Structure of prescription of gastroprotective drugs in patients receiving direct oral anticoagulants: results of a multicenter cross-sectional pharmacoepidemiological study


Cite item

Full Text

Open Access Open Access
Restricted Access Access granted
Restricted Access Subscription or Fee Access

Abstract

Background. In recent years, the frequency of prescribing direct oral anticoagulants (DOACs) for the prevention of thromboembolic complications in patients at risk for these conditions has sharply increased. However, taking some DOACs is associated with an increased risk of gastrointestinal bleeding and may cause dyspeptic symptoms that affect the prognosis and quality of life. In this regard, experts recommend considering the concomitant appointment of gastroprotectors for patients of this category. However, real clinical practice data on the appointment of gastroprotectors and drugs to protect the gastrointestinal tract in patients taking DOACs are practically absent in Russia. Objective. Evaluation of the frequency and structure of prescribing gastroprotective drugs in patients receiving DOACs. Methods. A multicenter cross-sectional (single-stage) pharmacoepidemiological study was conducted. From June 2021 to March 2022, data from inpatient and outpatient medicalrecords of662patients taking DOACs and examined in 26 centers in 15 cities of Russia (13 outpatient centers and 13 hospitals) were analyzed. Results. All 662 patients included in the study were taking DOACs. Previously, 64.8% of patients received DOACs, in 34.7% of cases they were prescribed for the first time. DOAC monotherapy was received by 86.6% of patients. Dual antithrombotic therapy (DOAC + antiplatelet) was prescribed in 10.6% of cases, triple therapy (DOAC + two antiplatelet agents) - in 2.8% of cases. Gastroprotective therapy (GPT) was administered to 57.1% of patients included in the study. The most commonly prescribed gastroprotective agents in patients taking DOACs and GPT were proton pump inhibitors (PPIs) - 80.2% and rebamipide - 27.8%. Monotherapy with any one gastroprotector and combination therapy, including 2 or more gastroprotectors in various combinations, were received by 89.2% and 10.8% of patients, respectively, among those who were prescribed GPT. In the case of DOAC monotherapy, 53.8% of patients received GPT, of which 63.9% took PPIs as monotherapy, 22.7% took rebamipide as monotherapy, and only 13.4% of patients received combined GPT. In general, gastroprotectors in the DOAC + ASA group were presented in the form of PPIs (monotherapy or as part of combined HPT - 94.3%) or rebamipide (22.9%). In the case of dual therapy (DOAC + clopidogrel), GPT was prescribed in 69.6% of cases; all patients received PPIs and only in one case - a combination of PPI and bismuth preparation. In the case of triple antiplatelet therapy, including DOAC and 2 antiplatelet agents, GPT was prescribed in 89.5% of patients. Conclusion. In Russia, in real clinical practice, the frequency of prescribing gastroprotectors to patients taking DOACs is only 57.1%, and since this directly affects the improvement of the prognosis of the disease, it is necessary to take additional measures aimed at raising physicians’ awareness of the need for such patient management tactics.

Full Text

Restricted Access

About the authors

Olga D. Ostroumova

Russian Medical Academy of Continuous Professional Education; Sechenov University

Email: ostroumova.olga@mail.ru
Dr. Sci. (Med.), Professor, Head of the Department of Therapy and Polymorbid Pathology n.a. Academician M.S. Vovsi; Professor Chair of Clinical Pharmacology and Propaedeutics of Internal Medicine Moscow, Russia

I. Yu Orlova

Russian Medical Academy of Continuous Professional Education; E.O. Mukhin Municipal Clinical Hospital

Moscow, Russia

A. I Kochetkov

Russian Medical Academy of Continuous Professional Education

Moscow, Russia

O. A Polyakova

Russian Medical Academy of Continuous Professional Education

Moscow, Russia

A. I Listratov

Sechenov University

Moscow, Russia

N. A Shatalova

Russian Medical Academy of Continuous Professional Education

Moscow, Russia

S. V Batyukina

Russian Medical Academy of Continuous Professional Education

Moscow, Russia

References

  1. Аракелян М.Г, Бокерия Л.А., Васильева Е.Ю. и др. Фибрилляция и трепетание предсердий. Клинические рекомендации 2020. Российский кардиологический журнал. 2021;26(7):190-260
  2. Hindricks G, Potpara T, Dagres N., et al., ESC Scientific Document Group. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021;42(5):373-498. doi: 10.1093/eurheartj/ehaa612
  3. Остроумова О.Д., Волкова Е.А., Кочетков А.И. и др. Профилактика желудочно-кишечных кровотечений у пациентов, получающих перо-ральные антикоагулянты: фокус на ингибиторы протонной помпы. Кардиоваскулярная терапия и профилактика. 2019;18(5):128-37
  4. Ruff C.T, Giugliano R.P, Braunwald E., et al.Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials. Lancet. 2014;383(9921):955-62. Doi: 10.1016/ S0140-6736(13)62343-0
  5. Holster I.L., Hunfeld N.G., Kuipers E.J., et al. On the treatment of new oral anticoagulant-associated gastrointestinal hemorrhage. J Gastrointestin Liver Dis. 2013;22(2):229-31
  6. Holster I.L., Valkhoff V.E., Kuipers E.J., Tjwa E.T.T.L. New oral anticoagulants increase risk for gastrointestinal bleeding: a systematic review and meta-analysis. Gastroenterol. 2013;145(1):105 12.e15. doi: 10.1053/j.gastro.2013.02.041
  7. Coleman C.I, Sobieraj D.M., Winkler S., et al. Effect of pharmacological therapies for stroke prevention on major gastrointestinal bleeding in patients with atrial fibrillation.Int J Clin Pract. 2012;66(1):53-63. doi: 10.1111/j.1742-1241.2011.02809.x
  8. Lauffenburger J.C., Rhoney D.H., Farley J.F., et al. Predictors ofgastrointestinal bleeding among patients with atrial fibrillation after initiating dabigatran therapy. Pharmacother. 2015;35(6):560-68. doi: 10.1002/phar.1597
  9. Steffel J, Verhamme P, Potpara T.S., et al., ESC Scientific Document Group. The 2018 European Heart Rhythm Association Practical Guide on the use of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation. Eur Heart J. 2018;39(16):1330-93. doi: 10.1093/eurheartj/ehy136.
  10. Naito Y, Yoshikawa T. Rebamipide: a gastrointestinal protective drug with pleiotropic activities. Expert Rev Gastroenterol Hepatol. 2010;4(3):261-70. doi: 10.1586/egh.10.25.
  11. Lai Y, Zhong W., Yu T, et al. Rebamipide Promotes the Regeneration of Aspirin-Induced Small-Intestine Mucosal Injury through Accumulation of Catenin. PLoS One. 2015;10(7):e0132031. Doi: 10.1371/ journal.pone.0132031.
  12. Симаненков В.И., Маев И.В., Ткачева О.Н. и др. Синдром повышенной эпителиальной проницаемости в клинической практике. Мультидисциплинарный национальный консенсус. Кардиоваскулярная терапия и профилактика. 2021;20(1):121-28
  13. Watanabe T., Takeuchi T., Handa O., et al. A multicenter, randomized, double-blind, placebo-controlled trial of high-dose rebamipide treatment for low-dose aspirin-induced moderate-to-severe small intestinal damage. PLoS One. 2015;10(4):e0122330. doi: 10.1371/journal. pone.0122330
  14. Pittayanon R., Piyachaturawat P, Rerknimitr R., et al. Cytoprotective agent for peptic ulcer prevention in patients taking dual antiplatelet agents: A randomized, double-blind placebo-controlled trial. J Gastroenterol Hepatol. 2019;34(9):1517-22. doi: 10.1111/jgh.14671.
  15. Yamashita T., Watanabe E., Ikeda T., et al. Observational study of the effects of dabigatran on gastrointestinal symptoms in patients with non-valvular atrial fibrillation. J Arrhythm. 2014;30(6):478-84. Doi: 10.1016/j. joa.2014.02.011.
  16. Консенсус экспертов по снижению риска желудочно-кишечных кровотечений у пациентов, получающих оральные антикоагулянты. Терапия. 2021;10:23-41.
  17. Дронова Ю.М., Белесикова В.В. Анализ обоснованности назначения ингибиторов протонной помпы у больных с ишемической болезнью серд -ца, получающих низкие дозы ацетилсалициловой кислоты. Кардиоваскулярная терапия и профилактика. 2022; 21(Suppl. 2):92
  18. Шахматова О.О., Комаров А.Л., Коробкова В.В. и др. Кровотечения из верхних отделов желудочно-кишечного тракта у пациентов со стабильной ишемической болезнью сердца (по результатам проспективного РЕГистра длительной Антитромботической ТерАпии - РЕГАТА). Терапевтический архив. 2020;92(9):30-8 doi: 10.26442/00403660.2020.09.000699.
  19. Стабильная ишемическая болезнь сердца. Клинические рекомендации 2020. Рос. кардиологический журнал. 2020;25(11):201-50 doi: 10.15829/1560-4071-2020-4076.
  20. Liu Y., Zhu X., Li R., Zhang J., et al. Proton pump inhibitor utilisation and potentially inappropriate prescribing analysis: insights from a single-centred retrospective study. BMJ. Open. 2020;10(11):e040473. Doi: 10.1136/ bmjopen-2020-040473

Supplementary files

Supplementary Files
Action
1. JATS XML

This website uses cookies

You consent to our cookies if you continue to use our website.

About Cookies