Delhi: Dabigatran etexilate (Pradaxa) is equally safe and effective as the standard of care (low molecular weight heparin or vitamin K antagonist) for the treatment of acute venous thromboembolism (VTE) in children, announced the pharmaceutical company Boehringer Ingelheim.


Findings from the two paediatric studies of dabigatran etexilate were presented at the International Society on Thrombosis and Haemostasis (ISTH) 2019 Congress in Melbourne, Australia.


There are several constraints to the current SOC treatment for the prevention and treatment of VTE in kids including non-oral means of administration and need for frequent monitoring.


The aim of these new dabigatran studies was to provide additional insight and knowledge on anticoagulation in paediatric patients with VTE, or at risk of recurrent VTE.


Although treatments are currently available to help manage VTE, there is still a need for effective, safe and more convenient options that have been investigated in children," Dr Martina Brückmann, Global Head of Clinical Development Cardiovascular, Cardiometabolic Medicine, Boehringer Ingelheim, said in the company's press release. "It is, therefore, encouraging that these studies suggest a comparable safety profile and efficacy for dabigatran for the potential treatment and prevention of recurrent VTE in children."


Also Read: ASH releases 2018 guidelines for venous thromboembolism

Diversity Trial


The DIVERSITY trial is an open-label, randomized, multicenter, phase 2b/3 that evaluated the efficacy and safety of dabigatran compared with SOC (low molecular weight heparin or vitamin K antagonist) in 240 children aged from birth to <18 years with acute venous thromboembolism (VTE) requiring treatment for 3 months.


The combined efficacy endpoint was the proportion of children with recurrent VTE, VTE-related death, and thrombus resolution. The secondary endpoints included safety as determined by bleeding events and pharmacokinetic/pharmacodynamic relationships.


Results found dabigatran to be non-inferior to SOC with a comparable safety profile.


Secondary VTE prevention study


This was an open-label, single-arm, prospective cohort, phase 3 trial evaluated the safety of dabigatran for secondary VTE prevention in approximately 200 children for up to 12 months.


The primary endpoints included VTE recurrence, bleeding events, and mortality at 6 and 12 months.


Results showed the overall frequency of recurrent VTE and any major bleeding event to be low. According to study authors, dabigatran demonstrated "favourable safety results" in children with VTE and persistent thrombosis risk factors.


Also Read: Depression and antidepressants may increase risk of venous thromboembolism

About Pradaxa


Currently, Pradaxa is approved in adults to reduce the risk of stroke and systemic embolism in non-valvular atrial fibrillation (AF); for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients treated with parenteral anticoagulant for 5 to 10 days; to reduce the risk of recurrent DVT/PE in patients who have been previously treated; and for prophylaxis of DVT/PE after hip replacement surgery.