New Analysis Shows Maintained Efficacy and Safety of LIXIANA®▼ (edoxaban) in Patients with Acute VTE Requiring a Reduced Dose Based on Clinical Criteria

MUNICH, September 30, 2016 /PRNewswire/ --

Results highlight the benefits of reduced dose edoxaban compared to warfarin in a

potentially higher risk venous thromboembolism (VTE) patient population[1]

Daiichi Sankyo Europe GmbH (hereafter Daiichi Sankyo) today announced data from a new analysis of the phase 3 Hokusai-VTE study, which showed that a reduced dose of LIXIANA(R)  (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.[1],[2]

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.[2] In the Hokusai-VTE trial, patients with a creatinine clearance of 30-50 ml/minute, body weight less than or equal to 60 kg or receiving certain P-glycoprotein inhibitors were given a reduced dose of 30 mg edoxaban once- daily. Of those patients that qualified for dose reduction, 733 were randomised to receive the reduced 30 mg edoxaban dose and 719 received a matching dose of warfarin.[1] Patients receiving standard treatment regimens, 3,385 were treated with 60 mg edoxaban and 3,403 treated with warfarin, adjusted to maintain the international normalised ratio between 2.0 and 3.0.[1]

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 (Hazard Ratio [HR]=0.96; 95 % Confidence Interval [CI]: 0.61-1.52).[1] Dose reduced patients also had fewer clinically relevant bleeds, a key adverse event, compared to similar patients taking warfarin (7.9% vs 12.8% HR=0.62; 95 % CI: 0.44-0.86; p

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