Pradaxa (dabigatran) approval

I’m steven greer we’re here in miami to review the recent events and medicines and his surgery and with this are the faculty of the university of miami miller school of medicine and over the last week there were a few drug approvals and a couple of drug rejections and some other incidents in the news so i thought we’d start out first with the new anticoagulant branded

As pradaxa or generic as a debbie katherine and i pronouncing that correctly and yes and and it got the indication for atrial fibrillation non valvular atrial fibrillation anticoagulation so if we could first begin with you dr. dr. robert meyer berg you are professor your cardiologist correct i served medicine and physiology and the division of cardiovascular

Medicine at the university of miami miller school of medicine so maybe if you can just briefly review the data that the fda used the pivotal trials for the drug where they convincing we’re there any controversies so for this specific approval which as you mentioned was for non valvular atrial fibrillation the pivotal study was the relied trial which was published

Within in journal of medicine in 2009 and basically what that looked at was a very large cohort of patients 18,000 patients in three groups one treated with titrated coumadin the second treated with a dosing schedule of the bigot ran of 110 milligrams twice a day and the third with the same drug at 150 milligrams twice a day this was an open-label non-inferiority

Trial so there are some questions about limitation so what data showed was that the bigot ran had a dose 150 milligrams twice a day compared to coumadin gave greater benefit in reducing thromboembolic and stroke risk at an equivalent level of bleeding risk at a hundred and ten milligrams twice a day it gave an equivalent effect on reducing stroke risk and a

Lower bleeding risk now the curious thing about the approval is that the fda went ahead and approved the hundred and fifty milligrams twice a day formulation but not the 110 twice a day formulation but they did allow a seventy-five milligram tablet to be marketed which if you do your math you can do one and a half of those twice a day and you get to 110 but that’s

Not what the fda intended and the fda has said if we can come up with an explanation of why they did that the reason it’s curious to me is have some conditions such as fiscal instability and so forth that might put them at a somewhat greater breezers and i might be happier with a hundred and ten twice a day formulation in those pages the closest i can come to an

Explanation for what the fda has to do with how the drug is excreted so it is excreted by the kidneys so what they wanted was a 75 out there to use and patients with rihanna with no clearances less than 30 but that was not in the truck so there’s some uncertainties about where all those glands what is not uncertain to me at this point is that 150 milligrams twice

A day formulation is seems to be better than coumadin it’s certainly not worse and it said an equivalent reviewers has the advantage that you don’t need to get inrs repeated 1000 so this gets to the issue of the patient’s ability or willingness to tolerate the inconvenience and coumadin versus a drug that is at worst equivalent to it and if that’s better and this

Is a good type of every doctor has a patient with afib yes what are your thoughts on this new drug that’s potentially to be safer than or less hassle than coumadin ii would it be worth the much greater cost how would you factor that in i’m glad you brought up cost that is a big issue so this if you go by what has been marketed in europe looking at something like

$10 a day cost compared to pennies in value for chromatid i imagine the company is going to have to respond to that stress because that’s going to play into whether or not the drug we use or how its transmitted disease as far as what it’s going to do these are being the cumin in market it’s hard to predict i think unquestionably patients who either have had events

On coumadin cannot take crewmembers one reason or another or are so bothered by the multiplicity of blood tests in terms of quality of life there’ll be a quick transition to this drug for patients who are perfectly content and can be managed with once a month inr testing they may stay on conan for a while and that’s what i’m going to advise my patients my view on

This is i whatever new drug comes out of it you know even the trial as size of all it says you don’t learn everything you’re going to learn and once it hits the module so i would like to see what somebody else’s patients do on this drug wow except in those instances when there is a reasonable indication or approach for just transitioning them over in which case

I’ll do it right away and yeah but let’s say intraday said i’m sorry it’s like a guys but german orthopedic surgery here i’m just gonna make the comment so mmmm that comes out to about $3,600 a year so i guess you have to figure out how much the blood test cause everything else the estimates are around five to six thousand dollars a year cost if you use the higher

End of the range of projected pricing but the other thing that would be nice to see would be to lower the bleeding risk and keep the advantage the same i mean i just have faces a gi bleeds or get the maximum get a lot more hemorrhage type problem i would guess and this is just a guess i don’t have any inside information on this i would guess that the fda is going to

Go back around formulation because there’s a good rationale i’m not bill o’neil i’m a dean of affairs and interventional cardiologist and i think that bob kind of has summarized the nuisance factor though but patients actually taking coumadin can’t be overemphasized and i think that you know if they need to be uncommon and they have to be loaded so it takes three or

Four days so just getting them on and off of the drug is a complete pain so if you have a patient that for instance is on coumadin that needs a dental procedure or needs some sort of surgery so i think that that factor is going to be huge well it’s a it’s a pain literally i mean sticking people will elderly late and but i think we have to kind of a word of caution

Because this is approved for prophylaxis anabolic events and patients who get ain’t it and nonviolent which is which is kind of a lovers group of patients and what i what i’m concerned about is kind of awfully louise so a patient that has a prosthetic mitral valve to take a very high risk example where we’re clouding that valve would be deadly in catastrophic and you

Switch them over you don’t really know you exactly how well it’s going to work in these other kind of primer settings so my suspicion is the factors will if their patients can pay for it or their insurance covers that will probably gradually start switching over but i don’t think it’s gonna be a sweeping you know blackberry off a really important point so for the

Patient the prosthetic that i feel needs to be ongoing i have no intention of taking those patients off of it until i see some data that says this is equivalent and there aren’t any at this point so we’re really talking about not only non prosthetic valve but this is not about people with valvular heart disease here so the patient with mitral regurgitation mitral

Stenosis who has atrial fibrillation is not who we’re talking about today we’re talking about the patient’s lawn down or electro-stimulation well that there may be standards from the assistant professors of an ecological ecology and do you foresee that this that would be eventually used for prophylaxis against the other strombone public events like honesty or for

Treatment of bees so it already is being used in europe for post-operative patients and there is a study that was reported at around around the same time as rely looking at patients with venous thromboembolism and showing beneficial effects so i’d love at least equivalent well i think the answer to that is yes and i’m much more comfortable jumping to that at this

Point that i am into a patient with valvular heart disease in atrial fib and certainly been impatient with prosthetic pals

Transcribed from video
Pradaxa (dabigatran) approval By The Healthcare Channel