Switching from enoxaparin to dabigatran etexilate: Pharmacokinetics, pharmacodynamics, and safety profile

European Journal of Clinical Pharmacology

Volumn 68, Issue 5, 2012, Pages 607-616

  Clemens, Andreas ^a   Van Ryn, Joanne ^a   Sennewald, Regina ^a   Yamamura, Norio ^a   Stangier, Joachim ^a   Feuring, Martin ^a   Härtter, Sebastian ^a  

^a BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG   (Germany)

Author keywords

Dabigatran etexilate; Enoxaparin; Pharmacodynamics; Pharmacokinetics; Switch

Indexed keywords

BLOOD CLOTTING FACTOR 10A; DABIGATRAN ETEXILATE; ECARIN; ENOXAPARIN; LIVER ENZYME;

ADULT; ANTICOAGULATION; AREA UNDER THE CURVE; ARTICLE; BACKACHE; BLOOD CLOTTING TEST; BLOOD CLOTTING TIME; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIARRHEA; DISEASE SEVERITY; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG ERUPTION; DRUG HALF LIFE; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG SUBSTITUTION; DRUG TOLERABILITY; DRUG WITHDRAWAL; EPISTAXIS; FATIGUE; FEMALE; HEMATOMA; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HUMAN EXPERIMENT; MALE; MAXIMUM PLASMA CONCENTRATION; NORMAL HUMAN; OPEN STUDY; PARTIAL THROMBOPLASTIN TIME; PHARMACODYNAMICS; PHARMACOKINETICS; PLASMA CONCENTRATION-TIME CURVE; PRIORITY JOURNAL; SIDE EFFECT; SINGLE DRUG DOSE; TANDEM MASS SPECTROMETRY; THROMBIN TIME; TREATMENT DURATION; VOLUNTEER;

ADULT; ANTICOAGULANTS; ANTITHROMBINS; BENZIMIDAZOLES; BIOLOGICAL AVAILABILITY; BLOOD COAGULATION; CROSS-OVER STUDIES; DRUG INTERACTIONS; DRUG MONITORING; ENOXAPARIN; FEASIBILITY STUDIES; FEMALE; HALF-LIFE; HUMANS; MALE; MIDDLE AGED; PYRIDINES;

EID: 84864283770     PISSN: 00316970     EISSN: 14321041     Source Type: Journal    
DOI: 10.1007/s00228-011-1205-2     Document Type: Article

References (22)

1. Geerts WH, Bergqvist D, Pineo GF, Heit JA, Samama CM, Lassen MR, Colwell CW, American College of Chest Physicians (2008) Prevention of venous thromboembolism: American College of Chest Physicians evidence-based clinical practice guidelines (8th edition). Chest 133:429S-433S
2. Randelli F, Biggi F, Della Rocca G, Grossi P, Imberti D, Landolfi R, Palareti G, Prisco D (2011) Italian intersociety consensus statement on antithrombotic prophylaxis in hip and knee replacement and in femoral neck fracture surgery. J Orthop Traumatol 12:69-76
3. Scottish Intercollegiate Guidelines Network (SIGN) (2010) Prevention and management of venous thromboembolism. A national clinical guideline. Available at: http://www.sign.ac.uk/pdf/sign122.pdf
4. Cardiovascular Disease Educational and Research Trust; Cyprus Cardiovascular Disease Educational and Research Trust; European Venous Forum; International Surgical Thrombosis Forum; International Union of Angiology; Union Internationale de Phlébologie (2006) Prevention and treatment of venous thromboembolism. International Consensus Statement (guidelines according to scientific evidence). Int Angiol 25:101-161
5. Kearon C, Kahn SR, Agnelli A, Raskob GE, Comerota AJ, American College of Chest Physicians (2008) Antithrombotic therapy for venous thromboembolic disease: American College of Chest Physicians evidence-based Clinical practice guidelines (8th edition). Chest 133:454S-545S (Pubitemid 351892971)
6. Torbicki A, Perrier A, Konstantinides S, Agnelli G, Galiè N, Pruszczyk P, Bengel F, Brady AJ, Ferreira D, Janssens U, Klepetko W, Mayer E, Remy-Jardin M, Bassand JP, ESC Committee for Practice Guidelines (CPG) (2008) Guidelines on the diagnosis and management of acute pulmonary embolism: the Task Force for the Diagnosis and Management of Acute Pulmonary Embolism of the European Society of Cardiology (ESC). Eur Heart J 29:2276-2315
7. European Medicines Agency (2011) Pradaxa summary of product characteristics. Available at: http://www.ema.europa.eu/docs/en-GB/document- library/EPAR-Product-Information/human/000829/WC500041059.pdf. Accessed 3 June 2011
8. Boehringer Ingelheim (2010) Pradaxa monograph. Available at: http://www.boehringeringelheim.ca/en/Home/Human-Health/Our-Products/ Product-Monographs/Pradax-pm.pdf, Accessed 11 Mar 2011
9. Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, Pogue J, Reilly PA, Themeles E, Varrone J, Wang S, Alings M, Xavier D, Zhu J, Diaz R, Lewis BS, Darius H, Diener HC, Joyner CD, Wallentin L (2009) Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 361:1139-1151
10. Connolly SJ, Ezekowitz MD, Yusuf S, Reilly PA, Wallentin L; Randomized Evaluation of Long-Term Anticoagulation Therapy Investigators (2010) Newly identified events in the RE-LY trial. N Engl J Med 363:1875-1876
11. Federal Drugs Administration (2010) Pradaxa highlights of prescribing information. Available at: http://www.accessdata.fda.gov/drugsatfda-docs/label/ 2010/022512s000lbl.pdf. Accessed 06 Apr 2011
12. Pharma Times Online (2011) Europe OK for Boehringer's Pradaxa to prevent AF-related strokes. Available at: http://www.pharmatimes.com/article/11-08-05/ Europe-OK-for-Boehringer-s-Pradaxa-to-prevent-AF-related-strokes.aspx. Accessed 11 Aug 2011
13. Blech S, Ebner T, Ludwig-Schwellinger E, Stangier J, Roth W (2008) The metabolism and disposition of the oral direct thrombin inhibitor, dabigatran, in humans. Drug Metab Dispos 36:386-399 (Pubitemid 351185753)
14. van Ryn J, Stangier J, Haertter S, Liesenfeld KH, Wienen W, Feuring M, Clemens A (2010) Dabigatran etexilate - a novel, reversible, oral direct thrombin inhibitor: interpretation of coagulation assays and reversal of anticoagulant activity. Thromb Haemost 103:1116-1127
15. Sanofi-Aventis (2011) Clexane summary of product characteristics. Available at: http://www.sanofi.co.uk/products/Clexane-SPCpdf Accessed 11 Aug 2011
16. Sanofi-Aventis (2011) Lovenox (enoxaparin sodium injection) for subcutaneous and intravenous use. Prescribing information. Available at: http://products.sanofi.us/lovenox/lovenox.html. Accessed 22 Nov 2011
17. RE-COVER Study Group, Schulman S, Kearon C, Kakkar AK, Mismetti P, Schellong S, Eriksson H, Baanstra D, Schnee J, Goldhaber SZ (2009) Dabigatran versus warfarin in the treatment of acute venous thromboembolism. N Engl J Med 361:2342-2352
18. Boehringer Ingelheim (2010) Advisory committee briefing document on dabigatran etexilate. Available at: http://www.fda.gov/downloads/ AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ CardiovascularandRenalDrugsAdvisoryCommittee/UCM226009.pdf Accessed 29 July 2011
19. Olsson SB, Executive Steering Committee of the SPORTIF III Investigators (2003) Stroke prevention with the oral direct thrombin inhibitor ximelagatran compared with warfarin in patients with non-valvular atrial fibrillation (SPORTIF III): randomised controlled trial. Lancet 362:1691-1698 (Pubitemid 37468318)
20. Albers GW, Diener HC, Frison L, Grind M, Nevinson M, Partridge S, Halperin JL, Horrow J, Olsson SB, Petersen P, Vahanian A, SPORTIF Executive Steering Committee for the SPORTIF V Investigators (2005) Ximelagatran vs warfarin for stroke prevention in patients with nonvalvular atrial fibrillation: a randomized trial. JAMA 293:690-698 (Pubitemid 40220342)
21. Schulman S, Wåhlander K, Lundström T, Clason SB, Eriksson H; Investigators THRIVEIII (2003) Secondary prevention of venous thromboembolism with the oral direct thrombin inhibitor ximelagatran. N Engl J Med 349:1713-1721 (Pubitemid 37315008)
22. U.S. National Institute of Health (Clinical Trials.Gov) (2011) Switching drug therapy for the prevention of blood clot formation from enoxaparin to rivaroxaban after orthopedic surgery for either total hip or total knee replacement. Available at: http://clinicaltrials.gov/ct2/show/study/NCT01094886 Accessed 1 Dec 2011