Early experience of the introduction of dabigatran etexilate into clinical practice

Abstract

This paper reviews the lessons learnt from the experience gained at Jaén Hospital, Spain, in the RE-MODEL™ and RE-NOVATE® trials with the oral direct thrombin inhibitor dabigatran etexilate, particularly with respect to issues relating to patient selection, dosage and treatment protocols. Dabigatran etexilate has the advantage that it does not require preoperative dosing, in contrast to injectable low-molecular-weight heparins (LMWHs) such as enoxaparin, and treatment should be started within 4 h post-surgery in patients undergoing total hip or total knee replacement. Ideally, protocols should be established to ensure that the first dose is given in the recovery room, and that subsequent doses are given at fixed times each day. If post-operative vomiting occurs, data show that the first dose can be delayed until the following day without decreased efficacy. If a patient has already been started on a LMWH, the switch to dabigatran etexilate can be made safely at the time when the next dose of LMWH would be due. Most patients can receive the standard dose (220 mg once daily), but a lower dose (150 mg once daily) is also available, which is indicated in certain subgroups, such as elderly patients and those with moderate renal impairment. Oral treatment with dabigatran etexilate has been found to be well accepted by both patients and nurses because it eliminates the need for subcutaneous injections while maintaining the efficacy and safety associated with injectable LMWHs such as enoxaparin.