Safety of Low Dose of Edoxaban to Treat Acute and Long Term Treatment of a VTE Occurred in a Very Young Adolescent

Abstract

The treatment of VTE with direct oral anticoagulant (DOACs) is a common treatment and therapeutic regimens and timing of treatment are well documented by international guidelines both for initial therapy and for extended therapy. Suggested doses of each drug are established after dose-findings studies and thereafter after phase III clinical trials. Suggested doses of edoxaban to treat VTE are based on 60 mg daily while other available dosages, in particular 30 mg daily are suggested if patients show impaired renal function with moderate kidney failure, low body weight or concomitant use of P-glycoprotein inhibitor drugs. However, there are not studies concerning the optimal treatment with any DOACs and in particular for edoxaban for patients aged less than 18 years, because in dose findings studies and in phase III trials alle selected subjects were major than 18 years old; these informations are also lacking in the Literature concerning real life studies too (e.g., case reports and so on). So 30 mg daily of edoxaban for patients younger than 18 years may be considered an off label target. Moreover the off label dosage of 30 mg daily of edoxaban to treat juvenile VTE is related not only to young age but also to other clinical characteristics as juvenile metabolism and body weight and BMI, gastrointestinal absorption and renal and liver metabolism. This report may so add useful information for a next future application of this kind of drugs also in young patients affected by VTE.