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.

Details

Serval ID
serval:BIB_812C1F7F28B7
Type
Article: article from journal or magazin.
Collection
Publications
Title
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.
Journal
Thrombosis and Haemostasis
Author(s)
Laporte S., Chapelle C., Bertoletti L., Lega J.C., Cucherat M., Zufferey P.J., Darmon J.Y., Mismetti P.
Working group(s)
META-EMBOL Group
ISSN
0340-6245 (Print)
ISSN-L
0340-6245
Publication state
Published
Issued date
2014
Volume
112
Number
3
Pages
503-510
Language
english
Notes
Publication types: Comparative Study ; Journal Article ; Meta-Analysis ; Research Support, Non-U.S. Gov'tPublication Status: ppublish
Abstract
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.
Keywords
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
Create date
23/12/2015 15:26
Last modification date
20/08/2019 15:41
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