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Daiichi Sankyo's Once-Daily Edoxaban Meets Primary Efficacy Endpoint for Stroke Prevention and Superiority for the Principal Safety Endpoint Compared to Warfarin for Patients with Atrial Fibrillation in a Phase 3 Clinical Trial
Date:11/19/2013

ition patients to open-label anticoagulation at the end of the trial, which resulted in a low and evenly distributed number of events post-discontinuation of study therapy. In the 30 days following the transition, the number of patients experiencing stroke or SEE was the same in all three treatment groups (n=7), while major bleeding occurred in 11 patients in the warfarin group compared to 10 and 18 patients in the edoxaban 60 mg and 30 mg treatment arms, respectively. These results demonstrate that the transition plan was effective in preventing undue risk of excessive stroke / SEE for edoxaban-treated subjects transitioning to a vitamin K antagonist (VKA) or a novel oral anticoagulant.2

About Atrial Fibrillation

Atrial fibrillation (AF) is a condition in which the heartbeat is rapid and irregular, and can potentially lead to a stroke. AF is a common condition, affecting approximately 1-2% of people in developed nations.3 Stroke is the second most common cause of death worldwide, responsible for approximately 6.2 million deaths each year.4 Compared to those without AF, people with the arrhythmia have a 3-5 times higher risk of stroke.3 Strokes due to AF are nearly twice as likely to be fatal than strokes in patients without AF5 and have poorer prognosis than non-AF related strokes with a 50% increased risk of remaining disabled at three months.6

About Edoxaban

Edoxaban is an investigational, oral, once-daily anticoagulant that specifically and reversibly inhibits factor Xa, which is an important factor in the coagulation system that leads to blood clotting.7 The global edoxaban clinical trial program includes two phase 3 clinical trials, Hokusai-VTE8 and ENGAGE AF-TIMI 48 (Effective aNticoaGulation with Factor XA Next GEneration in Atrial Fibrillation)1,2, which are evaluating edoxaban, administered once-daily, for tre
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SOURCE Daiichi Sankyo
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Related medicine technology :

1. Daiichi Sankyos Once-Daily Edoxaban Shows Comparable Efficacy and Superiority for the Principal Safety Endpoint Compared to Warfarin in a Phase 3 Study for the Treatment of Symptomatic VTE and Prevention of its Recurrence
2. Daiichi Sankyo CEO John Gargiulo Elected as National Pharmaceutical Councils Chairman of the Board
3. Daiichi Sankyo ha completato larruolamento dei pazienti per lo studio Hokusai-VTE su Edoxaban, il più ampio trial clinico di fase 3 per il trattamento delle tromboembolie venose ricorrenti
4. Daiichi Sankyo Completes Enrolment in Hokusai - VTE, investigating once-daily Edoxaban in the Largest Single Phase 3 Study for the Treatment and Prevention of Recurrence of VTE
5. Daiichi Sankyo, Inc. Receives FDA Approval to Package Product at New Facility in Bethlehem, PA
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