March 28, 2023

Little is known about the impact of appropriate dosing on the effectiveness and safety of two new agents used in patients with non-valvular atrial fibrillation. Paul Burton, MD, PhD, Vice President of Medical Affairs at Janssen, discusses data presented at ACC.16 in Chicago.

By now the safety and efficacy of the no acts is pretty well-established but little is known about the impact of appropriate dosing on the effectiveness and safety of a pixum an at a rivaroxaban which is what we’re talking about specifically in patients in real-world practice so we’re here to discuss the revisit u.s. study and it’s real world evidence of stroke

Prevention in patients with non valvular atrial fibrillation to the united states and to do so i’m with dr. paul burton who is an md and a phd and a vice president of medical affairs at janssen now this is data that’s being presented the european cardiac arrhythmia society in paris tell me a little bit about the trial first off yes so the revisit u.s. study is a

Very interesting study for us it’s just from the 31,000 patient so it’s large it’s a real-world claims database analysis and it compares rivaroxaban to warfarin and apixaban to warfarin and it asks a question what are the rates of important clinical events irreversible harm so intracranial hemorrhage and it’s quemic struck these are the events that we know physicians

And patients fear most what are the rates of those in real world practice so the results are fascinating what we find is that the rates of intracranial hemorrhage are reduced by 47% significantly for reve rocks abound versus warfarin and we find that the rates of ischemic stroke for rivaroxaban versus warfarin were reduced by 29 percent that is just not significant

These are data coming from what a couple of trials that you’re using data from aristotle and the registration trial for a pixum ban and rocket af which was the registration trial for rivaroxaban right so rocky day f was the registration trial for rivaroxaban aristotle was the registration trial for a picks event so what these numbers though are what we’re now finding

In the real world so they’re very encouraging and really demonstrate the continued utility of rivaroxaban xarelto in the world in a fit patient now in terms of dose because that’s kind of the interesting area where we haven’t had a whole lot of data too before what did you find there well the interesting thing is so we find a reduction in intracranial hemorrhage

An ischemic stroke for we’ve rocks around versus warfarin with a picc seban there’s also a reduction in the rate of intracranial hemorrhage at small 13% non significant increase in the rate of ischemic stroke we know that there are differences in adherence with twice daily and once daily drugs we know that patients also our physicians prescribe different doses of

Drugs so it’s a interesting finding because it now looks it tries to integrate real world use of these agents with clinical outcome and again we find very robust consistent reduction in these important events with serato so is there a lesson to be learned i mean doctors are really concerned about the risk of bleeding and of course patients need to be concerned about

Not only that but also the potential down the line of a stroke so in terms of dosing what can you say about a lesson learned from this yeah i think we published a study a while ago that showed that patients and physicians fear stroke almost as much as they fear dying we believe that you must not trade-off a reduction in bleeding which is preventable and is treatable

With reduction in an event that is irreversible so a stroke i think what we see here in this study for the first time is again consistent reduction in these end points for xarelto taking drugs appropriately there’s a very famous quote by c everett koop that drugs don’t work in patients who don’t take them and it’s true xarelto is our robust once daily medicine and

It continues to demonstrate it it’s great clinical utility here now in the real world just as it did in the round studies were you able to look at how well doctors are following the guidelines in terms of dosing we haven’t looked at that here we are our work certainly is not done we continue to do that we have 91 thousand patients now in real world studies and you

Know as well as i do that this explorer program of ours when all said and done we’ll have two hundred and seventy-five thousand patients enrolled in new indications seeking trials as well as well as real-world evidence and i think that when all said and done we’ll we’ll be able to really definitively answer that question but these data are provocative and and very

Reassuring their thing absolutely and we have a variety of coverage from a number of meetings as you might imagine in cardio source world news please check that out we’re i’m executive editor rick mcguire

Transcribed from video
Real-world Effectiveness and Safety of Apixaban and Rivaroxaban Compared with Warfarin: REVISIT-US By CSWNews