Assessment of Awareness and Experience of Using off-label Drugs by Doctors of Clinical Specialties.

Aim      To evaluate the frequency of off-label prescription of medicines in practice of clinical specialists and the awareness of respondents of the procedure of justified off-label prescription.Material and methods  The sample included 542 clinical specialists who worked in definite medical organizations in 26 entities of the Russian Federation. The respondents were proposed to fill in remotely an anonymous questionnaire to evaluate the experience of prescribing medicines off-label to adult patients.Results Prescribing medicines not in consistence with the officially approved instruction for medical use (off-label or "outside instruction") is a relevant issue of global medical care since convincing scientific evidence for safety of such use is scarce. Analysis of information about off-label prescription is one of current tasks of national medical research centers according to the Federal Project "Development of a network of national medical research centers and implementation of innovative medical technologies". According to the responses about the frequency of off-label prescriptions 67.5 % of respondents reported of no experience of off-label prescription, 27.7 % said "rarely" or "sometimes", and 4.8 % said "frequently" and "very frequently". Specialties of physicians who have more often used medicines off-label (50% and more) included obstetrics and gynecology, pediatrics, rheumatology, hematology, and pulmonology. Cardiologists, neurologists and clinical pharmacologists use medicines off-label relatively rarely (19.6%, 28.6 %, and 22.2 %, respectively). 40 % of medicines used off-label were those designed for the treatment of coronavirus infection SARS-CoV-2. The medicines most frequently used off-label included metformin, rituximab, and thioctic acid. 65 % of respondents assessed their knowledge of off-label prescription as insufficient. In addition, 75 % of respondents consider it useful to receive additional information about risks and benefits of off-label prescription in clinical practice.Conclusion      The survey revealed the need of physicians for information about risks of the off-label use of medicines in clinical practice.

Value of comparative studies of "real clinical practice" in modern cardiology. Position paper based on the expert council discussion dated 12/18/2020.

On December 18, 2020, an expert council was held with the participation of members of the Russian Society of Cardiology, the Eurasian Association of Ther-apists, the National Society for Atherothrombosis, the National Society for Evi-dence-Based Pharmacotherapy, and the Russian Heart Failure Society. The event was devoted to the discussion of the correct use of research data of "real clinical practice" in decision making.

Comparison of the outcomes of the prolonged antianginal therapy use in stable coronary artery disease patients according to the data of randomized and observational studies.

OBJECTIVE: To compare the results of treatment with antianginal drug nicorandil in patients with stable coronary artery disease according to the results of the observational study (OS) «NIKEA¼ and randomized controlled trial (RCT) «IONA¼. METHODS: «NIKEA ¼ observational program included 590 patients with stable angina pectoris. Subgroups in the OS were formed based on the adherence to nicorandil use. Adherence was assessed during follow-up direct questioning. «IONA ¼ RCT included 5126 patients with stable angina pectoris. RESULTS: Follow-up period and mean age of patients were equal in OS and RCT. In OS the group of adherent to nicorandil use patients had fewer males, life-saving drugs were administered significantly more often than in RCT, comorbidities (arterial hypertension, peripheral atherosclerosis and diabetes mellitus) were more pronounced. Angina pectoris class III was diagnosed in 32% of the OS patients vs 11% of the RCT patients, and class I - in 4.4% and 26%, respectively (р<0.001). Both in RCT and OS, there were significantly fewer cases of all cardiovascular events in the groups of nicorandil and adherent to nicorandil use patients in comparison with the groups of placebo and nonadherent patients. Both in RCT and OS the use of nicorandil led to significant decrease in the risk of all cardiovascular events. CONCLUSION: Results of the efficacy and effectiveness studies complement each other and give the opportunity to assess the realisation of the RCT results in real clinical practice.

[Novel Scale for Long-Term Prognostication of Risk of Death and Nonfatal Cardiovascular Complications in Patients From the PROGNOSIS-IHD Registry].

PURPOSE: To elaborate a risk score for prognostication of long-term survival of patients with chronic ischemic heart disease (CIHD) using data of the PROGNOSIS-IHD Registry. MATERIAL AND METHODS: Participants of the PROGNOSIS-IHD Registry (n=641, 500 men, 141 women) were inhabitants of Moscow region consecutively admitted for planned hospitalization with diagnosis of IHD to the clinic of the Center of Preventive Medicine from 01.01.2004 to 31.12.2007. During hospitalization all patients underwent coronary angiography. Diagnosis of IHD was not confirmed in 100 of 641 patients. In 2010 vital status was determined in 551 patients (86%). Mean duration of observation was 3.9 years. Uni- and multi-factorial analysis was used for assessment of prognostic value of clinical-anamnestic and instrumental parameters. RESULTS: The following parameters which were included into the risk score were most significant for prediction of occurrence of a primary end point (fatal and nonfatal cardiovascular complications [CVC]): feeling of shortness of breath (relative risk [RR] 1.86 and 1 point in risk score); history of unstable IHD course (acute coronary syndrome, myocardial infarction, unstable angina) (RR 1.76 and 1 point); need in diuretics before hospitalization (RR 1.92 and 1 point); stenosis of a cardiac valve (RR 2.95 and 2 points); zones of abnormal contractility of left ventricular myocardium at echocardiography (RR 2 and 1 point). Risk of death and nonfatal CVC in patients with suspected IHD was considered very low, low, medium, and high at score values 0, 1 (RR 1.6), 2 (RR 2.4), and more or equal 3 (RR 6.1), respectively. CONCLUSION: Novel scale has high prognostic significance relative to stratification of risk of death and nonfatal CVC in patients with suspected CIHD and can be used in wide clinical practice because of its informativeness, simplicity, and accessibility.

[Application of CAVI Index in Clinical Practice: Calculated Vascular Age as a Tool for Decision on Additional Examination of Patients With Cardiovascular Diseases].

OBJECTIVE: to analyze correspondence between determination of vascular age of patients with cardiovascular diseases by volumetric sphygmography and their chronological age, and to assess the influence of lipid factors and atherosclerotic lesions in carotid arteries (CA) on parameters associated with the cardio-ankle vascular index (CAVI). MATERIAL AND METHODS: Clinical, laboratory and instrumental examination which included volumetric sphygmography was carried out in 185 patients with various cardiovascular diseases. Calculated vascular age was determined on the basis of graphic conversion of ratio of CAVI and true age of a patient. RESULTS: Calculated vascular age exceeded chronological age in 43 patients (23.4%). Analysis of the data obtained in this subgroup, except natural interrelation between such characteristics as age, ankle-brachial index, CAVI and calculated vascular age revealed statistically significant correlations (p < 0.05) between following parameters: R-CAVI and male gender (r = 0.35), calculated vascular age (based on R-CAVI) and TG (r = -0,34), L-CAVI and BMI (r = -0.36), R-ABI and the presence of atherosclerotic plaques in carotid arteries (r = -9.34). Comparison of influence of lipid factors and CA atherosclerotic lesions on CAVI associated parameters revealed no significant differences between groups. CONCLUSION: Volumetric sphygmography with calculation of vascular age is an easily reproducible and accessible method of screening of early changes in the vascular wall. Determination of vascular age of patients with cardiovascular diseases by volumetric sphygmography suggests advisability of thorough medical examination at least in a quarter of total number of patients.

[THE QUALITY OF EXAMINATION OF PATIENTS WITH ARTERIAL HYPERTENSION BASED AT OUTPATIENT FACILITIES].

AIM: To analyze the quality of application of diagnostic methods in patients with arterial hypertension (AH) based at outpatient facilities in comparison with equipments of national clinical recommendations. MATERIALS AND METHODS: The study was conducted in the framework of the outpatient registry of cardiovascular diseases (REKVAZA). It included analysis of outpatient medical cards of 2850 patients with AH examined in two municipal polyclinics. Men accounted for 27.8% of the total. Patients with associated clinical conditions for 79.6%. Age median (interquartile range) for men and women was 64.8 (56.8; 74.8) and 70.6 (60.1; 77.6) years respectively. RESULTS: It was shown that the scope of real physical examination (measurements of height, mass, waist circumference, BMI) was below the target level (p < 0.001). Results of complete blood cell count for the previous 12 months could be found only in 71.7% of the cards, data on blood glucose level in 61/7%, total cholesterol in 42.7%, creatinine in 45.4%, results of ECG in 59.9%, echoCG in 9.5%, 24hr AP monitoring in 0.3%. Instrumental and laboratory studies were more often performed in patients with associated clinical conditions (p < 0.05). CONCLUSION: This study revealed poor quality of examination (physical, Instrumental and laboratory) of patients with arterial hypertension based at outpatient facilities.