Newly published phase III data on Lixiana (edoxaban) shows efficacy in VTE- Daiichi Sankyo

Daiichi Sankyo has announced data from a new analysis of the phase III Hokusai-VTE study, which showed that a reduced dose of Lixiana (edoxaban, once-daily 30 mg) was as effective and well-tolerated in preventing recurrent VTE episodes as the standard 60 mg edoxaban treatment regimen, and safer than warfarin in preventing bleeding events in patients meeting the criteria for dose reduction. Hokusai-VTE, the largest single comparative trial of a NOAC in patients with VTE to date, was a randomised, double-blind trial of 8,292 patients with acute VTE.

This new analysis, published in the peer-reviewed journal Thrombosis and Haemostasis, found that the reduced edoxaban 30 mg dose resulted in lower blood levels of edoxaban, but preserved efficacy against recurrent VTE in dose reduced patients compared to patients that received the full 60 mg edoxaban dose. Dose reduced patients also had fewer clinically relevant bleeds, a key adverse event, compared to similar patients taking warfarin (7.9% vs 12.8%).

See: "Dose reduction of edoxaban preserves efficacy and safety for the treatment of venous thromboembolism. Verhamme P et al. Thromb Haemost 2016; 116. Epub ahead of publication.