Boehringer Ingelheim announced results from 2 pediatric studies of dabigatran etexilate suggesting a comparable efficacy and safety profile compared with standard of care (SOC). Findings were presented at the International Society on Thrombosis and Haemostasis (ISTH) 2019 Congress in Melbourne, Australia.
The open label, randomized, multicenter, phase 2b/3 DIVERSITY trial 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 efficacy end points included the proportion of children with recurrent VTE, VTE-related death, and thrombus resolution; secondary end points included bleeding events and pharmacokinetic/pharmacodynamic relationships. Results found dabigatran to be non-inferior to SOC with a comparable safety profile.
Additionally, 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 end points 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 “favorable safety results” in children with VTE and persistent thrombosis risk factors.
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,” said Dr Martina Brückmann, Global Head of Clinical Development Cardiovascular, Cardiometabolic Medicine, Boehringer Ingelheim. “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.”
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.
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