Daiichi Sankyo to Present Findings From New Subgroup Analyses of Once-Daily LIXIANA®▼ (edoxaban) in NVAF and VTE at ACC'

MUNICH, March 24, 2016 /PRNewswire/ --

- Four abstracts highlight new subgroup analyses from the global phase 3 ENGAGE

AF-TIMI 48 and Hokusai-VTE studies to be presented in oral and poster sessions  

Daiichi Sankyo Europe GmbH Group (hereafter, Daiichi Sankyo) today announced that data from three new subgroup analyses from the phase 3 ENGAGE AF-TIMI 48 study, and one new subgroup analysis from the phase 3 Hokusai-VTE study, will be presented at the American College of Cardiology's 65th Annual Scientific Session, April 2-4, 2016, in Chicago, Illinois. Results will provide new insights into the safety and efficacy profile of once-daily edoxaban compared to warfarin in patients with non-valvular atrial fibrillation (NVAF) and venous thromboembolism (VTE).

The subgroup analysis data on edoxaban (known by the brand name LIXIANA(R)) will be presented. The complete list of presentations is included below:

Presentation Title Presenter Session Details

Oral Session

Outcomes in 2,824 Patients With Giulia Renda, MD, PhD, Monday, April 4,

Valvular Heart Disease Treated G. d'Annunzio 8:30-8:42 AM CDT

With Edoxaban or Warfarin in the University of Location: S405

ENGAGE AF-TIMI 48 Trial (ACC Chieti-Pescara,

Session #915-06) Chieti, Italy

Poster Presentations

Recurrent Venous Marjolein P.A. Sunday, April 3

Thromboembolism Brekelmans, MD 9:45-10:30 AM CDT

in Pulmonary Embolism Patients Department of Location: South

With Right Ventricular Vascular Medicine, Hall A1

Dysfunction in the Hokusai-VTE Academic Medical

Study Netherlands

Sudden Cardiac Death in 21,105 Alon Eisen, MD, Sunday, April 3

Patients With Atrial Brigham and Women's 9:45-10:30 AM CDT

Fibrillation: Insights From the Hospital, Boston, MA, Location: South

ENGAGE AF-TIMI 48 Trial (ACC USA Hall A1

Abstract #1188-338/338)

Moderated Poster Presentation

Edoxaban Versus Warfarin in 841 Jonathan Monday, April 4

Patients With Atrial Fibrillation Cunningham, MD, 12:45-12:55 PM CDT

and Peripheral Arterial Disease: Brigham and Location: South

Insights From the ENGAGE AF-TIMI Women's Hospital, Hall A1

48 Trial (ACC Session #1289M-03) Boston, MA, USA

About the ENGAGE AF-TIMI 48 Study 

The ENGAGE AF-TIMI 48 global phase 3 study investigated once-daily edoxaban in comparison to warfarin in 21,105 patients with NVAF. This represented the largest and longest trial with a novel oral anticoagulant (NOAC) in patients with atrial fibrillation (AF) performed to date, with a median follow-up of 2.8 years. Edoxaban demonstrated non-inferiority for stroke or systemic embolism (SE) in comparison to warfarin. Edoxaban was also found to be superior for the principal safety endpoint of major bleeding in comparison to warfarin.[1]

About the Hokusai-VTE Study 

The Hokusai-VTE global phase 3 study was the largest single comparative trial of a NOAC in patients with VTE, which evaluated once-daily edoxaban versus warfarin in 8,292 patients with either acute symptomatic deep vein thrombosis (DVT), pulmonary embolism (PE) or both. The Hokusai-VTE study was designed to reflect clinical practice using a flexible treatment duration of 3-12 months in a broad spectrum of VTE patients, including initial use of parenteral anticoagulant (heparin) for at least five days, the proven global standard of care. Edoxaban demonstrated non-inferiority to warfarin for the primary efficacy endpoint of recurrence of symptomatic VTE, and was found to be superior in the primary safety endpoint of clinically relevant bleeding compared to warfarin.[2]

About AF 

AF is a condition where the heart beats irregularly and rapidly. When this happens, blood can pool and thicken in the chambers of the heart causing an increased risk of blood clots. These blood clots can break off and travel through the blood stream to the brain (or sometimes to another part of the body), where they have the potential to cause a stroke.[3]

AF is the most common type of heart rhythm disorder, and is associated with substantial morbidity and mortality.[4] More than six million Europeans are diagnosed with AF, and this figure is expected to at least double over the next 50 years.[5],[6] Compared to those without AF, people with the arrhythmia have a 3-5 times higher risk of stroke.[7] One in five of all strokes are as a result of AF.[5]

About VTE 

VTE is an umbrella term for two conditions, DVT and PE. DVT is a disease caused by a blood clot found in deep veins, usually within the lower leg, thigh or pelvis, although they can occur in other parts of the body as well.[8] PE occurs when part of a clot detaches and lodges in the pulmonary arteries, causing a potentially fatal condition.[9]

VTE is a major cause of morbidity and mortality.[10] A 2007 study of morbidity and mortality from VTE in six European countries (France, Germany, Italy, Spain, Sweden and the UK) estimated a total of approximately 762,000 VTE episodes and a further 370,000 VTE-related deaths each year.[10] There is a high rate of recurrence after a first VTE event, which is reduced with anticoagulant treatment. Without anticoagulant treatment, approximately half of patients who experience an initial VTE event have recurrent VTE within three months.[11]

About Edoxaban 

Edoxaban is an oral, once-daily, direct factor Xa (pronounced "Ten A") inhibitor. Factor Xa is one of the key components responsible for blood clotting, so inhibiting this makes the blood thin and less prone to clotting.

Edoxaban received EU approval in June 2015 for the prevention of stroke and SE in adult patients with NVAF with one or more risk factors, such as congestive heart failure, hypertension, age greater than or equal to 75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA), as well as for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. Edoxaban is currently marketed in South Korea, the Netherlands, Ireland, the UK, Germany, Switzerland, the US and Japan, and was approved in Taiwan. In other countries, regulatory review is ongoing.

About Daiichi Sankyo  

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