Direct Acting Oral Anticoagulants Following Gastrointestinal Tract Surgery.

Szczegóły
Abstrakt

Tytuł:: Direct Acting Oral Anticoagulants Following Gastrointestinal Tract Surgery.
Autorzy:: Hakeam HA; Pharmaceutical Care Division, King Faisal Specialist Hospital & Research Centre, Riyadh, Saudi Arabia.; College of Medicine, Alfaisal University, Riyadh, Saudi Arabia.
Alkhani M; Department of Vascular Surgery, Hospices Civils de Lyon, Lyon, France.
Alyahya Z; Department of Surgery, Salford Royal NHS Foundation Trust, Manchester, United Kingdom.
Alawaji Z; College of Medicine, Qassim University, Burydah, Saudi Arabia ; and.
Ofori S; Department of Medicine, McMaster University, Hamilton, Ontario, Canada .
Źródło:: Journal of cardiovascular pharmacology [J Cardiovasc Pharmacol] 2021 Dec 01; Vol. 78 (6), pp. 867-874.
Typ publikacji:: Journal Article
Język:: English
Imprint Name(s):: Publication: Hagerstown, MD : Lippincott Williams & Wilkins
Original Publication: New York, Raven Press.
MeSH Terms:: Digestive System Surgical Procedures*
Factor Xa Inhibitors/*administration & dosage
Gastrointestinal Tract/*surgery
Pyrazoles/*administration & dosage
Pyridones/*administration & dosage
Rivaroxaban/*administration & dosage
Administration, Oral ; Adult ; Aged ; Biological Availability ; Drug Monitoring ; Factor Xa Inhibitors/blood ; Factor Xa Inhibitors/pharmacokinetics ; Female ; Gastric Absorption ; Gastrointestinal Tract/metabolism ; Humans ; Intestinal Absorption ; Male ; Middle Aged ; Pyrazoles/blood ; Pyrazoles/pharmacokinetics ; Pyridones/blood ; Pyridones/pharmacokinetics ; Retrospective Studies ; Rivaroxaban/blood ; Rivaroxaban/pharmacokinetics
References:: Kearon C, Akl EA, Ornelas J, et al. Antithrombotic therapy for VTE disease: CHEST guideline and expert panel report. Chest. 2016;149:315–352.
Steffel J, Verhamme P, Potpara TS, et al. 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;39:1330–1393.
Streiff MB, Abutalib SA, Farge D, et al. Update on guidelines for the management of cancer-associated thrombosis. Oncologist. 2021;26:e24–e40.
Key NS, Khorana AA, Kuderer NM, et al. Venous thromboembolism prophylaxis and treatment in patients with cancer: ASCO clinical practice guideline update. J Clin Oncol. 2020;38:496–520.
Hakeam HA, Al-Sanea N. Effect of major gastrointestinal tract surgery on the absorption and efficacy of direct acting oral anticoagulants (DOACs). J Thromb Thrombolysis. 2017;43:343–351.
Kubitza D, Becka M, Wensing G, et al. Safety, pharmacodynamics, and pharmacokinetics of BAY 59-7939--an oral, direct Factor Xa inhibitor--after multiple dosing in healthy male subjects. Eur J Clin Pharmacol. 2005;61:873–880.
Weitz JI, Connolly SJ, Patel I, et al. Randomised, parallel-group, multicentre, multinational phase 2 study comparing edoxaban, an oral factor Xa inhibitor, with warfarin for stroke prevention in patients with atrial fibrillation. Thromb Haemost. 2010;104:633–641.
Frost C, Wang J, Nepal S, et al. Apixaban, an oral, direct factor Xa inhibitor: single dose safety, pharmacokinetics, pharmacodynamics and food effect in healthy subjects. Br J Clin Pharmacol. 2013;75:476–487.
Stangier J, Rathgen K, Stähle H, et al. The pharmacokinetics, pharmacodynamics and tolerability of dabigatran etexilate, a new oral direct thrombin inhibitor, in healthy male subjects. Br J Clin Pharmacol. 2007;64:292–303.
Kröll D, Nett PC, Borbély YM, et al. The effect of bariatric surgery on the direct oral anticoagulant rivaroxaban: the extension study. Surg Obes Relat Dis. 2018;14:1890–1896.
Ruff CT, Giugliano RP, Braunwald E, et al. Association between edoxaban dose, concentration, anti-Factor Xa activity, and outcomes: an analysis of data from the randomized, double-blind ENGAGE AF-TIMI 48 trial. Lancet. 2015;385:2288–2295.
Rottenstreich A, Zacks N, Kleinstern G, et al. Direct-acting oral anticoagulant drug level monitoring in clinical patient management. J Thromb Thrombolysis. 2018;45:543–549.
Avezum A, Lopes RD, Schulte PJ, et al. Apixaban in comparison with warfarin in patients with atrial fibrillation and valvular heart disease: findings from the apixaban for reduction in stroke and other thromboembolic events in atrial fibrillation (ARISTOTLE) trial. Circulation. 2015;132:624–632.
Agnelli G, Buller HR, Cohen A, et al. Oral apixaban for the treatment of acute venous thromboembolism. N Engl J Med. 2013;369:799–808.
Mueck W, Stampfuss J, Kubitza D, et al. Clinical pharmacokinetic and pharmacodynamic profile of rivaroxaban. Clin Pharmacokinet. 2014;53:1–16.
Douxfils J, Ageno W, Samama CM, et al. Laboratory testing in patients treated with direct oral anticoagulants: a practical guide for clinicians. J Thromb Haemost. 2018;16:209–219.
Kubitza D, Becka M, Zuehlsdorf M, et al. Effect of food, an antacid, and the H2 antagonist ranitidine on the absorption of BAY 59-7939 (rivaroxaban), an oral, direct factor Xa inhibitor, in healthy subjects. J Clin Pharmacol. 2006;46:549–558.
Kushwah V, Arora S, Tamás Katona M, et al. On absorption modeling and food effect prediction of rivaroxaban, a BCS II drug orally administered as an immediate-release tablet. Pharmaceutics. 2021;13:283.
Fleisher D, Li C, Zhou Y, et al. Drug, meal and formulation interactions influencing drug absorption after oral administration. Clinical implications. Clin Pharmacokinet. 1999;36:233–254.
XARELTO (Rivaroxaban) Tablets, for Oral Use, Highlights Of Prescribing Information, Janssen Pharmaceutical Companies [database online]. 2021. Available at: https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/XARELTO-pi.pdf . Accessed June 1, 2021.
Mouly S, Paine MF. P-glycoprotein increases from proximal to distal regions of human small intestine. Pharm Res. 2003;20:1595–1599.
Disse E, Pasquer A, Pelascini E, et al. Dilatation of sleeve gastrectomy: myth or reality? Obes Surg. 2017;27:30–37.
Rottenstreich A, Barkai A, Arad A, et al. The effect of bariatric surgery on direct-acting oral anticoagulant drug levels. Thromb Res. 2018;163:190–195.
Cada DJ, Levien TL, Baker DE. Apixaban. Hosp Pharm. 2013;48:494–509.
Martin KA, Beyer-Westendorf J, Davidson BL, et al. Use of direct oral anticoagulants in patients with obesity for treatment and prevention of venous thromboembolism: updated communication from the ISTH SSC Subcommittee on Control of Anticoagulation. J Thromb Haemost.. 2021;19:1874–1882.
Substance Nomenclature:: 0 (Factor Xa Inhibitors)
0 (Pyrazoles)
0 (Pyridones)
3Z9Y7UWC1J (apixaban)
9NDF7JZ4M3 (Rivaroxaban)
Entry Date(s):: Date Created: 20211209 Date Completed: 20220217 Latest Revision: 20230914
Update Code:: 20240105
DOI:: 10.1097/FJC.0000000000001142
PMID:: 34882113
: Czasopismo naukowe

Abstract: Direct-acting oral anticoagulants (DOACs) vary in bioavailability and sites of absorption in the gastrointestinal tract (GIT). Data on DOAC use after major GIT surgery are limited. The aim of this case series was to report the impact of surgical resection or bypass of the GIT on rivaroxaban and apixaban peak plasma concentrations. This was a case series of patients who received rivaroxaban or apixaban after GIT surgery, during the period of July 1, 2019, to December 31, 2020. Peak plasma concentrations of rivaroxaban and apixaban were assessed for the expected concentrations. Of the 27 assessed patients, 18 (66.7%) received rivaroxaban, and 9 (33.3%) received apixaban. After rivaroxaban therapy, 4 of 5 patients (80%) who underwent gastrectomy, and 3 of 3 patients (100%) who underwent duodenum and proximal jejunum exclusion had peak plasma concentrations of rivaroxaban lower than the effective range, whereas 11 of 11 patients (100%) who underwent distal bowel or ileostomy had peak rivaroxaban plasma within the effective range. After apixaban therapy, 5 of 6 patients (83.3%) who underwent total or partial gastrectomy achieved effective peak concentrations. All the patients who underwent proximal and distal bowel resection or bypass had peak concentrations of apixaban within the effective range. In conclusion, surgical resection or bypass of the upper GIT could affect DOAC absorption and subsequently peak plasma concentrations. This effect was more observed among rivaroxaban recipients. An injectable anticoagulant or vitamin K antagonist may be preferred if DOAC concentrations cannot be measured after GIT surgery.
Competing Interests: The authors report no conflicts of interest.
(Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Informacja