Dabigatran is effective with a favourable safety profile in normal and overweight patients undergoing major orthopaedic surgery: A pooled analysis

Bengt I. Eriksson, Ola E. Dahl, Martin Feuring, Andreas Clemens, Herbert Noack, Stefan Hantel, Richard J. Friedman, Michael Huo

Research output: Contribution to journalArticle

12 Scopus citations

Abstract

Introduction: Three pivotal phase 3 trials have demonstrated that oral dabigatran etexilate showed similar safety and efficacy to enoxaparin 40 mg once daily (qd) for venous thromboembolism (VTE) prevention in patients undergoing total knee or hip replacement. Obesity is an established independent risk factor for VTE. Methods: A post-hoc pooled analysis of the three trials was performed to evaluate the safety and efficacy of dabigatran 220 mg qd versus enoxaparin 40 mg qd in patients with a normal body mass index (BMI) of > 20-25 kg/m 2, pre-obese patients (BMI > 25-30 kg/m2) and obese patients (BMI > 30 kg/m2). The primary efficacy endpoint was major VTE and VTE-related mortality; safety endpoints included major, clinically relevant, or any bleeding events. Results: The mean BMIs for patients in the dabigatran and enoxaparin arms from all three trials, separately, were between 27.5 and 29.9 kg/m2. Of the participants, 1417 (24.9%) had a normal BMI, 2373 (41.7%) were pre-obese and 1826 (32.1%) obese. In patients with normal BMI, the rates of the primary efficacy endpoint were significantly lower in the dabigatran than in the enoxaparin group (2.1% versus 4.3%; OR 0.48; 95% CI 0.24-0.97, P = 0.037). No significant difference between dabigatran and enoxaparin in the primary efficacy endpoint was observed in the other subgroups. Bleeding rates were also similar between treatments for BMI subgroups. Conclusions: Dabigatran is an effective thromboprophylactic therapy for normal, pre-obese and obese patients, and outcomes in patients with a BMI > 25 kg/m2 do not differ from the overall population.

Original languageEnglish (US)
Pages (from-to)818-820
Number of pages3
JournalThrombosis research
Volume130
Issue number5
DOIs
StatePublished - Nov 2012

Keywords

  • Body mass index
  • Dabigatran
  • Overweight
  • Total hip replacement
  • Total knee replacement
  • Venous thromboembolism

ASJC Scopus subject areas

  • Hematology

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