INGELHEIM, Germany - Tuesday, July 16th 2013 [ME NewsWire]
RE-LY® sub-analysis results support consistent benefit of Pradaxa® (dabigatran etexilate) over warfarin in non-valvular atrial fibrillation patients with and without previous symptomatic heart failure1
More than a quarter of patients in the landmark RE-LY® trial had a history of heart failure, increasing their risk of stroke and complicating their clinical management1
Pradaxa® showed potential to improve clinical outcomes in difficult-to-treat patients with multiple co-morbidities
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Published in the European Journal of Heart Failure1, results from a new sub-analysis of the RE-LY®i trial demonstrate important benefits of Pradaxa® (dabigatran etexilate) over warfarin in difficult-to-treat patients with non-valvular atrial fibrillation (AF) and previous symptomatic heart failure (HF). The outcomes in heart failure patients were consistent with the results from the main RE-LY® trial: Pradaxa® 150mg twice daily reduced the risk of stroke including ischaemic stroke with similar rates of major bleeding compared to warfarin and Pradaxa® 110mg twice daily showed similar rates of stroke but significantly reduced major bleeding compared to warfarin. Importantly, both doses of Pradaxa® significantly reduced intracranial as well as total bleeding.1,2,3
The new results support that Pradaxa® can also be beneficial for patients with multiple co-morbidities and further reinforce the consistent efficacy and safety profile of Pradaxa® that was shown in the main trial and various previous RE-LY® sub-analyses in several other patient subgroups, including patients with type 2 diabetes.4-8
"Atrial fibrillation and heart failure frequently coexist and are known to worsen patient prognoses. Heart failure is a specific risk factor for stroke in atrial fibrillation patients, therefore these patients especially need anticoagulant treatment,” said Dr. Jorge Ferreira, Cardiologist, Hospital Santa Cruz, Lisbon, Portugal. "However, anticoagulation with a vitamin-K-antagonist in these patients is often associated with poor INR control. This results in more challenging management and impacts the overall efficacy and safety of VKA treatment.”
From a total of 18,113 patients with non-valvular AF participating in the landmark RE-LY® trial, 4,904 patients (27%) had previous symptomatic HF.2,3 In the sub-analysis comparing the main outcomes of stroke and systemic embolism as well as major bleeding between patients with and without previous symptomatic heart failure, the results were consistent with no statistically significant differences (p-values for interaction) between the two patient groups.1 These results show that Pradaxa® is a valuable treatment alternative for patients who suffer from both atrial fibrillation and heart failure.
"These new results from RE-LY® highlight the value of Pradaxa® also for those atrial fibrillation patients that are traditionally considered difficult to treat and have multiple co-morbidities,” commented Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim.
Pradaxa® 150mg bid is the only novel oral anticoagulant, study of which has shown a significant reduction in the incidence of ischaemic strokes in patients with non-valvular AF compared to warfarin (67% median time in therapeutic range9), offering a relative risk reduction of 25%.2,3 Nine out of ten strokes in AF patients are ischaemic strokes,10 which can result in irreversible neurological injury with profound long-term consequences such as paralysis or inability to move one’s limbs or formulate speech.11
Furthermore in the main RE-LY® trial, Pradaxa® 150mg twice daily provided a 36% reduction in the overall risk of stroke versus warfarin, demonstrating superior protection.2,3 Pradaxa® 110mg twice daily, indicated for certain patients, was as effective as warfarin for the prevention of stroke and systemic embolism.2,3 Both doses of Pradaxa® were associated with significantly lower total, intracranial and life-threatening bleeding compared to warfarin.2,3 Pradaxa® 150mg twice daily showed a similar risk of major bleeds versus warfarin while Pradaxa® 110mg twice daily demonstrated a significantly lower risk.2,3 The RE-LY® trial was performed in PROBE design, i.e. prospective, randomized, open-label with blinded endpoint evaluation.
Pradaxa® is already widely approved for the prevention of stroke and systemic embolism in patient with non-valvular atrial fibrillation and for primary prevention of VTE following total hip replacement or total knee replacement surgery.9 Over 1.6 million patient years of experience in all licensed indications in over 100 countries support Pradaxa® as the leading novel oral anticoagulant.12
i RE-LY® was a PROBE trial (prospective, randomized, open-label with blinded endpoint evaluation), comparing two fixed doses of the oral direct thrombin inhibitor dabigatran etexilate (110mg bid and 150mg bid) each administered in a blinded manner, with open label warfarin.2,3
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