Started PT, would like to get off Plavix

The discussion of the Linus Pauling vitamin C/lysine invention for chronic scurvy

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ofonorow
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Started PT, would like to get off Plavix

Post Number:#1  Post by ofonorow » Wed Aug 03, 2011 3:44 am

My question is...do high amounts of vitamin c cause a thinning of the blood
I am using Plavix because of 5 stents I have. Larry


No - vitamin C has no known effect of "thinning" the blood. I do know that more than one trial of plavix has been canceled early ecause the plavix group was dying faster than the placebo group.

With that many stents you should definitely research and consider oing on Linus Pauling's vitamin C/lysine therapy.




Thank you for your prompt reply to my last question. I am 79 years old with 5 stents and I started the C/Lysine therapy in April 2011. It has given me great hope that I will not have to have anymore stents or heart procedur es. I have been on plavix since my last stent procedure which was June of 08, and would like to get off of it. I need your or one of your cardiolis t's recommendations. Larry
Owen R. Fonorow
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American Scientist's Invention Could Prevent 350,000 Heart Bypass Operations a year

Ranne

Re: Started PT, would like to get off Plavix

Post Number:#2  Post by Ranne » Sat Aug 20, 2011 6:52 pm

Owen do you communicate with this person? I'm interested to know why he wants to get off the Plavix (cost? side effects?)

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Re: Started PT, would like to get off Plavix

Post Number:#3  Post by ofonorow » Mon Aug 22, 2011 3:54 am

Most people want to get off drugs. In the case of Plavix, at least two and maybe three clinical trials were cut short because the Plavix groups were dying faster than the placebo groups!
Owen R. Fonorow
HeartCURE.Info
American Scientist's Invention Could Prevent 350,000 Heart Bypass Operations a year

Ranne

Re: Started PT, would like to get off Plavix

Post Number:#4  Post by Ranne » Mon Aug 22, 2011 9:22 am

The only trial I'm aware of where more deaths were reported in the Plavix-treated group was on people who had multiple risk factors for CAD but no diagnosed CAD (if you could point me to the others I'd like to read them.) Since Larry in your post had multiple stents I would guess he was diagnosed with CAD; I was interested in more information about his history (previous MIs, etc.) or what his specific concern about Plavix is. I was inquiring if you knew why Larry wanted to stop taking it or whether you could ask him... not so much your personal opinion of Plavix, which I'm already aware of.

"Most people want to get off drugs" is a vague and unhelpful thing to say. I don't think most women on birth control pills want to get off them, but if they do they usually have a specific reason.

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Re: Started PT, would like to get off Plavix

Post Number:#5  Post by ofonorow » Tue Aug 23, 2011 6:23 am

ACTIVE W trial
http://www.medicalnewstoday.com/releases/30280.php

Note that Plavix is the marketing name for Clopidogrel

CHARISMA trial
http://www.medicalnewstoday.com/releases/39838.php
While the CHARISMA trial (Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management and Avoidance) results have shown no benefit overall of the combination of Clopidogrel and aspirin in the long term in stable vascular patients, and some indication of harm in patients in primary prevention


http://www.medicalnewstoday.com/releases/87684.php
http://www.medicalnewstoday.com/releases/96377.php
http://www.medicalnewstoday.com/releases/102121.php
http://www.medicalnewstoday.com/releases/118997.php
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Re: Started PT, would like to get off Plavix

Post Number:#6  Post by Johnwen » Tue Aug 23, 2011 12:13 pm

They just keep coming everybodies trying to get their share of that 3 billion dollar market

http://www.medicines.org.au/files/appbrili.pdf
To steal ideas from one person is plagiarism. To steal from many is
research!

Ranne

Re: Started PT, would like to get off Plavix

Post Number:#7  Post by Ranne » Tue Aug 23, 2011 12:18 pm

ofonorow wrote:ACTIVE W trial
http://www.medicalnewstoday.com/releases/30280.php

Note that Plavix is the marketing name for Clopidogrel


Thank you Owen, so this is the study that was stopped? (I only see one that was.) You realize this ACTIVE W trial was for atrial fibrillation (an experiment to see if Plavix works on something else, besides what it is already known to be effective for?)

What Plavix has been shown clearly to do is protect patients after cardiac stenting. Larry confirms that is why he was given it: "I am using Plavix because of 5 stents I have." So although that trial is interesting, how is it relevant to Larry and his 5 stents to bring up a Plavix study on a condition he hasn't even claimed to have, in response to his post, while not mentioning studies that might actually apply: Dangers Of Stopping Clopidogrel (Plavix®) For Patients With Stents And Certain Other Conditions taking Plavix?

http://www.medicalnewstoday.com/releases/39811.php

Incidence of death and recurring acute coronary syndrome after stopping clopidogrel therapy in a large commercially-insured population in the US

http://www.ncbi.nlm.nih.gov/pubmed/21438795

Thank you for gathering the links.

CHARISMA trial
http://www.medicalnewstoday.com/releases/39838.php

While the CHARISMA trial (Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management and Avoidance) results have shown no benefit overall of the combination of Clopidogrel and aspirin in the long term in stable vascular patients, and some indication of harm in patients in primary prevention


The CHARISMA trial is the one I was familiar with. As I said, the higher mortality rate was in patients with multiple risk factors but without established vascular disease. In the stable vascular patients there was either some benefit or no benefit depending on the timeframe. Not "Plavix patients dying faster than the placebo group."

"Some potential benefit of dual antiplatelet therapy was detected when the patients with established cardiovascular disease were analyzed separately, but increased bleeding and higher mortality rates were revealed when the patients with multiple risk factors alone were analyzed. The CHARISMA investigators conclude that dual antiplatelet therapy should not be used in patients without a history of established vascular disease."

http://www.medscape.com/viewarticle/528468



TRITON-TIMI 38 was a head to head trial of Clopidogrel versus Prasugrel. You could summarize the results with "Clopidogrel good, Prasugrel better." Primary endpoint was combined cardiovascular death/non-fatal MI/non-fatal stroke. Clopidogrel reduced risk by 9.7 percent, Prasugrel reduced it by 11.9 percent.



Cerebrovascular stents, and some patients were resistant to Clopidogrel - they didn't respond to it. Mainly diabetics and those in certain age groups. I don't see where the treatment group was dying faster than a placebo group, but I will try to find another report on that study and see.



This is the TRITON-TIMI 38 trial again, just measuring a different endpoint (stent thrombosis) Again: Plavix good, Prasugrel better.



TRITON-TIMI 38, another endpoint (recurrent events). Plavix good, Prasugrel better.

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Re: Started PT, would like to get off Plavix

Post Number:#8  Post by ofonorow » Wed Aug 24, 2011 4:05 am

Interesting interpretations. More than one Plavix trial was stopped years ago, and since they were never published, these reports are hard to find. (I'll keep looking.)

Do you deny that more than one trial was curtailed early?

The reasons given for ending the clinical trial in the news reports were that the Plavix groups were experiencing higher mortality w/r to the placebo group. (There may have been bleeding or other issues.) It doesn't matter to me all that much why Plavix was apparently killing patients, but I may be missing something. If you feel comfortable with the distinction about the patient types, that is your opinion.

I do know that the FDA has also taken action to add warnings to the label, and here is the response to that action:


http://www.medicalnewstoday.com/releases/193278.php

Here are some of the latest FDA warnings:

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm207476.htm#Plavix:LowerEffectivenessinSomePeople

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm192103.htm#PlavixandPrilosecDrugInteraction

You can also keep an eye on the class action lawsuits against Plavix
e.g.

http://www.youhavealawyer.com/plavix/lawsuits-class-action.html

http://www.plavixmayincreasebleeding.com/


http://www.plavixhelp.com/plavix-lawsuit/index.html

I'll keep trying to find information on the trials that were halted.


p.s. Here is another trial that was halted, supposedly because of a bankruptcy.

http://www.theheart.org/article/1007145.do
COGENT trial results

As previously reported by heartwire, the COGENT trial was stopped early after the trial sponsor, Cogentus Pharmaceuticals (Palo Alto, CA), declared bankruptcy. The trial was a phase 3 study testing the company's combination product, known as CGT-2168, in patients requiring clopidogrel for at least 12 months, typically following non-ST-segment-elevation ACS, STEMI, or stent implantation. CGT-2168 was to be a once-daily pill that combined 75-mg clopidogrel with 20 mg of the gastroprotectant omeprazole.

The study was stopped with only 3627 patients enrolled out of the roughly 5000 investigators had hoped to recruit. Mean follow-up was 133 days (and a maximum of 362 days), with 136 adjudicated CV events and 105 adjudicated GI events. An additional 14 events have not yet been adjudicated, Bhatt noted.


Showing survival data out to 390 days, Bhatt reported that 67 cardiovascular events—a composite of CV death, nonfatal MI, CABG or PCI, or ischemic stroke—occurred in the placebo group and 69 in the omeprazole group, with superimposable event curves. For the end points of MI alone and revascularization procedures alone, event curves once again were identical.

In analyses taking into account baseline variables or medical history, there was no signal of increased cardiovascular events for patients treated with omeprazole in any subgroup. By contrast, looking just at GI events (upper-GI bleeding, symptomatic upper-GI bleeding, pain of presumed GI origin with underlying multiple erosive disease), researchers found that event rates were significantly higher in patients randomized to placebo.


Randomized to placebo?
Owen R. Fonorow
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American Scientist's Invention Could Prevent 350,000 Heart Bypass Operations a year

Ranne

Re: Started PT, would like to get off Plavix

Post Number:#9  Post by Ranne » Wed Aug 24, 2011 8:02 pm

I can't keep all your colors straight when I reply so forgive my wandering from blue to grey to black...
ofonorow wrote:Interesting interpretations. More than one Plavix trial was stopped years ago, and since they were never published, these reports are hard to find. (I'll keep looking.)

Do you deny that more than one trial was curtailed early?


As I said, I am not aware of more than one. If you can find them I'm happy to read them. If any are trials on people with stents post-MI, I'd sure like to know about them, believe me.

The reasons given for ending the clinical trial in the news reports were that the Plavix groups were experiencing higher mortality w/r to the placebo group. (There may have been bleeding or other issues.)


They stop the trial, they know the drug is dangerous to give to that type of patient, and it won't be prescribed for them. Plavix reduces mortality in certain people. I have no doubt it's bad for others. I started this conversation to determine whether it might be bad for Larry and why you would comment to him about studies that would appear to have no relevance to his situation.

It doesn't matter to me all that much why Plavix was apparently killing patients, but I may be missing something. If you feel comfortable with the distinction about the patient types, that is your opinion.


I'd be very uncomfortable NOT making the distinction. We are all patient types, like it or not. Someone with primary hyperoxaluria could rightly claim megadosing Vitamin C was dangerous... for them. Drinking water can be dangerous if you're already overhydrated. People with life-threatening anaphylactic reactions to nuts haven't frightened me away from eating almonds. Thalidomide has horrific results in pregnant women but is used effectively on leprosy patients. If you don't draw distinctions between different people taking Plavix I think you are missing something, yes.

No drug is meant for everybody to take. That's why they have contraindications. It's why we have prescriptions. It's an attempt to keep people who don't need a drug or are at risk from it away from it.



I'm not sure what your point is here.

I'm in favour of warnings on the labels and updating them whenever something new is learned. I got warnings from 3 doctors + a pharmacist before I even got to the label. I like that; nobody can make an informed choice if they're not informed.



If I kept an eye on all the lawsuits I'd have no time to go outside, but I'm sure some people have a case and some don't. If some people shouldn't have taken Plavix and suffered harm from it, the fault may lie with the drug company, or with the doctor who prescribed it, or even with the patient (if they didn't give an accurate history or misused the drug.) But the existence of lawsuits, on its own, really doesn't mean anything. Wherever there is money there will be people suing. It's encouraged by whopping settlements for things like coffee being too hot.

I'll keep trying to find information on the trials that were halted.


Okay.

p.s. Here is another trial that was halted, supposedly because of a bankruptcy.
http://www.theheart.org/article/1007145.do

COGENT trial results

As previously reported by heartwire, the COGENT trial was stopped early after the trial sponsor, Cogentus Pharmaceuticals (Palo Alto, CA), declared bankruptcy. The trial was a phase 3 study testing the company's combination product, known as CGT-2168, in patients requiring clopidogrel for at least 12 months, typically following non-ST-segment-elevation ACS, STEMI, or stent implantation. CGT-2168 was to be a once-daily pill that combined 75-mg clopidogrel with 20 mg of the gastroprotectant omeprazole.

The study was stopped with only 3627 patients enrolled out of the roughly 5000 investigators had hoped to recruit. Mean follow-up was 133 days (and a maximum of 362 days), with 136 adjudicated CV events and 105 adjudicated GI events. An additional 14 events have not yet been adjudicated, Bhatt noted.


Showing survival data out to 390 days, Bhatt reported that 67 cardiovascular events—a composite of CV death, nonfatal MI, CABG or PCI, or ischemic stroke—occurred in the placebo group and 69 in the omeprazole group, with superimposable event curves. For the end points of MI alone and revascularization procedures alone, event curves once again were identical.

In analyses taking into account baseline variables or medical history, there was no signal of increased cardiovascular events for patients treated with omeprazole in any subgroup. By contrast, looking just at GI events (upper-GI bleeding, symptomatic upper-GI bleeding, pain of presumed GI origin with underlying multiple erosive disease), researchers found that event rates were significantly higher in patients randomized to placebo.


Randomized to placebo?


Yes, GI events were higher in the placebo group without omeprazole.

Everyone took Plavix. The placebo group refers to Plavix by itself, you understand that right? The treatment group was Plavix + a stomach-protecting add-on.

The study was meant to find out 2 things: whether Plavix + omeprazole would reduce gastrointestinal bleeds/pain caused by the Plavix, but mainly whether the omeprazole might blunt the beneficial effects of the Plavix (interfere with absorption, etc.) They were concerned that if they added a gastrointestinal protectant to the Plavix, the number of heart attacks etc. would rise.

The cardiovascular events stayed the same in both groups, so the omeprazole was not affecting the Plavix working.

The bankruptcy is interesting because prior to this study, the media ran with a story that such 'combined therapy' would keep the clopidogrel from working properly, based on observational data, before a randomized placebo controlled trial was done. And the FDA issued statements that the combination might be dangerous. It seems the company claims this negative publicity is what sunk their drug. I wouldn't blame them for being pissed when they do a proper study showing the concern was baseless.

"...a panel of experts talked over one another to implore reporters to do a better job at differentiating between randomized controlled trial results and observational studies. The latter have been widely reported in the media—including on theheart.org—and have been largely responsible for raising concerns that concomitant PPI therapy, taken to minimize gastrointestinal side effects, might blunt antiplatelet effects of clopidogrel. Both the European Medicines Agency (EMEA) and the FDA have, in the past year, issued public statements on a possible adverse interaction between clopidogrel and PPIs.

"No more headlines about observational studies on theheart.org. Please," Dr Shamir Mehta (McMaster University, Hamilton, ON) scolded. "This is it. This is the real thing. This shows you how you can be completely misled by observational data, and those data can [lead] to opinions that are blown way out of proportion, to the point where health authorities change the labeling of these agents without randomized trial evidence. Now we have a randomized trial that shows this is not the case."

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Re: Started PT, would like to get off Plavix

Post Number:#10  Post by ofonorow » Thu Aug 25, 2011 4:55 am

I have no interest in Plavix.

I do not want to become an expert in Plavix.

I happened to notice news reports over the years that multiple trials of this drug have been halted. This raised a red flag, especially in one case when the Plavix group was dying faster than the placebo group.

Of course the drug company will attempt to put the best spin on this, by blaming the failure on a certain class of patients. The question is, how do you identify whether you are a member of a particular class? (I notice that the FDA now says, the risks increase because of a specific genetic disposition, and there is a genetic test for this.)

But I also noticed that the risks may be associated with a diminished P450 "system" which implies that ingesting grapefruit juice would be harmful with this drug!

Re:

I'd be very uncomfortable NOT making the distinction. We are all patient types, like it or not. Someone with primary hyperoxaluria could rightly claim megadosing Vitamin C was dangerous...


Not if they were megadosing with sodium ascorbate. According to Pauling, calcium oxalate stones generally form in acidic urine. Vitamin C can be taken in its non acidic form - sodium ascorbate, which would in theory be highly protective. References: Pauling's HOW TO LIVE LONGER AND FEEL BETTER, pg 350-351 (paperback)

We have posted this before, but as a review:

It is well known that there are two class of kidney stones, and that a tendency to form them should be controlled in two quite different ways. The stones of one class, comprising nearly one half of all urinary calculi, are composed of calcium phosphate, magnesium ammonium phosphate, calcium carbonate or mixtures of these substances. They tend to form in alkaline urine and persons with a tendency to from them are advised to keep their urine acidic. A good way, probably the best way, to acidify the urine is to take 1 gr or more of ascorbic acid every day. Ascorbic acid is used by many physicians for this purpose....

The kidney stones of the other class, which tend to form in acidic urine, are composed of calcium oxalate, uric acid, or cystine. Persons with a tendency to form these stones are advised to keep their urine alkaline. This can be achieved by their taking vitamin C as sodium ascorbate or by taking ascorbic acid with just enough sodium hydrogen carbonate (ordinary baking soda) or other alkalizer to neutralize it.

Not a single case has been reported in the medical literature of a person who formed kidney stones because of the large intake of vitamin C.

Linus Pauling HTLLAFB p.350



And this transcribing exercise reminded me of my initial contention - that anyone on a drug, by definition, a toxic substance foreign to the body, would want to get off the drug. For the best support of this contention, I might suggest taking the time to read the entire Pauling book HTLLAFB (1986).



p.s. Noticed that the FDA has issued a Mar/Jun 2011 recall for Plavix
http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm259420.htm
PRODUCT
PLAVIX (clopidogrel bisulfate) Tablets, 75 mg, 30 count bottles, NDC 63653-1171-6. Recall # D-557-2011
CODE
Lot 0F61121 Exp Jun 2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bristol-Myers Squibb Co., New Brunswick, NJ, by letters on March 1, 2011.
Manufacturer: Bristol Myers Squibb Manufacturing Co., Humacao, PR. Firm initiated recall is ongoing.
REASON
Chemical contamination; presences of 2,4,6-tribromoanisole (TBA).
VOLUME OF PRODUCT IN COMMERCE
105,576 bottles
DISTRIBUTION
Nationwide
Owen R. Fonorow
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American Scientist's Invention Could Prevent 350,000 Heart Bypass Operations a year


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