Aim. To analyze the readiness of the professional medical community for changes in the classification and implementation of novel approaches to heart failure (HF) treatment based on an online survey. Material and methods. Anonymous online survey of physicians on the official website of the Russian Society of Cardiology (www.scardio.ru) "Chronic heart failure. Unsolved issues" was held from September 30 to October 4, 2023. The survey involved 1015 doctors with an average length of work >10 years, mainly cardiologists (n=810, 83,2%). Results. The majority (n=591, 58,2%) of respondents considered it necessary to identify the HF prestage in the classification, similar to prediabetes or prehypertension, while only 2,2% (n=22) of respondents did not consider it necessary to indicate the HF risk in the classification. Simplifying the HF classification based on the left ventricular ejection fraction (LVEF) values with the identification of only two gradations of LVEF <50% and LVEF ³50% was supported by 60,3% (n=612) of specialists. The majority (80,8%) of respondents supported increasing the time of admission of a patient with HF to 30 minutes to ensure the healthcare quality. According to the survey, only 32% of respondents have the ability to determine the brain natriuretic peptide level in patients with HF without restrictions, which indicates insufficient material security for the implementation of clinical guidelines in practice. Quadruple therapy is prescribed to every patient with HF by only 37% of respondents who took part in the survey, which may indicate clinical inertia regarding following the guidelines. Conclusion. In general, the survey demonstrated high awareness of physicians about the problem of HF and readiness to assess the risk and diagnose HF at preclinical stages, as well as a positive attitude towards changing the classification.
Russian Society of Cardiology (RSC)With the participation: National Society of Myocardial Diseases and Heart Failure, Society of Heart Failure Specialists, Russian Scientific Medical Society of Internal MedicineEndorsed by the Research and Practical Council of the Ministry of Health of the Russian Federation (12.09.2024)
Objective: to evaluate the clinical and economic effectiveness of benralizumab in comparison with standard therapy in patients with severe bronchial asthma (SBA) with an eosinophilic phenotype in the Russian Federation. Material and methods. A clinical and economic analysis of using benralizumab in addition to standard therapy was carried out in comparison with standard therapy for SBA with an eosinophilic phenotype by means of a modeling method. Cost calculations were performed in a mathematical model adapted to the Russian healthcare conditions with the help of cost indicators and patient population characteristics. Results. The use of benralizumab as a mandatory component of standard therapy compared with standard therapy alone for SBA with an eosinophilic phenotype will allow for an additional 0.65 life years gained (LYGs) and 1.12 quality-adjusted life years (QALYs) per 1 patient during lifelong therapy. It will provide avoiding 4.95 exacerbations, simultaneously with a reduction in total costs by 584,144 rubles by reducing gross domestic product (GDP) losses due to mortality and temporary disability over an assessment horizon equal to life expectancy. The costs of 1 LYG and 1 QALY in the case of benralizumab were 869,455 and 1,252,056 rubles, in the case of standard therapy they were 911,615 and 1,303,811 rubles, respectively. Conclusion. Intensification of SBA therapy with an eosinophilic phenotype with benralizumab is clinically justified (leads to an increase in life expectancy, a decrease in the rate of exacerbations and an increase in patients’ working life), and is also economically feasible, as it allows to reduce direct costs and GDP losses of the state.
The Russian Society of Cardiology (RKO)With the participation of: Russian Scientific Medical Society of Internal Medicine (RSMSIM)Approved by the Research and Practical Council of the Ministry of Health of the Russian Federation (12.09.2024)
Aim. To present data from the AURA Registry (real-world data registry on AlbUminuRia detection rate among patients with previously undiAgnosed chronic kidney disease). It is important to perform population studies both to study the occurrence of markers (albuminuria (AU), decreased glomerular filtration rate (GFR)) and the prevalence of chronic kidney disease (CKD), which will provide information on the actual detection rate of CKD and the related markers in territories included in the registry of research centers.Material and methods. The article presents the first data from the AURA registry. Recruitment was carried out from March 6, 2023 to January 23, 2024. Thirty-four research centers in various federal districts of the Russian Federation and 104 doctors took part in the recruitment. We included 4580 subjects over the age of 40 years who had no previously established diagnosis of CKD and did not have type 1 or type 2 diabetes. During recruitment, the researchers were guided by the AURA study protocol (Version 1.7/12-26-2022).Results. AU more than 20 mg/g was detected in 64,9% of cases. At the same time, AU is more common at GFR values that may correspond to stage 3A of CKD. The rarer occurrence of AU in those examined with GFR >60 ml/min/1,73 m2 may be explained by less severe renal damage at this CKD stage. The incidence of AU was significantly higher in men, older people, smokers, people with metabolic syndrome, hypertension (HTN), prediabetes and overweight. The occurrence of AU also increased as HTN grade increased. AU detection rate was associated with hypertriglyceridemia, a high blood level of C-reactive protein, which is an integrative marker of inflammation that negatively affects cardiovascular risk.Conclusion. The presented first data from the AURA registry demonstrated the high AU prevalence in people over 40 years of age. A high incidence of AU was typical for patients with HTN, coronary artery disease, atrial fibrillation, heart failure, and prediabetes. An association has been demonstrated between the high incidence of AU and male sex, age, overweight, hyperuricemia, dyslipidemia, and a number of other cardiovascular risk factors.
Aim. To evaluate the dapagliflozin as part of various treatment regimens in patients with heart failure (HF) with reduced ejection fraction (HFrEF) ≤40% receiving medications within federal preferential drug program to achieve the "Reduction of cardiovascular mortality" of the State Program "HealthCare Development". To estimate the costs of reducing the cardiovascular mortality rate by 1 death per 100 thousand of population and achieving 1 percentage point of the target indicator "Reduction of cardiovascular mortality".Material and methods. The target patient population was Russian patients aged over 18 years diagnosed with NYHA class II-IV HFrEF (≤40%), included in the federal preferential drug program. We used model developed based on the DAPA-HF study results. We assessed the costs of drugs, the number of lives saved, the impact of therapy on achievement of the target indicator "Reduction of cardiovascular mortality" and other indicators in the Russian Federation (RF) as a whole and in each subject of the Russian Federation while using dapagliflozin as part of various treatment regimens for HFrEF including angiotensin-converting enzyme inhibitors (ACEi)/angiotensin II receptor blockers (ARB) or angiotensin receptor-neprilysin inhibitor (ARNi), beta blockers, diuretics, mineralocorticoid antagonists, cardiac glycosides.Results. In 2024, the treatment cost of 181351 patients with HFrEF included in the federal preferential drug program with dapagliflozin in combination with standard therapy (ST) will be RUB9265,4 million; in combination with ST without ARNi (ST including ACEi/ARB) — RUB8161,7 million; in combination with ST including ARNi — RUB17837,3 million. The additional number of lives saved when using dapagliflozin in combination with standard therapy was 2394, in combination with standard therapy without ARNi — 2340, in combination with standard therapy, including ARNi — 2913. Costs of therapy per patient per year when using dapagliflozin in combination with standard therapy amounted to RUB51090,90; in combination with standard therapy without ARNI — RUB45004,72; in combination with standard therapy, including ARNI — RUB98358,00. In 2024, the percentage (%) of achievement of the federal target for dapagliflozin in combination with ST is 11,22%, while in combination with standard therapy without ARNi (ST including ACEi/ARB) — 10,96%, in combination with ST including ARNi — 13,65%. Achievement of a 1% target reduction in cardiovascular mortality in 2024 reqiored RUB828,1 million for dapagliflozin in combination with ST, while in combination with ST without ARNI (ST including ACEi/ARB) — RUB748,2 million, in combination with ST including ARNi — RUB1293,3 million.Conclusion. Among the 3 options considered for adding dapagliflozin to ST (ARNi or ACEi/ARB, including ACEi/ARB, including ARNi), ST without ARNI (ST including ACEi/ARB) has the lowest cost required to achieve a 1% target reduction in cardiovascular mortality. At the same time, the standard therapy with ARNI has the highest cost required to achieve a 1% target reduction in cardiovascular mortality, which indicates its least cost-effectiveness.
Aim. To collect data on the patient phenotype at the highest risk of developing albuminuria, to assess the prevalence of albuminuria in the identified phenotypes, and to collect data on the characteristics, prescribed therapy, and comorbidities of patients with and without identified albuminuria.Materials and methods. Data on presence or absence of albuminuria are collected in this register of real clinical practice instantaneously. All patients seeking medical attention are screened for the presence and extent of albuminuria. All data are collected in anonymized form and entered into an electronic case report form. Inclusion criteria: 1) men and women aged 40 years and older at the time of data collection; 2) the possibility to perform an albuminuria test using dipsticks and/or a test for microalbuminuria or urine albumin/creatinine ratio in a spot urine sample. Exclusion criteria: 1) the patient’s reluctance to participate in the registry; 2) diagnosis of CKD made before screening for the registry; 3) diagnosis of diabetes mellitus type 1 or 2 made before screening for the registry; 4) pregnancy; 5) long distance running or very heavy physical activity in the last 24 hours.Results. At the time of submission of this material, the active phase of patient recruitment for the registry with the specified power has been ongoing. Based on the expected recruitment rate at 45–50 sites, the registry is expected to include data from 12,000–15,000 patients. If fewer than 12,000 patients are recruited and the estimated recruitment rate for the registry is insufficient, the number of study sites or the screening period may be extended.Conclusion. Despite the established prognostic significance of the data on AU, the test is prescribed in routine practice to individuals at risk of developing CKD or to patients with an established nephrological disorder. A local registry that combines diverse patient populations, namely patients not only from established CKD risk groups but also patients with a dipstick test for AU, is of scientific and practical interest and can be used in the development of national clinical guidelines and educational materials and used in clinical practice.
Objective. This study aims to assess the efficacy of single-pill combination ramipril/indapamide (Konsilar-D 24) in patients with grade 1 and 2 hypertension who did not achieve blood pressure (BP) control through previous therapy or did not receive antihypertensive treatment in routine clinical practice. The assessment is based on home BP monitoring (HBPM), long-term BP variability, and quality of life according to the visual analog scale (VAS) EuroQol. Design and methods. A multicenter open observational program involved 358 CONSONANCE program patients who provided home BP monitoring (HBPM) data and self-monitoring diaries for all visits. Among them, 326 patients (91,1 %) evaluated their well-being using VAS at each visit. The program protocol was approved by the independent ethics committee of the Almazov National Medical Research Centre (protocol № 200219 от 11.02.2019). All participants provided written informed consent before inclusion. Clinical BP changes were evaluated at baseline, 0,5, 1, 3 and 6 months into treatment. Patients measured their BP daily for the initial 2 weeks and then at least 3 times a week. The average of two consecutive measurements represented each reading. The effectiveness criterion for HBPM was achieving an average BP < 135/85 mm Hg. Visit-to-visit BP variability was assessed using standard deviation (SD). Patients self-assessed their quality of life by the VAS EuroQol scale from 1 to 100 points. Statistical analysis was performed with the use of Statistica 10. Quantitative variables were presented as means and standard deviations, and their changes were evaluated using paired Student’s t-test. Qualitative features were compared using McNemar’s test with Yates’ continuity correction. A p-value < 0,05 denoted statistical significance. Results. After 2 weeks of treatment, 268 (74,9 %) patients achieved clinical BP < 140/90 mm Hg, the number increased up to 356 (99,4 %) after 6 months. For home BP, 271 (75,7 %) and 326 (91,1 %) patients reached the target after 2 weeks and after 6 months, respectively. Visit-to-visit BP variability, while on unchanged antihypertensive therapy, was 4,1 ± 2,3 / 2,5 ± 1,1 mm Hg for clinical BP and 4,5 ± 3,5 / 2,8 ± 1,9 mm Hg for home BP. The initial VAS score was 54,7 ± 19,1 points, increasing to 86,6 ± 6,1 points after 6 months of treatment (a change of 31,9 ± 18,5 points; p < 0,0001). Conclusions. Optimizing antihypertensive therapy with the single-pill combination ramipril/indapamide (Consilar D 24) effectively reduces both clinical and home BP, leading to the swift achievement of the target BP level for most patients with previously uncontrolled arterial hypertension. Treatment with this single-pill combination also reduces visit-to-visit BP variability and enhances patients’ quality of life in real clinical settings.
The article discusses the classification of heart failure (HF). A novel HF classification and its advantages over the existing ones are shown. Variants of approximate diagnoses are given in accordance with the novel HF classification.
Objective. To evaluate the cost-effectiveness of the use of modern inhibitors of the renin-angiotensinaldosterone system (RAAS) in patients with arterial hypertension (HTN) in the Russian Federation. Design and methods. An analytical decision-making model was built in MS Excel, which enables to evaluate the additional benefit in reducing blood pressure and preventing cardiovascular outcomes when prescribing the most effective RAAS inhibitors in patients with HTN over 65 years of age on the background of antihypertensive therapy (AHT) (as a basic RAAS blocker the following agents were considered: valsartan 80 mg, enalapril 20–40 mg, lisinopril 10–20 mg, perindopril 2,5–5 mg, candesartan 8–32 mg, irbesartan 150 mg, losartan 50–100 mg, olmesartan 10 mg and telmisartan 40 mg). Results. Azilsartan medoxomil 80 mg is the most effective and will prevent 3,86 cases of myocardial infarction, 2,48 cases of acute cerebrovascular accident and 1,66 deaths from all causes per 1000 patient-years. At the same time, reducing the cost of managing complications and saving lives makes therapy with modern RAAS inhibitors economically feasible, reducing the total costs of illness. Taking into account the direct costs of treating adverse events, as well as the indirect costs of disability benefits and gross domestic product losses, the maximum potential savings can be achieved when using irbesartan 300 mg — 10,384,47 rubles/year of therapy, azilsartan 20 mg — 9 035,90 rubles/year of therapy, azilsartan 40 mg — 8 500,82 rubles/year of therapy, azilsartan 80 mg — 8 384,14 rubles/year of therapy, telmisartan 80 mg — 8 721,41 rubles/year of therapy and candesartan 32 mg — 8 204,21 rubles/year of therapy. Conclusions. The use of modern RAAS inhibitors, including azilsartan medoxomil in hypertensive patients, leads to a reduction in healthcare costs, the achievement of the targets of the national project “Fight against cardiovascular diseases”, while significantly improving the prognosis of patients and their quality of life.
The objective of this advisory board meeting was to discuss the place of vericiguat in the treatment algorithm for heart failure with reduced ejection fraction and the necessary requirements for its successful application in clinical practice.
Objective. To study the changes in the vascular wall, vascular age and metabolic parameters in polymorbid COVID-19 conva-lescents. Material and methods. The study included 62 patients with hypertension who reached the target blood pressure (BP) with dual an-tihypertensive therapy after severe and extremely severe COVID-19. The following examinations were performed: laboratory tests of metabolic parameters, assessment of changes in the vessel elasticity indices (pulse-wave velocity (PWV), augmentation index (AI), central systolic BP (cSBP), 24-hour BP monitoring, and non-invasive markers of liver fibrosis. Results. According to office BP measurements, after the coronavirus infection, an increase in systolic BP (SBP) by 29.6% and di-astolic BP (DBP) by 23.6%, as well as heart rate (HR) by 11.8% (p<0.05) was reported during regular antihypertensive therapy. In addition, 24-hour BP monitoring data indicated an increase in the average daily SBP, DBP, and heart rate. After the coronavirus infection, an increase in PWV by 35.4% (p<0.05), AI by 24.4% (p<0.05), cSBP by 22.1% were reported. Carbohydrate and lipid metabolism parameters deteriorated. A pronounced adverse effect of coronavirus infection on liver function was observed. The vascular age (according to the modified SCORE scale) increased by 6 years (p<0.05). Conclusion. Our study showed that patients after severe and extremely severe COVID-19 have a high risk of liver fibrosis, hypertension and lipid metabolism control worsening and accelerating vascular aging.Copyright © 2023, Media Sphera Publishing Group. All rights reserved.
Purpose. To evaluate the clinical and economic efficacy of the drug complex of beta-iron (III) oxyhydroxide, sucrose, and starch (Velphoro) in comparison with sevelamer in patients with stage 5 chronic kidney disease (CKD) receiving phosphate binding therapy during renal replacement therapy (RRT) in the conditions of the healthcare system of the Russian Federation. Materials and methods. An analytical decision-making model, which allows estimating the costs of managing patients with stage 5 CKD receiving phosphate binding therapy along with RRT, was built in MS Excel. The model included the costs of phosphate binding therapy with beta-iron (III) oxyhydroxide-sucrose-starch complex or sevelamer, as well as the cost and incidence of non-RRT hospitalizations in patients with CKD. The frequency of hospitalizations was determined according to a retrospective analysis of the data from End Stage Renal Disease Seamless Care Organizations (ESCOs), USA (2016-2018). The potential economic impact of using comparison strategies was calculated in 19,617 estimated patients with stage 5 CKD receiving RRT and phosphate binders. Results. The use of beta-iron (III) oxyhydroxide, sucrose, and starch complex in comparison with sevelamer is associated with a reduction in costs by 10,222 rubles or by 7.4 % on average per patient, which allows fully reimbursing the costs of more expensive drug therapy (the difference in costs minus the cost of drug therapy is 896 rubles in favor of the beta-iron (III) oxyhydroxide, sucrose, and starch complex), and reducing the number of hospitalizations in the target population by more than 6,000 cases. When used in the target cohort of patients, savings will amount to 200.5 million rubles (17.6 million rubles minus the difference in the cost of drug therapy). Conclusion. The use of beta-iron (III) oxyhydroxide, sucrose, and starch complex in patients with CKD during the RRT is clinically and economically feasible, as it allows reducing the number of hospitalizations and is characterized by fewer pills taken daily, reducing the overall costs of patient treatment.
Aim . To evaluate the cost-effectiveness of achieving the target indicator "Reduction of the cardiovascular mortality of the population" of the State Program "Health Development" when using drugs valsartan+sacubitril, dapagliflozin and empagliflozin in patients with New York Heart Association (NYHA) class II-IV heart failure with reduced ejection fraction ≤40% s in 2023-2024. Material and methods . The target population was Russian patients who received preferential medicines in the last two years after an acute cardiovascular disease. The population size was determined on the basis of Russian literary and statistical sources. To predict the cardiovascular death, a parametric modeling method was used based on published data from clinical trials. The amount of drug costs required to prevent one cardiovascular death, as well as to achieve a one target for reducing cardiovascular mortality, was calculated using each of the comparator drugs in the whole country and separately in each region. Results . The cost of drugs for the 1 st year of therapy to prevent one cardiovascular death in the case of valsartan+sacubitril was RUB 3,99 million, dapagliflozin — RUB 2,63 million, empagliflozin — RUB 4,43 million. There were following costs required to achieve one target indicator for reducing cardiovascular mortality of the State Program "Health Development" for valsartan+sacubitril, dapagliflozin and empagliflozin: in 2023 — RUB 2197,9 million, RUB 1451,5 million and RUB 2435,9 million, respectively; in 2024 — RUB 627,4 million, RUB 407,7 million and RUB 706,9 million, respectively. Conclusion . Among the agents considered, dapagliflozin seems to be the most cost effective for preventing one cardiovascular death and achieving one of the target "Reduction of the cardiovascular mortality" of the State Program "Health Development" in 2023-2024.
Aim . To analyze newly diagnosed diseases and features of the post-COVID course in patients after a coronavirus disease 2019 (COVID-19) within 12-month follow-up. Material and methods . A total of 9364 consecutively hospitalized patients were included in the ACTIV registry. Enrollment of patients began on June 29, 2020, and was completed on March 30, 2021, corresponding to the first and second waves of the pandemic. Demographic, clinical, and laboratory data, computed tomography (CT) results, information about inhospital clinical course and complications of COVID-19 during hospitalization were extracted from electronic health records using a standardized data collection form. The design included follow-up telephone interviews with a standard questionnaire at 3, 6, and 12 months to examine the course of post-COVID period. Results . According to the ACTIV registry, 18,1% of patients after COVID-19 had newly diagnosed diseases (NDDs) over the next 12 months. Hypertension (HTN), type 2 diabetes and coronary artery disease (CAD) prevailed in the NDD structure. Comparison of the age-standardized incidence of NDDs (HTN, CAD, diabetes) in the post-COVID period in the ACTIV registry with NDD incidence in 2019 according to Rosstat and the expected incidence of NDDs according to the EPOHA study revealed that HTN, diabetes, CAD in patients after COVID-19 were registered more often as follows: HTN by 7,0 and 4,4 times, diabetes by 7,3 and 8,8 times, CAD by 2,3 and 2,9 times, respectively. NDDs most often developed in patients aged 47 to 70 years. Comparison of the actual and expected number of cases of newly diagnosed HTN, CAD and diabetes depending on age showed that the actual number of cases in the population of patients in the ACTIV register is significantly higher than expected for patients aged 45-69 years and for patients with hypertension or diabetes and aged <45 years. Patients with NDDs, compared with patients without NDDs, had a more severe acute COVID-19 course. Statistically significant independent predictors of NDD occurrence (HTN and/or diabetes and/or CAD) within 1 year after hospital discharge were age (direct relationship), body mass index (direct relationship) and glucose levels upon admission to hospital (direct relationship). Conclusion . Available evidence suggests that a strategy for managing COVID-19 survivors should include mandatory screening for early detection of cardiovascular disease and diabetes, which will be key to reducing the risk of further COVID-19 consequences.
BACKGROUND. There is enough evidence of the negative impact of excess weight on the formation and progression of res piratory pathology. Given the continuing SARS-CoV-2 pandemic, it is relevant to determine the relationship between body mass index (BMI) and the clinical features of the novel coronavirus infection (NCI). AIM. To study the effect of BMI on the course of the acute SARS-COV-2 infection and the post-covid period. MATERIALS AND METHODS. AKTIV and AKTIV 2 are multicenter non-interventional real-world registers. The АКТИВ registry (n=6396) includes non-overlapping outpatient and inpatient arms with 6 visits in each. The АКТИВ 2 registry (n=2968) collected the data of hospitalized patients and included 3 visits. All subjects were divided into 3 groups: not overweight (n=2139), overweight (n=2931) and obese (n=2666). RESULTS. A higher BMI was significantly associated with a more severe course of the infection in the form of acute kidney injury (p=0.018), cytokine storm (p<0.001), serum C-reactive protein over 100 mg/l (p<0.001), and the need for targeted therapy (p<0.001) in the hospitalized patients. Obesity increased the odds of myocarditis by 1,84 times (95% confidence interval [CI]: 1,13–3,00) and the need for anticytokine therapy by 1,7 times (95% CI: 1,30–2,30).The patients with the 1st and 2nd degree obesity, undergoing the inpatient treatment, tended to have a higher probability of a mortality rate. While in case of morbid obesity patients this tendency is the most significant (odds ratio — 1,78; 95% CI: 1,13-2,70). At the same time, the patients whose chronical diseases first appeared after the convalescence period, and those who had certain complaints missing before SARS-CoV-2 infection, more often had BMI of more than 30 kg/m2 (p<0,001).Additionally, the odds of death increased by 2,23 times (95% CI: 1,05-4,72) within 3 months after recovery in obese people over the age of 60 years CONCLUSION. Overweight and/or obesity is a significant risk factor for severe course of the new coronavirus infection and the associated cardiovascular and kidney damage Overweight people and patients with the 1st and 2nd degree obesity tend to have a high risk of death of SARS-CoV-2 infection in both acute and post-covid periods. On top of that, in case of morbid obesity patients this tendency is statistically significant. Normalization of body weight is a strategic objective of modern medicine and can contribute to prevention of respiratory conditions, severe course and complications of the new coronavirus infection.