Th e comparison of economic parameters of insulin glargine 300 UI/ml (GLA-300) and insulin degludec 100 UI/ml (DEG-100) has been performed based on data of the direct comparison in BRIGHT trial and real world evidences (published and data of the Federal Register of Diabetes without personal data of patients). Direct cost for medications calculated according to daily doses of insulins and duration of treatment as well as of cost of hypoglycemic events. Estimations based on BRIGHT trial shown direct cost for DEG-100 treatment higher than for GLA-300 on 77,3% due to less cost of 1 UI of GLA-300. Hypoglycemic events rate was equal in both groups and they cost did not include into analysis. GLA-300 can be used in 158 pts if fi nance, which allocated for a treatment of 100 pts by DEG-100 will transfer for GLA-300. Economic advantages of GLA-300 are confi rmed by calculations of direct costs as well as cost/eff ective ratio in real world data collection. Cost of less hypoglycemic events in DEG-100 treatment demonstrated in some real world evidences does not compensate much higher expenditures in comparison with GLA-300 treatment. Th erapy with DEG-100 more costly on 43,6-55,2 % (depending of type of analysis). Further analysis of GLA-300 and DEG-100 economics is needed for better decision makes in state purchases.

Objective. To determine the consequences of the use of a fi xed combination of solifenacin and tamsulosin in patients whom recommended the prescription of these drugs. Methods. Analysis of prices of drugs solifenacin + tamsulosin controlled release (Vasomni), solifenacin (Vesicare), tamsulosin controlled release (Omnic Okas) and tamsulosin modifi ed-release (several registered trade names of the drug) conducted on the basis of information from several sources: 1 — the register of maximum ex-works prices of manufacturers of vital and essential medicines, 2 — data on average prices in pharmacies of Moscow (as of 15.02.2018), 3 — weighted average prices of public procurement for 2018 according to the monitoring of the pharmaceutical market. To determine the points of relative value of drugs, a survey of experts was conducted: 1 — to determine the values of the criteria for the drugs under consideration — urologists; 2 — to determine the weight of the criteria — persons involved in the decision-making on the selection and purchase of drugs. Results. We found that the cost of the equivalent course dose of Vesomni was on 40-42 % lower than the combination of drugs Vesicar and Omnik Okas. Compared with the non-fi xed combination of solifenacin with tamsulosin in a drug form with modifi ed release, no signifi cant diff erences in price levels were found. At the same time, the relative value of a fi xed combination is 5-6 percentage points higher compared to non-fi xed combinations, mainly due to ease of use. Conclusion. Use of a fi xed combination of solifenacin + tamsulosin can lead to budget savings with an increase in the level of relative value.

Objective. To determine the clinical and economic consequences of the drug mepolizumab in patients with severe bronchial asthma (SBA) and the ineff ectiveness of omalizumab. Methods. We conducted cost-eff ectiveness and budget impact analysis of the use of mepolizumab or omalizumab in omalizumab-refractory patients with SBA. Source of information about the eff ectiveness were the results of published clinical studies; the cost of drugs — maximum ex-works prices of manufacturers of vital and essential medicinal products and instructions for use of drugs; the cost of medical services — program of state guarantees of free medical assistance on the territory of the Russian Federation, as well as the coeffi cients of relative cost intensity for clinicalstatistical groups. Results. According to the results of a multicenter open study OSMO, the use of mepolizumab in patients with ineff ective omalizumab therapy led to a decrease in the frequency of clinically signifi cant exacerbations and exacerbations requiring hospitalization (1.18 and 0.19 cases / year, respectively) compared to 12 months before screening (3.26 and 0.63 events / year, respectively). Result of the cost analysis showed that switching to mepolizumab leads to signifi cant savings: the sum of direct medical costs was 865 217 and 1 666 401 RUB per patient per year, respectively. Budget impact analysis demonstrated savings in the CHI system in the treatment with mepolizumab within the analyzed cohort of patients (n=18) by 2.8 million rubles in the fi rst year and 12.7 million rubles in 5 years. Analysis of «missed opportunities» showed that the use of mepolizumab can allow to treat an additional 3 people for 1 year of therapy and 15 people for fi ve years of implementation of the analyzed drug. Conclusion. The use of mepolizumab in patients with SBA resistant to omalizumab, will reduce budget costs and will increase the eff ectiveness of treatment.

The aim. Based on a pharmacoeconomic analysis (PHe) of the use of sodium-glucose cotransporter-2 inhibitors (iSGLT2) and dipeptidyl peptidase-4 (iDPP-4) inhibitors to determine the optimal treatment strategy in patients with type 2 diabetes mellitus (T2DM) with inadequate glycemic control in metformin. Methodology. PE based on the clinical data obtained in the Russian multicenter observational epidemiological study FORSIGHT-T2DM and data obtained by analyzing and synthesizing previously published results of randomized controlled trials. Based on the obtained by Markov modeling outcomes we conduct a cost-eff ectiveness analysis with a calculation of cost-eff ectiveness ratio (CER). The time horizon was 7 years. Results. The highest survival rate observed in patients taking alogliptin and empaglifl ozin. The lowest total direct medical costs was on linagliptin (511,830 rubles) and canaglifl ozin (663,571 rubles). The highest utility index according to the EQ-5D questionnaire in iDPP-4 group was on vildagliptin (0.496), in iSGLT2 group on dapaglifl ozin (0.489) and canaglifl ozin (0.489). The highest life years gained (LYG) in iDPP-4 group was on alogliptin (0.65 years); in iSGLT2 group on empaglifl ozin (0.51 year). The highest quality adjusted life years (QALY) was on alogliptin (0.32) and empaglifl ozin (0.25). The results of PHe showed that the lowest discounted CЕR_LYG was on alogliptin (937 921 rubles) and empaglifl ozin (1 645 559 rubles). The lowest discounted CЕR_QALY was on alogliptin (1 918 522 rubles) and empaglifl ozin (3 369 349 rubles). The sensitivity analysis confi rmed that increasing the price of empaglifl ozin and alogliptin by 25 % and / or reducing the proportion of patients who reached the target of HbA1c level by 25 % when taking empaglifl ozin or alogliptin did not change the most cost-eff ectiveness strategy. Conclusion. The results of this PE showed that alogliptin and empaglifl ozin have the lowest CЕR_LYG and CЕR_QALY. In patients with inadequate glycemic control on metformin add-on empaglifl ozin or alogliptin is the most cost-eff ective treatment strategies.

Background. GP40041 is a biosimilar to Humulin® NPH. GP40041 is registered and administrated in Russia since 2004. However, due to changes in the regulatory requirements for biosimilar insulin development programme, we have conducted additional clinical trials of GP40041 including a comparative clinical trial of immunogenicity of biosimilar GP40041 and reference drug Humulin® NPH. Aims. To demonstrate a non-inferior immunogenicity, and comparable safety and effi cacy of GP40041
compared to Humulin® NPH. Materials and methods. 201 patients with T2DM were recruited at 14 centers. We randomly assigned patients 1:1 to receive Humulin® NPH (98 patients, the active control group) or GP40041 (103 patients). The trial included 2 parallel groups of T2DM patients, who received insulin for 28 weeks: 4 weeks of titration period and 24 weeks of treatment period. The primary endpoint was the anti-insulin antibody concentration and its change at Week 12 and 24 as compared to baseline. The secondary endpoint was change in glycated hemoglobin (HbA1c) level, insulin daily dose and fasting plasma glucose (FPG) concentrations at Week 24 as compared to baseline. Results. There was no statistically signifi cant diff erence in terms of immunogenicity endpoints between GP40041 and Humulin® NPH groups. There was no diff erence in the change of HbA1c level and insulin dose aft er treatment between both groups. Both drugs were well tolerated. Adverse eff ects were comparable between treatment groups. All hypoglycemic episodes were light and the most of the episodes were registered during daytime. Frequency of hypoglycemic episodes was comparable between GP40041 and Humulin® NPH groups. Conclusions. GP40041 is comparable to Humulin® NPH in T2DM patients in terms of immunogenicity, safety and efficacy.

Actuality. Rational and safe pharmacotherapy of patients in elderly and senile age is complicated by the polymorbidity of the majority of patients resulting in polypharmacy. The use of tools to identify prescription of potentially inappropriate medications (PIMs) (Beers criteria, STOPP / START criteria) helps to increase the safety of pharmacotherapy in elderly and old age patients. The objective of this work was to determine the prevalence of PIMs in out- and inpatients population ≥65 years old and to identify associated with PIMs factors. Materials and methods. Retrospective pharmacoepidemiology study of medical records of 401 patients ≥65 years old who were hospitalized in the period from 1st of June to 30th of December, 2017. Statistical analysis included methods of parametric and non-parametric statistics and multivariate analysis. Results. The average age was 77.4 + 7.18 years. The median of comorbidities was 3 (IQR 0—5). Th e average number of drugs prescribed per patient was 2 (IQR, 0—4). 37.4 % of patients received ≥5 drugs. The use of STOPP-2 criteria revealed 239 episodes of PIMs in 33.4 % of patients. No correlation was found between age, sex, and PIMs (p = 0.356 and p = 0.718, respectively). Multivariate analysis of PIMs demonstrated a high association with diabetes mellitus ([95 % CI] 28.168 [12.548, 63.230]; p = 0.000) and hypertension (OR [95 % CI] 2.698 [1.637, 4.448]). Conclusions The use of STOPP-2 criteria has shown the practical prevalence of PIMs especially for pharmacotherapy of cardiovascular diseases. The most common drugs identifi ed as PIMs were vasodilators, aspirin, and fi rstgeneration antihistamines. An association was shown for the hospitalizations rates, the presence of comorbidities and PIMs.

Premature newborns are group of high risk on development of infectious complications therefore the choice of effective and safe antibacterial therapy is relevant for them. In clinical practice treatment is complicated by the lack of data on sensitivity of bacterial cultures to antibacterial agents and the absence of accurate diagnostic markers, which are determined by blood tests or other laboratory tests. In order to determine the most rational and effective prescription of antibacterial therapy for premature newborns with infection of early neonatal sepsis, as well as for pregnant women at risk of prenatal outflow of amniotic fluid in preterm pregnancy, we analyzed the database of the perinatal center of ССР №24 with the data on prevalence and resistance of infectious agents among newborns and pregnant women. Taking into account the prevalence and sensitivity to the agents clinical protocol for the management of preterm birth and premature rupture of membranes with preterm pregnancy and recommendations for the treatment of early neonatal sepsis in newborns were compiled.

In the article the features of the organization of international and Russian registers of patients with atrial fibrillation (AF), the clinical and demographic characteristics of patients included in the registers, as well as the features of antithrombotic therapy of AF and its compliance with current clinical guidelines were observed. In a number of large randomized controlled trials (RCTs), not less effectiveness, and in some cases, the superiority of direct oral anticoagulants (DOACs) over warfarin, were proved in the prevention of ischemic insulin stroke patients with non-valvular AF with better safety profile and ease of use. However, the problem of the use of data obtained during RCTs in real clinical practice, for the solution of which medical registers are gaining much popularity, remains relevant. The article provides an analysis of 16 prospective multicenter international and Russian registers of patients with AF. For convenience of comparison, registers were divided into three groups in accordance with the features of the organization and inclusion criteria. Unambiguous conclusions were drawn about the incompatibility of the real clinical practice of antithrombotic therapy of AF with current clinical recommendations. Differences in the population of patients with AF in Russia compared with European countries were found, which led to the conclusion that insufficient detection of AF at the outpatient stage of diagnosis and the resulting inappropriate anticoagulant therapy aiming the prevention of stroke and ischemic complications take place, which may be due to the differences in the socioeconomic status of the regions and the characteristics of the organization of medical treatment and preventive care to the population.

Community-acquired pneumonia (CAP) is the leader among respiratory tract infections. The severity of CAP varies from mild forms (outpatient treatment) to severe, requiring hospitalization. A signifi cant number of negative clinical outcomes, including lethal, actualize regular analysis of patient’s management strategies with a focus on a rational antibiotic therapy. The purpose of the review is to evaluate a rational approach to the choice of an empirical drug for antibiotic therapy of CAP in diff erent patient populations. This review includes an analysis of modern clinical guidelines for CAP antibiotic therapy in pediatric patients and adults, considering current data on the resistance of the main pathogens and the results of clinical effi cacy trials involving antimicrobials listed in the given guidelines. Analysis of the prevalence of causative agents of CAP reveals leading positions of Streptococcus pneumoniae and atypical microfl ora with a tendency to increase of the role of potentially resistant microorganisms — Staphylococcus aureus and Gram-negatives (Pseudomonas aeruginosa, Haemophilus infl uenzae, family of Enterobacteriaceae). The schemes of CAP empiric antibiotic therapy in adults and children according to the clinical guidelines in Europe, USA, and Russia include β-lactams, macrolides, respiratory fl uoroquinolones and doxycycline. In Russian Federation, a suffi ciently high level of sensitivity of major CAP pathogens is detected for β-lactams (inhibitorprotected aminopenicillins, third-generation cephalosporins), respiratory fl uoroquinolones and macrolides (azithromycin, clarithromycin). Analysis of clinical effi cacy trials of empiric antibiotic therapy revealed benefi ts of aminopenicillins in treatment of outpatients, except in cases caused by atypical microfl ora macrolides are the drug of choice. The combination of β-lactam antibiotic plus macrolide is indicated for patients with increased CAP severity rates and risks of atypical microfl ora. Inhibitor-protected β-lactams, cephalosporins II and III generations, and respiratory fl uoroquinolones are essential to treat severe CAP.