title: [Dabigatran (Pradaxa): efficacy and safety].
abstract: There is considerable interest in developing new, orally available anticoagulants for the prevention and treatment of thrombotic disorders. In Europe, the low-molecular-weight heparins (LMWHs) are more commonly prescribed for thrombosis prevention, but require parenteral administration, platelets monitoring twice a week during the first month. Furthermore, LMWH are not synthetic. All of these characteristics can be an obstacle to optimal patient care, particularly when outpatient dosing is required after early discharge. New oral anticoagulants that require no monitoring and can be administered in a fixed dose without drug-drug and drug-food interactions would clearly offer practical advantages if shown to be safe and effective. dabigatran étexilate, a new oral, direct thrombin inhibitor, is the prodrug of the active compound dabigatran, which binds reversibly to thrombin with high affinity and specificity. This agent has a rapid onset of action, a predictable and reproducible that permit once-daily dosing. To date, more than 8,000 patients have been studied in clinical trials, and more than 38,000 individuals are enrolled in ongoing trials. Three major prospective, randomized, double-blind non-inferiority trials have compared the efficacy and safety of dabigatran étexilate (150 mg or 220 mg once-daily) starting postoperatively, with subcutaneous enoxaparin, in patients undergoing hip (RE-NOVATE trial) or knee arthroplasty (RE-MOBILIZE and RE-MODEL). Based on these trial results, dabigatran étexilate is approved for use in the European Union and Canada for primary prevention of VTE in patients having undergone elective total hip and knee arthroplasty. Pradaxa is now on the market in France since December 2008.
authors.affiliation: Service d'Anesthésie Réanimation, Hôpital Cochin, 75014 Paris, France. nadia.rosencher@cch.aphp.fr
authors.forename: N
authors.initials: N
authors.lastname: Rosencher
authors.forename: L
authors.initials: L
authors.lastname: Bellamy
mesh_terms: D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D000069604:Dabigatran; D006801:Humans; D011725:Pyridines / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000925:Anticoagulants; D001562:Benzimidazoles; D011725:Pyridines; D000069604:Dabigatran