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RELY-ABLE Data Presentation by Dr. Stuart Connolly

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RELY-ABLE®: Unprecedented long-term data support safety profile and sustained efficacy of PRADAX® for stroke prevention in AF.

You’re joining us from the 2012 american heart association scientific sessions to hear the eagerly anticipated results of the reliable study reliable is the large follow-up of the hugely successful rely trial this latest study looked at the effects of dubiga tranitexylate pradaxa this novel medication for burying engelheim is for patients with irregular heart rhythm

Called atrial fibrillation combined the studies provide over four years of safety and efficacy knowledge on dabigatran this is the first and only data showing how a novel oral anticoagulant is performing over the long term in clinical practice it also provided insights on the relative benefits of two different twice daily doses a lower dose of 110 milligrams and

A higher one of 150 milligrams for stroke prevention in non-valvular atrial fibrillation it’s an exciting time for physicians and patients across the world so let’s now hear from reliable study lead investigator professor stuart connelly of mcmaster university canada who’s going to present the results of the study for us rely able was a follow-up study to rely

As is well known uh the bigger trying to texylate was uh studied in the large global rely trial with a mean follow-up of two years which compared to two doses of dabigatran to standard therapy with warfarin the 150 milligram dose of debigatron reduced stroke or systemic embolism by 35 percent then 110 dose was not inferior to warfarin with the 20 reduction in

Major bleeding both doses had a very big impact on intracerebral bleeding and intracranial bleeding patients who were receiving dabigatran in rely were able to continue to receive the dose of dabigatran that dose of dabigatran during an extended period of follow-up approximately six thousand dabigatran patients were enrolled and reliable and followed for a mean

Follow-up of about two and a quarter years the main results of reliable are that the same event rates that we saw in rely with the bigatran continued to be observed during the reliable follow-up period showing that the effects of the bigatran are consistent over long-term follow-up this is true both for ischemic outcomes such as ischemic stroke and it’s also true

For hemorrhagic outcomes both doses have very similar and very low rates of both hemorrhagic stroke and subdural hemorrhage the major complications of warfarin therapy it’s a particular note that the very low rates of intracerebral bleeding that we saw in rely continued to be seen with the bigatran during the rely able period rely able also allows us to compare in

Somewha some more detail the two doses of dabigatran during rely we saw that the bigatron 150 has a lower rate of ischemic stroke but a higher rate of major hemorrhage compared to the bigatran 110. similar patterns are seen during the rely able period the two doses however are almost identical in the outcome of total mortality and in other measures of net clinical

Benefit so the final conclusion is that the results of rely are consistently seen during long-term follow-up there were no surprises we essentially confirmed that the rates of events that were observed during the rely study continue beyond the end of rely for an additional follow-up of 2.3 years on average so that over a period of more than four years we now

See consistently low rates of stroke and systemic embolism and of major bleeding on dabigatran

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RELY-ABLE Data Presentation by Dr. Stuart Connolly By Cision Canada