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The objective of this study was to assess the volume of consumption of anti-interleukins and janus kinase inhibitors in the period 2018–2021, used as well as preventive pathogenetic therapy of COVID-19.Materials and methods. Based on actual sales data in the segments of public procurement (including regional and federal preferential drug provision) and retail sales segment in the period 2018–2021, obtained from the IQVIA database. All data was recalculated into the number of established daily doses (DDDs), with the calculation of pharmacoepidemiological indicators «Incidence of prescribing drugs», «Cumulative risk of prescribing drugs», as well as «Prescribing prevalence per year» for tocilizumab, olokizumab, levilimab, sarilumab, kanakinumab, anakinra, baricitinib, tofacitinib and upadacitinib. Results and discussion. The growth of total sales volumes was demonstrated in all market segments, but mostly in the segment of regional purchases, primarily related to the purchase of these groups of medicines for COVID-19 therapy in the period 2020–2021. It was demonstrated that the increase in the number of cases, accompanied by the expansion of prescribing preventive pathogenetic therapy, led to a twofold increase in the number of new cases of prescribing of janus kinase inhibitors and an increase in this indicator for anti-interleukins by 1.5 times, taking into account the estimated number of patients with moderate and severe COVID-19. The cumulative risk of prescribing these classes of drugs increased proportionally: for JAK inhibitors from 14 to 32%, and for anti-IL drugs from 38 to 69%. Calculations showed that the proportion of people over 18 years of age in the Russian Federation who received at least one dose of janus kinase inhibitors and anti-interleukins increased many times, in 1000 times and 500 times. Conclusions. Taking into account the expansion of the use of these groups of medicines, careful monitoring of information about their safety is required. © 2023, HIV Infection and Immunosuppressive Disorders.All Rights Reserved.
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Objective: evaluation of the clinical and economic efficiency of using Levilimab in the treatment of moderate and severe COVID-19 based on real world data (RWD). Material and methods. A single-center observational retrospective case-control study was performed. According to the matching algorithm, 834 pairs of patients with moderate and 347 pairs with severe infection were selected, similar in gender, age, vaccination status, severity of the disease and the level of C-reactive protein. Results. The clinical efficiency of Levilimab with respect to in-hospital mortality was demonstrated both for the moderate course (6% in the Levilimab group and 10% in the standard therapy group;odds ratio (OR) 1.71;95% confidence interval (CI) 1.19-2.47;p<0.01) and for the severe course of COVID-19 (63% and 82%, respectively;OR 2.70;95% CI 1.90-3.82;p<0.01). The costs per 1 treated patient were also higher in the Levilimab therapy groups: the difference in costs compared to the standard therapy group for patients with moderate disease was 54 665.30 rubles, with severe disease - 91 285.85 rubles. The estimated cost of the additional effectiveness of Levilimab for the moderate course of the disease was 13, 666.32 rubles, for the severe course - 4, 804.51 rubles. Conclusion. The use of Levilimab for the treatment of moderate and severe COVID-19 is feasible both from a clinical and economic points of view. Conducting RWD trials is an important tool to understand the effectiveness of medical technologies in real clinical practice.Copyright © 2023 IRBIS LLC. All Rights Reserved.
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Objective. To evaluate safety of anti-interleukin drugs used as a pathogenetic therapy of COVID-19 as assessed by risks of infectious complications. Materials and methods. A systematic review of publications related to safety assessment of anti-interleukin drugs recommended as pathogenetic therapy in COVID-19 patients in terms of incidence of serious adverse events and adverse events of "Infections and Invasions" class and a meta-analysis of the data were performed. Results. The meta-analysis included 16 randomized and 3 non-randomized studies. The hazard ratio of serious adverse events between the comparison groups was 0.93 [95% CI 0.85;1.01] (p = 0.1), the hazard ratio of adverse event of "Infections and Invasions" class was 0.9 [95% CI 0.8;1.02] (p = 0.09), showing no differences in the incidence of those events. Conclusions. This meta-analysis did not demonstrate statistically significant differences in the relative risks of serious adverse events and adverse events of "Infections and Invasions" class for the use of anti-interleukin drugs in COVID-19 patients.Copyright © 2022, Interregional Association for Clinical Microbiology and Antimicrobial Chemotherapy. All rights reserved.
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Most of the medicines used to treat the novel coronavirus infection (COVID-19) are either approved under an accelerated procedure or not approved for the indication. Consequently, their safety requires special attention. The aim of the study was to review methodological approaches to collecting data on the safety of medicines, using COVID-19 treatment regimens involving azithromycin as a case study. Material(s) and Method(s): PubMed (MEDLINE), Scopus, eLIBRARY, and Cyberleninka databases were searched for publications on azithromycin as part of combination therapy for COVID-19 in 2020-2021. Search queries included names of the medicinal product or its pharmacotherapeutic group and words describing adverse drug reactions (ADRs) during treatment. Result(s): the analysis included 7 publications presenting the results of studies covering the use of azithromycin as part of COVID-19 combination therapy in more than 4000 patients. Most commonly, the patients receiving COVID-19 therapy including azithromycin developed cardiovascular ADRs (up to 30% of azithromycin prescription cases). In 3 of the analysed publications, safety information was collected through spontaneous reporting and active identification based on the findings of laboratory and instrumental investigations performed during the clinical studies;in other 3, only spontaneous reports were used;and in the last one, ADR database information was studied. Conclusion(s): currently, information on ADRs associated with the use of medicines is mainly gathered via spontaneous reporting. Direct sourcing of information on personal experiences with a certain product from patients, among other means through social media analysis, opens a promising direction towards the improvement of existing approaches to collecting safety data.Copyright © 2022 Obstetrics, Gynecology and Reproduction. All rights reserved.
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Introduction. On average, 10% of patients hospitalized due to new coronavirus infection (COVID-19) will be readmitted. To date, the reasons for readmission and the characteristics of these cases are not fully presented. The aim of the study was to analyze readmissions of COVID-19 patients to identify the causes of readmission, clinical features, examination data and treatment outcomes. Materials and methods. The study was performed retrospectively by using electronic records of the medical cases of the St. Petersburg City Hospital of St. George. Inclusion criteria: 1) the presence of two or more hospitalizations during 2020–2021;2) COVID-19 confirmed by polymerase chain reaction within 14 days before or during the first hospitalization, or the detection of changes in the lungs with a high probability associated with COVID-19 during primary computed tomography. One hundred and two people met the specified criteria. Results. In 85% of cases, the cause of re-admission was symptoms of respiratory infection;in 13% – thrombotic events (pulmonary embolism, acute cerebrovascular accident, deep vein thrombosis of the lower extremities);12% – severe pain syndrome of various localizations;11%-infectious and inflammatory processes;9% – antibiotic-associated diarrhea;5% – atrial fibrillation and less often other pathologies. Patients with respiratory symptoms had a high degree of respiratory failure, an increase in the volume of affected lung tissue and an increase in the content of various markers of inflammation in the blood when compared with the data of the initial examination. Nine percent of patients died during hospitalization. Conclusions. The leading cause of repeated inpatient treatment of COVID-19 patients were symptoms of reactivation of the infection with a number of indicators of a greater severity of this "second wave” of the disease. Further studies are required to reduce the risk of repeated inpatient treatment. © 2022, Remedium Group Ltd. All rights reserved.
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Introduction. On average, 10% of patients hospitalized due to new coronavirus infection (COVID-19) will be readmitted. To date, the reasons for readmission and the characteristics of these cases are not fully presented. The aim of the study was to analyze readmissions of COVID-19 patients to identify the causes of readmission, clinical features, examination data and treatment outcomes. Materials and methods. The study was performed retrospectively by using electronic records of the medical cases of the St. Petersburg City Hospital of St. George. Inclusion criteria: 1) the presence of two or more hospitalizations during 2020–2021;2) COVID-19 confirmed by polymerase chain reaction within 14 days before or during the first hospitalization, or the detection of changes in the lungs with a high probability associated with COVID-19 during primary computed tomography. One hundred and two people met the specified criteria. Results. In 85% of cases, the cause of re-admission was symptoms of respiratory infection;in 13% – thrombotic events (pulmonary embolism, acute cerebrovascular accident, deep vein thrombosis of the lower extremities);12% – severe pain syndrome of various localizations;11%-infectious and inflammatory processes;9% – antibiotic-associated diarrhea;5% – atrial fibrillation and less often other pathologies. Patients with respiratory symptoms had a high degree of respiratory failure, an increase in the volume of affected lung tissue and an increase in the content of various markers of inflammation in the blood when compared with the data of the initial examination. Nine percent of patients died during hospitalization. Conclusions. The leading cause of repeated inpatient treatment of COVID-19 patients were symptoms of reactivation of the infection with a number of indicators of a greater severity of this "second wave” of the disease. Further studies are required to reduce the risk of repeated inpatient treatment. © 2022, Remedium Group Ltd. All rights reserved.
ABSTRACT
Most of the medicines used to treat the novel coronavirus infection (COVID-19) are either approved under an accelerated procedure or not approved for the indication. Consequently, their safety requires special attention. The aim of the study was to review methodological approaches to collecting data on the safety of medicines, using COVID-19 treatment regimens involving azithromycin as a case study. Material(s) and Method(s): PubMed (MEDLINE), Scopus, eLIBRARY, and Cyberleninka databases were searched for publications on azithromycin as part of combination therapy for COVID-19 in 2020-2021. Search queries included names of the medicinal product or its pharmacotherapeutic group and words describing adverse drug reactions (ADRs) during treatment. Result(s): the analysis included 7 publications presenting the results of studies covering the use of azithromycin as part of COVID-19 combination therapy in more than 4000 patients. Most commonly, the patients receiving COVID-19 therapy including azithromycin developed cardiovascular ADRs (up to 30% of azithromycin prescription cases). In 3 of the analysed publications, safety information was collected through spontaneous reporting and active identification based on the findings of laboratory and instrumental investigations performed during the clinical studies;in other 3, only spontaneous reports were used;and in the last one, ADR database information was studied. Conclusion(s): currently, information on ADRs associated with the use of medicines is mainly gathered via spontaneous reporting. Direct sourcing of information on personal experiences with a certain product from patients, among other means through social media analysis, opens a promising direction towards the improvement of existing approaches to collecting safety data. Copyright © 2022 Obstetrics, Gynecology and Reproduction. All rights reserved.
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Objective. To evaluate safety of anti-interleukin drugs used as a pathogenetic therapy of COVID-19 as assessed by risks of infectious complications. Materials and methods. A systematic review of publications related to safety assessment of anti-interleukin drugs recommended as pathogenetic therapy in COVID-19 patients in terms of incidence of serious adverse events and adverse events of “Infections and Invasions” class and a meta-analysis of the data were performed. Results. The meta-analysis included 16 randomized and 3 non-randomized studies. The hazard ratio of serious adverse events between the comparison groups was 0.93 [95% CI 0.85;1.01] (p = 0.1), the hazard ratio of adverse event of “Infections and Invasions” class was 0.9 [95% CI 0.8;1.02] (p = 0.09), showing no differences in the incidence of those events. Conclusions. This meta-analysis did not demonstrate statistically significant differences in the relative risks of serious adverse events and adverse events of “Infections and Invasions” class for the use of anti-interleukin drugs in COVID-19 patients. © 2022, Interregional Association for Clinical Microbiology and Antimicrobial Chemotherapy. All rights reserved.
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Objective. The aim of the work was to analyze the results and treatment of acute appendicitis (AA) in patients infected with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) COVID-19. Material and methods. From March 16, 2020 to October 31, 2021, 139 patients with suspected AA were tread. In 104 patients (62 men and 42 women) the diagnosis of AA was confirmed. Inclusion criteria were: AA, a positive PCR (polymerase chain re-action) result for COVID-19, or a characteristic picture of viral pneumonia for COVID-19 based on computed tomography (CT). To clarify the diagnosis of acute appendicitis, all patients underwent CT scan of the abdominal organs. Results. When evaluating the symptoms of AA in patients with COVID-19, no specific signs were identified. The systematic inflammatory response could be due to both surgical disease and viral infection, making it difficult to interpret the chang-es. But, in 88 patients (84.61%) in the blood test was leukocytosis from 11.81 to 34.83·109/l, which is uncommon for patients with COVID-19 at the onset of the disease. The average time from the onset of clinical manifestations of AA to the operation was 57±14 hours. 139 diagnostic laparoscopies were performed. The diagnosis of AA was confirmed in 104 patients. 102 patients underwent laparoscopic appendectomy with pelvic drainage. One patient had laparotomy, appendectomy, intestinal intubation. One patient had laparoscopic resection of Meckel’s diverticulum plus appendectomy. A positive PCR result for SARS-CoV-2 effu-sion from the abdominal cavity was confirmed in 45 out of 75 patients (60%). According to the results of a pathomorphological study, 89 (85.58%) patients had phlegmonous appendicitis, 8 (7.69%) had gangrenous appendicitis, and 7 (6.73%) had gangre-nous-perforated appendicitis. Mortality was 0.96% (1 patient). Conclusion. Diagnostic problems of AA in patients with COVID-19 are associated with difficulties in interpreting local symptoms and systemic inflammatory response. Laparoscopy is the leading diagnostic method for suspected AA, including patients with COVID-19. In the absence of severe pneumonia, laparoscopic appendectomy is possible in most patients. All operations should be carried out in accordance with anti-epidemic measures. The clinical significance of detecting SARS-CoV-2 in the abdominal cavity needs further evaluation. The prognosis for patients is determined to a greater extent by the course of COVID-19. The tactics of treatment of patients with COVID-19, for whom surgical intervention is associated with an extremely high risk, needs to be clarified. © 2022, Media Sphera Publishing Group. All rights reserved.
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Introduction. As defined by the Food and Drug Administration, real-world data (RWD) is data related to a patient's health and/or health care delivery, usually collected from various sources as part of real-world clinical practice research. Objective: to describe the feasible and the most sought-after designs of non-interventional real-world clinical practice trials that provide evidence for the efficacy and safety of drug administration in the therapy of novel coronavirus infection. Material and methods. A search strategy for the terms “COVID-19 AND real-life”, “COVID-19 AND real-data”, “COVID-19 AND real-world” was developed to extract articles published between December 1, 2020 and March 12, 2021 from the databases: PubMed/MEDLINE, the Cochrane Database of Systematic Reviews, and the ClinicalTrials.gov database. Results. The search yielded 137 non-repetitive articles, 32 of them were included in the review. All randomized clinical trials (pragmatic and simplified large ones), studies of the effectiveness of laboratory diagnostic methods, medical triage, social distancing and other sanitary and epidemiological measures to cope with the epidemic were excluded. Conclusion. High-quality, non-randomized RWD studies can enhance the external validity of registration randomized clinical trials by complementing them with a broader range of indicators, which is essential in supporting medical and public health decision-making in the COVID-19 pandemic.
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Objectives: To describe the feasible and the most sought-after designs of non-interventional real-world clinical practice trials that provide evidence for the efficacy and safety of drug administration in the therapy of novel coronavirus infection. Methods: A search strategy for the terms "covid-19" AND "real-life", "covid-19" AND "real-data", "covid-19" AND "real-world" was developed to extract articles published between December 1, 2020, and March 12, 2021, in the literature review databases: MEDLINE/PubMed, the Cochrane Database of Systematic Reviews, and the database. Results: The search yielded 137 non-repetitive articles, of which 32 were included in the review. All randomized clinical trials (pragmatic and simplified large ones), studies of the effectiveness of laboratory diagnostic methods, medical triage, social distancing and other sanitary and epidemiological measures to contain the epidemic were excluded from the review. Conclusions: The inconsistency of the results suggests some concerns about the reliability of the data obtained in the framework of RWD. There is a need to analyze RWD with evidence-based medicine tools to obtain a more valid RWD or RWE (Real - world evidence). High-quality, non-randomized RWD studies can enhance the external validity of registration RCTs by complementing them with a broader range of indicators, which is essential in supporting medical and public health decision-making in the COVID-19 pandemic.
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Background. In relation with the COVID-19 new coronavirus infection epidemic that began in Russia in the spring of 2020, a completely new group of patients appeared: patients whose coronavirus infection was combined with the proximal femur fractures. In the course of practical work, hospital doctors had to gain experience in treating these complex patients, solve new organizational and medical tasks. The aim of the study was to evaluate the results of treatment of patients with the proximal femur fractures in combination with coronavirus infection in a "covid" hospital at the hospital stage, 30-day and 6-month terms. Materials and Methods. The retrospective study is based on the collection and generalization of data from 64 patients with the proximal femur fractures in combination with confirmed coronavirus infection who underwent inpatient treatment from 16.03.2020 to 31.05.2021. 38 (59.4%) patients had a femoral neck fracture, 26 (40.6%) had a fracture of the trochanter region. Forty (62.5%) patients underwent surgical treatment (hip replacement was performed in 23 cases, osteosynthesis was performed in 17 cases), 24 (37.5%) patients did not undergo surgery. Results. With conservative treatment, the hospital mortality rate was 41.6%, the 30-day mortality rate was 72.7%, and the 6 - month mortality rate was 95.5%. During surgical treatment, the hospital mortality rate was 5.0% (2 patients died). Early postoperative complications were detected in 5 (12.5%) patients. Thirty-one (77.5%) patients walked or stood with a walker on their own at the time of discharge;7 (17.5%) patients could not be activated. The thirty-day mortality rate in the group of patients who underwent surgical treatment was 8.6%, and the 6-month mortality rate was 32.1%. Conclusion. Surgical treatment of patients with the proximal femur fractures in combination with coronavirus infection is much more difficult than the treatment of patients without infectious pathology. However, despite number of unresolved problems, surgical treatment of such patients is possible with good results and should be actively applied.