Atrial Fibrillation (AFib) Support Group
Atrial fibrillation (AF or afib) is an abnormal heart rhythm (cardiac arrhythmia) which involves the two small, upper heart chambers (the atria). Heart beats in a normal heart begin after electricity generated in the atria by the sinoatrial node spread through the heart and cause contraction of the heart muscle and pumping of blood.
http://www.adverseevents.com/monitor/2014/02/06/ny-times-manufacturer-of-pradaxa-altered-trial-results-to-protect-company-profits/
I think we are in basic agreement:
The scientists who developed Pradaxa had concerns about monitoring for a subset of patients. Boehringer upper management decided to ignore these concerns in the marketing of Pradaxa, to keep the message simple and effective: no testing required. Both tort lawyers and upper management of large companies are primarily driven by the same profit motive.
I believe that the percentage of patients requiring some monitoring is larger than 10%. One of the criterion for monitoring seems to be age > 75. The median age of AFIB patients is 75, hence 50% of patients would require some monitoring.
http://www.hrsonline.org/News/Fact-Sheets/AFib-Facts#axzz2sw9A24yL
It is true that we are talking of monitoring at 1-2 years intervals, rather than the 4 weeks required by INR. But just mentioning some testing for 50% of patients would have greatly reduced the effectiveness of Pradaxa advertising.
I agree that most large companies would behave like Boehringer in a similar situation. But I believe that's unacceptable, hence I am glad that newspapers like the NY Times and Bloomberg addressed the issue.
Ecofr
It has always concerned me that 'one size fits all' with Pradaxa. How can a 200lb man active man have the same dosage requirement as a 100lb sedentary lady?
This weekend, studies showed that many drugs are affected by gender difference.
Of interest to me is last yr. I was taken off Pradaxa for 3 days prior to a dental extraction. I bleed for 12 hrs. Last week, I had an unplanned extraction. Took Pradaxa a 10 AM, had the extraction at 4PM and I barely bleed.
I would welcome a test every so often~
I agree with everything you said except for the percent that would need to be monitored from what I could ascertain. I would feel more comfortable with me (and everyone) getting an initial reading on plasma concentration and then at a certain interval depending on medical demographics. I would also feel that renal function should be monitored annually with each person's annual workup.
OK, back to the 50% number. While I agree with you that half of the afib patients are 75 or older and half below, that doesn't mean that everyone over that age would require 1-2 year testing, as long as renal function is monitored. Of course, I'm not a doctor. Probably to be safe, everyone over 80 should. So for sake of argument, lets say 35%. I guess that would be enough to screw up the simple message they would have liked to have given: no monthly monitoring for everyone... ever.
I'm not sure why it wouldn't have been acceptable to say annual monitoring only for those 80 years old and older or those with renal problems. I think what is happening is that doctors are prescribing Xarelto and Eliquis for patients 80 and over.
So it seems that Pradaxa 150 mg is not good for:
1) Those with GI issues
2) Those with renal problems
3) Those over 80 years old
That's my guess. I think the FDA was wrong not to approve 110 mg for those people that need 2 titration levels (150, 110, 75).
Hopefully improvements will be made to afib and anticoagulation treatment so many of these issues go away.
The older you get, the greater the likelihood of stroke and bleed. They may never be able to change that.
petey