References

medalphabet

Медицинский алфавит

Medical alphabet

2078-56312949-2807

ООО «Альфмед»

medalphabet-663

Research Article

Статьи

Антикоагулянтная терапия у пожилых пациентов: дилемма выбора между эффективностью и безопасностью

Anticoagulant therapy in elderly patients: dilemma of choice between efficacy and safety

Воробьева

Н. М.

Vorobyeva

N. M.

noemail@neicon.ru

Ткачева

О. Н.

Tkachyova

O. N.

noemail@neicon.ru

ФГБОУ ВО «Российский национальный исследовательский медицинский университет имени Н. И. Пирогова» Минздрава РоссииРоссияRussian National Research Medical University n.a. N. I. PirogovRussian Federation

2018

25052018

216

Кардиология

614

2018

Воробьева Н.М., Ткачева О.Н.

Vorobyeva N.M., Tkachyova O.N.

Данная работа распространяется под лицензией Creative Commons Attribution 4.0.

This work is licensed under a Creative Commons Attribution 4.0 License.

https://www.med-alphabet.com/jour/article/view/663

В статье обсуждаются вопросы эффективности и безопасности применения пероральных антикоагулянтов у пожилых пациентов с неклапанной фибрилляцией предсердий. Приводятся результаты рандомизированных контролируемых исследований RE-LY, ROCKET-AF, ARISTOTLE и ENGAGE AFTIMI 48, включая анализ подгрупп у лиц в возрасте от 75 лет, у пациентов с нарушением функции почек и высоким риском желудочно-кишечных кровотечений;даются рекомендации по оптимальному выбору перорального антикоагулянта у данных категорий пациентов. Также рассматриваются основные положения консенсусного документа FORTA, целью которого является индивидуализация лечения пожилых пациентов на основании клинических характеристик больного с учетом возможных ошибок при использовании лекарственных средств. Междисциплинарный совет экспертов FORTA считает апиксабан наиболее безопасным антикоагулянтом у пожилых пациентов.

The article discusses the effectiveness and safety of oral anticoagulants in elderly patients with non-valvular atrial fibrillation. The results of randomized controlled trials of RE-LY, ROCKET-AF, ARISTOTLE and ENGAGE AF-TIMI48, including subgroup analysis in patients over 75 years of age, in patients with renal dysfunction and a high risk of gastrointestinal bleeding, are given recommendations for optimal choice oral anticoagulant in these patient categories. The main provisions of the FORTA consensus document are also considered, the purpose of which is to individualize the treatment of elderly patients on the basis of clinical characteristics of the patient, taking into account possible mistakes in the use of medicines. The interdisciplinary expert council of FORTA considers apixaban to be the safest anticoagulant in elderly patients.

антикоагулянтная терапияпожилой пациентфибрилляция предсердийэффективностьбезопасность

anticoagulant therapyelderly patientatrial fibrillationefficacysafety

References1

Go A. S., Hylek E. M., Phillips K. A. et al. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the Anticoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA2001;285 (18):2370-2375.

Lloyd-Jones D.M., Wang T.J., Leip E. P. et al. Lifetime risk for development of atrial fibrillation: the Framingham Heart Study. Circulation 2004; 110 (9): 1042-1046.

Go A. S., Mozaffarian D., Roger V. L. et al. Heart disease and stroke statistics - 2014 update: a report from the American Heart Association. Circulation 2014; 129 (3): e28-e292.

Hylek E. M., D’Antonio J., Evans-Molina C. et al. Translating the results of randomized trials into clinical practice: the challenge of warfarin candidacy among hospitalized elderly patients with atrial fibrillation. Stroke 2006; 37 (4): 1075-1080.

Mant J., Hobbs F., FletcherK. et al., on Behalf of the BAFTA Investigators. Warfarin versus aspirin for stroke prevention in an elderly community population with atrial fibrillation (the Birmingham Atrial Fibrillation Treatment of the Aged Study, BAFTA): a randomised controlled trial. Lancet 2007; 370: 493-503.

Connolly S. J., Ezekowitz M. D., Yusuf S. et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009; 361 (12): 1139-1151.

Patel M. R., Mahaffey K. W., Garg J. et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 2011; 365 (10): 883-891.

Granger C. B., Alexander J. H., McMurray J.J. et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med 2011; 365 (11): 981-992.

Giugliano R. P., Ruff C. T., Braunwald E. et al. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med 2013; 369 (22): 2093-2104.

Turagam M. K., Velagapudi P., Flaker G. C. Stroke prevention in the elderly atrial fibrillation patient with comorbid conditions: focus on non-vitamin K antagonist oral anticoagulants. Clin Interv Aging 2015; 10: 1431-1444.

Halperin J. L., Hankey G. J., Wojdyla D.M. et al. Efficacy and safety of rivaroxaban compared with warfarin among elderly patients with nonvalvular atrial fibrillation in the Rivaroxaban Once Daily, Oral, Direct FactorXa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) Circulation 2014; 130 (2): 138-146.

Halvorsen S., Atar D., Yang H. et al. Efficacy and safety of apixaban compared with warfarin according to age for stroke prevention in atrial fibrillation: observations from the ARISTOTLE trial. Eur Heart J 2014; 35 (28): 1864-1872.

Lopes R. D., Al-Khatib S.M., Wallentin L. et al. Efficacy and safety of apixaban compared with warfarin according to patient risk of stroke and of bleeding in atrial fibrillation: a secondary analysis of a randomised controlled trial. Lancet 2012; 380 (9855): 1749-1758.

Toda Kato E., Giugliano R. P., Ruff C. T. et al. Abstract 16612: Efficacy and Safety of Edoxaban for the Management of Elderly Patients With Atrial Fibrillation: Engage AF-TIMI48. Circulation 2014; 130: A16612.

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): 955-962.

Connolly S. J., Eikelboom J., Joyner C. et al. Apixaban in patients with atrial fibrillation. N Engl J Med 2011; 364 (9): 806-817.

Deiner H.-C., Aisenberg J., Ansell J. et al. Choosing a particular oral anticoagulant and dose for stroke prevention in individual patients with non-valvular atrial fibrillation: part 2. Eur Heart J 2017; 38 (12): 860-868.

Reinecke H., Brand E., Mesters R. et al. Dilemmas in the management of atrial fibrillation in chronic kidney disease. J Am Soc Nephrol2009; 20:705-711.

Limdi N.A., Beasley T.M., Baird M.F. et al. Kidney function influences warfarin responsiveness and hemorrhagic complications. J Am Soc Nephrol2009; 20 (4): 912-921.

Pradaxa® (dabigatran etexilate mesylate) capsules for oral use [prescribing information] Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; 2015.

Eikelboom J. W., Connolly S.J., Gao P. et al. Stroke risk and efficacy of apixaban in atrial fibrillation patients with moderate chronic kidney disease. J Stroke Cerebrovasc Dis 2012; 21 (6): 429-435.

Fox K. A., Piccini J. P., Wojdyla D. et al. Prevention of stroke and systemic embolism with rivaroxaban compared with warfarin in patients with non-valvular atrial fibrillation and moderate renal impairment. Eur Heart J 2011; 32 (19): 2387-2394.

Hohnloser S. H., Hijazi 1., Thomas L. et al. Efficacy of apixaban when compared with warfarin in relation to renal function in patients with atrial fibrillation: insights from the ARISTOTLE trial. Eur Heart J 2012; 33 (22): 2821-2830.

US Food and Drug Administration. FDA Draft Briefing Document for the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) FDA; 2014. [Accessed July20,2015]. Available from: http://www.fda.gov/downloads/Advi-soryCommittees/CommitteesMeetingMaterials/Drugs/CardiovascularandRenalDrugsAd-visoryCommittee/UCM420704.pdf.

Chan K. E., Edelman E. R., Wenger J. B. et al. Dabigatran and rivaroxaban use in atrial fibrillation patients on hemodialysis. Circulation 2015; 131: 972-979.

Shah M., Avgil Tsadok M., Jackevicius C.A. et al. Warfarin use and the risk for stroke and bleeding in patients with atrial fibrillation undergoing dialysis. Circulation 2014; 129: 1196-1203.

Eliquis® (apixaban) tablets for oral use [prescribing information] Princeton, NJ: Bristol-Myers Squibb; 2012.

Kirchhof P., Benussi S., Kotecha D. et al. ESC Scientific Document Group. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J 2016; 37 (38): 2893-2962.

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 Mar 17. doi: 10.1093/eurheartj/ehy136.

Graham D.J., Reichman M.E., Wernecke M. et al. Cardiovascular, bleeding, and mortality risks in elderly medicare patients treated with dabigatran or warfarin for nonvalvular atrial fibrillation. Circulation 2015; 131: 157-164.

Vaughan Sarrazin M.S., Jones M., Mazur A. et al. Bleeding rates in Veterans Affairs patients with atrial fibrillation who switch from warfarin to dabigatran. Am J Med 2014; 127: 1179-1185.

Abraham N. S., Singh S., Alexander G. C. et al. Comparative risk of gastrointestinal bleeding with dabigatran, rivaroxaban, and warfarin: population based cohort study. BMJ 2015; 350: h1857.

Chang H. Y., 1hou M., Tang W. et al. Risk of gastrointestinal bleeding associated with oral anticoagulants: population based retrospective cohort study. BMJ 2015; 350: h 1585.

Larsen T. B., Gorst-Rasmussen A., Rasmussen L. H. et al. Bleeding events among new starters and switchers to dabigatran compared with warfarin in atrial fibrillation. Am J Med 2014; 127: 650-656.

Larsen T. B., Rasmussen L. H., Skjoth F. et al. Efficacy and safety of dabigatran etexilate and warfarin in “real-world” patients with atrial fibrillation: a prospective nationwide cohort study. J Am Coll Cardiol 2013; 61:2264-2273.

Chan E. W., Lau W. C., Leung W. K. et al. Prevention of dabigatran-related gastrointestinal bleeding with gastroprotective agents: a population-based study. Gastroenterology 2015; 149:586-595.

Goodman S. G., Wojdyla D. M., Piccini J. P. et al., Investigators RA. Factors associated with major bleeding events: insights from the ROCKET AF trial (rivaroxaban once-daily oral direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation). J Am Coll Cardiol2014; 63:891-900.

Piccini J. P., Garg J., Patel M. R. et al., Investigators RA. Management of major bleeding events in patients treated with rivaroxaban vs. warfarin: results from the ROCKET AF trial. Eur Heart J 2014; 35: 1873-1880.

Hori M., Matsumoto M., Tanahashi N. et al., J-ROCKET AF Study investigators. Rivarox-aban vs. warfarin in Japanese patients with atrial fibrillation - the J-ROCKET AF study. Circ J 2012; 76: 2104-2111.

Laliberte F., Cloutier M., Nelson W. W. et al. Real-world comparative effectiveness and safety of rivaroxaban and warfarin in non-valvular atrial fibrillation patients. Curr Med Res Opin 2014; 30: 1317-1325.

Abraham N. S., Noseworthy P.A., Yao X. et al. Gastrointestinal Safety of Direct Oral Anticoagulants: A Large Population-Based Study. Gastroenterology 2017; 152: 1014-1022.

Wehling M. Drug therapy in the elderly: too much or too little, what to do? A new assessment system: fit for the aged (FORTA) [in German]. Dtsch Med Wochenschr 2008; 133:2289-2291.

Wehling M. Multimorbidity and polypharmacy: how to reduce the harmful drug load and yet add needed drugs in the elderly? Proposal of a new drug classification: fit for the aged. J Am Geriatr Soc 2009; 57:560-561.

Kuhn-Thiel A.M., Weis C., Wehling M. FORTA authors/expert panel members. Consensus validation of the FORTA (Fit fOR The Aged) List: a clinical tool for increasing the appropriateness of pharmacotherapy in the elderly. Drugs Aging 2014; 31 (2): 131-140.

Wehling M., Collins R., Gil V. M. et al. Appropriateness of oral anticoagulants for the long-term treatment of atrial fibrillation in older people. Results of an Evidence-Based Review and International Consensus Validation Process (OAC-FORTA 2016). Drugs Aging 2017; 34 (7): 499-507.

Deitelzweig S., Luo X., Gupta K. et al. Comparison of effectiveness and safety of treatment with apixaban vs. other oral anticoagulants among elderly nonvalvular atrial fibrillation patients Current Medical Research and Opinion 2017; 33 (10): 1745-1754.

Li X., Deitelzweig S., Keshishian A. et al. Effectiveness and safety of apixaban versus warfarin in non-valvular atrial fibrillation patients in ((real-world» clinical practice. A propensity-matched analysis of 76,940 patients. Thromb Haemost2017; 117: 1072-1082.

The authors declare that there are no conflicts of interest present.