The Feasibility of Edoxaban for Asymptomatic Cancer-associated Thrombosis in Japanese Gastrointestinal Cancer Patients (ExCAVE study)

BackgroundAlthough an initial therapy with a parenteral anticoagulant is required before edoxaban, this strategy is frequently avoided in actual clinical practice because of its complexity. This study assessed the feasibility of edoxaban without initial heparin usage for asymptomatic cancer-associated thrombosis (CAT) in Japanese patients with gastrointestinal cancer (GIC) at a high risk of bleeding.MethodsIn this multicenter prospective feasibility study conducted at 10 Japanese institutions, patients with active GIC who developed accidental asymptomatic CAT during chemotherapy were recruited. Edoxaban was orally administered once daily without initial parenteral anticoagulant therapy within 3 days after detecting asymptomatic CAT. The primary outcome was the incidence of major bleeding (MB) or clinically relevant non-major bleeding (CRNMB) during the first 3 months of edoxaban administration. ResultsOf the 54 patients enrolled from October 2017 to September 2020, one was excluded because of a misdiagnosis of CAT. In the remaining 53 patients, the primary outcome occurred in six patients (11.3%). MB occurred in four patients (7.5%), including gastrointestinal bleeding in three patients and intracranial hemorrhage in one patient. CRNMB occurred in two patients (3.8%), including bleeding from the stoma site and genital bleeding in one patient each. There were no deaths attributable to bleeding, and all patients who had experienced MB and CRNMB recovered.ConclusionsThe risk of bleeding after edoxaban without heparin pretreatment was acceptable, demonstrating new treatment options for asymptomatic CAT in patients with GIC.

Recognition of Anemia in Elderly People in a Rural Community Hospital

Anemia in the elderly is a common disease associated with increased mortality and hospitalization rates. It is not clear how adequately elderly patients are assessed and treated in actual clinical practice. This study clarifies the frequency of anemia recognition before assessment and the factors related to recognition among older people in a rural community hospital. This cross-sectional study evaluated 156 elderly patients aged > 65 years. Data on several different variables were collected from patient medical records. Anemia was defined as a hemoglobin level < 11 g/dL. Patients were classified into “anemia recognition” and “no anemia recognition” groups. Statistical analysis of the data included multivariable logistic regression to examine the association between anemia recognition and other factors. The anemia recognition group comprised 63 (40.4%) patients. Age was significantly associated with the recognition of anemia (adjusted odds ratio = 0.70, 95% confidence interval: 0.53–0.92, p = 0.011). Appropriate medical care should be provided to the elderly; however, it may be limited according to age.

Fixed-dose combination of ivabradine and metoprolol in a patient with stable coronary artery disease: a case report

This article discusses a case of using fixed-dose combination of ivabradine/metoprolol in actual clinical practice.

Management of heart failure patients in Russia: perspectives and realities of the second decade of the XXI century

The article highlights the central components of Russian heart failure (HF) management programs in actual clinical practice. The experience of the Competence Center of Almazov National Medical Research Center, as well as opportunities and prospects for improving the monitoring of decompensated HF.

Familial dysbetalipoproteinemia: highly atherogenic and underdiagnosed disorder

Familial dysbetalipoproteinemia (FD) is a genetic, highly atherogenic disorder. The penetrance of FD depends on the patient’s lifestyle and concomitant diseases. Despite the fact that FD was described almost half a century ago, it is still insufficiently studied and is extremely rarely diagnosed. In actual clinical practice, physicians do not have clear understanding of clinical course and genetic basis of FD. The aim was to present the most complete, but at the same time a critical review with a modern view on FD. We analyzed Russian and foreign publications from following electronic databases: PubMed, eLIBRARY, Google Scholar. As a result, the phenotypic features and genetic variability of the disease were considered and the main issues of diagnosis and treatment of patients with FD were discussed. The data presented will help the clinician to timely suspect the FD, conduct a full range of investigations and prescribe evidence-based lipid-lowering therapy.

Assessment of the Risk of Antipsychotics in Patients with Dementia in Actual Clinical Practice in Primary Health Care

Behavioral and psychological symptoms are almost universal in elderly patients with dementia. Antipsychotic drugs can be used but only in specific contexts as they can generate severe adverse effects. The main aim of this research was to evaluate the use of antipsychotic drugs in patients with accompanying treatment for dementia in actual clinical practice in primary health care. We further sought to analyze risk variables and factors associated and to acknowledge how sociodemographic and clinical factors weighed on adverse effects’ occurrence. A multicentric cross-sectional descriptive study was performed in three provinces of Spain. Stratified random sampling was performed to select 332 patients. Clinical data from their digital medical records were collected by their family doctors. The Global risk defined if the patients were subjected to risk. Univariate, bivariate, and multivariate analyses were performed. The most used antipsychotics were quetiapine (65.5%), haloperidol (21.75%), and risperidone (15.8%); 93.8% of patients showed risk, and 81.1% of doses and 75.5% of treatment durations were inappropriate. These two last factors increased the global risk 23 and 20 times, respectively. Conclusions: In actual clinical practice conditions, a high use of antipsychotic drugs was found in patients with dementia. Most patients had inappropriate doses and treatment duration, factors that increased the risk of adverse effects considerably.

Effectiveness of immunosuppressive therapy for lymphocytic myocarditis according: data from actual clinical practice

Aim. To compare the effectiveness of standard heart failure therapy with and without combined immunosuppressive therapy in patients with documented lymphocytic myocarditis (LM) based on data from actual clinical practice.Material and methods. This observational study included 70 patients with documented LM, 40% (n=28) of whom received immunosuppressive therapy. All patients underwent standard echocardiographic and laboratory investigations, endomyocardial biopsy with histological, immunohistochemical and molecular genetic analysis. Contrast-enhanced cardiac magnetic resonance imaging was performed in 74% of patients. All patients received standard therapy for heart failure at baseline.Results. The groups did not differ in demographic and echocardiographic characteristics. The appointment of immunosuppressive therapy was accompanied by an increase in ejection fraction by 12,2% compared to 6,4% (p=0,02). There were no significant differences in combined endpoints (survival and the need for heart transplantation) depending on therapy regimen (log-rank p=0,97).Conclusion. The prognosis of patients with chronic LM depends on the process activity, the severity of impaired hemodynamics and ventricular arrhythmias, as well as on the presence of persistent viral infection. Compliance with patient selection algorithm before prescribing immunosuppressive therapy is associated with the improvement in myocardial global contractility.

Twenty-four-hour and office blood pressure measurement in a comprehensive assessment of the effectiveness of 12-week therapy with a triple fixed-dose combination of amlodipine/indapamide/perindopril in hypertensive patients in actual clinical practice

Aim. To study the efficacy and safety of the triple fixed-dose combination (FDC) of amlodipine/indapamide/perindopril on blood pressure (BP) profile in patients with grade I-II hypertension (HTN) in actual clinical practice.Material and methods. Data from 54 patients with paired 24-hour ambulatory BP monitoring (ABPM) data were included in the TRICOLOR subanalysis (ClinicalTrials. gov study ID — NCT03722524). The mean 24-hour, daytime, and nighttime BP were calculated at baseline and after 12-week follow-up. We determined the proportion of patients with nocturnal HTN (≥120/70 mm Hg) and nocturnal hypotension (<100/60 and <90/50 mm Hg) initially and after 12 weeks of triple FDC therapy. Patients with nocturnal BP decrease included dippers (D; 10-20%), reduced dippers (RD; 0-10%) and extreme dippers (ED; >20%), as well as those without nocturnal BP decrease (>0%, non-dipper (ND)). The smoothness index (SI) was analyzed as the ratio of the mean hourly SBP fall to its mean standard deviation in paired ABPM. To assess the BP phenotypes, two methods were used with reference values of <130/80 and <140/90 mm Hg for ABPM and office BP, respectively. Controlled hypertension (CHT), uncontrolled hypertension (UHT), white coat hypertension (WHT) and masked ineffectiveness of antihypertensive therapy were distinguished.Results. Among 1247 participants of the TRICOLOR study, 54 patients with valid paired ABPM were selected (men, 46%; mean age, 57,7 [12,1] years; mean office BP, 150,4 [16,6]/93,3 [10,7] mm Hg; HTN duration, 8,3 [7,5] years). Initially, the mean 24-hour, daytime and nighttime BP was 141,1 [15,4]/85,9 [9,9], 144,2 [15,5]/88,8 [10,5] and 132,6 [18,0]/78,1 [9,9] mm Hg, respectively. After 12-week follow-up, the mean 24-hour, daytime and nighttime BP was 123,1 [10,5]/75,6 [8,5], 125,7 [10,9]/77,9 [8,7] and 115,4 [10,2]/68,6 [8,8] mm Hg, respectively (p<0,001). After 12-week follow-up, the proportion of patients with nocturnal hypertension decreased from 64,8% to 25,0% (2,6 times) (p<0,001). The proportion of NDs and EDs decreased from 16,7% and 7,4% to 5,8% and 0%, respectively (p=0,048); the proportion of patients with RD and D patterns increased from 42,6% and 33,3 to 57,7% and 36,5%, respectively (p=0,048). With triple FDC therapy, the SI during the day was higher than 0,73 in half of the cases. According to the two methods, the proportion of patients with UHT decreased from 81,6% to 4,4%, WHT from 12,2% to 0%. The prevalence of CHT increased from 4,1% to 57,8%, while masked ineffectiveness of antihypertensive therapy — from 2,0% to 37,8%.Conclusion. Twelve-week FDC therapy of amlodipine/indapamide/perindopril led to a significant fall in the mean 24-hour, daytime and nighttime BP values. Comprehensive analysis of two techniques (24-hour and office BP measurement) identified patients requiring further triple FGC titration.

AB0838 ADHERENCE TO TREATMENT IN PATIENTS WITH RHEUMATIC PROFILE DEPENDING ON THE OPTION OF BASIC THERAPY

Background:Treatment adherence is an important issue in actual clinical practice. As defined by the WHO, adherence to treatment is seen as the degree to which a patient’s actions - taking medications, adhering to diet and other lifestyle interventions - correlate with following the doctor’s recommendations. Treatment of patients with rheumatic diseases continues for many years, and often for life. The identification of factors associated with adherence to therapy will justify the implementation of a number of measures in order to increase the effectiveness of treatment of patients. Biological disease modifying antirheumatic drugs (bDMARDs) therapy involves more frequent visits of patients to a doctor with close monitoring of their condition, which may have an impact on adherence to treatment in this group of patients.Objectives:to assess adherence to treatment of patients with rheumatological profile, depending on the basic therapy option.Methods:A survey of 84 patients was conducted: 48 (57.1%) women and 36 (42.9%) men, mean age 51 years (36.8; 60.3). Most patients are observed with a diagnosis of rheumatoid arthritis - 48 (57.1%) people, with psoriatic arthritis - 26 (30.9%) and with ankylosing spondyloarthritis - 10 (12.0%) people.The patients were divided into 2 groups depending on the type of basic therapy: Group 1 (40 people) - patients receiving combined therapy with bDMARDs and methotrexate; Group 2 (44 people) - patients with methotrexate monotherapy.Patients in group 1 received the following bDMARDs: 18 patients received sarilumab (200 mg sc once every 2 weeks), 22 people received secukinumab (150 mg sc once a month). All patients took methotrexate at an average dose of 17.5 (15.0; 20.0) mg / week and NSAIDs.Adherence to treatment was assessed using the Morisky-Green scale. Each of the 4 points is evaluated according to the principle of answers to the question “yes-no”, while the answer “yes” is estimated at 0 points, and the answer “no” - at 1 point. Patients who score 4 points are considered compliant (adherent); insufficiently committed and those at risk for the development of non-commitment - 3 points; not committed - 2 points or less.Results:The majority of patients are seen by a doctor monthly - 45.2% (38) and once a quarter - 33.3% (28). Only 7.1% (6) people are observed once every 6 months and 4.8% (4) once a year, and 9.6% (8) are not observed at all.The frequency of medical observations in the 1st group of patients was higher than in the 2nd: monthly - 60.0% (24) and 40.9% (18), every 3 months - 40.0% (16) and 45.5% (20), respectively (p = 0.072 and p = 0.089), and only patients of the 2nd group were observed once every 6 months (4.5% - 2 people) and once a year (9.1% - 4 people). There were no statistically significant differences in adherence indicators.When assessing adherence to treatment according to the Morisky-Green scale: only 37.5% (15) of patients in group 1 and 29.6% (13) in group 2 (p = 0.12) adhere to therapy, 30.0% are not adherent enough (12) and 22.7% (10) patients (p = 0.31), not adhering to treatment - 32.5% (13) and 47.7% (21) people, respectively (p = 0.39).Conclusion:Thus, basic therapy bDMARDs with more frequent medical supervision does not affect adherence to treatment. Only about a third of patients are adherent to bDMARDs therapy.Disclosure of Interests:None declared