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Dabigatran etexilate is a direct oral anticoagulant that promises to overcome the limitations of standard care for children with venous thrombosis.
(DIVERSITY) is designed to explore the reasonable dose, efficacy and safety of dabiga esters for pediatric patients.
DIVERSITY trial is a randomized, double-blind, open-label parallel group 2b/3 non-shoddy trial conducted in 65 centres in 26 countries.
The efficacy and safety of standard care (low molecular weight heparin, common heparin, vitamin K antagonists or sulfonda heparin) and oral dabiga esters in children under 18 years of age who require at least 3 months of anticoagulant therapy (5-21 days).
study process subjects were divided into the standard group or the Dabiga group by 1:2 and strated according to age .
the main endpoints of compound efficacy were the proportion of children who were completely dissolved by thrombosis, the proportion of children with non-relapsed venous thrombosis, and the death associated with venous thrombosis.
end points include safety and pharmacodynamics-pharmacological relationships.
No bleeding, no recurrence of venous thromboembolism rates from February 18, 2014 to November 14, 2019, a total of 328 children were recruited, of whom 267 were randomly grouped into two groups (90 in the standard group and 177 in the Dabiga group).
exposure time was 85.0 days in the standard group and 84.5 days in the Dabiga group.
the proportion of children in the two groups who met the compound efficacy endpoint was similar (42% vs. 46%, non-inefficient p.lt;0.0001).
treatment, 22 cases (24%) and 38 (22%) of bleeding events were reported in the standard group and the Dabiga group, respectively.
most common adverse reactions were vascular disease (standard group 3% vs D'Abigale group 1%) and gastrointestinal disease (2% vs 3%).
1 death in the standard group during the course of treatment (celiac haemorrhage, considered independent of the study treatment).
, this study shows that the age- and weight-adjusted method of administering dabiga esters is suitable for children under 18 years of age with venous thrombotic embolism.
efficacy of esters is no less effective than standard nursing, and its pharmacodynamics and pharmacodynamics are similar to between adults.
in short, Dabiga esters may be the appropriate alternative to standard care.
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