1. ETNA-VTE Europe: Benefits and risks of venous thromboembolism treatment using edoxaban in the first 3 months.
- Author
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Agnelli G, Hoffmann U, Hainaut P, Gaine S, Ay C, Coppens M, Schindewolf M, Jimenez D, Brüggenjürgen B, Levy P, Laeis P, Fronk EM, Zierhut W, Malzer T, Manu MC, Reimitz PE, Bramlage P, and Cohen AT
- Subjects
- Aged, Anticoagulants adverse effects, Europe, Female, Humans, Male, Middle Aged, Prospective Studies, Pyridines, Risk Assessment, Thiazoles, Pulmonary Embolism drug therapy, Venous Thromboembolism drug therapy
- Abstract
Introduction: Edoxaban had a positive risk-benefit ratio for the treatment of venous thromboembolism (VTE) compared to conventional therapy with warfarin. The objective of this analysis of the ongoing ETNA-VTE Europe study was to assess the real-world benefits and risks of edoxaban during the first 3 months of treatment, the highest risk period for further VTE events., Methods: ETNA-VTE Europe is a prospective, non-interventional, post-authorization study, conducted in eight European countries. Participants had initial or recurrent acute VTE (deep vein thrombosis [DVT] and/or pulmonary embolism [PE]) that occurred ≤2 weeks prior to enrolment and received edoxaban therapy., Results: The analysis set included 2672 patients (PE ± DVT, n = 1117; DVT only, n = 1555); mean age 62.9 ± 16.0 years, bodyweight 81.9 ± 17.4 kg, estimated glomerular filtration rate 95.4 ± 42.8 mL/min; 46.4% were female. Overall, 66.4% of patients (PE ± DVT, 68.5%; DVT-only, 64.8%) received heparin lead-in treatment for at least 5 days. Most patients (87.7%) received edoxaban at a dose of 60 mg once daily. Event rates at 3 months were: recurrent VTE 0.34% (n = 9), major bleeding 0.97% (n = 26), all-cause mortality 0.79% (n = 21). Rates were numerically higher in the PE ± DVT group compared with the DVT-only group (recurrent VTE, 0.45% (n = 5) versus 0.26% (n = 4); major bleeding, 1.34% (n = 15) versus 0.71% (n = 11); and all-cause mortality 1.16% (n = 13) versus 0.51% (n = 8))., Conclusions: The results support the safety and effectiveness of edoxaban in a general VTE population during the most critical time period, the first 3 months. The outcomes of this study extend the principal efficacy and safety data on edoxaban into the routine clinical practice setting., (Copyright © 2020. Published by Elsevier Ltd.)
- Published
- 2020
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