The aim of the review article was to highlight the methodologies for assessing the financial costs of adverse drug reactions exemplified by the Russian Federation and Brazil.Materials and methods: for a comparative analysis, materials from open sources were used. The study of the experience of methods used for assessing the burden of adverse drug reactions, was carried out using the system for calculating payments for medical care by clinical-statistical and clinical-profile groups, the methodology for assessing the severity of adverse events of the US National Cancer Institute, drug-associated problems, and “the decision tree” model.Results. When comparing the costs of ADR management in the Russian Federation and Brazil, the following results have been obtained: in the Russian Federation, the “cost” of reaction can be estimated only for a limited number of nosological groups that are regulated by the classification of diseases by clinical and statistical groups; in Brazil, when predicting the costs of adverse reactions management, the combination of “the decision tree” method and the Delphi method is used. In the Russian Federation, the cost of the 3rd and above severity adverse event (according to CTCAE v. 4.03), varies from 26,849.22 up to 26,196.37 RUB in the North-West region (St. Petersburg). In Brazil, the cost of ADR ranges from 13 USD (the best scenario for the patient) to 574 USD (the worst scenario for the patient), which is about 975 and 43,000 RUB, respectively. The introduction of methods that make it possible to predict the development and potential outcomes of adverse drug reactions, as well as taking into account the experiences of foreign colleagues in their modeling, will reduce economic costs in the Russian Federation at the federal level.Conclusion: for the economic value analysis and further forecasting, an improvement of existing methodologies is required. The models used in the Russian Federation (“the decision tree”, classification of diseases by clinical groups, Markov model) do not take into account the time factor, therefore, when planning the analysis of potential costs for adverse reactions, it is necessary to reinforce the methods with such tools as QALY, YLL, and YLD.
The group of non-steroidal anti-inflammatory drugs has occupied one of the leading positions in terms of demand by the population over the past decade. This fact is explained by non-prescription sale, a wide range of purposes and an affordable price range. The lack of proper control over the use of non-steroidal anti-inflammatory drugs (NSAIDs) greatly complicates the assessment of safety, timely detection and prevention of events associated with patient’ safety. Target. Evaluation of data from the national pharmacovigilance database of the safety of non-steroidal anti-inflammatory drugs. Materials and methods. This is a cross-sectional study covering the period from 2010 till 2020. The assessment of the safety profile of international non-proprietary names (INN) from the group of NSAIDs at the post-registration stage was carried out according to the data of uploading the national database (Automated Information System of Roszdravnadzor; AIS RZN), as well as PubMed, Medline, Google Scholar, Elibrary databases. Conclusions. Over a ten-year period, the number of registered spontaneous messages was 8,334. With regard to the three international generic names, the number of adverse drug reactions prevails - this is metamizole (1875 (22.5 %)), acetylsalicylic acid (1716 (20.6 %)), diclofenac (979 (11.7 %)). The main system organ class with safety-related events are described for skin and subcutaneous structures. This fact is not consistent with the data of reference sources of information, which indicates the ineffectiveness of post-marketing observations by marketing authorization holders.
Аннотация. Нестероидные противовоспалительные средства широко применяются пациентами и медицинскими работниками, как на территории Российской Федерации, так и за рубежом. Несмотря на устоявшееся общественное мнение о безопасности данной группы лекарственных средств, их применение ассоциировано с токсическими реакциями. В настоящем исследовании проанализирована выгрузка национальной базы данных «Фармаконадзор» за 11 лет (за период с 2010 по 2020 г.) с определением основных представителей данного класса медикаментов, вызывающих нежелательные реакции. Для сравнения нескольких независимых выборок пациентов, получавших разные МНН группы НПВС, применялся ранговый анализ вариаций по Краскелу -Уоллису (Kruskel-Wallis ANOVA) с применением пакетов Microsoft Excel 2013, STATISTICA 10.0. На основании полученных результатов можно заключить, что основная доля нежелательных реакций (НР) ассоциирована с женским полом и применением метамизола натрия. Кроме того, зарегистрированы НР, окончившиеся летальным исходом, большая часть которых связана с применением парацетамола.
Gout is one of the most common forms of inflammatory arthritis. Medical care for gout includes non-steroidal anti-inflammatory drugs (NSAIDs). This paper reviews the efficacy and safety of NSAIDs prescribed for the acute attack of gout, in particular, AMBENIUM® parenteral. It was demonstrated that phenylbutazone is a powerful NSAID that provides significant analgesic and anti-inflammatory effects. Considering a broad spectrum of adverse reactions of NSAIDs, these agents should be prescribed and used under in-depth analysis of patient’s condition, comorbidities and the level of their decompensation, and potential drug interactions. In addition, optimal dosages and duration of NSAID treatment are of particular importance. The authors conclude that AMBENIUM® parenteral is an effective and safe therapeutic modality for gout. Its profile and risk/benefit ratio are regarded as “favorable” compared to other NSAIDs. KEYWORDS: gout, arthritis, pain, non-steroidal anti-inflammatory drugs, parenteral, efficacy, safety. FOR CITATION: Vasilyuk V.B., Syraeva G.I., Faraponova M.V. Efficacy and safety of non-steroidal anti-inflammatory drugs for acute attack of gout. Russian Medical Inquiry. 2021;5(2):96–101. DOI: 10.32364/2587-6821-2021-5-2-96-101.
Relevance. Studies devoted to the assessment of consumption, as well as to the issues of pharmacosafety of nonsteroidal anti-inflammatory drugs, are limited at the national level in the Russian Federation. The study of these issues will determine the general trends of consumption and prescription of this group of drugs.Aim. To assess the consumption pattern of NSAIDs in the Russian Federation in the period from 2010 to 2020.Methods. Information was searched using data from the state register of drugs (GRLS) as well as national database downloads (automated information system of Roszdravnadzor; AIS RZN). To estimate the consumption of the main INN from the group of NSAIDs for the period 2010–2020 the information on the sales volume of all trade names, sold for sale in the Russian Federation was unloaded from the database of IQVIA Solutions Ltd. and analyzed.Results. The analysis showed that the first place by total amount of consumption was occupied by acetylsalicylic acid (5 953 058 854); second place — paracetamol (4 635 122 085); third place — ibuprofen (3 230 415 088); fourth place — metamizole (4 172 344 008); fifth place — ketorolac (91 617 809,04); sixth — nimesulide (69 761 7481,8). The claimed INNs showed a slightly different distribution when calculating the DDDs/P (patient-year) totals, namely, in descending order, nimesulide, ketorolac, ibuprofen, acetylsalicylic acid, paracetamol, and methamisole.Conclusion. The indicated levels of consumption do not correlate with the data of the national database “Pharmacovigilance”, which indicates insufficient post-marketing monitoring of the safety profiles of the indicated medicines.
Проведен сравнительный анализ фармакокинетических параметров янтарной кислоты после внутривенного введения препаратов «Унифузол, раствор для инфузий 1,4 %», «Реамберин, раствор для инфузий 1,5 %», «Ремаксол раствор для инфузий», «Цитофлавин, раствор для внутривенного введения» (ООО «НТФФ «ПОЛИСАН», г. Санкт-Петербург) по результатам серии клинических исследований, осуществленных в 2017 – 2022 гг. Установлено, что двухкамерная модель является оптимальной для определения параметров фармакокинетики янтарной кислоты, получены значимые различия между исследуемыми препаратами по фармакокинетическим параметрам (Cmax, Tmax, AUC0-∞, MRT), что связано с особенностями содержания активных компонентов, дозой и режимом введения. При этом антропометрические и гендерно-возрастные особенности добровольцев не оказывали значимого влияния на большинство фармакокинетических параметров янтарной кислоты.
Fludarabine is a purine antimetabolite with a pronounced immunosuppressive effect. The inhibitory effect of fludarabine depends on its concentration in blood plasma. In addition, the phenotypic characteristics of patients affect the pharmacokinetic and pharmacodynamic profile of the drug, which necessitates a personalized approach to the dosage regimen. The chromatography-mass spectrometric method for the quantitative determination of 2-fluorine in blood plasma was developed for studying the individual parameters of pharmacokinetics of the international non-proprietary name (INN) fludarabine in patients with B-cell chronic lymphocytic leukemia during the standard course. Such method for the quantitative determination of 2-fluorine in blood plasma was developed and validated in accordance with international requirements. Significant individual variability of the main pharmacokinetic parameters in patients with B-cell chronic lymphocytic leukemia with a single oral administration of the drug with INN fludarabine at a dose of 40 mg/m2 was established, so the coefficient of variability Cmax was 42 %, Tmax — 92 %, AUC0-t — 45 %, Kel — 23 %, T1/2 — 26 %. It should be noted that there is a high interindividual variability of fludarabine, for example, 24 hours after taking the study drug, the maximum and minimum plasma concentrations of the fludarabine metabolite 2-fluoro-ara-A in different in patients with B-cell chronic lymphocytic leukemia differed 9 times. Individual variability of pharmacokinetic parameters characterizing absorption (Cmax/AUC0-t) and total clearance of the active metabolite of fludarabine is statistically significantly associated with a combination of gender and anthropometric factors.
Аннотация. Актуальность. Интерпретация данных доклинических испытаний лекарственных средств имеет принципиальное значение. Корректность экстраполяции данных, полученных на животных, на человека обусловлены, в том числе, качественным и количественным разнообразием тестируемых систем, регистрируемых параметров и подходов к их интерпретации, а также статистических методов при определении возможного риска для человека. Цель. Сравнительная оценка параметров безопасности и переносимости, полученных в ходе доклинического и клинического исследования лекарственного препарата Реамберин® (ООО «НТФФ «ПОЛИСАН»), и выработка подходов к совершенствованию процессов планирования клинических исследований по оценке безопасности и переносимости с учётом результатов доклинических исследований. Материалы и методы. Был проведён сравнительный анализ параметров безопасности, возникших в ходе клинического исследования с участием здоровых добровольцев, и отклонений от контрольных уровней клинико-лабораторных показателей, установленных на этапе доклинического исследования на беспородных крысах и кроликах породы шиншилла лекарственного препарата с международным непатентованным наименованием (МНН) -меглюмина натрия сукцинат (торговое наименование (ТН) Реамберин® (ООО «НТФФ «ПОЛИСАН»)). Результаты. Установлены однонаправленные отклонения от нормальных (контрольных) значений, выявленные единичные случаи нежелательные явления у добровольцев (повышение активности печёночных трансаминаз, изменения артериального давления), которые не соотносились с данными доклинического исследования. Количество сопоставляемых показателей у лабораторных животных, для которых были установлены статистически значимые различия между опытными и контрольными группами, значительно превышало численность признаков в виде НЯ у добровольцев.
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