[A clinical and economic analysis of the use of dapagliflozin in patients with chronic heart failure in the entire spectrum of left ventricular ejection fraction in the Russian Federation].

AIM: To estimate the cost-effectiveness of dapagliflozin across the range of ejection fraction in patients with heart failure (HF) in Russian Federation. MATERIALS AND METHODS: Cost-effectiveness model was developed for estimate the use of dapagliflozin as part of standard therapy in patients with HF regardless of ejection fraction is unknown. The calculation of costs was carried out in a mathematical model adapted to the conditions of Russian healthcare system by using Russian costs inputs and patient population characteristics. RESULTS: In the model, dapagliflozin therapy yielded a mean of 0.209 additional life-years compared with standard of care in 10 years horizon. The incremental cost of 1 additional life-year was 665,715 RUB, which does not exceed the threshold of willingness to pay 2,235,202 RUB. CONCLUSION: Thus, the intensification of chronic HF therapy with dapagliflozin is cost effective. The use of dapagliflozin in a cohort of 1000 target patients over 10 years will avoid 146 hospitalizations and 39 emergency visits due to HF, as well as prevent 32 deaths from cardiovascular diseases.

[The impact of BMI on the course of the acute SARS-COV-2 infection and the risks that emerge during the first year after the hospital discharge. Subanalysis evidence of the AKTIV and AKTIV 2 registries].

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 yearsCONCLUSION.  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.

[Practical guidelines for the diagnosis and treatment of transthyretin amyloid cardiomyopathy (ATTR-CM or transthyretin cardiac amyloidosis)].

This paper summarizes the data from updated international protocols and guidelines for diagnosis of transthyretin amyloid cardiomyopathy (ATTR-CM). The invasive and non-invasive diagnosis techniques and their combinations are briefly reviewed; the evidentiary foundations for each diagnostic option and tool are analyzed. The paper describes a customized algorithm for sequential diagnosis and differential diagnosis of patients with suspected ATTR-CM with allowance for the combination of clinical signs and diagnostic findings. Along with the awareness of primary care providers about the red flags of the disease and visualization criteria, as well as providing information to the patients about the possibility of performing therapy of ATTR amyloidosis and the risks of delayed diagnosis, the proposed algorithm enables timely patient routing and prescribing specific treatment.

[ACTIV SARS-CoV-2 registry (Analysis of Chronic Non-infectious Diseases Dynamics After COVID-19 Infection in Adult Patients). Assessment of impact of combined original comorbid diseases in patients with COVID-19 on the prognosis].

AIM: Study the impact of various combinations of comorbid original diseases in patients infected with COVID-19 later on the disease progression and outcomes of the new coronavirus infection. MATERIALS AND METHODS: The ACTIV registry was created on the Eurasian Association of Therapists initiative. 5,808 patients have been included in the registry: men and women with COVID-19 treated at hospital or at home. CLINICALTRIALS: gov ID NCT04492384. RESULTS: Most patients with COVID-19 have original comorbid diseases (oCDs). Polymorbidity assessed by way of simple counting of oCDs is an independent factor in negative outcomes of COVID-19. Search for most frequent combinations of 2, 3 and 4 oCDs has revealed absolute domination of cardiovascular diseases (all possible variants). The most unfavorable combination of 2 oCDs includes atrial hypertension (AH) and chronic heart failure (CHF). The most unfavorable combination of 3 oCDs includes AH, coronary heart disease (CHD) and CHF; the worst combination of 4 oCDs includes AH, CHD, CHF and diabetes mellitus. Such combinations increased the risk of lethal outcomes 3.963, 4.082 and 4.215 times respectively. CONCLUSION: Polymorbidity determined by way of simple counting of diseases may be estimated as a factor in the lethal outcome risk in the acute phase of COVID-19 in real practice. Most frequent combinations of 2, 3 and 4 diseases in patients with COVID-19 primarily include cardiovascular diseases (AH, CHD and CHF), diabetes mellitus and obesity. Combinations of such diseases increase the COVID-19 lethal outcome risk.

Analysis of influence of background therapy for comorbidities in the period before infection on the risk of the lethal COVID outcome. Data from the international ACTIV SARS-CoV-2 registry («Analysis of chronic non-infectious diseases dynamics after COVID-19 infection in adult patients SARS-CoV-2¼).

Aim      To study the effect of regular drug therapy for cardiovascular and other diseases preceding the COVID-19 infection on severity and outcome of COVID-19 based on data of the ACTIVE (Analysis of dynamics of Comorbidities in paTIents who surVived SARS-CoV-2 infEction) registry.Material and methods  The ACTIVE registry was created at the initiative of the Eurasian Association of Therapists. The registry includes 5 808 male and female patients diagnosed with COVID-19 treated in a hospital or at home with a due protection of patients' privacy (data of nasal and throat smears; antibody titer; typical CT imaging features). The register territory included 7 countries: the Russian Federation, the Republic of Armenia, the Republic of Belarus, the Republic of Kazakhstan, the Kyrgyz Republic, the Republic of Moldova, and the Republic of Uzbekistan. The registry design: a closed, multicenter registry with two nonoverlapping arms (outpatient arm and in-patient arm). The registry scheduled 6 visits, 3 in-person visits during the acute period and 3 virtual visits (telephone calls) at 3, 6, and 12 mos. Patient enrollment started on June 29, 2020 and was completed on October 29, 2020. The registry completion is scheduled for October 29, 2022. The registry ID: ClinicalTrials.gov: NCT04492384. In this fragment of the study of registry data, the work group analyzed the effect of therapy for comorbidities at baseline on severity and outcomes of the novel coronavirus infection. The study population included only the patients who took their medicines on a regular basis while the comparison population consisted of noncompliant patients (irregular drug intake or not taking drugs at all despite indications for the treatment).Results The analysis of the ACTIVE registry database included 5808 patients. The vast majority of patients with COVID-19 had comorbidities with prevalence of cardiovascular diseases. Medicines used for the treatment of COVID-19 comorbidities influenced the course of the infectious disease in different ways. A lower risk of fatal outcome was associated with the statin treatment in patients with ischemic heart disease (IHD); with angiotensin-converting enzyme inhibitors (ACEI)/angiotensin receptor antagonists and with beta-blockers in patients with IHD, arterial hypertension, chronic heart failure (CHF), and atrial fibrillation; with oral anticoagulants (OAC), primarily direct OAC, clopidogrel/prasugrel/ticagrelor in patients with IHD; with oral antihyperglycemic therapy in patients with type 2 diabetes mellitus (DM); and with long-acting insulins in patients with type 1 DM. A higher risk of fatal outcome was associated with the spironolactone treatment in patients with CHF and with inhaled corticosteroids (iCS) in patients with chronic obstructive pulmonary disease (COPD).Conclusion      In the epoch of COVID-19 pandemic, a lower risk of severe course of the coronavirus infection was observed for patients with chronic noninfectious comorbidities highly compliant with the base treatment of the comorbidity.

[International register "Analysis of Chronic Non-infectious Diseases Dynamics After COVID-19 Infection in Adult Patients (ACTIV SARS-CoV-2)"].

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The economic burden of chronic thromboembolic pulmonary hypertension in Russian Federation.

AIM: The aim of current study was to estimate the economic burden of the chronic thromboembolic pulmonary hypertension (CTEPH) in Russia based on patient registry. MATERIALS AND METHODS: Cost of illness study was based on data derived from CTEPH patient registry that was developed at the Division of hypertension of FSBI "National Medical Research Center of Cardiology". Demographic and clinical patient characteristics were analyzed with descriptive statistic methods. Cost of illness study was performed from the state perspective and with bottom-up approach. Bootstrapping was used for calculation of average costs per patient/year. Within the study direct costs (medical costs: outpatient, inpatient, emergency, PAH-specific therapy, concomitant therapy; non-medical costs: pension due to disability status, payments for patients on sick-leave) and indirect costs (loss in GDP) were estimated. RESULTS: Overall, 113 CTEPH patients (67 women and 46 men) from 33 Russian regions were included, mean age of patients with CTEPH was 54.6±13.95 years. Most of the patients (55%) were in able-bodied age. It was found that about half of patients with diagnosed CTEPH had a disability. Average duration of disease at the time of analysis was 6.88±11.41 years. Period from the first occurrence of symptoms to the confirmation of diagnosis of CTEPH was 2.58±5.21 years on average. More than 70% of patients had III and IV FC (WHO) at the time of diagnosis. Mean number of outpatient visits was 1.97±1.65 per patient/year, and inpatient visits were reported for 59% of patients. About 54% of patients used PAH-specific therapy, moreover 46% patients had interruptions of PAH-specific therapy (58.4±66.3 days). The total costs of CTEPH per patient/year were calculated as 805,901 RUB. The overall burden of CTEPH in Russia for total CTEPH population (470 patients) was 379 million RUB per year. CONCLUSION: CTEPH is the rare disease that is characterized with later diagnosis due to absence of disease-specific symptoms. Therefore economic burden of the CTEPH is significantly low in comparison to widespread cardiovascular diseases. Development of network of expert PH-centers and increase of the access for PAH-specific therapy will help to increase the quality of health care for patients with CTEPH.

[Optimization of BP Control and Arterial Elasticity With Fixed Combination Therapy Perindopril and Amlodipine In Patients With Arterial Hypertension and Increased Pulse Wave Velocity].

The aim of the study was to assess the possibility of fixed combination perindopril+amlodipine to improve arterial elesticity in patients with hypertension and high pulse wave velocity, despite previous combination antihypertensive therapy. In an open, multicenter, observational study duration of 24 weeks 80 patients were included, divided into 4 equal-sized groups, depending on initial antihypertensive therapy: Group 1 - the combination of ACE inhibitor and diuretic, Group 2 - the combination of ACE inhibitor and calcium channel blocker, Group 3 - the combination of diuretic and angiotensin receptor blocker, Group 4 - the combination of angiotensin receptor blocker and calcium antagonist. All patients underwent ambulatory BP monitoring, applanation tonometry (assessment of augmentation index and central blood pressure), pulse wave velocity measurement. According to the office BP measurements fixed combination perindopril+amlodipine provided the SBP reduction by 17.5%, 15.6%, 15, 6%, 15.5% and 17.7%, DBP reduction by 14.6%, 12.9%, 13.8%, respectively, in groups ACEI+D initial combination therapy, ACEI+AC initial combination therapy, ARB+D initial combination therapy, ARB+AC initial combination therapy. According ABPM data SBP has been decreased by 12.2%, 12.4%, 11.3%, 12.6% and DBP by 14.3%, 11.1%, 8.9%, 12.6%. The fixed combination perindopril+amlodipine reduced PWV by 25.2%, 21.6%, 23.1%, 23.0%, augmentation index by 43.4%, 48.9%, 41.5%, 38.3%, central SBP by 16.1%, 15.5%, 14.4%, 15.2%, the central DBP by 15.1%, 13.8%, 13.8%, 18.0% (p<0.01 vs. baseline). CONCLUSIONS: Fixed combination perindopril+amlodipine provides goal blood pressure control, improves arterial elasticity indexes (augmentation index, PWV, central blood pressure). Additional properties include reduction of BMI and lipid metabolism improving in patients initially treated with a combination antihypertensive therapy.

[Optimization of Control of Blood Pressure, Metabolic Disorders and Target Organs Protection With Fixed Perindopril and Indapamide Combination in Treated Patients With Arterial Hypertension].

PURPOSE: to assess the potential of fixed perindopril/indapamide combination (FPIC) to improve angioprotection in patients with arterial hypertension (AP) with various efficacy of preceding therapy with combination of losartan and hydrochlorothiazide (HCTZ). MATERIAL AND METHODS: We included in this open study 50 patients with AP divided into two equal-sized groups in dependence on the achievement of target blood pressure (BP) less than 140/90 mm Hg on preceding therapy with losartan (100 mg) and HCTZ (12.5 mg). All patients underwent ambulatory BP monitoring (ABPM), applanation tonometry (assessment of augmentation index and central blood pressure), measurement of pulse wave velocity (PWV), laboratory tests (lipid profile, fasting glucose, HOMA index, homocysteine, leptin, adiponectin, high sensitivity C reactive protein [hsCRP]). Study duration was 12 weeks. RESULTS: Treatment with FPIC in patients not at target BP provided 14.5 and 6.6% reduction of systolic and diastolic BP (SBP and DBP), respectively (p<0.01), while in patients with target BP it was associated with additional reductions of SBP and DBP by 3.9 and 5.4%, respectively (p<0.01). According to ABPM data average day- and nighttime SBP decreased by 16.9 and 15.0%, average day- and nighttime DBP - by 10.6 and 13.6% (p<0.01) in the group of patients not at target BP. Reductions of PWV (by 15.2 and 2.2%), augmentation index (by 10.7 and 9.4%), central SBP (by 10.9 and 2.1%), central pulse BP vascular age (by 8.7 and 6.0%) were observed in groups of patients without and with target BP on preceding therapy, respectively (p<0.01). Leptin level decreased by 10.0 and 14.4%, hsCRP - by 17.7 and 11.0%; while level of adiponectin increased by 6.7 and 9.9% (p<0.01). CONCLUSION: Our results demonstrated advantages of FPIC over losartan+HCTZ combination relative to BP control, improvement of arterial elasticity, alleviation of insulin resistance and inflammation.

[The prevalence of anxiety and depression in different regions of the Russian Federation and its association with sociodemographic factors (according to the data of the ESSE-RF study)].

AIM: To study the prevalence of anxiety and depression by psychometric methods (the Hospital Anxiety and Depression Scale (HADS) in different regions of the Russian Federation (RF), which are characterized by various climatic, geographic, economic, and demographic indicators. SUBJECTS AND METHODS: The investigation used the data of the multicenter epidemiological survey of cardiovascular diseases in different regions of the Russian Federation--the ESSE-RF study. The subjects of the study were representative samples from unorganized male and female populations aged 25-64 years from 10 RF regions. The survey included a total 16,877 people (6244 men and 10,623 women). All the examinees were interviewed using a standard questionnaire. An analysis involved their gender, age, education level, place and region of residence, and income and morbidity level. The HADS validated in Russia was used to rate the level of anxiety/depression. RESULTS: The total prevalence of higher anxiety and depression averaged 46.3 and 25.6%, respectively. Respondents with clinical anxiety/depression constituted more than one third of those who had a higher level of these conditions. In the examined population, the moderate level of anxiety/depression was 7.5 ± 0.06 and 5.1 ± 0.04, respectively. The population of Volgograd, Samara, Saint Petersburg, and Tomsk had the similar values of the moderate level of anxiety/depression (p > 0.05). The lowest level of anxiety/ depression (p < 0.0001) was seen in the dwellers of Tyumen (5.9 ± 0.1 and 3.4 ± 0.1, respectively) and the highest in the Republic of North Ossetia-Alania (NOA) (8.4 ± 0.1 and 6.8 ± 0.1, respectively). These regions showed the lowest and highest prevalence of higher anxiety (22% in Tyumen and 59.8% in the Republic of NOA (p < 0.0001). CONCLUSION: All the 10 selected RF regions differing in demographic, economic, climatic, and geographical parameters are characterized by a high level of anxiety that remains statistically significant after adjusting for gender and age, so are parameters, such as income and morbidity levels are present in only 4 of the 10 regions.

[Efficiency perindopril at patients with arterial hypertension and obesity].

We gave perindopril (10 mg/day) for 24 weeks to 30 patients with arterial hypertension and obesity and proved its ability to effectively lower arterial pressure, exert cardio-, angio-, and nephro-protection, improve parameters of lipid, carbohydrate and purine metabolisms in these patients. Moreover perindopril in these patients diminished manifestations of insulin resistance, hyperleptinemia, and inflammation; it also exerted pronounced positive effect on anthropometric parameters and percent of fat deposits. Basing on the aggregate of clinical and pharmacodynamics effects perindopril can be considered the drug of choice for treatment of arterial hypertension at the background of obesity.

[Nephroprotection diabetes mellitus type 2: lessons from the ADVANCE trial].

Based on the results of the ADVANCE study, the article considers the issues of medication nephroprotection in patients with type 2 diabetes mellitus, including patients with uncontrolled arterial hypertension. Potentials for use of fixed combination of perindopril + indapmide, which provides therapeutic effect at all stages of renal continuum, are discussed. It is established that improved control of blood pressure by combination of perindopril + indapmide leads to a significant decrease in mortality in DM 2 patients.