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Aim. To study medication adherence in elderly patients with coronary artery disease (CAD) in primary care practice.Material and methods. The study conducted in out-patient clinic of Moscow city. 293 elderly (≥65 years) patients with established CAD included. The following patient data obtained via electronic medical record system: demography, medical history, modifiable risk factors and prescribed pharmacotherapy. Level of medication adherence measured by Morisky scale (MMAS-8) via telephone survey.Results. According to Morisky scale high adherence was identified in 146 (49.8%) elderly patients, moderate adherence – in 99 (33.8%) patients, low adherence – in 48 (16.4%) patients. Analysis of specific questions of the scale done in non-adherent patients revealed signs of unintentional non-adherence due to forgetfulness (45.9%) and signs of intentional non-adherence due to patients feeling worse (35.8%) or better (28.4%). By means of dichotomic interpretation of Morisky scale results the population under research was divided into two groups: 147 (50.2%) non-adherent patients and 146 (49.8%) – totally adherent patients. These groups were comparable in terms of sex (female 71.2 vs 68.0%; p>0.05) and age (median 73.5 vs 73.0 years; p>0.05) distribution, and medical history: myocardial infarction (39.0% vs 38.8%), atrial fibrillation (37.0 and 41.5%), chronic heart failure (90.4% vs 91.2%), diabetes (26.7% vs 24.5%). There were fewer smokers in adherent group (0.7% vs 6.5%; p0.05). Drugs that improve prognosis were also prescribed comparably: antiplatelets (66.4% vs 61.9%; p>0.05), anticoagulants (36.3% vs 44.9%; p>0.05), statins (82.2% vs 79.6%; p>0.05), renin-angiotensin system inhibitors (89.0 and 87.8%; p>0.05). Adherent patients had lower mean values of lipids: total cholesterol (4.7±1.2 vs 5.2±1.4 mmol/l; p0.05).Conclusion. Half of elderly patients with CAD are non-adherent to treatment in primary care setting. Medical history and structure of pharmacotherapy do not influence level of adherence in this population. Among adherent patients fewer individuals smoke and mean values of lipids are lower. Non-adherent elderly patients cause higher load on general practitioner, supplementary pharmaceutical provision program provided no better adherence in the population under research.

Background. Currently, the main treatment for Gaucher disease is enzyme replacement therapy. Recombinant glucocerebrosidase (imiglu-cerase) is the first biotechnological drug for enzyme replacement therapy with proven clinical efficacy and safety for the treatment of patients of different ages with Gaucher disease type 1 and type 3, used in clinical practice since 1994. In Russia, within the framework of the “Pharma 2020” pharmaceutical industry development strategy, the first biosimilar of imiglucerase, the drug Glurazyme®, was developed. The obtained results of preclinical studies became the basis for a phase I randomized comparative crossover clinical trial.The objective of the study was to assess the short-term safety and pharmacokinetic parameters of Glurazyme® in comparison with the Cerezyme® after a single intravenous administration to healthy volunteers.Materials and methods. 23 healthy volunteers aged 18—45 years were included in a 3-stage clinical trial. The study during the 1st and 2nd stages was open, randomized, comparative, crossover. At the 1st stage, volunteers from the 1st group received the Glurazyme®, from the 2nd group — the Cerezyme® once in doses of 30 U/kg. At the 2nd stage, Cerezyme® was administered to the 1st group, Glurazyme® - to the 2nd group once at doses of 30 U/kg. After the end of the 1st and 2nd stages, the 3rd stage was carried out for the 3rd group (n = 5) with the administration of the test drug once at a dose of 60 U/kg.Results. For all studied pharmacokinetic parameters, after administration of the test and reference drugs in doses of 30 U/kg, 90 % confidence interval was in the range from 80 to 125 %, which indicates the pharmacokinetic compared drugs equivalence. A total of 6 adverse events of mild and moderate severity were recorded. Of these, 4 adverse events were noted after administration of the study drug and were not associated with its administration. A comparative analysis of safety assessment parameters in this study (frequency and severity of adverse events, physical examination of healthy volunteers with an assessment of vital signs, laboratory tests, electrocardiography) did not reveal intergroup differences.Conclusion. The pharmacokinetic equivalence of the Glurazyme® and the reference drug in a dose of 30 U/kg has been established. A nonlinear dependence of the main pharmacokinetic parameters on studied drug administered dose was revealed. Safety and the absence of adverse reactions after a single injection of the study drug are shown.

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 p

This article covers important aspect of methodology of clinical trials - source medical documents. Special attention is always paid to source medical records in phase 1 trials when the future of novel medicinal product is at stake. Authors discuss some issues of development and application of trial-specific forms as part of source medical documentation on the basis of practical experience in conducting phase 1 studies on healthy volunteers. Primary focus is on the structure and content of these forms with respect to specific procedures and study population in early phase research. Authors believe that implementation of trial-specific forms improves the quality of clinical trials.

This article discusses the role of pharmacist in early phase clinical trials. Authors emphasize that in Russian phase I units pharmacists are rarely involved in clinical research activities. Probably the lack of regulatory documentation in this field is one of the main reasons. The opposite situation occurs abroad where pharmacist is key member of investigational team. This problem is particularly relevant because number of phase I studies in Russia steadily increases over the last years. Based on their practical experience authors describe the range of pharmacist functions and responsibilities when working in early phase research. Qualification requirements and skills of such specialist are pointed out as well. Due to the fact that not only number of trials but also number of phase I units increases (including private departments) the value of pharmacist in clinical research will grow.

The article describes the results of retrospective epidemiology (non-interventional study) two-stage study. This study was initiated to reveal and analyze changes occurred in the field of detection and modification of cardiovascular risk factors in patients with stable angina over the five-year period. The study identified some positive shifts in how doctors of outpatient cardiology clinic captured information about risk factors in medical records and how they implemented measures of non-pharmacological modification. However, in general degree of physicians’ attention to cardiovascular risk factors remains low.

Aim. To assess five-year trend in terms of specialists’ adherence to guidelines on secondary prevention of cardiovascular diseases in patients with stable angina on the level of out-patient specialized healthcare institution in Moscow.Material and methods. Two-stage retrospective pharmacoepidemiological study was conducted. The object of the study – patient medical records. At the first stage of the study medical records of 2915 patients with stable angina visited the healthcare institution for the first time in 2006 were included, at the second stage – medical records of 1633 patients with stable angina with primary visit in 2011.Results. Over the five-year period prescription rates of drugs improving prognosis in patients with stable angina significantly increased: antiplatelets – up to 82.7%, beta-blockers – up to 74.3%, statins – up to 45.6%. Despite of no changes registered in prescription rate of the ACE inhibitors, marked increase up to 14.7% in prescription rate of angiotensin receptor blockers was revealed. In the prescription structure of pharmacological groups changes were detected concerning the preferred choice of a specific drug. Due to implementation of dual antiplatelet therapy into clinical practice a reduced number of recommendations of acetylsalicylic acid as monotherapy (down to 93.0%) and increased – in combination with clopidogrel (up to 5.4%) was registered at the second stage of the study. Over a five-year period bisoprolol (55.0%) occupied the leading position in the group of beta-blockers. Metoprolol’s prescription rate decreased to 27.4%. Prescription rate of atenolol decreased down to 3.1%, while that of nebivolol increased up to 8.3%. When choosing among statins specialists recommended significantly more often atorvastatin (up to 52.9%). In the group of ACE inhibitors three drugs preserved their leading positions. Meanwhile the number of recommendations of enalapril increased up to 50.8%, perindopril – up to 24.1%. Analysis of prescribed doses revealed significant increase in recommendations of specific drugs in higher daily doses: acetylsalicylic acid 100 mg – up to 71.1%, simvastatin and atorvastatin 20 mg – up to 60.5% and 41.9%, respectively. When prescribing beta-blockers and ACE inhibitors specialists continued to use minimal and medium therapeutic doses, possibly due to dose titration in patients with comorbidities.Conclusion. Study results demonstrated positive trend in terms of specialists’ adherence to guidelines on secondary prevention of cardiovascular diseases in patients with stable angina. However, a number of problem aspects were identified that require further optimization of medical and preventive measures in healthcare institutions.

Aim. To study secondary prevention of cardiovascular diseases among patients of different age groups with a history of myocardial infarction by the example of outpatient cardiology institution.Material and methods. Retrospective pharmacoepidemiological study was conducted by analyzing the medical records of 825 patients with a history of myocardial infarction, who visited the outpatient cardiology institution for the first time in 2011. Patients were divided into two groups according to their age: younger than 60 years (n=308), and 60 years and older (n=517).Results. The population of elderly patients was more severe: significantly more often patients had disability and comorbidities. The prevalence of the main modifiable risk factors could not be assessed fully due to the lack of information in patients’ medical records. Elderly patients were significantly less likely to receive β-blockers (80.3%) and statins (63.8%). No significant differences were found in daily doses of the main prescribed preventive drugs between two groups.Conclusion. Secondary prevention of cardiovascular diseases among patients of different age groups could not be considered proper, as there is low level of attention to the modifiable risk factors and recommendation on their correction. A tendency to under-prescription of angiotensin converting enzyme inhibitors was revealed, as well as significantly lower number of recommendations for taking statins and β-adrenoblockers in the group of elderly patients.

The paper deals with the problem of the interchangeability of brand-name and generic drugs. Touching upon official terminology and the normative documents that govern the registration of generics in Russia and foreign countries, the authors state that there is no concerted approach to estimating drug interchangeability, indicate that there are some disadvantages of using a method for proving the bioequivalence of the compared drugs as evidence for their therapeutic equivalence, and point out that Russia’s legal regulation of drug circulation lacks attention to the proper use of generics. The problem of interchangeability is particularly acute when prescribing narrow therapeutic range drugs, including anticonvulsant drugs. The results of the investigations discussed in the article demonstrate the need for a very cautious approach to using generic drugs in the therapy of epilepsy due to the fact that the disease may worsen. The authors come to the conclusion that treatment with less expensive generic drugs is far from always more economical. The change from a brand-name for a generic drug should be carefully approached, basing on the data of properly designed and conducted studies of therapeutic equivalence.

Aim. To assess 5 years trend in level of doctor’s adherence to actual guidelines on secondary prevention of cardiovascular diseases in patients with a history of myocardial infarction in ambulatory specialized healthcare institution in Moscow. Material and methods. There were 752 patients firstly visited healthcare institution in 2006 and 825 patients – in 2011. Their data was included in two-stage retrospective pharmacoepidemiology study. Results. Prescription rate significantly increased for three of four prophylactic groups recommended for patients with a history of myocardial infarction (antiplatelets – 91.76%, beta-blockers – 83.39%, statins – 69.45%). When assessing prescribed doses of drugs, an increase in a number of their higher doses prescriptions was revealed (at the second stage of the study acetylsalicylic acid 100 mg/day received 75.32% of patients, enalapril 20 mg/day – 30.45%, simvastatin and atorvastatin 20 mg/day – 64.52% and 47.89% of patients, respectively). Conclusion. Results showed growing level of doctor’s adherence to actual recommendations on therapy and secondary prevention of cardiovascular diseases. Nevertheless, the level of adherence remains unsatisfactory and requires additional work with doctors.

Aim. To assess the real clinical practice implementation of the recommendations on secondary cardiovascular disease (CVD) prevention in patients after myocardial infarction (MI).Material and methods. In total, 6,000 ambulatory medical cards were randomly selected from all cards of the patients visited the city cardiology dispanser in 2006. Among the selected cards, 752 belonged to patients with an MI in anamnesis. The information on main CVD risk factors (RFs), achievement of target levels of body mass index (BMI), blood pressure (BP), total cholesterol (TCH), and low-density lipoprotein CH (LDL-CH), as well as the data on pharmaceutical treatment, invasive diagnostics and therapy of coronary heart disease (CHD), were analysed.Results. Inadequate attention of ambulatory specialists to the main modifiable and non-modifiable CVD RFs was observed. The prevalence of achieved target levels of BMI, BP, TCH, and LDL-CH was very low. In post-MI patients, anti-aggregants, statins and anticoagulants as a part of the pharmaceutical secondary CVD prevention, were not administered often enough by the specialists working at polyclinics and the cardiology dispanser. The usage of invasive diagnostics and treatment of CHD remained low.Conclusion. The recommendations on secondary CVD prevention in post-MI patients were implemented inadequately.

Aim. To evaluate the real-world clinical practice implementation of modern international and national recommendations on primary and secondary prevention and pharmacotherapy of cardiovascular disease (CVD) among patients with Type 2 diabetes mellitus (DM-2) in one administrative area of Moscow City (2004-2006).Material and methods. Cross-sectional retrospective analysis of ambulatory medical card data was performed among 1146 DM-2 patients attending one out of three Moscow City South-West Area policlinics (2004-2006). Quality of primary and secondary prevention and pharmacotherapy was assessed by compliance with modern international and national standards. The following data from ambulatory medical cards were analyzed: general information on the patient, main risk factors (RFs), comorbidities, instrumental and laboratory tests and their results, number of hospitalizations and sick-leaves, administered therapy.Results. Ambulatory cards contained inadequate information on RFs and recommendations on RF correction. Alcohol consumption and smoking were mentioned only in 0,53 % and 6,19 % of the cases, respectively. Recommendations on reducing alcohol consumption were recorded for 0,70 %, smoking cessation - for 1,83 %, and salt intake reduction - for 2,44 %. Body weight control was recommended in 1,05 % of the cases only, despite overweight and obesity prevalence of 30 % and >45 %, respectively. The levels of blood pressure (BP), lipids, fasting glucose, glycated hemoglobin (HbAlc) were higher than respective target levels stated in national and international recommendations. Target level of BP was achieved in 4,36 % of DM-2 patients, low-density lipoprotein cholesterol - in 18,35 %, fasting glucose - in 27,67 %, and HbAlc - in 24,80 %.Conclusion. Real-world clinical practice of ambulatory treatment of DM-2 patients was not consistent with modern international and national standards of CVD prevention and therapy.

Aim. To assess compliance with international clinical guidelines on coronary heart disease (CHD) secondary prevention, as well as on stable angina pectoris diagnostics and treatment, in Russian clinical practice settings. Material and methods . Among 5000 randomly selected out-patients visiting Moscow City Cardiology Dispanser (MCCD) in 2001, 1840 patients with stable angina diagnosis were identified. Out-patient medical documents were studied, and information on CHD risk factor (RF) registration, clinical diagnosis, clinical and laboratory tests, therapy (agents and their doses), associated diseases and their treatment, was analyzed. Results. Moscow doctors, in spite of existing international and national clinical guidelines, do not use objective diagnostic tests and rely on subjective complaints, while assessing disease severity and determining management tactics, in every second patient (49.2%). The doctors inadequately address RF in stable angina patients, fail to modify RF effectively, and do not attain RF target levels. The principal problems of pharmacotherapy are inadequately low use of statins in CHD secondary prevention (1.8% at out-patient clinics; 6.4% Ц at MCCD), as well as use of minimal effective doses for most antianginal agents. Coronarography, coronary angioplasty, and bypass surgery rates are substantially lower than those in Eastern European countries. Conclusion. The recommendations of national and international guidelines on CHD secondary prevention, stable angina diagnostics and treatment, are still fulfilled inadequately.

Aim. To assess the implementation of international guidelines on coronary heart disease (CHD) treatment and secondary prevention into Russian clinical practice, by examining Moscow- population patients with myocardial infarction (MI). Material and methods. Five thousand out-patient medical cards of the individuals, who attended the Moscow City Cardiology Dispanser in 2001, were randomly selected. Among them, 623 patients had MI in anamnesis. According to medical documents data, the prevalence of CHD risk factors (RF), drug therapy administered, invasive CHD diagnostics and treatment, and CHD secondary prevention advice, were analyzed. Results. Among Moscow physicians, inadequate awareness on CHD RF was observed. International guidelines were not followed: in particular, under-treatment with statins, antiplatelet agents, effective doses of antihypertensives, as well as over-treatment with first-generation calcium antagonists, were registered. Invasive CHD diagnostics and treatment were still used rarely, comparing to developed countries in Europe and worldwide. Conclusion. In the area of CHD secondary prevention for MI patients, a huge gap between international guidelines and actual clinical practice was observed.

The two-stage retrospective review of 1375 medical records of ambulatory patients with myocardial infarction was carried out in order to assess the delivery rate of up-to-date international and domestic guidelines for secondary CVD prevention over a period of 2001- 2006. The gap between the current guidelines for medicamental prophylaxis and their implementation in clinical outpatient practice was revealed. In spite of the fact that doctors began to prescribe preventive drugs more often target levels for cholesterol and blood pressure were not achieved in the major part of patients with myocardial infarction. The prescription rate of antiaggregants, anticoagulants and statins is still rather low.