Real World Data From PREFER in AF Patient Registry Highlights Increased Stroke Risk Among Diabetes Patients in Atrial Fibrillation

MUNICH, August 29, 2016 /PRNewswire/ --

Sub-analysis data from atrial fibrillation patient registry sponsored by Daiichi Sankyo reveals at-risk patient groups and recent trends in disease management^[1],[2]

Not for US media

Daiichi Sankyo Europe GmbH (hereafter, Daiichi Sankyo) today announced data from new sub-analyses of the PREvention oF thromboembolic events-European Registry in Atrial Fibrillation (PREFER in AF) patient registry which reveal at-risk patient groups, current treatment gaps in the management of atrial fibrillation (AF) and trends associated with specific patient characteristics^[1],[2]. The registry provides unique insights on recent developments in AF management across Europe and the current treatment challenges, helping to bolster the body of evidence of AF patient outcomes in a clinical setting. These data are being presented at ESC Congress 2016, August 27-31, in Rome, Italy.

The registry, sponsored by Daiichi Sankyo, informs on AF patient profiles in a real-world clinical context, helping to identify specific at-risk patient groups, including those with co-morbidities that predispose them to thrombotic events. Data from the registry reveals that AF patients with diabetes, on insulin treatment are at a significantly increased risk of stroke/systemic embolism at one year follow-up compared to AF patients without diabetes (5.2% versus 1.9% respectively; Hazard Ratio [HR] 2.89, 95% Confidence Interval [CI] 1.67-5.02; P=0.0002) and compared to those with diabetes not on insulin treatment (5.2% versus 1.8% respectively; HR 2.96, 1.49-5.87; P=0.0019)^[1]. Interestingly, diabetic patients not receiving insulin therapy had similar incidence of thromboembolic events than patients without diabetes (HR 0.97, 0.58-1.61; P=0.9)^[1].

"These results are greatly beneficial to physicians in clinical practice," commented Dr. Giuseppe Patti, Campus Bio-Medico University, Rome, Italy and lead author of the study. "The burden of AF is a considerable healthcare issue which carries a heightened risk of stroke for over six million sufferers in Europe. The availability of robust, real-world data to inform on patients at even greater risk of stroke or systemic embolism, will help identify where specific care is needed to minimise these outcomes."

Through comprehensive data capture, the registry has also enabled a comparison of specific patient characteristics such as gender alongside clinical aspects including therapy choice and clinical outcomes. The registry has revealed that women experience a greater burden of symptoms compared to men and that treatment with oral anticoagulation is similar in both genders^[2]. Compared to men, women were found to be at 65% lower age and country-adjusted risk of coronary revascularisation at one year (95% CI [0.22, 0.56]), 40% lower risk of acute coronary syndrome (0.38 to 0.93) and 20% lower risk of chronic heart insufficiency/reduced left ventricular ejection fraction (0.68, 0.96)^[2]. There was no evidence that men and women differed in stroke, transient ischaemic attack, arterial thromboembolic events and major bleeding events over one year^[2]. While the results provide an indication of gender differences, further research is needed to establish whether this can be used to enhance AF management, determining prevention and treatment needs.

"AF represents a significant concern across Europe, and we are pleased that the PREFER in AF registry sheds light on the current management of AF in a clinical setting, through delivery of this additional sub-study data," stated Dr. Juan-Carlos Jaramillo, Senior Vice President, Head of Market Access & Medical Affairs, Daiichi Sankyo Europe GmbH. "By adding to the data available in this important disease area, Daiichi Sankyo is committed to supporting advancement in cardiovascular medicine and improvements in patient care."

Providing new insights into AF management, six abstracts from the PREFER in AF and PREFER in AF Prolongation registries are being presented throughout the course of ESC Congress 2016.

About PREFER in AF   

The initial PREFER in AF registry enrolled 7,243 AF patients across 461 centres in Austria, France, Germany, Italy, Spain, Switzerland and the UK. The aim of this registry was to provide information on the characteristics and management of patients with AF with focus on prevention of thromboembolic events, specifically stroke, together with other important patient-focused considerations such as management, quality of life and treatment satisfaction of patients with AF^[3].

The PREFER in AF Prolongation registry was designed to extend the PREFER in AF registry to gain further insights on AF management. Also, the extension to the PREFER in AF registry includes two additional countries (Belgium and the Netherlands). Data was collected from 5,000 patients across 325 centres in the nine European countries)^[4].

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^[5].

AF is the most common type of heart rhythm disorder, and is associated with substantial morbidity and mortality^[6]. Over six million Europeans suffer from AF and this figure is expected to at least double over the next 50 years^[7]. Compared to those without AF, people with the arrhythmia have a 3-5 times higher risk of stroke^[8]. One in five of all strokes are a result of AF^[7].

Daiichi Sankyo in Antithrombosis  

Daiichi Sankyo is your partner in antithrombotic therapy with the discovery and development of innovative products, to help patients with a wide range of cardiovascular conditions. These include Efient^® (prasugrel) for acute coronary syndromes and LIXIANA^® (edoxaban) for non-valvular atrial fibrillation, deep vein thrombosis and pulmonary embolism. Daiichi Sankyo's ongoing commitment in this field is demonstrated by their continued investment into patient-relevant clinical development activities that aim to advance the care and improve the lives of people suffering with these diseases. For more information, please visit: http://www.daiichisankyo.eu.

About Daiichi Sankyo   

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address diversified, unmet medical needs of patients in both mature and emerging markets. With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 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 hypertension and thrombotic disorders, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases. For more information, please visit: http://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. Ricottini E et al. Insulin-requiring versus non-insulin requiring diabetes and thromboembolic risk in patients with atrial fibrillation: a PREFER in AF Registry substudy. [Abstract accepted for presentation at ESC Congress 2016].  
2. Schnabel RB et al. Gender differences in clinical Presentation and predictors of one-year outcomes in atrial fibrillation. [Abstract accepted for presentation at ESC Congress 2016].
3. Kirchhof P, et al. Management of atrial fibrillation in seven European countries after the publication of the 2010 ESC Guidelines on atrial fibrillation: primary results of the PREvention oF thromboembolic events - European Registry in Atrial Fibrillation (PREFER in AF). Europace 2013. doi: 10.1093/europace/eut263.  
4. PREFER in AF Prolongation Registry. European Multinational Prolongation Registry on Prevention of Thromboembolic Events in Atrial Fibrillation. DSE-EAF-01-13. Data on file.
5. National Heart, Lung and Blood Institute - What is Atrial Fibrillation. Available at: http://www.nhlbi.nih.gov/health/dci/Diseases/af/af_diagnosis.html. Last accessed: July 2016.
6. Iqbal MB, et al. Recent developments in atrial fibrillation. BMJ. 2005;330(7485):238-43.
7. Camm, A. et al. ESC Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation. Eur Heart J. 2010;31(19):2369-2429.  
8. Ball J, et al. Atrial fibrillation: Profile and burden of an evolving epidemic in the 21st century. Int J Card. 2013;167:1807-1824.

EDX/16/0183
August 2016

Contact
Lydia Worms (Europe)
Daiichi Sankyo Europe GmbH
Edoxaban Communications & Product PR Europe
+49-(89)-7808751

SOURCE Daiichi Sankyo Company, Limited