Pharmacoeconomic evaluation of apixaban use for the treatment and prevention of venous thromboembolism in the general population and patients with oncological diseases

Aim. To conduct a pharmacoeconomic analysis of the use of the drug Eliquis® (apixaban), belonging to direct oral anticoagulants (DOACs), for the treatment and prevention of deep vein thrombosis (DVT) and/or pulmonary embolism (PE), including in patients suffering from cancer disease compared with other anticoagulants. Materials and Methods. The economic assessment was made from the standpoint of the healthcare of the Russian Federation. Comparative evaluation of the effectiveness of DOACs was carried out on the basis of the combined rate of the incidence of VTE and death from VTE, as well as death from any cause. Safety assessment — based on the rate of major bleeding (MB) and clinically significant non-severe bleeding (CSNSB). The evaluation was performed on the basis of data obtained in the course of previously performed meta-analyses, the results of which were published. The total cost of patient management for each of the compared alternative treatment tactics was estimated by calculating the cost of a course of drug therapy, as well as the cost of managing adverse events in the study horizon, which was 12 months. The conclusion about the most preferred alternative was made on the basis of data on the relationship between the effectiveness and cost of treating the patient. Results. Apixaban compared with dabigatran and rivaroxaban was associated with a lower risk of developing MB and CSNSB. In addition, in patients taking apixaban, there was a trend towards a decrease in the risk of death from any cause compared with patients who used dabigatran and rivaroxaban, which did not reach statistical significance, which in turn led to the choice of the method of pharmacoeconomic analysis — “cost minimization”. It has been established that the use of apixaban is characterized by the lowest costs, the cost of managing one patient amounted to 59 271,89 rubles per year, which is 28,8 % and 27,2 % lower than similar costs for treatment regimens with the original drugs dabigatran and rivaroxaban, respectively. The difference in costs was due to both the cost of treating complications (1362.8 rubles vs. 2536.3 rubles vs. 3170.9 rubles for apixaban, rivaroxaban and dabigatran, respectively), and the cost of treatment and prophylaxis of DOACs (31 514,20 RUB vs 46 434,8 RUB vs 46 790,6 RUB, respectively). Similar results were achieved in the group of patients suffering from oncological diseases, as DOACs also allowed to reduce costs by 4–5 times compared with the use of LMWH. Conclusion. Among the original DOACs and traditional LMWH therapies, the apixaban regimen has the best cost-effectiveness ratio and is the most preferred alternative in terms of pharmacoeconomic analysis

Comparative pharmacoeconomic analysis of the use of apixaban, rivaroxaban and dabigatran for prevention of stroke and embolism in the vessels of the systemic circulation in patients with non-valvular atrial fibrillation

Aim. To compare the effectiveness of direct oral anticoagulants (DOACs) in patients with non-valvular atrial fibrillation (AF) for preventing stroke and systemic thromboembolism (embolism in the vessels of the systemic circulation, systemic embolism) in terms of pharmacoeconomic indicators. Materials and Methods. The economic assessment was carried out from the standpoint of the healthcare system of the Russian Federation. We used published data on the clinical efficacy and safety of DOACs, which were obtained earlier in clinical trials. The efficacy of therapy was assessed by the incidence of ischemic stroke (IS) of systemic embolism (SE), while the safety was assessed by the incidence of major bleeding (MB) and clinically signifi cant minor bleeding (CSNMB). The total cost of patient management for each alternative treatment option included both the cost of drug therapy and the cost of managing adverse events over a study horizon of 12 months. The conclusion about the most preferred alternative was made on the basis of the ratio of effectiveness and cost of treating the patient. Results. The use of apixaban to prevent IS or SE in patients with AF was accompanied by a decrease in the incidence of their development (HR 0.80, 95 % CI 0.73–0.89; HR 0.72, 95 % CI 0.60–0.85 — compared with rivaroxaban and dabigatran, respectively), as well as a decrease in the frequency of MB compared with other DOACs (HR 0.55, 95 % CI 0.53–0.59; HR 0.78, 95 % CI 0.70–0.87 — compared with rivaroxaban and dabigatran, respectively). Since apixaban was more effective and safer than rivaroxaban and dabigatran, a cost-effectiveness approach was applied in this study. The least expensive treatment regimen included apixaban, the direct cost was 33,263 roubles per patient. The advantage was achieved both due to the lower of therapy with apixaban (29.6–34.0 % lower than other DOACs) and the minimum cost of managing the adverse events: for MB and CSNMB, it was reduced by 20.7 % compared to dabigatran and by 44.7 % compared to rivaroxaban; for stroke/SE, it was reduced by 25.9 % and 20.6 %, respectively. Conclusion. In patients with AF, apixaban was more cost-effective compared with rivaroxaban or dabigatran for preventing IS and SE, as it led to higher clinical efficacy and safety while requiring less healthcare system costs

Use of pharmacoinvasive approach to the treatment of patients with ST segment elevation acute coronary syndrome: state of the problem

Role of pharmacoinvasive tactics in the treatment of patients with ST-segment elevation acute myocardial infarction is considered. The expert opinions reflected in the final version of the guideline are given, as well as the results of clinical trials in which the efficacy of thrombolytic therapy at early stage after acute myocardial infarction onset comparedwith primary percutaneous coronary intervention. The place of pharmacoinvasive tactics in real clinical practice is discussed

Современные подходы к выбору лекарственной формы ацетилсалициловой кислоты в кардиологии

The article is devoted to modern approaches to the selection of optimal dosage forms of acetylsalicylic acid (ASA), which ensure high bioavailability of ASA drugs. The relevance of improving the tactics of ASA use for both primary and secondary prevention of cardiovascular diseases is discussed. Changes in the role of ASA in the prevention of cardiovascular disease complications are discussed, including as part of combined antithrombotic therapy, including ASA and either P2Y12 inhibitor or low-dose rivaroxaban. Evidence is presented that has led to doubts about the sufficient bioavailability of the enteric form of ASA, as well as the predictability of the response to therapy. A separate part of the article is devoted to the safety of different forms of ASA, in particular - the effect on the mucosa of the small intestine. The results of clinical studies evaluating the effect of ASA intake in enteric-soluble and buffered forms on the small intestinal mucosa and the risk of bleeding are presented. In addition, the problem of decreased effectiveness of ASA intake in overweight or obese individuals is considered. The article provides information on ongoing randomized trials to assess the effectiveness of increasing the frequency of ASA intake, as well as the effectiveness of chronopharmacological approaches to optimize the use of ASA. The analysis performed leads it to conclude that the buffer form can now be considered the preferred acetylsalicylic acid (ASA) dosage form, which, on the one hand, exerts a less pronounced effect on the gastric and small intestinal mucosa, and on the other hand, ensures high bioavailability, as well as minimal variability of treatment response.Статья посвящена современным подходам к выбору оптимальных лекарственных форм ацетилсалициловой кислоты (АСК), которые обеспечивают высокую биодоступность препаратов АСК. Рассматривается актуальность усовершенствования тактики применения АСК с целью как первичной, так и вторичной профилактики развития сердечно-сосудистых заболеваний. Обсуждается изменение роли АСК в профилактике развития осложнений сердечно-сосудистых заболеваний, в т. ч. в составе комбинированной антитромботической терапии, включающей АСК, а также либо ингибитор P2Y12, либо низкую дозу ривароксабана. Приводятся доказанные данные, которые стали основанием для сомнений в достаточной биодоступности кишечнорастворимой формы АСК, а также в предсказуемости ответной реакции на терапию. Отдельная часть статьи посвящена вопросам безопасности разных форм АСК, в частности – влиянию на слизистую оболочку тонкого кишечника. Приводятся результаты клинических исследований, в ходе выполнения которых оценивали влияние приема АСК в кишечнорастворимой и буферной форме на слизистую оболочку тонкого кишечника, а также риск развития кровотечений. Кроме того, рассматривается проблема снижения эффективности приема АСК у лиц с избыточной массой тела или ожирением. В статье предоставляется информация о продолжающихся рандомизированных исследованиях по оценке эффективности увеличения кратности приема АСК, а также по эффективности хронофармакологических подходов к оптимизации применения АСК. На основании выполненного анализа делается вывод о том, что в настоящее время предпочтительной лекарственной формой АСК можно считать буферную форму, которая, с одной стороны, обеспечивает менее выраженное влияние на слизистую оболочку желудка и тонкого кишечника, а с другой – обеспечивает высокую биодоступность, а также минимальную вариабельность ответной реакции на лечение

Latent opportunities for the prevention of ischemic stroke in patients with atherosclerosis-related diseases: additional analysis of randomized trials on rivaroxaban

Practical introduction of drugs requires determining the relationship between the benefits of its use and adverse effects, as well as identifying clinically significant additional benefits of new treatment approaches by analyzing additional parameters or reanalyzing data of randomized controlled trials. Despite the lack of evidence of such analyzes, they often affect the prospects of using drugs in a particular clinical situation. The article discusses new data on the prospects for the use of low-dose rivaroxaban (2,5 mg 2 times a day), which were obtained not only in initial analyzes, but also secondary analyzes of data obtained in randomized trials involving patients with atherosclerosis-related cardiovascular diseases and sinus rhythm

COMMENTS ON GUIDELINES OF AMERICAN COLLEGE OF CARDIOLOGY, AMERICAN HEART ASSOCIATION AND EUROPEAN SOCIETY OF CARDIOLOGY (2006) FOR THE MANAGEMENT OF PATIENTS WITH ATRIAL FIBRILLATION

Comments on Guidelines of American College of Cardiology, American Heart Association and European Society of Cardiology (2006) for the management of patients with atrial fibrillation.</p

SEARCH FOR UNIVERSAL COMBINED ANTIHYPERTENSIVE THERAPY WITHIN LIMITED DATA ON THE COMPARATIVE EFFICACY OF ANTIHYPERTENSIVE AGENTS

Modern approaches to the choice of antihypertensive drugs are considered. Definitions of the "universal" combined antihypertensive therapy that can be effective in most hypertensive patients, regardless of their individual characteristics are discussed. Results of the most significant clinical trials evaluating the efficacy of combined antihypertensive therapy and the relevant provisions of up-to-date clinical recommendations are given as arguments