Daiichi Sankyo Europe GmbH

New Analysis Shows Maintained Efficacy and Safety of LIXIANA® (edoxaban) in Patients with Acute VTE Requiring a Reduced Dose Based on Clinical Criteria

Munich (ots/PRNewswire) - Results highlight the benefits of reduced dose edoxaban compared to warfarin in a potentially higher risk venous thromboembolism (VTE) patient population[1]

Daiichi Sankyo Europe GmbH (hereafter Daiichi Sankyo) today announced data from a new analysis of the phase 3 Hokusai-VTE study, which showed that a reduced dose of LIXIANA® (edoxaban, once-daily 30 mg) was as effective and well-tolerated in preventing recurrent VTE episodes as the standard 60 mg edoxaban treatment regimen, and safer than warfarin in preventing bleeding events in patients meeting the criteria for dose reduction.[1],[2]

Hokusai-VTE, the largest single comparative trial of a NOAC in patients with VTE to date, was a randomised, double-blind trial of 8,292 patients with acute VTE.[2] In the Hokusai-VTE trial, patients with a creatinine clearance of 30-50 ml/minute, body weight <= 60 kg or receiving certain P-glycoprotein inhibitors were given a reduced dose of 30 mg edoxaban once- daily. Of those patients that qualified for dose reduction, 733 were randomised to receive the reduced 30 mg edoxaban dose and 719 received a matching dose of warfarin.[1] Patients receiving standard treatment regimens, 3,385 were treated with 60 mg edoxaban and 3,403 treated with warfarin, adjusted to maintain the international normalised ratio between 2.0 and 3.0.[1]

This new analysis, published in the peer-reviewed journal Thrombosis and Haemostasis, found that the reduced edoxaban 30 mg dose resulted in lower blood levels of edoxaban, but preserved efficacy against recurrent VTE in dose reduced patients compared to patients that received the full 60 mg edoxaban dose (Hazard Ratio [HR]=0.96; 95 % Confidence Interval [CI]: 0.61-1.52).[1] Dose reduced patients also had fewer clinically relevant bleeds, a key adverse event, compared to similar patients taking warfarin (7.9% vs 12.8% HR=0.62; 95 % CI: 0.44-0.86; p < 0.01 for superiority).[1]

"The Hokusai-VTE study identified higher bleeding rates in warfarin-treated patients who met the criteria for dose reduction compared to those that did not, indicating that there is a sub-set of patients who could benefit from a safer therapy," said Dr Peter Verhamme, Associate Professor of Cardiology at KU Leuven, Belgium and lead author of the new analysis. "It is therefore reassuring to see that a reduced dose of once-daily edoxaban offers an alternative to those patients treated with warfarin who meet the criteria for dose reduction, with an enhanced safety profile."

VTE is the formation of blood clots in the vein and is a potentially fatal condition.[3] VTE is the collective term for pulmonary embolism (PE) and deep-vein thrombosis (DVT) and represents a major health problem in the EU, with over 1.5 million VTE events in Europe every year.[4] Incidence is also seen to be rising with the ageing population.[1] Anticoagulant therapy, such as edoxaban, helps to prevent blood clots from forming and can help prevent thromboembolic events.[1]

"We welcome this sub-analysis of the Hokusai-VTE study, which builds on the existing wealth of data on edoxaban and supports the understanding of different treatment strategies for patients with VTE," said Oliver Appelhans, Senior Vice President, Head of Cardiovascular Products, Business Development & NPP at Daiichi Sankyo Europe GmbH.

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 VTE

VTE is an umbrella term for two conditions, deep vein thrombosis (DVT) and pulmonary embolism (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.[3] PE occurs when part of a clot detaches and lodges in the pulmonary arteries, causing a potentially fatal condition.[5]

VTE is a major cause of morbidity and mortality.[6] In 25 EU countries VTE exceeds 1.5 million events per year and the annual incidence of VTE in developed countries is estimated to be 1-3 per 1,000 adults.[4],[7] A prior incidence of a VTE is the most significant risk factor of a second occurrence, and after the age of 50, the risk doubles every ten years.[8]

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.

The edoxaban Summary of Product Characteristics can be viewed here: http://pressportal.lixiana.com/further-content/summary-of-product-characteristics/

Extensive Clinical Research Program for Edoxaban

Daiichi Sankyo is committed to expanding scientific knowledge about edoxaban, as demonstrated through our research programs evaluating its use in a broad range of cardiovascular conditions, patient types and clinical settings in atrial fibrillation (AF) and venous thromboembolism (VTE). The extensive edoxaban research program includes multiple RCTs (randomized, controlled trials), registries and non-interventional studies, with the goal of generating new clinical and real-world-data regarding its use in AF and VTE populations. Daiichi Sankyo expects that more than 100,000 patients will participate in the edoxaban clinical research program, including completed, ongoing and future research.

The RCTs include:

- ENSURE-AF (EdoxabaN vs. warfarin in subjectS UndeRgoing cardiovE
  rsion of Atrial Fibrillation), in AF patients undergoing electrical
  cardioversion;
- ENTRUST-AF PCI (EdoxabaN TReatment versUS VKA in paTients with AF
  undergoing PCI), in AF patients undergoing percutaneous coronary 
  intervention;
- Hokusai-VTE Cancer (Edoxaban in Venous Thromboembolism Associated 
  with Cancer), in patients with cancer and an acute VTE event. 

In addition, global and regional registry studies will provide important real-world-data about the use of edoxaban and other oral anticoagulants in everyday practice, and include:

- ETNA-AF (Edoxaban Treatment in routiNe clinical prActice in 
  patients with non valvular Atrial Fibrillation);
- ETNA-VTE (Edoxaban Treatment in routiNe clinical prActice in 
  patients with Venous ThromboEmbolism);
- EMIT-AF/VTE (Edoxaban Management In diagnostic and Therapeutic 
  procedures-AF/VTE);
- Prolongation PREFER in AF (PREvention oF thromboembolic events - E
  uropean Registry) in patients with AF. 

We are committed to adding to the scientific body of knowledge around edoxaban in a variety of AF and VTE patients, including those who are vulnerable.

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.daiichi-sankyo.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. Verhamme P et al. Dose reduction of edoxaban preserves efficacy 
   and safety for the treatment of venous thromboembolism. Thromb 
   Haemost 2016; 116. Epub ahead of publication.
2. Büller H, et al. Edoxaban versus warfarin for the treatment of 
   symptomatic venous thromboembolism. N Engl J Med. 
   2013;369(15):1406-1415.
3. Deep Vein Thrombosis (DVT) / Pulmonary Embolism (PE) - Blood Clot 
   Forming in a Vein. Centers for Disease Control and Prevention. 
   Available at:http://www.cdc.gov/ncbddd/dvt/facts.html. [Last 
   accessed: September 2016].
4. The Coalition to Prevent VTE. Available at: http://www.coalitionto
   preventvte.org/INDEX_CFM/T/THE_BURDEN_OF_VTE/VID/DCD0A03F_1422_16B
   3_78E0B9EB0571.HTM. [Last accessed September 2016].
5. Ozaki, A. Cleveland Clinic (2014). Venous thromboembolism. 
   Available at: http://www.clevelandclinicmeded.com/medicalpubs/dise
   ase-management/cardiology/venous-thromboembolism/#s0010. Last 
   accessed September 2016.
6. Bramlage, P. et al. Current concepts for the prevention of venous 
   thromboembolism. European Journal of Clinical Investigation. 
   2005;35(1):4-11.
7. Braekkan, S. K. et al. Body height and risk of venous thrombo- 
   embolism: The Tromsø Study. American Journal of Epidemiology. 
   2010;171:1109-1115.
8. Zagaria, M. Venous Thrombosis: Pathogenesis and Potential for 
   Embolism. US Pharm. 2009;34:22-24. 
Contact

Lydia Worms (Europe)

Daiichi Sankyo Europe GmbH

Edoxaban Communications & Product PR Europe

+49(89)7808751



September 2016

EDX/16/0229 



Weitere Meldungen: Daiichi Sankyo Europe GmbH

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