Innovative drugs for the treatment of primary headaches: migraine

The article presents information about innovative drugs for the treatment of primary headaches (in particular, migraine), which are at the stages of clinical or preclinical studies, or were recently introduced to the foreign pharmaceutical market. The classes of these drugs, their mechanism of action, as well as the results of past studies are presents in article

Modern aspects of epidemiology of congenital anomalies of development: methodological issues and the translation of research fndings into clinical practice

Progress achieved in the identifcation and characterization of the risk factors for congenital anomalies occur mainly from epidemiological studies, which gave many associations between risk factors and groups of birth defects. However, in clinical practice the transmission of these associations as the actual reasons remains very difcult. Characteristics and epidemiological analysis of possible factors, including drugs, associated with the occurrence of congenital anomalies, are crucial for the development of prevention activities that have an impact on the incidence of defects. To further reduce the global burden of birth defects can help the integration of studies in epidemiology, genetics and epigenetics through personalized and population oriented preventive strategies

Quality assessment of pharmaceutical care to patients with headaches using the simulated patient method: interaction practice

Relevance. WHO assesses headaches as a global world problem. Russia occupies a leading position in the prevalence of primary headaches. Headaches are one of the most common reasons for visiting a pharmacy for self-medication. The interaction of the pharmacist and the visitor with the headache problem in general determines the quality of pharmaceutical care.Aim. To assess the practice of the interaction between a patient with a headache and a pharmacist using the simulated patient method.Materials and methods. Trained simulated patients (women aged 20, 40 and 58 years) visited a total of 101 pharmacies. The dialogue was recorded on a voice recorder, all the features of the interaction were additionally recorded aſter the visit. Special forms were filled out based on the information received. The data was processed using Microsoſt Excel 2010 and STATISTIKA 10.0.Results. The average interaction time was 98.2±3.8 seconds. There was a high frequency of spontaneous recommendations without preliminary questions (66.3%), a small number of questions asked (0.84±0.1). These indicators practically did not depend on various factors (type of pharmacy organization, age of the pharmacist, age of the simulated patient, the presence of a queue, and others).Conclusion. The results of the study demonstrate a low level of interaction between pharmacists and visitors with a headache, as well as a practical absence of involvement in the process of providing pharmaceutical care, which negatively affects its quality: frequent spontaneous recommendations, short consultations and rare questions. The approach to the interaction of pharmacists with visitors with headaches is formal and requires standardization

Quality assessment of pharmaceutical care to patients with headaches using the simulated patient method: drug recommendations and pharmaceutical counseling

Relevance. Headaches are one of the most important health problems both in Russia and around the world, as well as one of the most common reasons for self-treatment in a pharmacy due to the availability of over-the-counter drugs. Pharmaceutical workers play an important role in the control of self-medication, and the rationality of drug recommendations determines the quality of pharmaceutical care.Aim. To assess the rationality of drug recommendations for a patient with a headache and pharmaceutical drug counseling using the simulated patient method.Materials and methods. Trained simulated patients (women aged 20, 40 and 58 years) visited a total of 101 pharmacies. The dialogue was recorded on a voice recorder, all the features of the interaction were additionally recorded aſter the visit. Special forms were filled out based on the information received. The data was processed using Microsoſt Excel 2010 and STATISTIKA 10.0.Results. There was a high frequency of spontaneous recommendations without preliminary questions (66.3%), recommendations (14.9%) and dispensing of prescription drugs (5.0%), frequent recommendations of combined drugs (91.0%). Trade name Pentalgin (46.5%) and trade name Nurofen (42.6%), INN Ibuprofen (47.5%) were the most recommended. Combination analgesics were purchased in most of the visits (72.0%), information on the duration of use of the drug and the need to visit a doctor was never provided.Conclusion. Pharmacists' recommendations are in most cases irrational, focused on the drug as a product and sometimes unsafe, and counseling is practically non-existent. Improving the quality of pharmaceutical care at this stage should include the development of standards for drug recommendations and adequate counseling

The rationality of recommendations of drugs for patients with cephalgia in simulated situations in the pharmacy

Relevance. According to statistics of the World Health Organization, at least half of the world’s adult population experienced headaches at least once a year. Patients suffering from headaches do not always have the opportunity to visit a doctor, therefore, an important role in helping these patients is assigned to pharmacists. Purpose. Based on the pharmacoepidemiological study to identify the features of providing pharmaceutical care to patients with headache in pharmacies in the issue of rationality of recommendations of pharmaceutical workers. Materials and methods. A pharmacoepidemiological study was conducted based on a survey of 153 pharmaceutical workers (Saratov) using a specially developed questionnaire that includes free-form questions with a simulated situation. The data was processed using Microsoft Excel 2010 and STATISTIKA 6.0. Results Of the groups recommended to visitors, INNs in the group «Nonsteroidal anti-inflammatory and antirheumatic drugs [M01A]» account for 45.0 % of all INNs, and the group «Analgesics [N02]» - 55.0 %. Ibuprofen (62.8 %) and the combination of drotaverine + caffeine + naproxen + paracetamol + phenylephrine (41.2 %) were noted as the most frequently recommended. A visit to a doctor was recommended by the majority of respondents (52.3 %, n=153) in the case of a patient with a headache accompanied by nausea and vomiting. Ibuprofen (90.8 %) or paracetamol (45.8 %), moreover in the form of suspension or suppositories, are the preferred recommendations for headache in children under 3 years of age (n=131). Paracetamol in combinations (69.2 %) prevails as the first recommendation for headache associated with acute respiratory viral infections (n??=146). Non-selective NSAIDs for a patient with gastrointestinal complications could be recommended by 43.4 % of specialists (n=113). The NSAID recommendation is the most frequent (51.8 %, n=110) in the case of an 80-year-old patient without concomitant diseases. Paracetamol (50.0 %) or ibuprofen (34.7 %) would be more often recommended by pharmaceutical workers for a pregnant woman with headache (n=98). In case of headache after trauma, 47.1 % recommend a visit to a doctor (n=153). Conclusion. The frequent recommendation of combined analgesics and their association with the development of drug-induced headaches indicates the need for careful recommendation of these drugs. Not always correct recommendations indicate the need to increase the level of professional knowledge, study clinical recommendations for the therapy and diagnosis of cephalgia, which can make it possible to make a rational choice of the drug, initially assume that the visitor has conditions that require a visit to a doctor, and ultimately improve the quality of pharmaceutical care

Evaluation of adherence of patients with atrial fibrillation to anticoagulant therapy at the outpatient stage of treatment

Despite clinical guidelines for the treatment of atrial fibrillation (AF) patient adherence to oral anticoagulants (OACs) in routine clinical practice remains low. Assessing the factors affecting adherence to the OACs regimen and developing strategies for its improvement is important. Aim. To assess the adherence of patients with AF to the prescribed anticoagulant therapy at the outpatient stage of treatment. Methodology. The object of the study was 165 patients with nonvalvular AF undergoing treatment in a specialized cardiology department or receiving outpatient treatment in a specialized cardiological dispensary in Saratov from February 2018 to December 2019. After 3, 6, 12 months, a telephone contact with the patients was carried out, a specially designed questionnaire was filled out, in which the anticoagulant therapy received by AF patients was reflected, the Morisky-Green questionnaire was filled out, the answers of patients about the reasons for skipping or stopping the administration of the OACs were recorded. Results. After 3 months. 16.6 % of AF patients replaced the OACs intake with antiplatelet agents, 16 % refused antithrombotic therapy; 43.1 % of AF patients were adherent to OACs. After 6 months. antiplatelet agents were taken by 24.5 % patients (p<0.05), 11.9 % completely stopped taking antithrombotic drugs; 30.8 % of patients were adherent to OACs (p<0.05). After 12 29,5 % patients replaced OACs treatment with antiplatelet agents, 7.6 % patients did not take any antithrombotic drugs; 31.8 % of AF patients were adherent to OACs. The most common reasons for a decrease in the adherence to OACs therapy were the cost of drugs, lack of understanding of the value of OACs administration in AF, and the lack of appreciable effect of OACs administration. Conclusion. At the outpatient stage of treatment, there was an insufficient level of adherence of AFpatients to OACs treatment

Analysis of antithrombotic therapy of atrial fibrillation in international and Russian registries

In the article the features of the organization of international and Russian registers of patients with atrial fibrillation (AF), the clinical and demographic characteristics of patients included in the registers, as well as the features of antithrombotic therapy of AF and its compliance with current clinical guidelines were observed. In a number of large randomized controlled trials (RCTs), not less effectiveness, and in some cases, the superiority of direct oral anticoagulants (DOACs) over warfarin, were proved in the prevention of ischemic insulin stroke patients with non-valvular AF with better safety profile and ease of use. However, the problem of the use of data obtained during RCTs in real clinical practice, for the solution of which medical registers are gaining much popularity, remains relevant. The article provides an analysis of 16 prospective multicenter international and Russian registers of patients with AF. For convenience of comparison, registers were divided into three groups in accordance with the features of the organization and inclusion criteria. Unambiguous conclusions were drawn about the incompatibility of the real clinical practice of antithrombotic therapy of AF with current clinical recommendations. Differences in the population of patients with AF in Russia compared with European countries were found, which led to the conclusion that insufficient detection of AF at the outpatient stage of diagnosis and the resulting inappropriate anticoagulant therapy aiming the prevention of stroke and ischemic complications take place, which may be due to the differences in the socioeconomic status of the regions and the characteristics of the organization of medical treatment and preventive care to the population

Анализ объемов потребления психотропных лекарственных средств, применяемых для лечения шизофрении, в стационарах различного типа

the goal of our research was to carry out an analysis of psychotropic drug utilization used for patients with schizophrenia in two (state and municipal) in-patient clinics during 2000 and 2010, using the DDD methodology. As the result, we found out that psychotropic drug utilization increased from 2000 to 2010 in both types of in-patient clinics. Consumption of second-generation antipsychotics increase in state clinic in 2010. And in the state clinic we can observe a favorable trend in the decrease of antidepressants and tranquilizers consumption.открытое фармакоэпидемиологическое ретроспективное исследование потребления психотропных лекарственных средств, применяемых для лечения шизофрении, проводилось в 2000-2010 гг. Цель: целью данного исследования было проведение анализа объемов потребления психотропных лекарственных средств (ЛС), применявшихся для лечения параноидной шизофрении в двух стационарах разного типа в 2000 и 2010 гг. с помощью методики «определенных дневных доз». Материалы и методы: оценивались демографические данные пациентов, диагноз, синдром, тип течения заболевания, длительность госпитализации, возраст начала заболевания; названия нейролептиков (НЛ) и препаратов сопутствующей терапии с указанием режима их применения (доза, кратность, путь введения), с использованием методики «определенных дневных доз» (Defined Daily Doses – DDD). Также оценивались побочные эффекты психофармакотерапии и исход лечения. Результаты: обнаружено, что объемы потребления психотропных ЛС при стационарном лечении шизофрении выросли с 2000 по 2010 г., независимо от типа стационара. Объемы использования атипичных НЛ в 2010 г. выросли при снижении объемов потребления антидепрессантов и транквилизаторов

Results of a clinical study of Traumeel® S and Zeel® T in patients with knee osteoarthritis and concomitant cardiovascular disease

Objective: to evaluate the efficacy and safety of simultaneous intramuscular administration of Traumeel® S and Zeel® T followed by therapy with the tablet medication Zeel® T in patients with knee osteoarthritis (OA) and concomitant cardiovascular diseases.   Material and methods. The analysis included 119 patients aged 45–79 years (78.2 % women and 21.8 % men) with confirmed diagnosis of knee OA according to Altman criteria, stage II–III according to Kellgren–Lawrence and confirmed cardiovascular disease. The main indicator of efficacy was the change in pain intensity in the target knee joint according to the “Pain” subscale of the WOMAC questionnaire (A) at the final examination compared to the baseline. Other criteria were the dynamics of each symptom of knee OA according to the WOMAC questionnaire (pain, stiffness, and functional impairment, total score) on each visit, pain intensity in the target joint on a visual analogue scale (VAS), time it takes to travel 15 m, and the patient's overall disease assessment on the VAS. In addition, duration of use and dose of paracetamol (if used) were assessed, as well as quality of life by EuroQol and adverse events (AEs). Treatment safety was also analyzed in patients who had received at least one dose of the study drug.   Results and discussion. WOMAC pain intensity decreased by on average of 3.8 points: from 7.6 to 3.8 points (95 % confidence interval, CI from -4.3 to -3.3). Data on changes in knee OA symptoms (pain, stiffness, and functional impairment) for each WOMAC subscale and the total score showed significant improvement at each follow-up visit (p < 0.0001). The VAS pain level decreased by 52%. An improvement in joint function was noted: the time it takes to travel 15 m fell from 19.5 to 16.4 s (p < 0.0001). The EuroQol quality of life score also improved from 57.1 ± 16.2 points at baseline to 71.1 ± 14.8 points on the 84<sup>th</sup> day of therapy. Thirty (25.2 %) patients had AEs, mainly neurological: headache (7.6 %) and hypoesthesia (1.7 %). No serious AEs were recorded. An association between AEs and study drug use was noted in 4 patients (headache, hypoesthesia, muscle cramps, and injection site pain).   Conclusion. The results of the study confirm the efficacy and safety of the use of Traumeel® S and Zeel® T in patients with knee OA who have concomitant cardiovascular disease. During therapy, a significant decrease in pain and other clinical signs of OA (stiffness, limitation of physical activity) was observed, which allows us to recommend this treatment regimen for patients with comorbid pathology, as well as with the risk of developing of AEs during non-steroidal anti-inflammatory drugs therapy

Extended Thromboprophylaxis with Betrixaban in Acutely Ill Medical Patients

Background Patients with acute medical illnesses are at prolonged risk for venous thrombosis. However, the appropriate duration of thromboprophylaxis remains unknown. Methods Patients who were hospitalized for acute medical illnesses were randomly assigned to receive subcutaneous enoxaparin (at a dose of 40 mg once daily) for 10±4 days plus oral betrixaban placebo for 35 to 42 days or subcutaneous enoxaparin placebo for 10±4 days plus oral betrixaban (at a dose of 80 mg once daily) for 35 to 42 days. We performed sequential analyses in three prespecified, progressively inclusive cohorts: patients with an elevated d-dimer level (cohort 1), patients with an elevated d-dimer level or an age of at least 75 years (cohort 2), and all the enrolled patients (overall population cohort). The statistical analysis plan specified that if the between-group difference in any analysis in this sequence was not significant, the other analyses would be considered exploratory. The primary efficacy outcome was a composite of asymptomatic proximal deep-vein thrombosis and symptomatic venous thromboembolism. The principal safety outcome was major bleeding. Results A total of 7513 patients underwent randomization. In cohort 1, the primary efficacy outcome occurred in 6.9% of patients receiving betrixaban and 8.5% receiving enoxaparin (relative risk in the betrixaban group, 0.81; 95% confidence interval [CI], 0.65 to 1.00; P=0.054). The rates were 5.6% and 7.1%, respectively (relative risk, 0.80; 95% CI, 0.66 to 0.98; P=0.03) in cohort 2 and 5.3% and 7.0% (relative risk, 0.76; 95% CI, 0.63 to 0.92; P=0.006) in the overall population. (The last two analyses were considered to be exploratory owing to the result in cohort 1.) In the overall population, major bleeding occurred in 0.7% of the betrixaban group and 0.6% of the enoxaparin group (relative risk, 1.19; 95% CI, 0.67 to 2.12; P=0.55). Conclusions Among acutely ill medical patients with an elevated d-dimer level, there was no significant difference between extended-duration betrixaban and a standard regimen of enoxaparin in the prespecified primary efficacy outcome. However, prespecified exploratory analyses provided evidence suggesting a benefit for betrixaban in the two larger cohorts. (Funded by Portola Pharmaceuticals; APEX ClinicalTrials.gov number, NCT01583218. opens in new tab.