Indirect comparison meta-analysis of two enoxaparin regimens in patients undergoing major orthopaedic surgery. Impact on the interpretation of thromboprophylactic effects of new anticoagulant drugs.

Détails

ID Serval
serval:BIB_812C1F7F28B7
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Titre
Indirect comparison meta-analysis of two enoxaparin regimens in patients undergoing major orthopaedic surgery. Impact on the interpretation of thromboprophylactic effects of new anticoagulant drugs.
Périodique
Thrombosis and Haemostasis
Auteur(s)
Laporte S., Chapelle C., Bertoletti L., Lega J.C., Cucherat M., Zufferey P.J., Darmon J.Y., Mismetti P.
Collaborateur(s)
META-EMBOL Group
ISSN
0340-6245 (Print)
ISSN-L
0340-6245
Statut éditorial
Publié
Date de publication
2014
Volume
112
Numéro
3
Pages
503-510
Langue
anglais
Notes
Publication types: Comparative Study ; Journal Article ; Meta-Analysis ; Research Support, Non-U.S. Gov'tPublication Status: ppublish
Résumé
Two enoxaparin dosage regimens are used as comparators to evaluate new anticoagulants for thromboprophylaxis in patients undergoing major orthopaedic surgery, but so far no satisfactory direct comparison between them has been published. Our objective was to compare the efficacy and safety of enoxaparin 3,000 anti-Xa IU twice daily and enoxaparin 4,000 anti-Xa IU once daily in this clinical setting by indirect comparison meta-analysis, using Bucher's method. We selected randomised controlled trials comparing another anticoagulant, placebo (or no treatment) with either enoxaparin regimen for venous thromboembolism prophylaxis after hip or knee replacement or hip fracture surgery, provided that the second regimen was assessed elsewhere versus the same comparator. Two authors independently evaluated study eligibility, extracted the data, and assessed the risk of bias. The primary efficacy outcome was the incidence of venous thomboembolism. The main safety outcome was the incidence of major bleeding. Overall, 44 randomised comparisons in 56,423 patients were selected, 35 being double-blind (54,117 patients). Compared with enoxaparin 4,000 anti-Xa IU once daily, enoxaparin 3,000 anti-Xa IU twice daily was associated with a reduced risk of venous thromboembolism (relative risk [RR]: 0.53, 95% confidence interval [CI]: 0.40 to 0.69), but an increased risk of major bleeding (RR: 2.01, 95% CI: 1.23 to 3.29). In conclusion, when interpreting the benefit-risk ratio of new anticoagulant drugs versus enoxaparin for thromboprophylaxis after major orthopaedic surgery, the apparently greater efficacy but higher bleeding risk of the twice-daily 3,000 anti-Xa IU enoxaparin regimen compared to the once-daily 4,000 anti-Xa IU regimen should be taken into account.
Mots-clé
Anticoagulants/therapeutic use, Clinical Protocols, Clinical Trials as Topic, Drug Dosage Calculations, Enoxaparin/therapeutic use, Humans, Orthopedic Procedures, Postoperative Complications/drug therapy, Risk Assessment, Thrombosis/etiology, Thrombosis/prevention & control
Pubmed
Web of science
Création de la notice
23/12/2015 14:26
Dernière modification de la notice
20/08/2019 14:41
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