SARTANS OF THE SECOND GENERATION: THERAPEUTIC POTENTIAL EXTENSION

Peculiarities of the treatment with angiotensin II receptor blocker telmisartan are analyzed taking into account its clinical and pharmacological characteristics. Special attention is paid to the telmisartan benefits in comparison with other sartans. Key details of telmisartan interaction with peroxisome proliferator-activated receptors (PPAR) are discussed. Mode of this interaction distinguishes pharmacodynamic effects of different medicines. On the basis of presented data author concludes that antihypertensive therapy with telmisartan provides significant benefits

Evaluation of the health care budget impact of secukinumab treatment in patients with ankylosing spondylitis

Objective: clinical and economic analysis of including of secukinumab (SEC) in the essential drug list (EDL) and Federal Reimbursement (ONLS) to ensure the availability of the drug to patients with ankylosing spondylitis (AS) at the expense of health. Material and methods. A budget impact analysis was used. Only cost of drugs was taken into account. Adalimumab (ADA) and infliximab (INF) were used for comparison. Basing on the calculated number of patients treated with these drugs in 2016 from the budget of health care system impact on 3-years budgets of State Guarantee Program (SGP) and ONLS was analyzed. The analysis scenario was based on the replacement of ADA and INF with SEC. Results. Expenditure of a 3-year therapy cycle with SEC amounted to 1.703 million rubles, which was 41.6% less than that with ADA (2.917 million rubles) and 57.7% less than that with INF (4.022 million rubles) in the same period. The budget impact analysis to estimate the cost of SGP demonstrated that the use of SEC during a 3-year period would result in a reduction in expenses by 51.2% (saving of 3.8 billion rubles). When SEC is used within the ONLS, its cost during 3 years will be reduced by 51.9% (savings of 1.9 billion rubles). Conclusion. The inclusion of SEC in EDL and ONLS is appropriately and economically justified, as it enables a substantial reduction in the expenditure of health care budgets to treat patients with AS and to maintain the clinical effectiveness of therapy

EFFECT OF ANTIHYPERTENSIVE THERAPY WITH RILMENIDINE ON COGNITIVE FUNCTION IN ELDERLY HYPERTENSIVE PATIENTS

Aim.  To assess antihypertensive efficacy of rilmenidine (Albarel, EGIS, Hungary) and its effect on cognitive function in elderly hypertensive patients. Material and methods. 30 elderly (in average 68 y.o.) hypertensive patients were observed. Each patient received therapy with rilmenidine 2 mg daily during 6 months. 24 hours monitoring of blood pressure before and after therapy was done in each patient. In order to assess cognitive disorders all patients passed neuropsychological tests, which allowed revealing damages of memory, attention, concentration, mental efficiency and psychomotor functions. Raten tests, Veksler test, vocal activity, memory (10 words), serial counting and kinetic probes were used. Results. After 24 weeks of monotherapy with rilmenidine, decrease in daily average systolic blood pressure (SBP) by 7.2% (p<0.01) and diastolic blood pressure (DBP) by 5.5% (p<0.05) was observed. Therapy with rilmenidine showed decrease in daily average burden by SBP and by DBP (by 25.3% and 18.8% respectively; p<0.05) and daily average time index of hypertension for SBP and DBP (by 32.5 and 60.6% respectively; p<0.05) According to the results of neuropsychological tests at the end of treatment, average time for Raten test completion decreased by 16.7% (p<0.05), and for Veksler test completion – by 15.6% (p<0.05). At the same time significant increase in vocal activity of patients is noted: number of words at free associations tests, verbs and plants denomination have grown by 5.8%, 5.1% and 6.3% respectively (p<0.05); number of mistakes in these tests decreased respectively by 71.4%, 50% and 33.3% (p<0.05). Positive dynamics in characteristics of memory: number of words at first and last immediate and postponed reproduction increased respectively by 36.4%, 21.6% and 14.1% (p<0.05),  average time of serial counting and average time of memorization decreased respectively by 13.2% and 31.8% (p<0.05). Velocity in both hands increased, which was observed both in tests on grip and fingering, and on reciprocal coordination. Conclusion. Well-defined antihypertensive effect of rilmenidine in elderly AH patients is accompanied by significant improvement of cognitive functions. This greatly expands opportunities of treatment with rilmenidine in this age group

Individualisation of basal insulin therapy of type 2 diabetes: evidence from large randomized controlled trials

Initiation of insulin therapy with basal insulin analogues has become the standard of care for type 2 diabetes mellitus (T2DM). Timely administration of insulin allows not only to slow down the progression of type 2 diabetes, but also to reduce the frequency and severity of complications associated with it. This paper reviews the efficacy and safety of the use of the latest basal insulin analogues in type 2 diabetes from the perspective of current clinical guidelines, and also reviews updated data on the efficacy and safety of therapy by various members of the class. In this paper a review of the efficacy and safety of latest basal insulin analogues use in T2DM from the standpoint of current clinical guidelines has been carried out, and updated data on the efficacy and safety of therapy by various members of the class have been reviewed, taking into account their impact on the risk of hypoglycemia and glycemic variability. The available data indicate that insulin degludec 200 U/mL may be the drug of choice for those at high risk of developing severe forms of hypoglycemia. Since severe hypoglycemia and high glycemic variability are important risk factors for cardiovascular events and mortality, it has been shown that a differentiated approach to insulin therapy in the treatment of T2DM is currently advisable, taking into account the effect on the risk of hypoglycemia and glycemic variability

Фармакоэкономический анализ применения препарата цефтазидим+авибактам (Завицефта®) при лечении сепсиса, вызванного карбапенеморезистентными энтеробактериями

Aim: to assess the economic outcomes of using ceftazidime + avibactam (compared with the recommended treatments) in adult patients with sepsis caused by carbapenem-resistant enterobacteria.Methods. The economic assessment was made using the cost-effectiveness analysis and budget impact analysis. The cost-effectiveness and budget impact analyses were performed using the Microsoft Excel software.Results. The treatment efficacy analysis showed that patients treated with the fixed-dose combination ceftazidime + avibactam had fewer days spent in the ICU and higher clinical cure rates than patients receiving the reference drug combinations (8 vs 18 days and 75% vs 34.8%, respectively, p=0.031). The cost of treatment with ceftazidime + avibactam amounted to 228.3 thousand rubles, which was lower than the cost of using the alternative treatment regimens by 34.5-229.5 thousand rubles or 13.12-50.14%. According to the cost-effectiveness analysis, the use of ceftazidime + avibactam is pharmacoeconomically effective as it reduces the cost of patient clinical cure case by 61-72% (depending on the treatment regimen used); in addition, the ceftazidime + avibactam allows for managing the hospitalized patient at a cost lower by 76270 thousand rubles or 16-40% than the compared treatment. The median economic benefit from using the fixed dose combination ceftazidime + avibactam is 154 thousand rubles (28% savings compared with the current practice). The budget impact analysis showed that the reduction in the health budget burden would reach 29% or 34.3 million rubles in year. The sensitivity analysis confirmed the above results.Conclusion. Based on the obtained results, we conclude that the ceftazidime + avibactam combination in patients with sepsis caused by carbapenem-resistant bacteria is economically preferable as compared with the current antibiotic therapy regimens.Цель - провести оценку экономических последствий применения препарата цефтазидим+авибактам в сравнении с рекомендованными схемами терапии у взрослых пациентов с сепсисом, вызванным карбапенеморезистентными энтеробактериями.Материалы и методы. Оценка экономических последствий проведена с использованием анализа «затраты-эффективность » и анализа влияния на бюджет. Расчет затрат проводился в модели, разработанной в программе Microsoft Excel.Результаты. Анализ эффективности показал, что пациенты, получавшие фиксированную комбинацию цефтазидим/авибактам, характеризовались меньшим количеством дней, проведенных в отделении реанимации и интенсивной терапии (ОРИТ) и более высокими показателями клинического излечения, чем пациенты, получающие комбинации сравнения в течение 14 дней от начала лечения (8 против 18 дней и 75% против 34,8% соответственно, р=0,031). Стоимость курса цефтазидим+авибактам составила 228,3 тыс. руб., что на 34,5-229,5 тыс. руб. (13,12-50,14%) ниже расходов на альтернативные схемы лечения. По результатам анализа «затраты-эффективность» показано, что применение препарата цефтазидим+авибактам фармакоэкономически эффективно и позволяет снизить стоимость случая клинического излечения больного на 61-72% в зависимости от используемой схемы терапии, при этом характеризуясь наименьшей стоимостью ведения больного, позволяя сократить сумму прямых затрат на ведение больного на 76270 тыс. руб. (16-40%). Медиана экономической выгоды при использовании фиксированной комбинации цефтазидим+авибактам составляет 154 тыс. руб. (28% экономии в сравнении с текущей практикой). Анализ влияния на бюджет показал, что это приведет к снижению нагрузки на бюджет системы здравоохранения на 29%, или на 34,3 млн руб. в год. Анализ чувствительности подтвердил полученные результаты.Заключение. На основании комплексного фармакоэкономического исследования можно сделать вывод о том, что применение препарата цефтазидим+авибактам у пациентов с сепсисом, вызванным карбапенеморезистентными бактериями с экономической точки зрения является предпочтительной опцией по сравнению с применением текущих схем антибактериальной терапии

Improving blood pressure control, organoprotection and metabolic disorders correction in patients with hypertension switching from diuretic-based combinations to fixed combination lisinopril + amlodipine + rosuvastatin

The aim of the study was to assess the possibility of fixed combination Lisinopril + amlodipine + rozuvastatin to improve arterial elesticity in patients with hypertension and high pulse wave velocity, despite previous diuretic-based combination antihypertensive therapy. Materials and methods. In an open, observational study duration of 24 weeks was included 60 patients on previous diuretic-based combination antihypertensive therapy. All participants underwent 24-hour blood pressure monitoring, applanation tonometry (augmentation index and central blood pressure), pulse wave velocity measurement, laboratory tests (lipid profile, fasting glucose, insulin resistance index - NOMA), leptin, high-sensitivity C-reactive protein before and after the switching to a fixed combination of lisinopril + amlodipine + rosuvastatin. Results. According to measurements of office blood pressure switching of patients on double combinations based on diuretics to a fixed combination of lisinopril + amlodipine + rosuvastatin, a further decrease in systolic blood pressure (SBP) by 13.7% and diastolic BP (DBP) by 18.8% was observed. According to the ABPM, the decline in the average daily SBP was 15.8%, DBP - 22.5%, average SBP - 16.2%, DBP - 19.8%. The combination of lisinopril + amlodipine + rosuvastatin reduced PWV by 15.9%, augmentation index by 13.5%, central SBP by 8.4% (

Оценка влияния на бюджеты системы здравоохранения препарата секукинумаб при лечении пациентов с анкилозирующим спондилитом

Objective: clinical and economic analysis of including of secukinumab (SEC) in the essential drug list (EDL) and Federal Reimbursement (ONLS) to ensure the availability of the drug to patients with ankylosing spondylitis (AS) at the expense of health. Material and methods. A budget impact analysis was used. Only cost of drugs was taken into account. Adalimumab (ADA) and infliximab (INF) were used for comparison. Basing on the calculated number of patients treated with these drugs in 2016 from the budget of health care system impact on 3-years budgets of State Guarantee Program (SGP) and ONLS was analyzed. The analysis scenario was based on the replacement of ADA and INF with SEC. Results. Expenditure of a 3-year therapy cycle with SEC amounted to 1.703 million rubles, which was 41.6% less than that with ADA (2.917 million rubles) and 57.7% less than that with INF (4.022 million rubles) in the same period. The budget impact analysis to estimate the cost of SGP demonstrated that the use of SEC during a 3-year period would result in a reduction in expenses by 51.2% (saving of 3.8 billion rubles). When SEC is used within the ONLS, its cost during 3 years will be reduced by 51.9% (savings of 1.9 billion rubles). Conclusion. The inclusion of SEC in EDL and ONLS is appropriately and economically justified, as it enables a substantial reduction in the expenditure of health care budgets to treat patients with AS and to maintain the clinical effectiveness of therapy. Цель исследования – клинико-экономическая экспертиза целесообразности включения препарата секукинумаб (СЕК) в перечень жизненно необходимых и важнейших лекарственных препаратов (ЖНВЛП) и программу обеспечения необходимыми лекарственными средствами (ОНЛС) для обеспечения доступности препарата за счет средств бюджетов здравоохранения пациентам с анкилозирующим спондилитом (АС). Материал и методы. Использовался анализ «влияние на бюджет». Учитывали только затраты на лекарственные препараты. Препаратами сравнения служили адалимумаб (АДА) и инфликсимаб (ИНФ). Произведен расчет числа пациентов с АС, леченных указанными препаратами в 2016 г. за счет средств системы здравоохранения. На этой основе проанализировано влияние на 3-летние бюджеты программы государственных гарантий (ПГГ) и программы ОНЛС. Сценарий анализа основывался на замене препаратов АДА и ИНФ препаратом СЕК. Результаты. Подсчет стоимости лекарственных средств показал, что затраты на 3-летний курс терапии СЕК составляют 1,703 млн рублей, что на 41,6% меньше, чем затраты за тот же период на препарат АДА (2,917 млн руб.) и на 57,7% меньше, чем затраты на препарат ИНФ (4,022 млн руб.). Анализ влияния на бюджет ПГГ продемонстрировал, что использование СЕК за 3-летний период приведет к снижению расходов на 51,2% (экономия – 3,8 млрд руб.). В случае применения СЕК в рамках программы ОНЛС ее расходы за 3 года сократятся на 51,9% (экономия – 1,9 млрд руб.). Выводы. Включение препарата СЕК в перечень ЖНВЛП и программу ОНЛС целесообразно и экономически обоснованно, так как позволяет существенно сократить расходы бюджетов здравоохранения на лечение больных АС при сохранении клинической эффективности терапии.

Optimization of blood pressure control, organ protection and metabolic disorders using a fixed-dose combination of lisinopril+amlodipine+rosuvastatin in hypertensive patients after COVID-19

Aim. To evaluate the potential of a fixed-dose combination of lisinopril+amlodipine+rosuvastatin (Equamer®) in achieving additional vascular protection in patients with hypertension and high pulse wave velocity (PWV) after severe and very severe coronavirus disease 2019 (COVID-19), complicated by bilateral multisegmental viral pneumonia, with the use of biological therapy, who had not previously received combination antihypertensive therapy.Material and methods. This 12-week open-label observational study included 30 patients with or without antihypertensive therapy. The patients underwent 24-hour blood pressure monitoring, applanation tonometry (determination of the augmentation index (AI) and central blood pressure (CBP)), PWV measurement, blood laboratory tests (lipid profile, fasting glucose, C-reactive protein, complete blood count, ferritin, fibrinogen, D-dimer, alanine aminotransferase, aspartate aminotransferase, creatinine, uric acid) before and after switch to a fixed-dose combination of lisinopril+amlodipine+rosuvastatin.Results. At baseline, the patients had an increase in office blood pressure (BP) up to 152,6/89,1 mm Hg. After prescribing a fixed-dose combination of lisinopril+amlodipine+rosuvastatin, there was a decrease in systolic blood pressure (SBP) by 15,8% and diastolic blood pressure (DBP) by 12,2%. According to 24-hour blood pressure monitoring, the decrease in SBP was 15%, DBP — by 9%, PWV — by 23,8%, AI — by 9%, CBP — by 12,4% (p<0,05 for all compared to baseline values). Vascular age (VA) was initially increased to 41,9 years with a chronological age of 35,03 years. After the end of therapy, there was a significant decrease in VA to 36,5 years, low-density lipoproteins by 46,8%, triglycerides by 16,8% and an increase in high-density lipoproteins by 10,7% (p<0,05 for all compared to baseline values). In addition, the levels of C-reactive protein, fibrinogen, D-dimer, glucose, and uric acid significantly decreased.Conclusion. The fixed-dosed combination of lisinopril+amlodipine+rosuvastatin provides better blood pressure control, improved vascular elasticity parameters (AI, PWV, CBP, decrease in VA), and also improves lipid and carbohydrate metabolism, reduces inflammation in patients with hypertension and hyperlipidemia after severe COVID-19

Pharmacoepidemiological analysis of routine management of heart failure patients in the Russian Federation. Part II

Aim. To assess the healthcare system costs for the management of patients with heart failure (HF) based on a retrospective analysis of primary medical documentation.Material and methods. We performed the analysis of outpatient records of 1000 patients, followed up for 1 year by a general practitioner or cardiologist in ambulatory clinic in 7 Russian regions. The assessment of the HF socioeconomic burden was carried out from the perspective of the state. A bottom-up approach was applied to the cost analysis. To calculate the average costs per patient per year, the costs for each patient were calculated, followed by estimation for the entire cohort. Direct costs (medical: outpatient care, inpatient care, drug therapy; nonmedical: disability pensions and temporary disability) and indirect costs (loss of gross domestic product) were estimated.Results. It was shown that the average cost of managing 1 HF patient is RUB 160338 per year. The cost of drug therapy varied significantly depending on the source of funding. So, the total therapy cost was about RUB 90000 per year, while within the drug assistance programs — about RUB 7000 per year. Thus, the proportion of drug therapy in cost pattern per patient from the state’s perspective was only 4,7%, while the maximum costs were for inpatient care (45,5%), stay in intensive care units (16,4%) and disability payments (21,6%). The direct costs for HF therapy, with the exception of drug therapy (examination, inpatient and outpatient treatment), averages RUB 108291 per year. The total direct nonmedical and indirect costs per HF patient per year were about RUB 44519 per year. It should be noted that the rehabilitation costs were not included in the calculation.Conclusion. Taking into account the significant burden of HF on the Russian healthcare system, the growing costs of healthcare and the increase in life expectancy, prevention and treatment of HF should be improved. The development of a HF centers’ network, creating a seamless system of HF care, as well as improving the availability of medication therapy and the inpatient management of patients can improve the healthcare quality for HF patients in Russia

Practical efficacy and safety of Konsilar D24 in patients with hypertension: data from the KONSONANS program

Aim. In practice, to evaluate the efficacy, safety and long-term adherence to therapy with a fixed-dose combination of ramipril/indapamide (Konsilar-D24) in patients with grade 1-2 hypertension (HTN) who have not achieved blood pressure (BP) control with prior therapy or have not taken antihypertensive therapy.Material and methods. This multicenter open-label observational program included 524 patients with grade 1-2 HTN who did not take antihypertensive therapy or did not reach the target BP level with mono or dual antihypertensive therapy, as well as patients shifted to Konsilar-D24 therapy no later than two weeks before the start of the program. All patients signed a written informed consent to participate in the program. The safety analysis set includes all patients who have taken at least one dose of a fixed-dose combination of ramipril/indapamide and have visited physician at least once during the program. The effectiveness analysis set included all patients in the safety population who completed the study in accordance with protocol (n=511). Clinical systolic blood pressure (SBP), diastolic BP (DBP) and heart rate were assessed at baseline, as well as at 0,5, 1, 3 and 6 months of treatment. A post hoc subgroup analysis of changes in BP and heart rate was performed depending on age, sex and baseline body mass index.Results. The fixed-dose combination of ramipril with indapamide significantly reduced SBP and DBP after 2-week treatment (-20,9±10,1 mm Hg; pConclusion. Despite the limitations inherent in observational studies, the KONSONANS program has demonstrated high efficacy and safety of fixed-dose combination of ramipril/indapamide taken once a day in hypertensive patients. Ramipril/indapamide fixed-dose combination therapy significantly improved BP control and achieved even lower individual target BP levels in the majority of hypertensive patients