Results of open-label non-randomized comparative clinical trial: “Bromhexine and spironolactone for coronаvirus infection requiring hospitalization (BISCUIT)

Introduction The aim of this study was to assess the efficacy and safety of a combination of bromhexine at a dose of 8 mg 4 times a day and spironolactone 50 mg per day in patients with mild and moderate COVID 19. Material and methods It was an open, prospective comparative non-randomized study. 103 patients were included (33 in the bromhexine and spironolactone group and 70 in the control group). All patients had a confirmed 2019 novel coronavirus infection (COVID 19) based on a positive polymerase chain reaction (PCR) for SARS-CoV-2 virus RNA and/or a typical pattern of viral pneumonia on multispiral computed tomography. The severity of lung damage was limited to stage I-II, the level of CRP should not exceed 60 mg/dL and SO2 in the air within 92-98%. The duration of treatment is 10 days. Results The decrease in scores on the SHOKS-COVID scale, which, in addition to assessing the clinical status, the dynamics of CRP (a marker of inflammation), D-dimer (a marker of thrombus formation), and the degree of lung damage on CT (primary endpoint) was statistically significant in both groups and differences between them was not identified. Analysis for the group as a whole revealed a statistically significant reduction in hospitalization time from 10.4 to 9.0 days (by 1.5 days, p=0.033) and fever time from 6.5 to 3.9 days (by 2.5 days, p<0.001). Given the incomplete balance of the groups, the main analysis included 66 patients who were match with using propensity score matching. In matched patients, temperature normalization in the bromhexine/spironolactone group occurred 2 days faster than in the control group (p=0.008). Virus elimination by the 10th day was recorded in all patients in the bromhexine/spironolactone group; the control group viremia continued in 23.3% (p=0.077). The number of patients who had a positive PCR to the SARS-CoV-2 virus on the 10th day of hospitalization or longer (≥10 days) hospitalization in the control group was 20/21 (95.2%), and in the group with bromhexine/spironolactone -14/24 (58.3%), p=0.012. The odds ratio of having a positive PCR or more than ten days of hospitalization was 0.07 (95% CI: 0.008-0.61, p=0.0161) with bromhexine and spironolactone versus controls. No side effects were reported in the study group. Conclusion The combination of bromhexine with spironolactone appeared effective in treating a new coronavirus infection by achieving a faster normalization of the clinical condition, lowering the temperature one and a half times faster, and reducing explanatory combine endpoint the viral load or long duration of hospitalization (≥10 days). © 2020 Limited Liability Company KlinMed Consulting. All rights reserved

Position paper. The role of iron deficiency in patients with chronic heart failure and current corrective approaches

Further to the discussions, a position paper with the following main provisions was elaborated: 1. Iron Deficiency (ID) must be regarded as an independent clinically significant concomitant condition, with the prevalence reaching 50% among Chronic Heart Failure (CHF) patients in Russia. 2. According to observation studies iron deficiency in patients with CHF adversely affects functional performance and is associated with increased hospitalization rates and mortality. 3. ID must be excluded in all CHF patients, regardless of haemoglobin levels; the severity of ID should be evaluated. Blood ferritin concentration and transferrin saturation (TSAT, transferrin saturation coefficient) are currently optimal parameters for defining ID. 4. According to current data, therapy aimed only at increasing blood haemoglobin concentrations does not seem to have advantages in influencing the prognosis and clinical manifestations of CHF, while the elimination of ID in CHF patients leads to significant clinical benefits even in the absence of anaemia. 5. According to recently available data (the results of Randomized Clinical Trials, RCTs), the intravenous use of ferric carboxymaltose should be considered the most consistent approach for the treatment of ID in CHF patients. © 2020 Seoul National University. All rights reserved

The use of diuretics in chronic heart failure. Position paper of the Russian Heart Failure Society [Экспертное мнение по применению диуретиков при хронической сердечной недостаточности Общество специалистов по сердечной недостаточности]

The document focuses on key issues of diuretic therapy in CHF from the standpoint of current views on the pathogenesis of edema syndrome, its diagnosis, and characteristics of using diuretics in various clinical situations

Consensus of Russian experts on the evaluation of arterial stiffness in clinical practice

Recently, there was plenty studies published on the arterial stiffness assessment, and importance of this was proved as an independent prediction parameter, together with standard cardiovascular risk factors. In current document, we collect and structure the available clinical and scientific data from abroad and Russian studies. The aim of current publication is the need to bring a reader the importance of demanded in clinical practice ways of arterial wall stiffness assessment, information about conditions when it is important to the assessment, and available restrictions, as the issues remaining unresolved

Consensus of Russian experts on the evaluation of arterial stiffness in clinical practice [Согласованное мнение российских экспертов по оценке артериальной жесткости в клинической практике]

Recently, there was plenty studies published on the arterial stiffness assessment, and importance of this was proved as an independent prediction parameter, together with standard cardiovascular risk factors. In current document, we collect and structure the available clinical and scientific data from abroad and Russian studies. The aim of current publication is the need to bring a reader the importance of demanded in clinical practice ways of arterial wall stiffness assessment, information about conditions when it is important to the assessment, and available restrictions, as the issues remaining unresolved. © 2016 Vserossiiskoe Obshchestvo Kardiologov. All rights reserved

Consensus of Russian experts on the evaluation of arterial stiffness in clinical practice

Recently, there was plenty studies published on the arterial stiffness assessment, and importance of this was proved as an independent prediction parameter, together with standard cardiovascular risk factors. In current document, we collect and structure the available clinical and scientific data from abroad and Russian studies. The aim of current publication is the need to bring a reader the importance of demanded in clinical practice ways of arterial wall stiffness assessment, information about conditions when it is important to the assessment, and available restrictions, as the issues remaining unresolved

Management of adherence-based treatment. Consensus document – Clinical guidelines. English version [упРАВЛЕНИЕ ЛЕЧЕНИЕМ НА ОСНОВЕ пРИВЕРЖЕННОСТИ. КОНСЕНСуСНЫй ДОКуМЕНТ – КЛИНИЧЕСКИЕ РЕКОМЕНДАЦИИ. АНГЛОЯзЫЧНАЯ ВЕРСИЯ]

Consensus Document «Management of adherence-based treatment» developed based on clinical guidelines of Russian Scientific Medical Society of Internal Medicine approved by the XIV National Congress of physicians (Moscow, 20 November 2019). The document is intended primarily to assess adherence to drug therapy, adherence to lifestyle modification, and adherence to medical support for patients who need long-term or permanent treatment. The document’s authors considered the treatment adherence unanimously as the compliance of the patient’s behavior with the recommendations received from the Doctor regarding medication, dieting, and other measures of lifestyle modifications. Insufficient adherence to treatment is a global problem. Assessing adherence as a basis for making medical decisions is an essential element of improving the quality of the healthcare system. Predictions of treatment outcomes cannot be considered effective if individualized levels of adherence are not used to justify project planning and evaluation. In medical practice, quantitative assessment of adherence is preferred, suitable for patients with various diseases, and with the possibility of automated data entry and processing. Therefore, sections on medical interventions based on the assessment of treatment adherence should be reflected in national clinical guidelines. These Joint Recommendations are based on these provisions. © Group of authors, 202

Treatment management based on adherence: Patient recommendation algorithms. Cross-disciplinary guidelines [УПРАВЛЕНИЕ ЛЕЧЕНИЕМ НА ОСНОВЕ ПРИВЕРЖЕННОСТИ: АЛГОРИТМЫ РЕКОМЕНДАЦИЙ ДЛЯ ПАЦИЕНТОВ. МЕЖДИСЦИПЛИНАРНЫЕ РЕКОМЕНДАЦИИ]

The algorithms (sample templates) of recommendations for patients, which are an integral part of adherence-based treatment management technologies, were developed by an interdisciplinary Working Group coordinated by the Treatment Adherence Section of the Russian Scientific Medical Society of Physicians. The Working Group includes opinion leaders and experts in the therapeutic, gastroenterology, cardiology, preventive medicine, gerontology, oncology, hematology, immunology, phthisiopulmonology, infectious diseases, oncohematology, neurology, intensive care, rehabilitation and other specialties, both involved by the section of RSMSIM, and recommended by the Gastroenterological Scientific Society of Russia, National Association of experts in Thrombosis, Clinical Hemostasiology and Hemorheology, Gerontological Society of the Russian Academy of Sciences, Russian Oncohematologists Society, Russian Society of Phthisiatrists, Society of Evidence-based Neurology. The algorithms are based on the materials of «The First Russian Consensus on Quantitative Assessment of adherence to treatment», approved by the XII National Congress of Internal Medicine (2017) and Clinical Guidelines «Treatment Management on the Basis of adherence», approved by the XIV National Congress of Internal Medicine (2019), taking into account the Consenting Document - Interdisciplinary Guidelines of RSMSIM, GSSR, NATH, SEN, GSRAS, ROHS, RSP «Treatment Management on the Basis of Adherence» (2020). The algorithms of treatment strategies are recommended by the Working Group to be used as a basis for inclusion into relevant sections of clinical guidelines and clinical handbooks developed by professional medical communities, as well as for use by practitioners in medical practice. © 2020 Stavropol State Medical University. All rights reserved