Фармакоэкономический анализ терапии пациентов с хронической обструктивной болезнью легких в стационарных условиях

Objective. To determine the priority used to vital drugs in сhronic obstructive pulmonary disease (COPD) patients in hospitals of the Kirov region.Materials and Methods. We analyzed 143 medical records of the patient, the analysis of cost of illness, ABC\ VEN — analysis.Results. The results of АВС analysis show that the percentage correlation of medicines of different groups generally corresponds to the recommended norm. The results of VEN analysis prove that the number of vital drugs is decreased while the number of second line drugs is increased.Conclusion. Most of the financial costs were for the treatment of exacerbations of COPD, the appropriate Federal clinical guidelines, simultaneously, there is an active assignment of the second line drugs. Reducing their use and rational therapy of acute conditions will enable competently reallocate financial resources in favour of vital drugs to increase the effectiveness of treatment and reduce the cost of inpatient care.Цель. Определить приоритет использования жизненно-важных лекарственных средств (ЛС) у больных хронической обструктивной болезнью легких (ХОБЛ) в стационарах Кировской обл.Материал и методы. Были проанализированы 143 медицинские карты стационарного пациента, проведен анализ стоимости болезни, ABC/VEN-анализ.Результаты исследования. В ходе АВС-анализа было установлено, что процентное соотношение препаратов между группами в целом соответствует рекомендуемому. Результаты VEN-анализа свидетельствуют об уменьшении количества жизненно важных препаратов и расширении группы второстепенных лекарственных средств (ЛС).Заключение. Большая часть финансовых затрат идет на терапию обострений ХОБЛ, соответствующую федеральным клиническим рекомендациям, одновременно имеет место активное назначение второстепенных ЛС. Сокращение их использования и рациональная терапия обострений позволят грамотно перераспределить денежные ресурсы в сторону жизненно-необходимых препаратов, повысить эффективность лечения и сократить расходы на стационарное лечение

ABC-, VEN- и частотный анализ терапии фибрилляции предсердий в условиях «типичной практики»

Atrial fibrillation is a serious social and health problems, the most common arrhythmia in practice, leading to an increased risk of death, stroke, heart failure. The results of pharmacoeconomical studies allow to evaluate the quality of drug therapy for atrial fibrillation, find rational drug usage and identify ways to optimize the consumption of medications. The objective of investigation is to hold ABC-, VENand frequency analysis of atrial fibrillation in out-patients to assess their compliance with national and international recommendations. Materials and methods. To analyze the treatment of atrial fibrillation 98 outpatients with atrial fibrillation were randomly selected. Every patient appealed to the reception to the physician at least twice in 2013. The data was recorded in a special card, and then analyzed using ABC-, VENand frequency analysis. Results. For the treatment of patients with different forms of atrial fibrillation has been used 114 types of drugs to the INN. Patients received from 3 to 12 drugs. For the treatment of patient with atrial fibrillation it spends an average of 11245.2 rubles per patient, for the treatment of heart disease it spends 8379.51 rubles., that is about 74.5%. The study found that received data is satisfied modern recommendations. The results of frequency analysis showed that the most prescribed drugs are medications with proven efficacy to the quality and duration of life. Conclusions. Data analysis revealed that the percentage volume of drugs between the groups as a whole corresponds to the recommended distribution of drugs.Фибрилляция предсердий – серьезная социальная и медицинская проблема, наиболее часто встречающаяся в практике аритмия, ведущая к увеличению риска смерти, острого нарушения мозгового кровообращения, сердечной недостаточности. Результаты фармакоэкономических исследований позволяют объективно оценить качество фармакотерапии фибрилляции предсердий, выяснить рациональность использования медикаментов и определить пути оптимизации потребления лекарственных препаратов. Задача исследования – провести ABC-, VENи частотный анализ терапии фибрилляции предсердий в условиях «типичной практики» для оценки их соответствия национальным и международным рекомендациям. Материалы и методы. Для проведения анализа лечения фибрилляции предсердий случайным образом было отобрано 98 амбулаторных карт пациентов, страдающих фибрилляцией предсердий, которые хотя бы дважды обращались на прием к участковому терапевту за 2013 г. Полученные данные заносили в специальную карту, затем анализировали с помощью ABC-,VENи частотного анализа. Результаты. Всего для лечения пациентов с различными формами фибрилляции предсердий было использовано 114 наименований препаратов по МНН. Больным назначалось от 3 до 12 препаратов. При лечении фибрилляции предсердий на амбулаторном этапе на одного пациента тратилось в среднем 11245,2 руб., из них непосредственно на лечение сердечной патологии – 8379,51 руб., то есть около 74,5%. При проведении ABC-, VEN-анализа выявлено примерное соответствие реальных показателей рекомендуемым. При проведении частотного анализа оказалось, что чаще всего назначаются препараты с доказанной эффективностью, влияющие на качество и продолжительность жизни. Выводы. При анализе рациональности использования лекарственных средств в поликлинике выявлено, что процентный объем препаратов между группами в целом соответствует рекомендуемому распределению ЛС

Прогнозирование влияния прямых оральных антикоагулянтов на прямые медицинские затраты у больных фибрилляцией предсердий

Aim. To evaluate clinical-economical effectiveness of direct oral anticoagulants (DOAC) dabigatran, rivaroxaban, and apixaban in comparison with warfarin in atrial fibrillation (AF) therapy.Materials and Methods. Mathematical modeling (tree derivation of solutions) on a temporary 5-year horizon from the medical healthcare system perspective. Methods of clinical-economic analysis: analysis “cost-effectiveness”, “budget impact”, and “the analysis of unseized opportunities”.Results. Total direct costs (DC) were lower by 10.3% when dabigatran was used, by 5.2%, when rivaroxaban was used, and by 10.9%, when apixaban was used in comparison with warfarin. The most significant difference was observed due to different cost of therapy for bleeding complications (in the structure of the costs, it occupied 30-38%). In the group of dabigatran, DC on bleeding complications were lower than in the group of warfarin by 22.0%, in the group of rivaroxaban – by 10.9%, in the group of apixaban – by 36.8%. Besides, in the group of dabigatran, the costs associated with the treatment for ischemic stroke were lower by 28.1% The strategy of the application of DOAC in comparison with warfarin provided more adjusted life years (ALY), complications adjusted life years (CALY), and its lower cost. The application of DOAC saves significant funds. At the same time, the saved funds will provide the purchase of additional modern drugs for patients. The cost-cutting reaches 12% for 5 years and up to 33 patients out of 1000 can receive additional treatment.Conclusion. Due to the prevention of thromboembolic complications in patients that received direct oral anticoagulants, the direct costs can be reduced by 28.1% and due to the prevention of bleeding complications – by 36.8% in comparison with the application of warfarin. Direct oral anticoagulants provide more adjusted life years and complications adjusted life years at a lower cost. Цель. Оценить клинико-экономическую эффективность использования прямых оральных антикоагулянтов (ПОАК) – дабигатрана, ривароксабана, апиксабана по сравнению с варфарином при лечении фибрилляции предсердий (ФП).Материалы и методы. Математическое моделирование (построение дерева решений) на временном горизонте 5 лет с перспективы системы здравоохранения. Методы клинико-экономического анализа: анализ «затраты-эффективность»; анализ «влияния на бюджет»; анализ  «упущенных возможностей».Результаты. Суммарные прямые затраты (ПЗ) при использовании дабигатрана были на 10,3% меньше, при использовании ривароксабана – на 5,2% меньше; при использовании апиксабана – на  10,9% меньше по сравнению с варфарином. При этом наибольшая разница возникала вследствие различной стоимости терапии геморрагических осложнений (в структуре затрат они составляли 30–38%). В группе дабигатрана ПЗ на геморрагические осложнения была меньше группы варфарина на 22,0%, в группе ривароксабана – на 10,9%, в группе апиксабана – на 36,8%. Кроме того, в группе дабигатрана на 28,1% были меньше затраты, связанные с лечением ишемического инсульта. Стратегия применения ПОАК по сравнению с варфарином позволяет обеспечить большее количество сохраненных лет жизни (СЛЖ) и сохраненных лет жизни без осложнений (СЛЖБО) и меньшую их стоимость. Использование ПОАК позволяет сохранить  значительные средства бюджета, при этом сэкономленные средства позволяют пролечить  современными ЛС пациентов дополнительно. Экономия средств достигает 12% за 5 лет, при этом  до 33 больных из 1000 могут быть пролечены дополнительно.Заключение. Прямые затраты в результате предупреждения тромбоэмболических осложнений при использовании прямых оральных антикоагулянтов в сравнении с варфарином могут быть снижены на 28,1%, геморрагических осложнений – на 36,8%. Прямые оральные антикоагулянты позволяют  сохранить большее количество лет жизни и лет жизни без осложнений за меньшую стоимость. 

Antiinflammatory Therapy with Canakinumab for Atherosclerotic Disease

Background: Experimental and clinical data suggest that reducing inflammation without affecting lipid levels may reduce the risk of cardiovascular disease. Yet, the inflammatory hypothesis of atherothrombosis has remained unproved. Methods: We conducted a randomized, double-blind trial of canakinumab, a therapeutic monoclonal antibody targeting interleukin-1β, involving 10,061 patients with previous myocardial infarction and a high-sensitivity C-reactive protein level of 2 mg or more per liter. The trial compared three doses of canakinumab (50 mg, 150 mg, and 300 mg, administered subcutaneously every 3 months) with placebo. The primary efficacy end point was nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. RESULTS: At 48 months, the median reduction from baseline in the high-sensitivity C-reactive protein level was 26 percentage points greater in the group that received the 50-mg dose of canakinumab, 37 percentage points greater in the 150-mg group, and 41 percentage points greater in the 300-mg group than in the placebo group. Canakinumab did not reduce lipid levels from baseline. At a median follow-up of 3.7 years, the incidence rate for the primary end point was 4.50 events per 100 person-years in the placebo group, 4.11 events per 100 person-years in the 50-mg group, 3.86 events per 100 person-years in the 150-mg group, and 3.90 events per 100 person-years in the 300-mg group. The hazard ratios as compared with placebo were as follows: in the 50-mg group, 0.93 (95% confidence interval [CI], 0.80 to 1.07; P = 0.30); in the 150-mg group, 0.85 (95% CI, 0.74 to 0.98; P = 0.021); and in the 300-mg group, 0.86 (95% CI, 0.75 to 0.99; P = 0.031). The 150-mg dose, but not the other doses, met the prespecified multiplicity-adjusted threshold for statistical significance for the primary end point and the secondary end point that additionally included hospitalization for unstable angina that led to urgent revascularization (hazard ratio vs. placebo, 0.83; 95% CI, 0.73 to 0.95; P = 0.005). Canakinumab was associated with a higher incidence of fatal infection than was placebo. There was no significant difference in all-cause mortality (hazard ratio for all canakinumab doses vs. placebo, 0.94; 95% CI, 0.83 to 1.06; P = 0.31). Conclusions: Antiinflammatory therapy targeting the interleukin-1β innate immunity pathway with canakinumab at a dose of 150 mg every 3 months led to a significantly lower rate of recurrent cardiovascular events than placebo, independent of lipid-level lowering. (Funded by Novartis; CANTOS ClinicalTrials.gov number, NCT01327846.

Clinical features of post-COVID-19 period. Results of the international register “Dynamic analysis of comorbidities in SARS-CoV-2 survivors (AKTIV SARS-CoV-2)”. Data from 6-month follow-up

Aim. To study the clinical course specifics of coronavirus disease 2019 (COVID-19) and comorbid conditions in COVID-19 survivors 3, 6, 12 months after recovery in the Eurasian region according to the AKTIV register. Material and methods.The AKTIV register was created at the initiative of the Eurasian Association of Therapists. The AKTIV register is divided into 2 parts: AKTIV 1 and AKTIV 2. The AKTIV 1 register currently includes 6300 patients, while in AKTIV 2 — 2770. Patients diagnosed with COVID-19 receiving in- and outpatient treatment have been anonymously included on the registry. The following 7 countries participated in the register: Russian Federation, Republic of Armenia, Republic of Belarus, Republic of Kazakhstan, Kyrgyz Republic, Republic of Moldova, Republic of Uzbekistan. This closed multicenter register with two nonoverlapping branches (in- and outpatient branch) provides 6 visits: 3 in-person visits during the acute period and 3 telephone calls after 3, 6, 12 months. Subject recruitment lasted from June 29, 2020 to October 29, 2020. Register will end on October 29, 2022. A total of 9 fragmentary analyzes of the registry data are planned. This fragment of the study presents the results of the post-hospitalization period in COVID-19 survivors after 3 and 6 months. Results. According to the AKTIV register, patients after COVID-19 are characterized by long-term persistent symptoms and frequent seeking for unscheduled medical care, including rehospitalizations. The most common causes of unplanned medical care are uncontrolled hypertension (HTN) and chronic coronary artery disease (CAD) and/or decompensated type 2 diabetes (T2D). During 3- and 6-month follow-up after hospitalization, 5,6% and 6,4% of patients were diagnosed with other diseases, which were more often presented by HTN, T2D, and CAD. The mortality rate of patients in the post-hospitalization period was 1,9% in the first 3 months and 0,2% for 4-6 months. The highest mortality rate was observed in the first 3 months in the group of patients with class II-IV heart failure, as well as in patients with cardiovascular diseases and cancer. In the pattern of death causes in the post-hospitalization period, following cardiovascular causes prevailed (31,8%): acute coronary syndrome, stroke, acute heart failure. Conclusion. According to the AKTIV register, the health status of patients after COVID-19 in a serious challenge for healthcare system, which requires planning adequate health system capacity to provide care to patients with COVID-19 in both acute and post-hospitalization period

THE COMPARATIVE COST-EFFICACY ANALYSIS OF VARIOUS ANTIHYPERTENSIVE THERAPIES

Aim. To perform the comparative cost-efficacy analysis of various antihypertensive therapies in hypertensives patients.Material and methods. 140 hypertensive patients with history of ineffective antihypertensive therapy were randomized in to 4 groups, 35 patients in each one. Patients of Group A received indapamide retard plus perindopril; group B - indapamide retard plus amlodipine; group C - amlodipine plus lisinopril; group D - amlodipine plus bisoprolol. The Russian version of general questionnaire MOS-SF-36 was applied for quality of a life estimated. Endothelium function was evaluated with B-mode ultrasonography (Acuson 128 ХР/10). Albuminuria level was detected by immunoturbometric method (Integra-700, Roche).Results. The drug combination B had the least cost. The drug combination C was the most effective. The drug combination C was the most economically rational. The drug combination A was the least economically rational for BP reduction. However the drug combination A was comparable with drug combination C in effects on quality of life and on endothelium function, and it was the most economically rational for albuminuria reduction.Conclusion. Indapamide retard plus perindopril combination is the most economically rational in patients with target-organ lesions (nephropathy). Lisinopril plus amlodipine combination is economically rational in patients without target-organ lesions. </p

Pleiotropic effects of antihypertensive therapy variants

Aim. То compare the effects of different two-component antihypertensive therapy (AHT) variants on endothelial dysfunction (ED) and albuminuria (AU) in patients with arterial hypertension (AH).Material and methods. The study included 140 AH patients (mean age 57,0±8,9 years): 28,6 % men and 71,4 % women. Inclusion criterion was ineffective AHT in anamnesis. Endothelial function (EF) was assessed by ultrasound, AU — by turbidimetry, and glomerular filtration rate (GFR) — by MDRD formula. All participants were randomised into 4 groups, containing 35 persons each. The treatment phase lasted for 12 weeks.Results. Most AH patients demonstrated ED symptoms, including paradox vasoconstriction. The most severe ED variants were observed in patients with diabetes mellitus. A significant reduction in blood pressure level was achieved in all groups, while АНТ benefits for EF were observed only in Groups A, В and C. Comparing to Group D, perindopril combination more effectively reduced AU. A small, but significant increase in GFR was achieved in patients receiving lisinopril and amlodipine. The combination of bisoprolol and amlodipine did not show any significant effects on ED and AU.Conclusion. Twelve-week combined АНТ (perindopril + indapamide retard, amlodipine + indapamide retard, lisinopril + amlodipine) was associated with significantly improved EF. The most effective combinations included ACE inhibitors. The combination of bisoprolol and amlodipine was not effective in patients with reduced GFR and microalbuminuria, as it did not improve EF

TOLERABILITY OF VARIOUS ANTIHYPERTENSIVE COMBINATIONS

Aim. To compare tolerability of various antihypertensive combinations in patients with arterial hypertension (HT).Material and methods. 140 patients with HT with history of non-effective antihypertensive therapy were randomized in 4 groups, 35 patients in each. Patients of group A received indapamide retard/perindopril; group B - indapamide retard/amlodipine; group C – amlodipine/lisinopril; group D – amlodipine/bisoprolol. Therapy duration was 12 weeks.Results. 28 (20%) patients dropped out of the study. All antihypertensive combinations significantly decreased blood pressure level. Patients of group A did not stop therapy because of adverse events. 6 (17,1%) dropped out of the study because of ineffective therapy in maximal doses and therapy rejection. Palpitation was a reason of drug withdrawal in 3 (8,6%) of 8 (22,9%) dropped patients of group B. Low limb edema was a reason of drug withdrawal in 4 (11,4%) of 8 (22,9%) dropped patients of group D. Cough was a reason of drug withdrawal in 4 (11,4%) of 5 dropped patients of group C. Dose reduction was needed in some patients of all groups because of hypotension.Conclusion. The adverse events were observed in 25% of patients during 12 weeks of therapy. The patients received indapamide retard/amlodipine and amlodipine/bisoprolol had the highest rate of drug withdrawal because of adverse events. Low limb edema, cough and palpitation were the most frequent adverse events needed therapy withdrawal

STUDY OF TYPICAL PRACTICE OF MANAGEMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE AT THE STATIONARY STAGE

In the course of work 143 medical inpatient cards were studied by a method of retrospective pharmacoepidemiologic analysis for their compliance with national recommendations and standards. Only 47.5% of patients receive the recommended basic therapy. The most common mistakes: insufficient broncholytic therapy, prescription of iGCS if there are no indications for them; excessive use of antibacterial drugs; use of irrationally lowered dosages of sGCS. The obtained results are indicative of the fact that for the purposes of increase of the therapy effectiveness educational programs on therapy of COPD for doctors of inpatient clinics as well as administrative control of implementation of federal clinical recommendations on COPD are required

ABC-, VEN- AND FREQUENCY ANALYSIS OF TREATMENT OF ATRIAL FIBRILLATION IN OUTCOME PATIENTS

Atrial fibrillation is a serious social and health problems, the most common arrhythmia in practice, leading to an increased risk of death, stroke, heart failure. The results of pharmacoeconomical studies allow to evaluate the quality of drug therapy for atrial fibrillation, find rational drug usage and identify ways to optimize the consumption of medications. The objective of investigation is to hold ABC-, VENand frequency analysis of atrial fibrillation in out-patients to assess their compliance with national and international recommendations. Materials and methods. To analyze the treatment of atrial fibrillation 98 outpatients with atrial fibrillation were randomly selected. Every patient appealed to the reception to the physician at least twice in 2013. The data was recorded in a special card, and then analyzed using ABC-, VENand frequency analysis. Results. For the treatment of patients with different forms of atrial fibrillation has been used 114 types of drugs to the INN. Patients received from 3 to 12 drugs. For the treatment of patient with atrial fibrillation it spends an average of 11245.2 rubles per patient, for the treatment of heart disease it spends 8379.51 rubles., that is about 74.5%. The study found that received data is satisfied modern recommendations. The results of frequency analysis showed that the most prescribed drugs are medications with proven efficacy to the quality and duration of life. Conclusions. Data analysis revealed that the percentage volume of drugs between the groups as a whole corresponds to the recommended distribution of drugs