Boehringer Ingelheim today announces the ten-year anniversary of the RE-LY® trial publication(1-3) 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. 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. , 15 million people worldwide suffer a stroke each year. One–third of these people die as a consequence.
About RE-LY®
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 stroke(1-3,11)
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 bleeding ...
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