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Venous thromboembolic disease in older adults
Published in Wilbert S. Aronow, Jerome L. Fleg, Michael W. Rich, Tresch and Aronow’s Cardiovascular Disease in the Elderly, 2019
Laurie G. Jacobs, Justin B. Kaplan, Ruchi Jain
Edoxaban does not currently have an indication for VTE prophylaxis after orthopedic surgery in the United States, although a growing body of literature is emerging that should make this agent another viable option in the future (49). Betrixaban does not have an indication for thromboprophylaxis in orthopedic surgery patients.
Briefing Therapeutic Approaches in Anticoagulant, Thrombolytic, and Antiplatelet Therapy
Published in Debarshi Kar Mahapatra, Sanjay Kumar Bharti, Medicinal Chemistry with Pharmaceutical Product Development, 2019
Edoxaban was approved in July 2011 in Japan for the prevention of venous thromboembolisms (VTE) following lower-limb orthopedic surgery. It was also approved by the FDA in January 2015 for the prevention of stroke and non-central nervous system systemic embolism. It inhibits free factor Xa and prothrombinase activity and inhibits thrombin-induced platelet aggregation [50]. Portola submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval to market betrixaban for extended-duration prophylaxis of venous thromboembolism (VTE) in acute medically ill patients with risk factors for VTE [51]. Darexaban (YM150) is a direct inhibitor of factor Xa created by Astellas Pharma. The development of darexaban was discontinued in September 2011 [52]. Otamixaban is an experimental injectable anticoagulant direct factor Xa inhibitor that was investigated for the treatment for acute coronary syndrome. In 2013, Sanofi announced that the drug candidate showed poor performance in a Phase III clinical trial [53]. The advantages of the xabans over vitamin K antagonists include no requirement for routine anticoagulation monitoring as well as a fast and reliable onset of action [54–56].
Betrixaban for first-line venous thromboembolism prevention in acute medically ill patients with risk factors for venous thromboembolism
Published in Expert Review of Cardiovascular Therapy, 2018
Tarek Nafee, C. Michael Gibson, Megan K. Yee, Fahad Alkhalfan, Gerald Chi, Ryan Travis, Mahshid Mir, Arzu Kalayci, Mehrian Jafarizade, Aditya Ganti, Syed Hassan Kazmi, Eiman Ghaffarpasand, Anmol Pitliya, Sudarshana Datta, Sadaf Sharfaei, Mahda Alihashemi, Ahmed Elsaiey, Iqra Qamar, Mohamadmostafa Jahansouz, Usama Talib, Farima Kahe, Shaghayegh Habibi, Mohammed Abdelwahed, Feham Tariq, Manpreet Kaur, Ahmed Younes, Sargun S. Walia, Amandeep Singh, Syed Muhammad Dildar, M. Khurram Afzal, Mathieu Kerneis
Subsequent to the publication of the APEX trial primary results, various analyses in special populations of interest were performed (Table 3). The efficacy of betrixaban was assessed according to the administered dose of study drug. Most subjects received the full dose of betrixaban (80 mg), but subjects with severe renal impairment (CrCl <30 mL/min) or those receiving concomitant P-glycoprotein inhibitors received a reduced dose of study drug (40 mg). Commonly used P-glycoprotein inhibitors include Amiodarone, Verapamil, Azole antifungals, and Macrolides. Analysis of outcomes among the mITT population, which is requested by the FDA to minimize the impact of missing data due to absent or incomplete assessment for asymptomatic proximal DVT by compression ultrasound, is also described. Finally, outcomes among high-risk subgroups such as subjects with D-dimer ≥2X ULN or subjects with a history of VTE were explored.
Effectiveness and safety of betrixaban extended prophylaxis for venous thromboembolism compared with standard-duration prophylaxis intervention in acute medically ill patients: a systematic literature review and network meta-analysis
Published in Journal of Medical Economics, 2019
Vicki Laskier, Holly Guy, Mark Fisher, W. Richey Neuman, Iwona Bucior, Alexander T. Cohen, Shijie Ren
The results of the NMA showed a significant reduction in VTE morbidity and mortality with betrixaban compared with LMWH, UFH, and placebo. Reducing VTE events would reduce recurrent VTE morbidity and complications such as CTEPH and PTS, which are very costly to manage and severely impact quality-of-life49,50. This further indicates that extended VTE prophylaxis with betrixaban may lead to prolonged patient health benefits.
The benefit of betrixaban for the extended thromboprophylaxis in acutely ill medical patients
Published in Expert Opinion on Pharmacotherapy, 2019
Daniele Scarpa, Gentian Denas, Luciano Babuin, Vittorio Pengo
Betrixaban, is an oral factor Xa inhibitor, that has been approved by FDA as an alternative to enoxaparin for VTE prophylaxis in low bleeding risk acute medically ill patients. Because of its pharmacological profile, it is suitable to for acutely ill patients given their high risk of renal dysfunction.