18.12.2019 – 09:00
Large Real-World Data Confirm Safety and Effectiveness of LIXIANA® (edoxaban) in Routine Clinical Practice for Elderly AF Patients with Comorbidities
· Results published in the European Heart Journal - Cardiovascular Pharmacotherapy, showed rates of thromboembolism similar to those observed in the ENGAGE AF-TIMI 48 clinical trial
· Study reports LIXIANA outcomes from one of the largest observational studies in mainly Caucasian AF patients
· Many patients were elderly with comorbidities and almost one-fourth (23.5%) had a hospital diagnosis of cancer
· These real-world findings reinforce LIXIANA's effectiveness and safety in elderly AF patients in routine clinical practice
Daiichi Sankyo Europe GmbH (hereafter, "Daiichi Sankyo") today announced outcomes from one of the largest observational studies in mainly Caucasian atrial fibrillation (AF) patients being treated with LIXIANA® (edoxaban). The results of the Danish observational cohort study, published in the European Heart Journal - Cardiovascular Pharmacotherapy, showed that rates of thromboembolism (ischemic stroke and systemic embolism) were similar to those observed in the composite 'stroke' outcome in the ENGAGE AF-TIMI 48 clinical trial, a study that compared the long-term efficacy and safety of LIXIANA with warfarin in AF patients. In addition, primary (composite) bleeding outcomes requiring hospitalisation were approximately 50% lower than observed in ENGAGE AF-TIMI 48.1 The real-world findings reinforce LIXIANA's efficacy and safety profile in elderly AF patients in routine clinical practice.1
Many patients were elderly with comorbidities and almost one-fourth (23.5%) had a hospital diagnosis of cancer.
Commenting on the study, lead author, Assoc. Professor Peter Brønnum Nielsen, Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Faculty of Health, Aalborg University, Denmark, said: "These new data, reporting on outcomes in a European AF population seen in routine clinical practice, are reassuring as they reinforce previous evidence that edoxaban has a good safety profile and is an effective treatment for the prevention of stroke in a broad AF population."
643 patients (28 %) received LIXIANA 30 mg dosage regimen and 1,642 (72 %) LIXIANA 60 mg which is similar to the split in ENGAGE AF-TIMI 48.
The primary effectiveness endpoint of thromboembolism, comprised of a composite outcome of stroke and systemic embolism, occurred 41 times. In patients taking LIXIANA 30 mg daily (dose reduced) the event rate was 2.07 per 100 person-years, and in those taking LIXIANA 60 mg daily (full dose) the event rate was 1.62 per 100 person-years.
The safety outcomes, comprised of a composite of all bleedings, including intracranial, gastrointestinal and major bleeding in other anatomic sites, occurred 89 times. Safety outcome event rates were similar among the full dose and dose reduced groups, with rates of 3.87 and 3.85 per 100 person-years respectively.
Gastrointestinal bleeding occurred <10 times and intracranial bleeding occurred <12 times among the total cohort. The remaining bleeds (74 major) were in other anatomical locations. In addition, 40 of the total bleeds required hospitalisation (1.74 per 100 person-years in the dose reduced group and 1.69 in the full dose group).
"Real-world data, such as these, provide us with a greater understanding of AF treatment pathways and broaden our insight into the patient population," said Wolfgang Zierhut, MD, Executive Director Medical Affairs and Head Thrombosis and Cardiovascular at Daiichi Sankyo Europe. "We are committed to adding to the growing body of evidence on the use of edoxaban through real-world data, particularly in the underserved elderly population."
About the Danish Registry: https://www.daiichi-sankyo.eu/danish-registry
About Atrial Fibrillation: https://www.daiichi-sankyo.eu/danish-registry
About Edoxaban: https://www.daiichi-sankyo.eu/danish-registry
About Daiichi Sankyo
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. For more information, please visit: www.daiichisankyo.com.
This press release contains forward-looking statements and information about future developments in the sector, and the legal and business conditions of DAIICHI SANKYO Co., Ltd. Such forward-looking statements are uncertain and are subject at all times to the risks of change, particularly to the usual risks faced by a global pharmaceutical company, including the impact of the prices for products and raw materials, medication safety, changes in exchange rates, government regulations, employee relations, taxes, political instability and terrorism as well as the results of independent demands and governmental inquiries that affect the affairs of the company. All forward-looking statements contained in this release hold true as of the date of publication. They do not represent any guarantee of future performance. Actual events and developments could differ materially from the forward-looking statements that are explicitly expressed or implied in these statements. DAIICHI SANKYO Co., Ltd. assume no responsibility for the updating of such forward-looking statements about future developments of the sector, legal and business conditions and the company.
1. Peter Brønnum Nielsen, Torben Bjerregaard Larsen, Flemming Skjøth et al. Effectiveness and safety of edoxaban in patients with atrial fibrillation: data from the Danish nationwide cohort. European Heart Journal - Cardiovascular Pharmacotherapy (2019) doi: 10.1093/ehjcvp/pvz070. Published by Oxford University Press on behalf of the European Society of Cardiology.
Date of preparation: December 2019
Job Code: EDX/19/1129
Contact Lydia Worms (Europe) Daiichi Sankyo Europe GmbH Edoxaban Communications & Product PR Europe +49-(89)-7808751
Original content of: Daiichi Sankyo Europe GmbH, transmitted by news aktuell