические нарушения усиливаются, достигая значений, укладывающихся в понятие «хронического глазного ишемического синдрома». Выявили, что интенсивность аутоиммунного воспаления определяет глубину гемодинамических нарушений в орбите. Наряду с этим тяжесть ЭОП отражает интраорбитальное давление, что также может вызывать гемодинамические нарушения, изменяя кровоток в орбите. ЗАКЛЮЧЕНИЕ. Найдены и идентифицированы факторы, определяющие характер гемодинамических нарушений в магистральных сосудах глаза и орбиты при ЭОП. К ним относятся: вид дисфункции щитовидной железы, интенсивность орбитального воспаления, компрессионный фактор, длительность заболевания щитовидной железы и возраст пациента

Клиническое исследование эффективности и безопасности препарата Визомитин®, глазные капли, у пациентов с возрастной катарактой

PURPOSE: The assessment of possibility to add a new indication for the registered pharmaceutical. Evaluation of safety and efficacy of Visomitin® compared to placebo in patients with age-related cataracts. METHODS: A randomized, double-blind, placebo-controlled clinical study of Visomitin® eye drops in patients with age-related cataracts was conducted in accordance with Good Clinical Practice guidance, the Declaration of Helsinki and the Russian regulatory requirements. The study included 80 patients (23 men and 57 women) aged 45 to 75 years with diagnosed age-related cataract. All subjects were randomized into two groups of 40 patients each. In the treatment group patients received Visomitin® eye drops and in the control group, patients were given placebo (vehicle, i.e. eye drops with the same composition as Visomitin® except for the active substance SkQ1) in the form of instillations of one drop per each eye three times daily for six months. The study comprised 7 monthly visits. The following standard ophthalmological examinations were used to evaluate the effectiveness of the therapy: visual acuity measurement, refractometry, biomicroscopy of the eye, ophthalmoscopy, tonometry, computer perimetry, densitometry. At certain visits lacrimal fluid was taken for evaluation of its antioxidant activity. Blood pressure and heart rate were measured as a part of safety evaluation which also included documentation of complaints and adverse events. Concomitant therapies were also documented. RESULTS: Analysis of safety parameters showed Visomitin® to be safe and well tolerated for patients with age-related cataract. Practically no adverse effects were documented during the study. In both groups a decrease of the number of patients with subjective complaints was observed. These complaints included: visual deterioration, dryness, grittiness, burning eyes, eye fatigue. The decrease of the number of complaints in the Visomitin® group was more pronounced than in the placebo group. During the first months of treatment an improvement of visual acuity was observed in both groups. This result can be explained by a protective effect of hypromellose contained in both Visomitin® and placebo. However, between the 4th and the 6th months, the improvement in visual acuity significantly slowed down in the placebo group, while positive dynamics remained the same in the Visomitin® group. At the end of the treatment visual acuity increased by more than 50% in Visomitin® group and remained at the level of 10-15% in the placebo group (statistically significant difference between placebo and Visomitin® groups,

Explore the Possibility of Early Clinical Diagnosis of Endocrine Ophthalmopathy Based on Eye Symptoms of Hyperthyroidism

Purpose: to study the possibility of early clinical diagnosis of endocrine ophthalmopathy based on ocular symptoms of hyperthyroidism. Patients and methods: we analyzed the prevalence of ocular symptoms of hyperthyroidism in 139 patients (278 orbits) with newly diagnosed endocrine ophthalmopathy (group 1), developed on the background of diffuse toxic goiter. The comparison group consisted of 80 patients (160 orbits) with newly diagnosed diffuse toxic goiter with no radiographic evidence of endocrine ophthalmopathy (group 2). All patients were examined by an ophthalmologist and endocrinologist. We analyzed the prevalence of ocular symptoms of hyperthyroidism (symptom Dalrymple’, Mobius’, Zenger’, and combinations thereof), often encountered in diffuse toxic goiter, flowing with endocrine ophthalmopathy, and/or lack thereof - in the group of “thyrotoxic exophthalmos”. We took into account the frequency distribution of these clinical signs, and their combinations. We analyzed the clinical sensitivity and specificity of diagnosis based on the three most common symptoms, and their combinations, associated both with thyrotoxicosis and with endocrine ophthalmopathy. Results: Dalrymple’ symptom, is more common in thyrotoxic exophthalmos than with endocrine ophthalmopathy (compared to 100.0% versus 61.9 %, p<0,001). This suggests that Dalrymple’ symptom leads to over diagnosis aspect endocrine ophthalmopathy. It is obvious that it can be used to recognize and thyrotoxic exophthalmos hyperthyroidism, but you cann’t credibly claim based on orbit about the presence of the disease. In this aspect, the greatest practical interest to provide a comparative assessment of the frequency of detection of symptoms of Mobius’ and Zenger’ and their combinations in a population of endocrine ophthalmopathy and in the group of thyrotoxic exophthalmos. Significantly more symptoms Zenger’ and Mobius’ developed with endocrine ophthalmopathy (66,2% and 81,7% vs. 7,5% and 15,0%, respectively, p<0,001). It had the highest sensitivity and symptoms of Mobius’, Zenger’ (reached 83.5% and 66.2%, respectively). It proved to be less sensitive symptom Dalrymple’ (61.9%) and a combination of these symptoms. The highest specificity (98.1%) showed a combination of three symptoms were less specific symptoms tandem Zenger’ and Mobius’ (93.8%) and the tandem symptom Dalrymple’ with Zenger’ symptoms (92.5%). In other words, identifying a patient at thesame time the three symptoms: Mobius’, Dalrymple’ and Senger’, or both symptoms and Senger’, Mobius’ allows to clinically diagnose with a high probability his endocrine ophthalmopathy, and conversely, a negative result of the test eliminates the desired highly specific disease. Conclusion: The presented results of statistical studies reveal the possibility of early clinical diagnosis of subclinical forms of endocrine ophthalmopathy based on monosymptom thyrotoxicosis Mobius’ and Zenger’, their tandem, as well as combinations of the symptoms of Mobius’, Zenger’ and Dalrymple’

Modern Recommendations and Real Clinical Practice: the Results of the SILA Study

Aim. To assess efficacy and safety of single-pill combination (SPC) amlodipine/perindopril and amlodipine/indapamide/perindopril in patients with uncontrolled hypertension (HT) in routine clinical practice.Material and methods. 16144 patients with uncontrolled HT were included into this multicenter observational study. Eventually 6% of patients were excluded owing to violations of protocol. 15193 patients became subjects to the final statistical analysis; they all were prescribed with single-pill combination amlodipine/perindopril or amlodipine/indapamide/perindopril and subsequently purchased these drugs. Study lasted for 3 months; during this time researchers performed office blood pressure (BP) and heart rate measurements on a monthly basis. Additionally, the researchers registered adverse effects and assessed efficacy and safety using 7-point scale.Results. Initially, patients had an average systolic BP of 1 64.2 ± 1 1.4 mm Hg, diastolic BP - 94.8±8.1 mm Hg, and they also had antihypertensive therapy in 85-89% of cases (in different regions). Patients received ACE inhibitors in 50-54% of cases, angiotensin receptor blockers - in 1 9-23%, calcium channel blockers - in 24-31 %, thiazide diuretics - in 29-36%, beta-blockers - in 27-32%. Monotherapy with ACE inhibitors was used in 1 2-18% of patients, and monotherapy with other antihypertensive drugs - in 1 -4%. Mean age was 60.5 years, mean body mass index - 29.3 kg/m2, 43% of patients had a very high risk by SCORE scale. Prescribed therapy: SPCs amlodipine/perindopril (54%) and amlodipine/indapamide/ perindopril (46%) in different doses. By the end of treatment course, the following results have been got: 88% of patients achieved target BP levels (92% and 85% among patients who took SPCs amlodipine/perindopril and amlodipine/indapamide/perindopril, respectively). Systolic BP decreased by 36,6±11,4 mm Hg (22.0±5.9%), diastolic BP - by 15.6±8.5 mm Hg (16.0±8.1%), pulse BP decreased by 21.0±11.4 mm Hg (28.8±13.9%). Mean efficacy assessment rate was 6.9±0.37 points out of 7; mean safety assessment rate was 6.9±0.37 points out of 7. Adverse events were recorded in 257 patients, which constituted 1.7% of the entire patients' population.Conclusion. Using SPC amlodipine/perindopril and amlodipine/indapamide/perindopril is associated with fast achievement of the target BP levels among most patients with a small number of adverse effects

Rosuvastatin microcirculatory effects in patients with dyslipidemia and arterial hypertension

Aim. To assess microcirculation (MC) dynamics during rosuvastatin therapy in patients with dyslipidemia (DL) and mild to moderate arterial hypertension (AH). Material and methods. The study included 25 patients with total cholesterol (TCH) level >5,0 mmol/l, low-density lipoprotein CH (LDL-CH) level > 3,0 mmol/l, systolic blood pressure (SBP) 140-179 mm Hg, and diastolic BP (DBP) 90-109 mm Hg. For 12 weeks, all participants received rosuvastatin, in constant dose of 10 mg/d. MC was assessed by laser Doppler flowmetry. Results. Rosuvastatin beneficially influenced MC, in various pathological MC types – spastic and hyperemic, according to main MC parameters – MC and capillary blood flow reserve. Regulatory mechanisms’ changes (myogenic amplitude increase) pointed to a decrease in peripheral vascular resistance. Another positive vascular effect of rosuvastatin manifested in significant SBP and DBP reduction, by 8 and 6 mm Hg, respectively. Rosuvastain also demonstrated a substantial lipid-lowering effect. Conclusion. A new statin, rosuvastatin, demonstrated not only substantial lipid-lowering effect, but also beneficial vascular action: it improved MC and reduced BP in patients with DL and mild to moderate AH

CHANGE OF HYPERTENSION TREATMENT SCHEME IN OUTPATIENT CARE AT SPECIALIZED CARDIOLOGIC INSTITUTION, AND FACTORS ASSOCIATED WITH THE CHANGE OF ANTIHYPERTENSION THERAPY

Compliance to the recommended treatment strategy is a significant component ofadherence to antihypertension therapy (AT) that is associated with treatmentefficacy and economical benefits.Aim. To study the scheme of drug therapy in patients with arterial hypertension (AH),first time requested cardiological assessment, during 6 month since the moment ofthe admittance with the assessment of factors associated with the treatmentscheme.Material and methods. The study done in 2 stages. First stage was focused onthe selection of patients who first time presented at one of the districtcardiodispensaries in Moscow (CD) among those with AH, from January toDecember. The expert charts were completed according to the source documents(n=1766). Second stage was focused on the phone survey in 6 months afterprimary admittance (n=1419).Results. Analysis of AT compliance showed that the patients in specializedcardiological institution have low level of adherence to physicians' recommendationson the treatment scheme; in 6 months only 25,1% continued taking recommendeddrugs. More than a half (52,4%) of those who changed treatment scheme, done inon their own, without physician assessment. One of the reasons was distrust to physician's recommendations (48,6%). Probability of the change of cardiologist-recommended AT was significantly related to the factors as an opportunity to get the drugs by discount rate (as incentives) (OR 2,4), coronary heart disease (OR 2,0), hypertension for less than 5 years (OR 1,5), hypertensive crises (OR 1,9), intake of three and more cardiovascular drugs (OR 2,4) and the absence of drug combinations in the scheme (OR 1,4).Conclusion. Patients of the specialized cardiological institution have low level of physician recommendations adherence by the 6-month scheme of treatment, they correct their treatment themselves, and the motivation for the scheme change their name distrust to the treating physician

EVALUATION OF THE REGULARITY OF ANTIHYPERTENSIVE DRUGS USAGE AS A COMPONENT OF TREATMENT ADHERENCE IN OUTPATIENTS OF A SPECIALIZED CARDIOLOGY CENTER

High adherence to blood pressure (BP) medical correction determines clinical and socioeconomic efficacy of antihypertensive treatment. Separate components of adherence are to be studied, including regularity of drugs intake and reasons for non-compliance with medical recommendations in different categories of patients.Aim. Evaluation of antihypertensive drugs (AHD) intake regularity (as a component of treatment adherence) and factors it is influenced by in hypertensive patients who had for the first time visited a specialized cardiology center during the 6-month follow-up after the primary consultation.Material and methods. First, a number of hypertensive patients who had visited a cardiologist of one of Moscow’s district cardiology clinics for the first time in 2010 (n=1766) had formed a sample of the study participants. The expert cards were filled out in accordance with the primary medical documentation data. The second step was conducted 6 months after the first visit by a phone survey with the completion of questionnaires (n=1419).Results. Majority of respondents (74.9%) had been taking AHD regularly 6 months after the primary consultation and 16.2% of the patients had been using them occasionally. 8.9% of the respondents completely refused to control hypertension with drugs. Respondents of male sex (OR=1.4), with poor BP self-control in home settings (OR=2.5), unable to get drugs under the medicine assistance scheme (OR=1.8), those without coronary heart disease (OR=1.9), with hypertension duration less than 5 years (OR=1.9), with changes in antihypertensive therapy regimen as compared to the one recommended by a cardiologist (OR=1.5), those who had 1-2 drugs in the treatment regimen at the moment of the survey (OR=2.4) and patients who had no fixed drug combinations in the treatment scheme (OR=1.4) were shown to have significantly higher probability of irregular AHD intake or complete treatment refusal.Conclusion. Outpatients of the specialized cardiology center are characterized by rather high treatment adherence by AHD intake regularity. We have revealed a number of factors that significantly correlate with reduced antihypertensive treatment adherence. These factors must be taken into account at treatment regimen selection and patients’ follow-up.</p