Anniversary of the pivotal RE-LY® trial marks a decade of innovation for stroke prevention in AF patients
Boehringer Ingelheim today announces the ten-year anniversary of the RE-LY® trial publication1-3 recognising the contribution made in the decade since by patients, healthcare professionals (HCPs) and researchers.
In the fifty years prior, warfarin had been the standard of care for stroke prevention in atrial fibrillation (SPAF). While effective, warfarin has a number of known interactions, meaning patients require careful monitoring, and the warfarin dose being adjusted accordingly. The pivotal RE-LY® trial investigated the efficacy and safety in stroke prevention of dabigatran compared to warfarin in 18,113 atrial fibrillation (AF) patients. It marked the first time that a non-vitamin K antagonist oral anticoagulant (NOAC), that has since been brought to market, was shown to be at least as effective and safer than warfarin in stroke prevention in a randomised setting.1-3 This represented the first puzzle piece in the growing knowledge base around NOACs as an alternative therapy option to vitamin K antagonists (VKAs) for SPAF.
“RE-LY® was the first crucial sign that a new, safer therapy option for SPAF was on its way,” said Stuart J. Connolly, MD, Professor Emeritus, Division of Cardiology at McMaster University in Hamilton, Ontario. “The positive results brought a real sense of excitement to researchers, HCPs and patients alike, and the subsequent approval of dabigatran for SPAF from 2010 onwards provided a safer, effective and more manageable therapy option. AF patients now had greater reassurance around stroke prevention and without the impact that regular monitoring and dose adjustment had on their day-to-day life.”
RE-LY® was just the start of the journey. The design, evaluation and subsequent approval of the first and only widely-available specific reversal agent (idarucizumab) in 2015 added to the bigger picture of understanding and reassured patients that the effects of dabigatran could be quickly and effectively reversed for emergency surgery / urgent procedures and in life-threatening or uncontrolled bleeding.5,6
“Today, Boehringer Ingelheim continues to deliver on its commitment to patients with high unmet need in the cardiovascular space and beyond,” said Dr Waheed Jamal, Corporate Vice President, Head of CardioMetabolic Medicine, Boehringer Ingelheim. “Thank you to the patients, HCPs and researchers who have helped and continue to help develop and expand access to safer and innovative therapies that improve the care of patients with a range of cardiometabolic conditions.”
About Stroke Prevention in Atrial Fibrillation (SPAF)
AF is the most common sustained heart rhythm condition.7 It can lead to a five-fold increase in the risk of ischaemic stroke for the 33.5 million people living with AF around the world.8,9 15 million people worldwide suffer a stroke each year. One–third of these people die as a consequence.10
The RE-LY ® trial, which was published in the New England Journal of Medicine in September 2009, compared dabigatran to warfarin for preventing stroke in patients with AF.1-3 In the RE-LY® trial, 18,113 patients with non-valvular atrial fibrillation and a risk of stroke were investigated, using a PROBE (prospective, randomised, open label with blinded endpoint evaluation) design to assess the safety and efficacy of dabigatran 150mg or 110mg twice daily vs. dose-adjusted warfarin.11
Trial results demonstrated that dabigatran had notable advantages over warfarin even when warfarin is well controlled.1-3 Compared to warfarin:
Dabigatran 150mg twice daily was superior for the prevention of stroke / SE and significantly reduced the risk of both ischaemic and haemorrhagic stroke1-3,11
- Rates of the primary outcome were 1.12% per year in the group that received 150mg of dabigatran (relative risk, 0.65; 95% CI, 0.52 to 0.81; P<0.001)
- Rates of the primary outcome were 1.72% per year in the warfarin group, as compared with 1.54% per year in the group that received 110 mg of dabigatran (relative risk with dabigatran, 0.89; 95% confidence interval [CI], 0.73 to 1.09; P=0.89) 1-3,12
Dabigatran significantly reduced the risk of intracranial haemorrhage (ICH), along with significant reductions in the risk of both life threatening and total bleeding1-3,12
- The rate of major bleeding was 3.61% per year in the warfarin group, as compared with 2.92% per year in the group receiving 110 mg of dabigatran (P=0.003)1-3,12
- The rate of major bleeding was 3.40% per year in the group receiving 150 mg of dabigatran (P=0.41)
About Pradaxa® (dabigatran etexilate)
Clinical experience of Pradaxa® equates to over 10 million patient-years in all licensed indications worldwide. Pradaxa® has been in the market for more than eight years and is approved in over 100 countries.4
Currently approved indications for Pradaxa® are:5,6
- Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and a risk factor for stroke
- Primary prevention of venous thromboembolic events in patients undergoing elective total hip replacement surgery or total knee replacement surgery
- Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and the prevention of recurrent DVT and recurrent PE in adults
Dabigatran, a direct thrombin inhibitor (DTI), was the first widely approved drug in a new generation of direct oral anticoagulants, available to target a high unmet medical need in the prevention and treatment of acute and chronic thromboembolic diseases.13-15 Potent antithrombotic effects are achieved with direct thrombin inhibitors by specifically blocking the activity of thrombin, the central enzyme in the process responsible for clot (thrombus) formation.15 In contrast to vitamin K antagonists, which variably act via different coagulation factors, dabigatran provides effective, predictable and reproducible anticoagulation with a low potential for drug-drug interactions and no drug-food interactions, without the need for routine coagulation monitoring or mandatory dose adjustment.4,12
Pradaxa® is the only non-vitamin K antagonist oral anticoagulant with an approved, widely available reversal agent. Praxbind® is approved in the European Union and United States for adult patients treated with Pradaxa® who require rapid reversal of its anticoagulant effects prior to urgent procedures/emergency surgery or in life threatening or uncontrolled bleeding.5,6
Please click on the following link for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/press-release/re-ly-trial-publication-10-year-anniversary
This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. It is directed to the international audience outside Germany. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.
Media + PR
Phone: +49 6132 77 182085
Mobile: +49 151 44061760
Fax: +49 6132 77 6601
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Ipsen to Present New Data at 13th Annual Conference of the International Liver Cancer Association (ILCA 2019)20.9.2019 16:30:00 CEST | Press release
Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY) today presents results from the matching-adjusted indirect comparison (MAIC) of cabozantinib (Cabometyx®) versus regorafenib (Stivarga®) for the second-line treatment (2L) of patients with advanced hepatocellular carcinoma (aHCC) who received sorafenib as the only prior systemic therapy. Using data from the Phase III CELESTIAL and RESORCE trials, the MAIC showed that cabozantinib offers greater efficacy versus regorafenib. Using data from the Phase III CELESTIAL and RESORCE trials, the MAIC showed that in the 2L CELESTIAL sub-population who had received sorafenib as the only prior systemic therapy, cabozantinib significantly improved progression-free survival (PFS), with an additional 2.4 months provided vs. regorafenib (5.6 months vs. 3.2 months [95% confidence interval (CI): 4.90-7.26], p<0.05). Median overall survival (OS) was also favorable with cabozantinib (11.4 months vs. 10.8 months), though statistical significance was not met
RoboSense RS-LiDAR-M1 Smart LiDAR Sensor Wins AutoSens Awards 201920.9.2019 13:30:00 CEST | Press release
On September 18, 2019, RoboSense announced at Brussels, Belgium that its flagship product RS-LiDAR-M1 Smart LiDAR Sensor has been awarded the elite AutoSens Awards trophy in the “Best Automotive Safety System” category, given to only the highest-rated innovative product or technology in the automotive industry. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190920005309/en/ Robosense Along With Other Winnners At The Autosens Awards Ceremony At Brussels, Belgium (Photo: Business Wire) True autonomous driving requires human-like advanced sensing of the environment for driving with little or no human input. The safety of passengers and passers-by is always the priority concern for autonomous driving. When the RS-LiDAR-M1 is integrated into the current autonomous driving car perception system, it overcomes the weaknesses of millimeter wave radar and camera technologies on identifying obstacles, and eliminates car accidents, such
Boehringer Ingelheim Partners with Inflammasome Therapeutics to Develop Novel Therapies for Patients with Retinal Diseases20.9.2019 12:00:00 CEST | Press release
Boehringer Ingelheim and Inflammasome Therapeutics Inc. (Inflammasome) today announced they have entered into a co-development and license agreement to develop up to three therapies for patients with retinal diseases. By combining Inflammasome’s unique intravitreal (IVT) drug delivery technologies with Boehringer Ingelheim’s compounds from its retinal disease pipeline portfolio, Boehringer Ingelheim aims to develop novel therapies for retinal diseases. In 2019 there were an estimated 82 million patients in the seven key countries (U.S., Japan, Germany, U.K., Spain, Italy, France) affected by one of the three major forms of retinal disease: Age related macular degeneration (AMD), diabetic retinopathy (DR), and diabetic macular edema (DME). Globally, the prevalence rates of these and other retinal diseases are expected to increase over the next 10 years primarily due to aging populations and the global diabetes epidemic. Despite therapeutic advances in some disease areas during the past
Visa B2B Connect Expands to 32 New Countries and Announces Integration With Infosys20.9.2019 11:00:00 CEST | Press release
Visa Inc. (NYSE:V) today announced that its Visa B2B Connect network has doubled its reach – from 30 global trade corridors at launch in June 2019, to 62, with the goal to expand to over 100 countries in 2020. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190920005082/en/ Visa B2B Connect (Graphic: Business Wire) In addition, Infosys, a global leader in next-generation digital services and consulting, is integrating with the Visa B2B Connect network to bring Visa B2B Connect platform access to their participating financial institutions worldwide. Through this new connection, participating financial institutions worldwide can take advantage of the ability to quickly and securely process corporate cross-border payments globally through Visa B2B Connect.1 “Visa B2B Connect is a fast, secure and more efficient network, designed specifically to overcome obstacles in the cross-border corporate payments space,” said Alan Koenigsbe
Open Day at ISAE-SUPAERO!20.9.2019 09:53:00 CEST | Press release
As part of the Science Festival, this year organized on the theme of “Talking about Science, Imagining the Future”, ISAE-SUPAERO will open up its entire campus to the public on Saturday, October 12th from 10 am to 6 pm. Intended for families, companies, partners, journalists and alumni, this event should bring in over 3,000 attendees, as was the case in the three previous years! The program for the day includes many opportunities to discover science today and our vision of the science of the future, with the challenges this entails for the future of our planet. On the program: ➢ Visits to the laboratories and research departments with flight simulators ➢ Visit to the aeroacoustic wind tunnel, unique in Europe, ➢ Demonstrations: how to fly an airplane, Enoskelet, augmented humans, aeroelasticity, drones, use of the gyroscopic effect in space systems, piezoelectric effect, lasers for communicating at the speed of light on Earth and in space, the infinitely small in 3D, Robot Firefighter
William Priest to Step Down as CEO in 2020, Will Remain at Firm as Executive Chairman and Co-CIO20.9.2019 07:00:00 CEST | Press release
Epoch Investment Partners, Inc., announced that William Priest will step down as the firm's CEO effective April 1, 2020. He will become Epoch's Executive Chairman and will continue to lead the investment team and serve as co-CIO. He will also retain his portfolio management responsibilities, including his lead portfolio manager role with Epoch's Global Choice and Global Absolute Return strategies. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190920005076/en/ Philipp Hensler (Photo: Business Wire) Philipp Hensler, Epoch's President and COO, will become the firm's CEO. Hensler brings to the role extensive leadership experience at asset management firms globally. His earlier background as a portfolio manager has imbued him with an investment-oriented perspective that aligns with Epoch's investment-centric culture. “Investing remains my lifelong passion," said Priest, who helped found Epoch in 2004. “Best practice suggests a s