Hello everybody my name is danilo medina’s i’m from the catholic university of hawaii q i’m a medicine a student and here you can see my social media the topic i’m going to talk about is adversity mug for dabigatran rivaroxaban is a direct ramen innovator utilized for stroke prevention in patients with not bipolar outrun tribulation and for venice charm embolism
Prevention and treatment despite the increasing use of direct oral anticoagulants there currently are no available drugs specific reversal agents a duration map is a monoclonal antibody fragment binden dublicate run with neutralizing effects on anticoagulation medical application of this study in the u.s. practice win which is a duracell simha is now indicated in
Patients willing with pradaxa which is the bigoted run when reversal of the anti colon effects of the videotron is needed this means for emergency surgery or an origin procedure or in life-threatening or uncontrolled wedding regulatory reviews and submissions in other countries are ongoing here i’m going to present a video which talks a little bit about production
My dad has atrial fibrillation or afib he has the most common kind it’s not caused by a heart valve problem dad it says you’re a kid which had five times greater risk of stroke that’s why i take my warfarin every day it looks like maybe we should ask your doctor about pradaxa we’re in a clinical trial for docs that dabigatran at excellent messily was proven
Superior to warfarin in reducing the risk of stroke and unlike war friend with no regular blood tests or dietary restrictions my doctor products is not for people with artificial heart valves don’t stop taking pradaxa without talking to your doctor stopping increases your risk of stroke ask your doctor if you need to stop production before surgery or medical
Or dental procedure for dax that can cause serious and sometimes fatal bleeding don’t take products if you have abnormal leaving or have had a heart valve replaced seek immediate medical care for unexpected signs of bleeding like unusual bruising pradaxa may increase your bleeding risk of your 75 or older have a bleeding condition or stomach ulcer take aspirin
Nsaids or blood thinners or if you have kidney problems especially if you take certain medicines tell your doctors about all medicines you take pradaxa side effects include indigestion stomach pain upset or burning if you or someone you love as a fib not caused by a heart valve problem ask your doctor about reducing the risk of stroke with pradaxa okay here i have
Another video which talks a little more about the side effects of pradaxa the new drug pradaxa is also a blood thinner it works differently than coumadin but is supposed to accomplish the same result the sales pitch for pradaxa is the fact that patients don’t have to go to their doctor regularly to have their blood levels checked that certainly sounds a lot more
Convenient than coumadin but pradaxa is significantly different than coumadin and one very important aspect there is no way to emergently reverse the blood thinning effects of pradaxa so if a patient who is on pradaxa has a bad accident or needs emergency surgery they were simply out of luck many will simply bleed to death and there’s nothing their doctor can do
The manufacturer pradaxa boehringer ingelheim has admitted that in the short time since the drug was first launched in late 2010 over 260 deaths have been caused by pradaxa a quick review of pradaxa website does not even mention the fact that the blood thinning effects of the drug cannot be reversed in an emergency we first heard that pradaxa could cause surgical
Patients to bleed to death from a physician who called us irate that a patient of his had bled to death during surgery he was frustrated that there was nothing that he could do to prevent this tragedy he was furious that the fda had approved a drug that could kill patients when there were safer alternative drugs that were effective and had okay here i have another
Video which talks about the study which is called the reverse id study of – the analysis we’re presenting at is th is of the first 90 patients of those 51 were what we call group a which are the patients who have serious or life-threatening bleeding while taking too big a trant and the clinician at the bedside thinks that they would benefit from reversal and 39 in
Group b which means the patients are not bleeding on presentation but they are taking too big a trend they need an invasive procedure that can’t be delayed more than eight hours and the operator doesn’t want to do that without good hemostasis so what we saw was that without any adverse safety signal from the drug a days has a map completely successfully reversing
Any question on defects of the bigger train in both group a and group b patients the bleeding patients and the three procedure patients very quickly the primary opposed to then 4hours we saw the efficacy signal within minutes so it’s a specific reverse relation for dabigatran what it does for clinicians in a very high risk high stakes clinical scenario is that
It can remove the concern for any coagulation from the care of the patient so that the clinician can then attend to other issues that contribute to the bleeding or the surgical morbidity about the path of this study the reversal was evident immediately after administration of the first vial of other systemic and was complete in all but one patient after four and
Fifty and twelve hours laboratory tests showed normal calculation levels in almost 90% of patients norman blood clotting imus assists during surgery was reported in 92 percent of the patients that required surgery or invasive procedures there was no signal of a pro kwajalein effect following administration of whatever system oh here’s another video which talks
About the results of this study most of these paintings we have established strategy to manage this blitz however the availability of a specific reversal agent that promptly reverses an aquatic activity of tapping a truck without any other effects on coagulation is expected to be an additional tool that helps clinicians to manage these patients the addition of
Winter seasonal deaden references into quadrant activity of dublicate ron will complete the management strategy of approach to bleeding that we currently have at all disposition in the emergency rooms what stands out most in your data these bleeding complications are rare we know that the the no acts as a class present with fewer bleeding complications than does
Warfarin but they still occur they tend to occur in older people who are taking these drugs for atrial fibrillation so they tend to have multiple comorbidities often reduced renal function so basically the picture of trying to pay for it yes we’re looking at some pretty sick patients with an acute insult either bleeding badly in front of your head bleed or they
Are not waiting but they’ve got a surgical emergency so this is a pretty sick population of patients and what stands out is the immediacy of the effect of ideas is met in terms of reversing the effect of the bigger trend literally within minutes and then keeping it reversed after 24 hours so what that does is it removes any coagulation from the treating clinicians
List of concerns for that patient i’m an er doc if i’ve got a patient who’s say a 75 year old who’s got atrial fibrillation taking the bigger trend rex’s car on the expressway a patient comes in hemodynamically unstable maybe you’ve got a bleed instead leading his chest bleed has that been bleeding this pelvis bad bad situation the first thing that jumps out to me
Is my gosh ease anticoagulants can make it even worse so if i can take the anticoagulation away by reversing it so effectively so predictably then i’ve still got lots of other problems he’s got bleeds everybody’s got holes in places that i need to patch and may need to go the operating room to fix but i take that that really primal concern that we have about the
Severity of the situation what are the kinds of the addresses and robotic events occurred in five patients none on whom was received and tipple antibiotic therapy at the time of the event there were 918 they were 80 that’s overall mortality within 96 hours of the study involvement appeared to be related to the original reason for emergency admission to the hospital
While all later events appeared to be related to co mobility issue a tiny nectar in february and march of this present you addresses in map was suddenly submitted under an accelerated approval pathway to the us food and drug administration european medicine and agencies and health canada for use in patients who require urgent reversal of the bigotry boring here
Hillman plans to submit addresses a map in all countries where the bigger trend is listen set further submissions are ongoing and accelerated process will be preset with regulatory authorities for available okay and here we have the my geography work tooth information thank you very much for watching
Transcribed from video
Idarucizumab for Dabigatran Reversal By Leonela Bastidas