Thromboprophylaxis with dabigatran etexilate in patients over seventy-five years of age with moderate renal impairment undergoing or knee replacement
- Ola E. DahlAffiliated withDepartment of Orthopaedics, Elverum Central HospitalThrombosis Research Institute Email author
- , Andreas A. KurthAffiliated withOrthopaedic University Hospital Mainz
- , Nadia RosencherAffiliated withDepartment of Anaesthesiology and Intensive Care, Paris Descartes University, Cochin Hospital (AP HP)
- , Herbert NoackAffiliated withMedical Data Services, Boehringer Ingelheim Pharma GmbH & Co. KG
- , Andreas ClemensAffiliated withDepartment of Medical Affairs, Boehringer Ingelheim GmbH
- , Bengt I. ErikssonAffiliated withDepartment of Orthopaedic Surgery, University Hospital Sahlgrenska/Östra
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Prospective, double-blind studies in orthopaedic patients have been conducted using the direct thrombin inhibitor dabigatran etexilate (hereafter referred to as dabigatran), with two doses investigated and approved for adults (220 mg and 150 mg once daily) to prevent venous thromboembolism (VTE). The European Medicines Agency decided that in major joint orthopaedic surgery, the lower dose should be used in elderly patients (aged over 75 years) and those with reduced renal function (creatinine clearance between 30 and 50 ml/min). Our objective was to understand the efficacy and bleeding data for the lower dose in this subpopulation.
We extracted and analysed data from the elderly or from moderately renally impaired patients (n 632 of = 5,539) from the orthopaedic clinical development programme of dabigatran.
Dabigatran 150 mg once daily was as effective as the standard European enoxaparin regimen, with numerically fewer major bleeding events. Rates of major VTE were 4.3% vs 6.4% of patients, respectively. Major bleeding events occurred in four (1.3%) vs 11 (3.3%), which shows a trend towards lower bleeding with dabigatran 150 mg [odds ratio (OR) 0.40; 95% confidence interval (CI) 0.13–1.25; p = 0.110]. Mean volume of blood loss was 395 vs 417 ml, and transfused units were 2.4 vs 2.5, respectively. Other safety parameters, including the incidence of wound infections and complications, were similar for 150 mg once daily dabigatran and enoxaparin.
For patients at higher risk of bleeding, dabigatran 150 mg once daily is as effective as enoxaparin following major orthopaedic surgery and is associated with a favourable bleeding rate.
- Thromboprophylaxis with dabigatran etexilate in patients over seventy-five years of age with moderate renal impairment undergoing or knee replacement
Volume 36, Issue 4 , pp 741-748
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- 1. Department of Orthopaedics, Elverum Central Hospital, Kirkevn 7, 2418, Elverum, Norway
- 2. Thrombosis Research Institute, 1 Manresa Road, London, SW3 6LR, UK
- 3. Orthopaedic University Hospital Mainz, Langenbeckstr. 1, 55131, Mainz, Germany
- 4. Department of Anaesthesiology and Intensive Care, Paris Descartes University, Cochin Hospital (AP HP), rue du Faubourg Saint-Jacques, 75014, Paris, France
- 5. Medical Data Services, Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Strasse 173, 55216, Ingelheim am Rhein, Germany
- 6. Department of Medical Affairs, Boehringer Ingelheim GmbH, Binger Strasse 173, 55216, Ingelheim am Rhein, Germany
- 7. Department of Orthopaedic Surgery, University Hospital Sahlgrenska/Östra, Smorslottsgatan 1, 41685, Gothenburg, Sweden