Dabigatran etexilate has favourable safety profile in children
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Dabigatran etexilate has favourable safety profile in children Dabigatran etexilate has a favourable safety profile for the prevention of secondary venous thromboembolism (VTE) in paediatric patients, according to findings of a Boehringer Ingelheim-funded study published in Blood. This multinational open-label phase III safety study enrolled infants (aged 3–23 months), children (2–11 years) and adolescents (12–17 years) who had been diagnosed with VTE and received standard of care (SoC) for at least 3 months, or had received dabigatran or SoC in the DIVERSITY trial, and had one or more VTE risk factors requiring anticoagulation. Prophylactic dabigatran was administered for 12 months or until the risk factors for VTE resolved. In total, 203 patients received dabigatran for up to 57 (median 36.3) weeks. On-treatment VTE recurrence was reported in 1.0% of patients, and 1.5%, 1.0% and 18.2% of patients experienced major bleeding, clinicallyrelevant non-major bleeding, and minor bleeding, respectively. No deaths were reported during treatment with dabigatran. Postthrombotic syndrome was reported in 1.2% of patients whose most recent VTE event was deep vein thrombosis or central line thrombosis. Overall, drugrelated adverse events (AEs) were reported in 21.2% of patients and serious AEs were reported in 12.3%. The most frequently reported drug-related AEs were dyspepsia (4.4%), abdominal pain (3.4%), epistaxis (3.4%), nausea (3.4%), headache (1.5%), diarrhoea (1.0%) and vomiting (1.0%). "In conclusion, this trial has shown favorable safety of pediatric formulations of dabigatran for secondary prevention of VTE in children aged from >3 months to 3 months to
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