Large Real-World Data Confirm Safety and Effectiveness of LIXIANA® (edoxaban) in Routine Clinical Practice for Elderly AF Patients with Comorbidities

Munich (ots/PRNewswire) - · Results published in the European Heart Journal -
Cardiovascular Pharmacotherapy (https://academic.oup.com/ehjcvp/advance-article-
abstract/doi/10.1093/ehjcvp/pvz070/5644339?redirectedFrom=fulltext), showed
rates of thromboembolism similar to those observed in the ENGAGE AF-TIMI 48
clinical trial[1]

· Study reports LIXIANA outcomes from one of the largest observational studies
in mainly Caucasian AF patients[1]

· Many patients were elderly with comorbidities and almost one-fourth (23.5%)
had a hospital diagnosis of cancer[1]

· These real-world findings reinforce LIXIANA's effectiveness and safety in
elderly AF patients in routine clinical practice[1]

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 (https://academic.oup.com/ehjcvp/
advance-article-abstract/doi/10.1093/ehjcvp/pvz070/5644339?redirectedFrom=fullte
xt), 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.[1]

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.[1]

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.[1]

The safety outcomes, comprised of a composite of all bleedings, including
intracranial, gastrointestinal and major bleeding in other anatomic sites,
occurred 89 times.[1] 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.[1]

Gastrointestinal bleeding occurred <10 times and intracranial bleeding occurred
<12 times among the total cohort.[1] The remaining bleeds (74 major) were in
other anatomical locations.[1] 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).[1]

"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.

Forward-looking statements

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.

References

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

Additional content: https://www.presseportal.de/pm/62920/4472361
OTS: Daiichi Sankyo Europe GmbH

Original-Content von: Daiichi Sankyo Europe GmbH, übermittelt durch news aktuell