400 person study on lower INR (1.5-2.5) with mechanical valve

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Humboldtgrrl

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My practice is involved with a large number of drug studies on eye drugs for various retinal conditions. When these studies are initiated a lot of thought goes into trying to design the study as likely to work as possible. Recently one of the drug companies had a failed study. They analyzed the study and decided that the way it was set up allowed the study to fail. So feeling confident that their product would ultimately pass muster they set up another study done slightly differently which they hope will succeed. This INR stuff is a lot like that. Concoct weird statistics (adding bleeding+stroke) showing they are "superior" in one group and getting the FDA to OK this device. Also I think there is a trend for the FDA to OK things that possibly in the past would not be OKed. For example one of the drugs for Alzheimers was authorized even though it did not show direct clinical efficacy for Alzheimers. It only showed a marker being altered. Somewhat like the defense industry in the US there is a revolving door between government and industry in other departments like the FDA. So there may be conflicts of interest in making these decisions.
Side Bar Issue - any thots re Coselli's surgical prowess for aneurysm redo (original stent+AVR was done by another surgeon a year ago, but now has aneurysms at both end of the stent)? Have tried to link up you & my sister (toadhall blog name) up online before her Houston consult, but unclear that my limited techno-literacy efforts succeeded. TIA
 

slipkid

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My practice is involved with a large number of drug studies on eye drugs for various retinal conditions. When these studies are initiated a lot of thought goes into trying to design the study as likely to work as possible. Recently one of the drug companies had a failed study. They analyzed the study and decided that the way it was set up allowed the study to fail. So feeling confident that their product would ultimately pass muster they set up another study done slightly differently which they hope will succeed. This INR stuff is a lot like that. Concoct weird statistics (adding bleeding+stroke) showing they are "superior" in one group and getting the FDA to OK this device. Also I think there is a trend for the FDA to OK things that possibly in the past would not be OKed. For example one of the drugs for Alzheimers was authorized even though it did not show direct clinical efficacy for Alzheimers. It only showed a marker being altered. Somewhat like the defense industry in the US there is a revolving door between government and industry in other departments like the FDA. So there may be conflicts of interest in making these decisions.

Wise man. I agree with everything you said above.

I used to work in the pharma industry. For about 5 years I was a programmer involved with creating the reports that were used for FDA submissions, mostly phase II clinical trials.

Adverse effects was always our biggest shall we say "challenge". Those reports would be reviewed & "massaged" (IE: altered) up the wazoo to increase the chances of FDA approval at the direction of the MDs overseeing the studies working for the pharma company. If the adverse events were too serious or common the data would be looked at with a microscope to find ways to exclude "outliers" resulting in a more favorable report, or simply scrap the study and implement a new study with more targeted "patient screening" likely to get better results.

Then add to this that the FDA is motivated largely by $$ as is the whole industry of course. The greater the perceived profits the more likely whatever it is will get approval by the FDA. And there are the ties of FDA employees who came from big pharma with relationships with their old companies even if not out in the open salary drawing situations. The whole system is corrupt and the FDA is largely toothless or at least chooses to be.

Yeah I'm generalizing but if you think the FDA's #1 focus is to protect patients I have some prime real estate avialable for sale real cheap down around New Orleans or Northern California you might want to invest in.

[Edit: By the word "you" above I don't mean vitdoc, I mean anyone reading my post. And - as I say "don't get me started" - what the FDA does regarding approving generics is downright pathetic IMO based on my own personal experience]
 
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tom in MO

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...Then add to this that the FDA is motivated largely by $$ as is the whole industry of course. The greater the perceived profits the more likely whatever it is will get approval by the FDA. And there are the ties of FDA employees who came from big pharma with relationships with their old companies even if not out in the open salary drawing situations. The whole system is corrupt and the FDA is largely toothless or at least chooses to be.

Yeah I'm generalizing but if you think the FDA's #1 focus is to protect patients I have some prime real estate avialable for sale real cheap down around New Orleans or Northern California you might want to invest in....

You are incorrect and slandering the FDA. I work in several areas that are regulated by the FDA. They are a dedicated group of public servants who call themselves "fraud fighters" in their internal training documents. I have had interactions with many FDA employees both at conferences, webinars, meetings and as a subject of FDA inspections. They come about once every 4 years because we are a "good" company thus our surveillance inspection rate is not high. They have all been good people dedicated to protecting your health but also to providing drugs, devices and treatments to ill people like you. In an FDA inspection one must always provide objective proof of compliance to the regulations and an effective product. The FDA are so good at their job they have leveled fines that range up to $2 billion dollars. See here:
FDA settlements

 
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Warrick

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Shame to read that the FDA is bent more than a banana... as a "friends of NATO" country from what I've seen our pharmaceuticals industry here take all the approvals as gospel.
I'll flog a dead horse and say I have spoken to of a number of people on warfarin for Afib switched over to Dabigatran in the last few years
 

vitdoc

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When drugs/devices are certified by the FDA the products are evaluated by panels of “experts” who review the data and vote on approval or not.
The FDA gets the data ready from the manufacturer and makes sure it was done appropriately.

I am sure that most of the FDA people are honest and not in any way corrupt.

But huge amounts of money is sloshing around from the drug industry. These “experts “ often have various connections with the industry as consultants, testing locations or talking heads.
The experts probably feel that their recommendations are not biased. But with the money out there can they really be unbiased?
As drugs get more expensive the stakes get higher.

Given a few head scratchers that have passed FDA evaluation it just makes one wonder how well the system is working. I don’t think however that it is completely corrupt or inept.
 

slipkid

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You are incorrect and slandering the FDA. I work in several areas that are regulated by the FDA. They are a dedicated group of public servants who call themselves "fraud fighters" in their internal training documents. I have had interactions with many FDA employees both at conferences, webinars, meetings and as a subject of FDA inspections. They come about once every 4 years because we are a "good" company thus our surveillance inspection rate is not high. They have all been good people dedicated to protecting your health but also to providing drugs, devices and treatments to ill people like you. In an FDA inspection one must always provide objective proof of compliance to the regulations and an effective product. The FDA are so good at their job they have leveled fines that range up to $2 billion dollars. See here:
FDA settlements


Not been my experience in regards to some issues I alluded to but good to know that some at the FDA actually do their jobs as they should.
 

thomas999

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I get my INR checked every month, and the last 2 months it has been 3.0, with the last check being this morning. I have always thought that anybody with a St Jude mechanical valve would have a target range of 2.5 to 3.5. This has been my understanding for the 35 years I have had the valve. Actually, I have a St Jude valve prosthesis, which of course is a St Jude valve inserted into a Dacron mesh tube that replaced a damaged aorta due to an aneurysm. I was wondering what others in here understand to be the target value for this type of valve prosthesis? I asked my cardiologist, and he deferred me to my primary care physician, who is hard to get a hold of right now because he has one foot in the door of retirement and is not very active in his practice anymore. I am in the process of getting a new primary care physician, which can be a hassle. So my question is, what range do you understand to be the proper Target range?
 

Humboldtgrrl

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Sorry, I cannot help with your query re the Target INR range. Do I understand that you have a St Jude mechanical valve that is stented with a Dacron mesh tube that was used to repair an aneurysm + aortic valve some 35 yrs ago? My sister is scheduled soon for replacement of a surgical (aneurysm stent + tissue aortic valve) because the stent area developed aneurysms at both ends after one year. The second surgery is scheduled with Coselli at Baylor-St. Lukes in Houston. (the first surgery was done in KS). It has been difficult to find someone with a similar history, even on this forum. It sounds as tho your St. Jude valve-stent prosthesis has done very well for you, as you do not mention any performance complications - only the question of the INR range. If I understand your situation correctly, this is a reassuring experience for my sister's pending surgery.
 
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Chuck C

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I get my INR checked every month, and the last 2 months it has been 3.0, with the last check being this morning. I have always thought that anybody with a St Jude mechanical valve would have a target range of 2.5 to 3.5. This has been my understanding for the 35 years I have had the valve. Actually, I have a St Jude valve prosthesis, which of course is a St Jude valve inserted into a Dacron mesh tube that replaced a damaged aorta due to an aneurysm. I was wondering what others in here understand to be the target value for this type of valve prosthesis? I asked my cardiologist, and he deferred me to my primary care physician, who is hard to get a hold of right now because he has one foot in the door of retirement and is not very active in his practice anymore. I am in the process of getting a new primary care physician, which can be a hassle. So my question is, what range do you understand to be the proper Target range?

In my operation, I was given a St Jude mechanical valve with a Dacron sleeve, which replaced my ascending aorta and aortic root. This procedure is usually referred to as a Bental Procedure. My INR was set at 2.5 to 3.5, for the first 3 months. I had a couple of episodes of afib in the hospital, so this may have influenced this INR target. After 3 or 4 months it was clear that there were no longer any signs of afib. At my follow up appointment, my cardiologist and I discussed the appropriate target, given afib was no longer in the picture, and it was reset to 2.0 to 3.0.
 

dick0236

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This may be a bit of a stupid question but what exactly is the big attraction of a lower INR anyway? I was on warfarin for three months post op and my range was 1.8 to 2.5 but I never really felt all that comfortable when I was around the 1.8. I was always more comfortable around the 2.5 and I didn't mind if I went a bit over but I never liked to be under the 1 8. My valve is tissue so its not the same I know but still....I'd always be a bit iffy about being on the lower side of the range, especially with mechanical?
I agree 100%. The only issue I've had was a stroke when my INR got too low. I've never had an issue with a high INR and uncontrolled bleeding. BTW, I've successfully been on warfarin 55+ years.......my range is 2.5-3.5 and I am most comfortable a little above 3........lower INR is a marketing gimmick.
 

thomas999

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I agree 100%. The only issue I've had was a stroke when my INR got too low. I've never had an issue with a high INR and uncontrolled bleeding. BTW, I've successfully been on warfarin 55+ years.......my range is 2.5-3.5 and I am most comfortable a little above 3........lower INR is a marketing gimmick.
I have related this story before in this forum, but my INR jumped to over 12.5 .
This was due to an abrupt medication change. For about 5 years I took Xanax at bedtime to help me sleep, and then stopped it abruptly. Xanax is a medication that probably shouldn't be stopped abruptly but tapered off. I think my system got so used to the Xanax being there everyday that it sort of went haywire when it didn't get it anymore all of a sudden. I started bleeding from every soft tissue in my body, and in fact my legs were turning blotchy red as if the blood wanted to seep out. I was coughing up blood from my lungs and probably my stomach and esophagus. I had to be hurried to the emergency room and they got things under control. Thin blood has its dangers as well as not being thin enough has. It's good to stay within the range your doctors advise because both sides of the coin, so to speak, can be really dangerous.
 

Protimenow

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Anticoagulated blood CAN be a problem, but it would take a LOT of warfarin to make your INR jump THAT high (something like dropping Xanax cold turkey).

Like Dick, I'm much more comfortable with my INR at 3 or above, although 2.5 is okay. I had a TIA about nine years ago because I trusted my InRatio meter which was telling me my INR was 2.6 -- the hospital lab result was 1.7.

Having an INR as high as 4.0 (and sometimes even higher than 4) hasn't been a problem for me. It just means I should slightly lower my dosage.

I just started taking a new medication that isn't supposed to affect INR. I'm testing today, just to make sure.
 

thomas999

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Having an INR as high as 4.0 (and sometimes even higher than 4) hasn't been a problem for me. It just means I should slightly lower my dosage.
When it gets to be a bit too high it could cause internal bleeding which might go unchecked because an individual can't see it happening. I have had a St Jude aortic valve for 35 years now and my INR has been as low as 1.9 and as high as 3.7. This of course doesn't include the time it jumped to well over 12 and I was in the hospital. That was sort of an anomaly. It of course is a good idea for all of us to stay within the range the doctors suggest. When mine gets a bit on the high side I start to notice bruising occurring often.
 
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