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01.12.2016 | Original clinical investigation | Ausgabe 1/2016 Open Access

Thrombosis Journal 1/2016

Dabigatran etexilate for thromboprophylaxis in over 5000 hip or knee replacement patients in a real-world clinical setting

Zeitschrift:
Thrombosis Journal > Ausgabe 1/2016
Autoren:
Nadia Rosencher, Charles M. Samama, Martin Feuring, Martina Brueckmann, Eva Kleine, Andreas Clemens, Simon Frostick
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​s12959-016-0082-4) contains supplementary material, which is available to authorized users.

Competing interests

Nadia Rosencher has received personal fees and fees paid to employing institution from Bayer, Sanofi, GSK, Boehringer Ingelheim, Pfizer and Bristol-Myers Squibb, outside the submitted work. Simon Frostick has received grants from Biomet Inc. and fees paid to employing institution from Boehringer Ingelheim and Biomet Inc, outside the submitted work. Charles M. Samama reports personal fees and nonfinancial support from Boehringer Ingelheim, Bayer and Daichi and personal fees from Bristol-Myers Squibb. Martin Feuring, Martina Brueckmann and Eva Kleine are employees of Boehringer Ingelheim. Andreas Clemens was an employee of Boehringer Ingelheim at the time of the study and is currently a full time employee at Novartis Pharma AG.

Authors’ contributions

All of the authors have contributed to the design of the study or the acquisition, analysis, or interpretation of the data; drafting or reviewing and revising the manuscript content; and approving the final version.

Abstract

Background

Thromboprophylaxis is recommended for patients undergoing total hip or total knee replacement (THR, TKR). An international, open-label, prospective, observational, single-arm study in a routine clinical setting was performed to assess the safety and efficacy of dabigatran etexilate 220 mg once daily in patients undergoing THR or TKR, and in subgroups of patients with potentially increased risk of bleeding or venous thromboembolism (VTE).

Materials and methods

Patients were ≥18 years and required to be eligible to receive dabigatran 220 mg once daily (first dose 110 mg 1–4 h after THR/TKR surgery) according to the European Summary of Product Characteristics. The primary safety and efficacy outcomes were incidence of major bleeding events (MBEs), and the composite incidence of symptomatic VTE events and all-cause mortality, respectively.

Results

In total, 5292 patients (median age 64 years) were enrolled and received dabigatran (2734 THR and 2558 TKR). Median drug exposure was 31 days (THR 34 days; TKR 27 days). Overall incidence of MBEs was 0.72 % (95 % confidence interval [CI] 0.51, 0.98), and this rate was comparable between types of surgery and was not significantly affected by protocol-defined risk factors. The overall incidence of symptomatic VTE and all-cause mortality was 1.04 % (95 % CI 0.78, 1.35); the only significant risk factor was history of VTE events (odds ratio 5.59; 95 % CI 2.53, 11.08). A post-hoc analysis showed that the incidence of MBEs in this observational study was similar to or lower than those reported in previous phase 3 trials.

Conclusions

Results from this observational study of dabigatran etexilate administered to patients undergoing THR or TKR surgery are reassuring and supportive of those obtained in dabigatran phase 3 trials.

Trial registration

ClinicalTrials.gov identifier: NCT00846807.
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