Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice

Journal Information
ISSN / EISSN : 2588-0519 / 2618-8473
Current Publisher: Publishing House OKI (10.37489)
Total articles ≅ 56
Current Coverage

Latest articles in this journal

, Yu. M. Gomon, O. I. Karpov, ,
Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice; doi:10.37489/2588-0519-2020-5-38-49

Cystic fibrosis (CF) is a chronic genetic disease with social significant weight because it influences on social humanitarian part of health and on sources of health care system as well. Materials and methods. Data of CF Register and treatment methodology based on clinical guidelines were used for analysis. Direct and indirect medical costs as well as indirect costs have been calculated per one patient per year. Direct costs included diagnostic costs and treatment based on Obligatory medical Insurance fund tariffs, costs of drugs and medical devices, rehabilitation, payments due to disability; indirect costs included loss of GDP. Results. Total expenditures were calculated as 3,1 mln RUR for one patient annually, direct medical costs were 71 % of total. Main part of expenditures was allocated for out-patient stage of treatment — 1,57 mln RUR. Exacerbations costs were estimated as 399,4 thousand RUR. Indirect medical cost was 314,6 thousand RUR, and indirect cost as 582,9 thousand RUR as well annually. Total economic burden of CF for Russian Federation was calculated as 10,37 bln RUR/year, main part was a direct medical expenditures — 73 %. Conclusion. CF is a big social-economic burden in the Russian conditions. Reducing the number of exacerbations and improving lung function, as well as increasing the life expectancy of patients with CF due to introduction of new technologies in health care (targeted therapy) is aimed at reducing the social burden of the disease, which will require increasing the availability of effective (targeted) drugs in the future.
V. V. Sikachev, V. V. Gorin, , D. Yu. Belousov
Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice; doi:10.37489/2588-0519-2020-5-64-69

The article describes the modern legal aspects of conducting research on real clinical practice both in the European Union and United States of America, as well as in Russia and EAEU member states.
G. S. Maskova, A. L. Khokhlov, A. M. Sirotkina
Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice; doi:10.37489/2588-0519-2020-5-70-79

Arterial hypertension (АH) among obese children and adolescents is diagnosed with a frequency of 24,8 — 40 % of cases. The pathogenesis high blood pressure (HB) among childhood obesity continues to be studied in connection with the identification of new genetic and epigenetic factors that determine its course. Polymorphism of genes of arterial hypertension can serve as a reason for maintaining increased vascular tone, even if the nutritional status of the child is optimized. The objective was to study polymorphisms of genes of arterial hypertension AGT: 704, AGТ: 521; AGTR2: 1675; еNOS3:786 among children with obesity and arterial hypertension, depending from the dynamics of blood pressure after courses of diet and physical rehabilitation. Materials and methods. The study has included 50 obese and hypertensive children aged 11—14 years who were prescribed diet and courses of special physical exercises for 6 months. We have compared 2 groups of children: children who have had arterial hypertension after treatment («АH6 month +») and children who had no arterial hypertension after treatment («АH6 month -»). The comparison group has consisted of 34 healthy children with normal body mass index and blood pressure. We have performed clinical and instrumental, laboratory examination, anamnestic assessment of heredity, laboratory analysis of genotypic variants AGT: 704, AGТ: 521; AGTR2: 1675; еNOS3:786 among the studied population of children. Results. Comparative analysis of genotypic variants has showed a disproportionate distribution of alleles depending on the dynamics of blood pressure. Among children o «АH 6 month +» there were a predominance of mutant homozygous alleles of the gene AGTR2 AA (A) 45 % (22 %) and a decrease in the frequency a normal homozygous allele GG 9,0 % (9,6 %). We found a greater affinity of the CC homozygote for AGT 704, the CT heterozygote for AGT521 and the CC homozygote for the eNOS gene for the group of children «АH 6 month +» than among children «AH 6 months -» and healthy children. Conclusion. The revealing of causal polymorphisms of genes of arterial hypertension in obese children will allow predicting the risk of developing stable hypertension and determining treatment.
I. N. Dyakov,
Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice; doi:10.37489/2588-0519-2020-5-4-14

Insulin glargine 100 U/ml (iGla) is gradually giving way to a fixed combination of insulin glargine 100 U/ml+ lixisenatide (iGlaLixi) — an effective and safe drug for Diabetes Mellitus Type 2 (DM2T) control. It has demonstrated the economic benefits in naïve patients as well as for treatment intensification aft er failure of insulins. Economic aspects of iGlaLixi in DM2T in comparison with another effective drugs — insulin degludec (iDeg) and insulin degludec + insulin aspart (iDegAsp) were not evaluated before. Materials and methods. Indirect treatment comparison (ITC) for iGlaLixi with others EDL drugs — iDeg and iDegAsp — has been performed through common comparator — iGla based on published results of efficacy in naïve and insulinized DM2T patients separately. Patients reached target HbA1c level (%) were chosen as a criterion of drugs efficacy. Odds ratio (OR) of efficacy has been calculated, modelling has been performed for direct and indirect costs. Sensitivity analysis was done for validation of results. Results. Efficacy of iGlaLixi were higher as well in naïve as in insulinized patients in comparison with iDeg family: with iDeg comparison OR 2.23 (95 % CI 1.40; 3.53); 3.34 (2.06; 5.40), with iDegAsp OR 1.90 (1.23; 2.95) и 2.49 (1.54; 4.04) accordingly. Direct costs in sum for iGlaLixi were less for iDeg on 22.1, and on 18.3 % for iDegAsp in naïve patient group, and on 35.9 % and 7.0 % for insulinized patients respectively. In total expenditures (direct and indirect costs) for iGlaLixi were less vs iDeg and iDegAsp for naïve patients on 18.9 % and 28 %, and on 15.5 % and 8.9 % for insulinized patients accordingly for 26 weeks treatment. Sensitivity analysis has confirmed of results. Conclusion. iGlaLixi has economic benefits vs iDeg and iGedAsp for DM2T treatment.
, I. A. Vilum, , , O. I. Karpov
Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice; doi:10.37489/2588-0519-2020-5-27-37

Pompe disease with late onset (PDLO) can’t be diagnosed in time due to common symptoms with several neuro-muscular diseases. Screening and diagnostic measures could lead to efficacy enzyme replaced therapy (ERT) with alglucosidase alfa with aim of severe complications prediction. Screening has a nominal cost, so evaluation of it’s clinical-economic reason to use is important, especially in the local conditions. Materials and methods. Dynamic of expenditures for PDLO in case of screening in kids from risks groups has been performed, including treatment with alglucosidase on time in 12-months horizon — cost of illness. Direct and non-direct costs were calculated in case of diagnostic on time and for non-diagnosed patients, cost-effective ratios were calculated and compared in both cases. Results. The analysis showed a 10 % reduction in the total cost per year with 50 % coverage of children at risk group and 18 % (837 mln RUR) — in case of 100 %-coverage with screening on PDLO. These changes in costs are associated with a significant reduction in the burden on outpatient and inpatient care units. Cost-effective ratio in case of early treatment with alglucosidase alfa was less than in non-diagnosed group on 18,1 %. ERT had main cost in diagnosed group, and costs of complications and disability were main in nondiagnosed group. Conclusion: Health Care system expenditures are expecting less in case of screening on PDLO in risks groups.
, V. S. Krysanova,
Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice; doi:10.37489/2588-0519-2020-5-15-26

Background. Severe Asthma is a most social important chronic illness due to highest expenditures of Health Care System for control and treatment of exacerbations and decreasing of GDP. Situation with modern treatment is better now because biologic drugs have introduced into real practice. Biologic drugs — dupilumab, mepolizumab, reslizumab and benralizumab — decrease annual exacerbation rate of severe asthma as well as improve a lung function. Comparison of clinical-economic analyses of biologic drugs usage can help choose an optimal treatment technology of severe asthma. Materials and methods. Calculation of direct and indirect costs of treatment based of indirect treatment comparison of biologic drugs in severe asthma has been performed. Weighted average annual number of exacerbations prevention was chosen as efficacy criteria and their were for dupilumab 200 mg — 0,41, 0,26 for mepolizumab, 0,22 for reslizumab, 0,16 — for benralizumab. Cost-effective ratios were calculated, and sensitivity analysis has been performed for results confirmation. Results. Direct annual costs were less for dupilumab treatment — 834 970 RUR/ patient/year. Same costs for others biologicals were: for mepolizumab — 935 931 RUR, for reslizumab — 1 582 577 RUR/patient/ year, for benralizumab — 1 224 786 RUR/patient/year. Dupilumab has demonstrated less indirect costs in severe asthma patients. Disability is a major contributor of GDP loss. Total expenditures were higher in mepolizumab (on 11,3 %), in reslizumab (on 82,9 %), in benralizumab (on 43,4 %) in compare with the same parameter for dupilumab. Sensitivity analysis has confirmed a stability results calculated in different scenariois. Conclusion. Dupilumab 200 mg in severe asthma is an preference alternative in the treatment compare with other biologics because it has better efficacy and less annual costs.
E. S. Vvedenskaya, A. V. Palekhov
Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice; doi:10.37489/2588-0519-2020-5-80-86

The article provides a detailed analysis of the main palliative care organization in the Russian Federation provisions in the light of the new federal legislation amendments approved in 2019, the work collaboration of primary and specialized palliative care units, as well as interaction with the social care institutions and organizations; the issue of storage and use of narcotic and psychotropic drugs by citizens living in inpatient social care organizations purchased with prescriptions is being discussed.
Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice; doi:10.37489/2588-0519-2020-5-50-63

Ipragliflozin is a selective sodium-glucose cotransporter 2 (SGLT2) inhibitor that reduce plasma glucose concentrations by inhibiting glucose reabsorption by the kidney through inhibiting SGLT2 sodium-glucose cotransporter and induce glycosuria. SGLT2 inhibitors are a new class of glucose lowering drugs most recently approved for treatment of type 2 diabetes mellitus (T2DM). Unlike other antidiabetic agents, SGLT2 inhibitors improve glycemic control (by HbA1c) and provide multiple additional benefits, including decreased body weight, blood pressure, and other multiple pleiotropic effects. The completed clinical trials and real world data have provided evidence that including of SGLT2 inhibitors in the treatment of T2DM has benefits of reduction of cardiovascular and renal outcomes. Goal. The aim of the study was to conduct a clinical and economic examination of ipragliflozin in comparison with other regimens of glucose-lowering therapy with other SGLT2 inhibitors. Methods. In carrying out the pharmacoeconomic analysis itself, a cost-effectiveness analysis (CEA) was applied with the calculation of the corresponding cost-effectiveness ratio (CER), incremental cost-effectiveness ratio (ICER) according to the formula, as well as an a «budget impact analysis». Multiple one-way sensitivity analysis, check the robustness of the results of the main scenario results to changes in key parameters such as the cost of drugs and complications of diabetes. The time horizon for analyzing the dynamics of economic consequences when using ipragliflozin as a glucose-lowering therapy for T2DM was 5 years. Results. The weighted average cost per patient per year when using the ipragliflozin treatment strategy is 31,182 rubles. The costs of the empagliflozin strategy are 61,291 rubles per patient. In the case of using dapagliflozin, the weighted average costs are 30,032 rubles per patient per year, the total direct medical costs for the current drug therapy option, calculated on the initial number of target practice in 72,143 patients with type 2 diabetes, amounted to 3,068,642,442 rubles. Analysis of the trend of changes in weighted average costs showed that the broader use of ipragliflozin for the treatment of T2DM in the target population leads to reducing in diabetes related direct medical costs by 6.7 %, while the total economic effect of ipragliflozin introduction over five years will be 501,539,327 rubles. Conclusions. Use of ipragliflozin + metformin in T2DM treatment is a cost-effective strategy compared to empagliflozin + metformin. The combination of ipragliflozin with metformin versus dapagliflozin + metformin is economically feasible in terms of cost-effectiveness.
A. V. Matveev, ,
Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice; doi:10.37489/2588-0519-2020-s4-35-38

No published trials measuring effectiveness of tofacitinib in COVID-19 have been identified. Some professional associations recommend discontinuing tofacitinib if SARS-CoV-2 infections is detected. Taken into account possible complications of the use of tofacitinib (infections, lymphopenia, venous thromboembolism), routine use of tofacitinib cannot be recommended unless within clinical trials under supervision of qualified healthcare professionals.
V. A. Otdelenov, A. V. Matveev,
Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice; doi:10.37489/2588-0519-2020-s4-60-63

The use of anakinra cannot be currently recommended outside of clinical trials as pathogenetic treatment of “cytokine storm” in severe COVID-19.
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