121
Views
0
CrossRef citations to date
0
Altmetric
Drug Evaluation

The benefit of betrixaban for the extended thromboprophylaxis in acutely ill medical patients

ORCID Icon, , &
Pages 261-268 | Received 21 Apr 2018, Accepted 07 Dec 2018, Published online: 07 Jan 2019

References

  • Cohen AT, Tapson VF, Bergmann JF, et al. Venous thromboembolism risk and prophylaxis in the acute hospital care setting (ENDORSE study): a multinational cross-sectional study. Lancet. 2008;371:387–394.
  • Samama MM, Cohen AT, Darmon JY, et al. A comparison of enoxaparin with placebo for the prevention of venous thromboembolism in acutely ill medical patients. prophylaxis in medical patients with enoxaparin study group. N Engl J Med. 1999;341:793–800.
  • Leizorovicz A, Cohen AT, Turpie AG, et al. Randomized, placebo-controlled trial of dalteparin for the prevention of venous thromboembolism in acutely ill medical patients. Circulation. 2004;110:874–879.
  • Cohen AT, Davidson BL, Gallus AS, et al. Efficacy and safety of fondaparinux for the prevention of venous thromboembolism in older acute medical patients: randomised placebo controlled trial. Bmj. 2006;332:325–329.
  • Kahn SR, Lim W, Dunn AS, et al. Prevention of VTE in nonsurgical patients: antithrombotic therapy and prevention of thrombosis, 9th ed: american College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2012;141:e195S–e226S.
  • Dentali F, Douketis JD, Gianni M, et al. Meta-analysis: anticoagulant prophylaxis to prevent symptomatic venous thromboembolism in hospitalized medical patients. Ann Intern Med. 2007;146:278–288.
  • Amin AN, Varker H, Princic N, et al. Duration of venous thromboembolism risk across a continuum in medically ill hospitalized patients. J Hosp Med. 2012;7:231–238.
  • Hull RD, Schellong SM, Tapson VF, et al. Extended-duration venous thromboembolism prophylaxis in acutely ill medical patients with recently reduced mobility: a randomized trial. Ann Intern Med. 2010;153:8–18.
  • Cohen AT, Spiro TE, Buller HR, et al. Rivaroxaban for thromboprophylaxis in acutely ill medical patients. N Engl J Med. 2013;368:513–523.
  • Goldhaber SZ, Leizorovicz A, Kakkar AK, et al. Apixaban versus enoxaparin for thromboprophylaxis in medically ill patients. N Engl J Med. 2011;365:2167–2177.
  • Spyropoulos AC, Ageno W, Albers GW, et al. Rivaroxaban for thromboprophylaxis after hospitalization for medical illness. N Engl J Med. 2018;379:1118–1127.
  • Fanikos J, Stevens LA, Labreche M, et al. Adherence to pharmacological thromboprophylaxis orders in hospitalized patients. Am J Med. 2010;123:536–541.
  • Cohen AT, Harrington RA, Goldhaber SZ, et al. Extended thromboprophylaxis with betrixaban in acutely ill medical patients. N Engl J Med. 2016;375:534–544.
  • Cohen AT, Harrington R, Goldhaber SZ, et al. The design and rationale for the acute medically ill venous thromboembolism prevention with extended duration betrixaban (APEX) study. Am Heart J. 2014;167:335–341.
  • FDA. Guidance for industry: enrichment strategies for clinical trials to support approval of human drugs and biological products. Silver Spring, MD: U.S. Department of Health and Human Services; 2012.
  • Chan NC, Bhagirath V, Eikelboom JW. Profile of betrixaban and its potential in the prevention and treatment of venous thromboembolism. Vasc Health Risk Manag. 2015;11:343–351.
  • Gibson CM, Halaby R, Korjian S, et al. The safety and efficacy of full- versus reduced-dose betrixaban in the acute medically ill VTE (venous thromboembolism) prevention with extended-duration betrixaban (APEX) trial. Am Heart J. 2017;185:93–100.
  • Turpie AG, Bauer KA, Davidson BL, et al. A randomized evaluation of betrixaban, an oral factor Xa inhibitor, for prevention of thromboembolic events after total knee replacement (EXPERT). Thromb Haemost. 2009;101:68–76.
  • Connolly SJ, Eikelboom J, Dorian P, et al. Betrixaban compared with warfarin in patients with atrial fibrillation: results of a phase 2, randomized, dose-ranging study (Explore-Xa). Eur Heart J. 2013;34:1498–1505.
  • Zhang P, Huang W, Wang L, et al. Discovery of betrixaban (PRT054021), N-(5-chloropyridin-2-yl)-2-(4-(N,N-dimethylcarbamimidoyl)benzamido)-5-methoxybenz amide, a highly potent, selective, and orally efficacious factor Xa inhibitor. Bioorg Med Chem Lett. 2009;19:2179–2185.
  • Gibson CM, Nafee T, Yee MK, et al. Symptomatic event reduction with extended-duration betrixaban in acute medically ill hospitalized patients. Am Heart J. 2018;198:84–90.
  • Gibson CM, Goldhaber SZ, Cohen AT, et al. When academic research organizations and clinical research organizations disagree: Processes to minimize discrepancies prior to unblinding of randomized trials. Am Heart J. 2017;189:1–8.
  • Gibson CM, Chi G, Halaby R, et al. Extended-duration betrixaban reduces the risk of stroke versus standard-dose enoxaparin among hospitalized medically ill patients: an APEX trial substudy (acute medically ill venous thromboembolism prevention with extended duration betrixaban). Circulation. 2017;135:648–655.
  • Gibson CM, Korjian S, Chi G, et al. Comparison of fatal or irrever-sible events with extended-duration betrixaban versus standard 540dose enoxaparin in acutely ill medical patients: an APEX trial substudy. J Am Heart Assoc. 2016;6(7):e006015
  • Chi G, Yee MK, Amin AN, et al. Extended-duration betrixaban reduces the risk of rehospitalization associated with venous thromboembolism among acutely ill hospitalized medical patients: findings From the APEX trial (acute medically ill venous thromboembolism prevention with extended duration betrixaban trial). Circulation. 2018;137:91–94.
  • Morganroth J, Gretler DD, Hollenbach SJ, et al. Absence of QTc prolongation with betrixaban: a randomized, double-blind, placebo- and positive-controlled thorough ECG study. Expert Opin Pharmacother. 2013;14:5–13.
  • Cohen AT, Alikhan R, Arcelus JI, et al. Assessment of venous thromboembolism risk and the benefits of thromboprophylaxis in medical patients. Thromb Haemost. 2005;94:750–759.
  • Raskob GE, Spyropoulos AC, Zrubek J, et al. The MARINER trial of rivaroxaban after hospital discharge for medical patients at high risk of VTE. Design, rationale, and clinical implications. Thromb Haemost. 2016;115:1240–1248.
  • Kearon C, Akl EA, Ornelas J, et al. Antithrombotic therapy for VTE disease: CHEST guideline and expert panel report. Chest. 2016;149:315–352.
  • Righini M, Galanaud JP, Guenneguez H, et al. Anticoagulant therapy for symptomatic calf deep vein thrombosis (CACTUS): a randomised, double-blind, placebo-controlled trial. Lancet Haematol. 2016;3:e556–e562.
  • Barbar S, Noventa F, Rossetto V, et al. A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism: the padua prediction score. J Thromb Haemost. 2010;8:2450–2457.
  • Palareti G. How I treat isolated distal deep vein thrombosis (IDDVT). Blood. 2014;123:1802–1809.
  • Anderson DR, Dunbar M, Murnaghan J, et al. Aspirin or rivaroxaban for VTE prophylaxis after hip or knee arthroplasty. N Engl J Med. 2018;378:699–707.
  • Eikelboom JW, Connolly SJ, Bosch J, et al. Rivaroxaban with or without aspirin in stable cardiovascular disease. N Engl J Med. 2017;377:1319–1330.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.