The pharmacokinetics, pharmacodynamics and tolerability of dabigatran etexilate, a new oral direct thrombin inhibitor, in healthy male subjects
TLDR
The data suggest that dabigatran etexilate is a promising novel oral DTI with predictable PK and PD characteristics and good tolerability, and further investigation of dabig atran e Texilate for the treatment and prophylaxis of patients with arterial and venous thromboembolic disorders, acute coronary syndromes and other medical conditions is warranted.Abstract:
Aims
The novel direct thrombin inhibitor (DTI), dabigatran etexilate (Boehringer Ingelheim Pharma GmbH & Co. KG), shows potential as an oral antithrombotic agent. Two double-blind, randomized trials were undertaken to investigate the pharmacokinetics (PK), pharmacodynamics (PD) and tolerability of orally administered dabigatran etexilate in healthy male subjects.read more
Citations
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Journal ArticleDOI
Dabigatran versus warfarin in patients with atrial fibrillation
Stuart J. Connolly,Michael D. Ezekowitz,John W. Eikelboom,Jonas Oldgren,Amit Parekh,Janice Pogue,Paul A. Reilly,Ellison Themeles,Jeanne Varrone,Susan Wang,Marco Alings,Denis Xavier,Jun Zhu,Rafael Diaz,Basil S. Lewis,Harald Darius,Hans-Christoph Diener,Campbell D. Joyner,Lars Wallentin +18 more
TL;DR: In patients with atrial fibrillation, dabigatran given at a dose of 110 mg was associated with rates of stroke and systemic embolism that were similar to those associated with warfarin, as well as lower rates of major hemorrhage.
Journal ArticleDOI
The 2018 European Heart Rhythm Association Practical Guide on the use of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation.
Jan Steffel,Peter Verhamme,Tatjana S. Potpara,Pierre Albaladejo,M Antz,Lien Desteghe,Karl Georg Haeusler,Jonas Oldgren,Holger Reinecke,Roldan-Schilling,Nigel Rowell,Peter Sinnaeve,Ronan Collins,Alan John Camm,Hein Heidbuchel +14 more
TL;DR: Non-vitamin K antagonist oral anticoagulants (NOACs) are an alternative for vitamin K antagonists (VKAs) to prevent stroke in patients with atrial fibrillation (AF) and have emerged as the preferred choice, particularly in patients newly started on antICOagulation.
Journal ArticleDOI
Dabigatran etexilate - a novel, reversible, oral direct thrombin inhibitor: Interpretation of coagulation assays and reversal of anticoagulant activity
Joanne van Ryn,Joachim Stangier,Sebastian Haertter,Karl-Heinz Liesenfeld,Wolfgang Wienen,Martin Feuring,Andreas Clemens +6 more
TL;DR: Although there is no specific antidote to antagonise the anticoagulant effect of dabigatran, due to its short duration of effect drug discontinuation is usually sufficient to reverse any excessive anticogulant activity.
Journal ArticleDOI
Oral Anticoagulant Therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines
Walter Ageno,Alexander Gallus,Ann K. Wittkowsky,Mark Crowther,Elaine M. Hylek,Gualtiero Palareti +5 more
TL;DR: There is a large amount of evidence on laboratory and clinical characteristics of vitamin K antagonists and a growing body of evidence is becoming available on the first new oral anticoagulant drugs available for clinical use, dabigatran and rivaroxaban.
Journal ArticleDOI
Regional anesthesia in the patient receiving antithrombotic or thrombolytic therapy: American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Third Edition).
Terese T. Horlocker,Denise J. Wedel,John C. Rowlingson,F. Kayser Enneking,Sandra L. Kopp,Honorio T. Benzon,David L. Brown,John A. Heit,Michael F. Mulroy,Richard W. Rosenquist,Michael Tryba,Chun-Su Yuan +11 more
TL;DR: The ASRA consensus statements represent the collective experience of recognized experts in the field of neuraxial anesthesia and anticoagulation and are based on case reports, clinical series, pharmacology, hematology, and risk factors for surgical bleeding.
References
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Oral Anticoagulants: Mechanism of Action, Clinical Effectiveness, and Optimal Therapeutic Range
Jack Hirsh,James E. Dalen,David Anderson,Leon Poller,Henry I. Bussey,Jack Ansell,Daniel Deykin +6 more
TL;DR: The mainstay treatment for atrial fibrillation is Coumadin Aspirin Reinfarction, but the use of aspirin for other reasons is also being considered.
A randomized double-blind trial
Chaim M. Roifman,Harry W. Schroeder,Melvin Berger,Ricardo U. Sorensen,Mark Ballow,Rebecca H. Buckley,Anita T Gewurz,Phillip Korenblat,Gordon Sussman,Georg Lemm +9 more
TL;DR: This study compares safety, toxicity and efficacy of two intravenous immunoglobulin products: a novel formulation, IGIV caprylate/chromatography (IGIV-C; Gamunexk, 10%) and a licensed solvent/detergent- treated product, GamimuneRN, 10% (IG IV-SD).
Journal ArticleDOI
A new oral direct thrombin inhibitor, dabigatran etexilate, compared with enoxaparin for prevention of thromboembolic events following total hip or knee replacement: the BISTRO II randomized trial
Bengt I. Eriksson,Ola E. Dahl,Harry R. Büller,Rohan Hettiarachchi,Nadia Rosencher,Bravo Ml,Lennart Ahnfelt,Piovella F,Joachim Stangier,Peter Kälebo,Paul A. Reilly +10 more
TL;DR: In this paper, a multicenter, parallel-group, double-blind study, 1973 patients undergoing total hip or knee replacement were randomized to 6-10 days of oral Dabigatran etexilate (50, 150,mg twice daily, 300,mg once daily, 225, mg twice daily), starting 1-4 h after surgery, or subcutaneous enoxaparin (40 mg once daily) starting 12 h prior to surgery.
Journal ArticleDOI
Pharmacokinetic profile of the oral direct thrombin inhibitor dabigatran etexilate in healthy volunteers and patients undergoing total hip replacement.
Joachim Stangier,Bengt I. Eriksson,Ola E. Dahl,Lennart Ahnfelt,Gerhard Nehmiz,Hildegard Stähle,Karin Rathgen,Robbyna Svard +7 more
TL;DR: Administration of the dabigatran etexilate capsule with food has no effect on the extent of dabig atran absorption, with a moderate decrease when coadministered with pantoprazole, and these pharmacokinetic characteristics confirm the suitability of this oral solid dosage form for use in future clinical trials.
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