Dabigatran Etexilate: A Review of Its Use in the Treatment of Acute Venous Thromboembolism and Prevention of Venous Thromboembolism Recurrence

Abstract

Dabigatran etexilate (Pradaxa(®), Prazaxa(®)) has recently been approved for the treatment of acute venous thromboembolism (VTE) and prevention of VTE recurrence. Dabigatran etexilate is an oral prodrug of dabigatran, a selective, reversible, competitive, direct thrombin inhibitor. Dabigatran etexilate has a wide therapeutic range that allows for fixed-dose administration without the need for routine monitoring, a requirement of standard vitamin K antagonist (VKA) therapy. In randomized phase III trials in patients with acute VTE (RE-COVER and RE-COVER II), long-term treatment with oral dabigatran etexilate 150 mg twice daily for 6 months after initial parenteral anticoagulation was noninferior to dose-adjusted warfarin with regard to the incidence of recurrent symptomatic VTE or related death. In randomized trials of patients with previously treated VTE, extended dabigatran etexilate treatment was noninferior to warfarin (RE-MEDY) and significantly more effective than placebo (RE-SONATE) with regard to the incidence of recurrent VTE or related death. Dabigatran etexilate was generally well tolerated, with a similar incidence of major bleeding to that with warfarin in individual studies (although pooled data showed a significantly lower incidence in patients with acute VTE), and significantly lower incidences of the combined endpoint of major or clinically relevant nonmajor bleeding and of any bleeding than with warfarin. However, in the RE-SONATE trial, dabigatran etexilate was associated with a higher risk of bleeding than placebo. In conclusion, dabigatran etexilate is a valuable treatment option for acute VTE and prevention of VTE recurrence, providing an effective and convenient alternative to standard VKA therapy with the potential for a lower overall rate of bleeding.

Dabigatran inhibits intravitreal thrombin activity

“…It should however still be taken into account that the use of a compound such as dabigatran, with potential side-effects including haemorrhages, should be introduced with great precaution (Cui et al 2014;Greig & McKeage 2014;Graham et al 2015). It should however still be taken into account that the use of a compound such as dabigatran, with potential side-effects including haemorrhages, should be introduced with great precaution (Cui et al 2014;Greig & McKeage 2014;Graham et al 2015).…”

“…Taken together, our data suggest that thrombin inhibition with a DTI such as dabigatran may be an interesting therapeutic option in the prevention of PVR development. It should however still be taken into account that the use of a compound such as dabigatran, with potential side-effects including haemorrhages, should be introduced with great precaution (Cui et al 2014;Greig & McKeage 2014;Graham et al 2015).…”

Novel Oral Anticoagulants for Venous Thromboembolism with Special Emphasis on Risk of Hemorrhagic Complications and Reversal Agents

“…Table 8 describes the dose adjustments of novel anti-
coagulants in some high risk patient populations approved for use in the USA. [1, 10, 12, 38, 39]. The dose adjustments in high risk patients with atrial fibrillation for stroke prevention are different and may not be applicable to patients with VTE due to different therapeutic targets, demographics and co-morbidities.…”

Use of new anticoagulants for the treatment of venous thromboembolism in the context of the results of the XALIA study — clinical trials and routine clinical practice

“…There are also some pooled analyses of results available [15,16]. In the analysis of the results of the phase 3 trials with the use of rivaroxaban (pooled ana lysis: EINSTEIN DVT and PE), the primary effectiveness endpoint was reported in 2.1% of patients in the group receiving rivaroxaban and in 2.3% of patients treated with the standard anticoagulant therapy (major bleedings in 1.0% and 1.7% of patients, respectively) [15].…”