I haven't read the article, but I did read that Melanie True Hills said,
"so-called "data" was really just computer simulation" So, it is not based on real life data.

I'm really glad that Warfarin in working for you!!!!

Wow! This is huge. Looks like profit over patients has taken the front seat again. Looks like I'll stay on Coumadin until the smoke clears, might be several years now.

Yogacat you really should read this article and the videos of some doctors talking about this. It presents real data, not simulation of data.

There is nothing new or huge about this info. All it says is that BI withheld info regarding the benefits of testing/titration for the old/frail and those with kidney problems. Pradaxa and the other NOACs are still the most effective and safe anticoagulants. These critics of Pradaxa inadvertently praised Pradaxa as better than Coumadin. Read below:

Here is what they had to say (excerpt from http://www.forbes.co...lheims-pradaxa/ ) :

"Analyses performed by the company, Cohen reports, found that if the plasma levels of the drug were measured and the dose was adjusted accordingly major bleeds could be reduced by 30-40% compared with well controlled warfarin. The adjustment would have little or no effect on the risk of ischemic stroke. The internal report concluded that Optimally used (=titrated) Dabigatran has the potential to provide patients an even better efficacy and safety profile than fixed dose dabigatran and also a better safety and efficacy profile than a matched warfarin group."

BETTER EFFICACT AND SAFETY THAN WARFARIN?COUMADIN.



I guess that's why BI wanted to have 110 dose approved... to provide another dose for those people with renal issues or the very old/frail. But the bottom line is that this is pretty much the same old claim, that BI withheld information that titration might be beneficial in some cases. But BI's answer is that the internal debate arose out of a simulation, that would need to be studied further. The issue of plasma levels of the drug have been addressed previously. As I understand it, plasma levels can vary greatly with little or no effect for most people.

Sensationalism.

Bottom line:

The big win for those with afib on anticoagulants is that the staunchest critics say that Dabigatran can work much better (efficacy and safety) then Coumadin, even though BI was not transparent and forthcoming regarding dose monitoring and titration for the old and those with renal problems.



Gotta love it. Larry Huston is making a career out of Pradaxa articles. Reading them is like listening to a friend complain about their ex-spouse. You've heard it all before, so all you can do is nod and smile.

petey

If you want the truth about the simulations, read below. I get so sick of these articles people put out. Warfarin/Coumadin has many identified risks and bizarre side effects. It causes more brain bleeds. Pradaxa has more gastrointestinal bleeds. I would rather protect my brain. You might have a "gut" reaction to the Pradaxa article, but it is better to use your "head". :-)

http://us.boehringer-ingelheim.com/news_events/press_releases/press_release_archive/2014/07-23-14-benefits-safety-pradaxa-dabigatran-etexilate-mesylate-repeatedly-confirmed.html




July 23, 2014
Benefits and Safety of Pradaxa (dabigatran etexilate mesylate) Repeatedly Confirmed


Subject: British Medical Journal publishes biased article regarding PRADAXA

.



Ridgefield, CT, July 23,2014 Boehringer Ingelheim (BI) wants to set the record straight following misleading statements that the British Medical Journal (BMJ) published today regarding Pradaxa (dabigatran etexilate mesylate). We are concerned that this publication may alarm patients and prompt them to stop taking PRADAXA, thereby increasing their risk of stroke.

To be clear, many of the allegations made by BMJ were reported months ago in the media and have been previously addressed in full by BI.

Our company has provided regulators with the complete data set and analyses of clinical evidence demonstrating PRADAXAs benefits and safety, and FDA and EMA have affirmed RE-LYs conclusions and state that PRADAXA provides an important health benefit when used as directed.

BMJ was provided this information by Boehringer Ingelheim, but chose not to include it.

Contrary to the BMJs accusation that BI withheld analyses, here are the facts: in 2012, our scientists performed preliminary, exploratory simulations with mathematical models to understand whether dose adjustments based on plasma concentrations might further improve PRADAXAs benefits and safety.

DID YOU GET THAT? EXPLORATORY SIMULATIONS.

Because the simulations did not offer reliable predictions of actual patient outcomes, they were not provided to regulators. However, all of the data that was used for the simulations had already been provided.

It is inappropriate to provide regulators simulations that are unreliable and have limitations. Post-hoc exploratory analyses are commonly performed to generate or test hypotheses and are not structured to direct patient management. Thus, they generally are not shared with regulators and first need to be tested in a clinical trial, as many hypotheses, such as the one discussed here, prove to be incorrect.

Boehringer Ingelheim made a robust effort to find ways to utilize plasma levels to further improve the risk/benefit profile of PRADAXA and it is irrational to suggest otherwise, said Sabine Luik, M.D., senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. The truth is the totality of scientific evidence does not support dosing decisions for PRADAXA based on blood levels. The research shows that individual patient characteristics, such as kidney function and certain medications, are critical factors in contributing to the risk of bleeding.

We are deeply concerned that the BMJs biased reports could compromise the health and safety of people who may benefit from PRADAXA to reduce their risk of thrombotic events.

Further, innuendos that we should have done more than one trial are false. The pivotal RE-LY trial was intensively discussed and agreed to with regulatory authorities. RE-LY included more than 18,000 patients in over 40 countries, and is one of the largest trials ever conducted in non-valvular atrial fibrillation patients to assess stroke risk reduction. Post-market data assessments from FDA reinforce the favorable risk/benefit profile shown in RE-LY.

FDA published a perspective on the findings from a Mini-Sentinel study in the New England Journal of Medicine in 2013. On May 13, 2014, FDA once again reaffirmed PRADAXAs positive benefit-risk profile when it issued a Drug Safety Communication that included results from a Medicare study comparing new users of PRADAXA and warfarin who had received a diagnosis of atrial fibrillation. This included more than 134,000 Medicare patients, who were 65 years or older. The new study found that, among new users of blood-thinning drugs, PRADAXA was associated with a lower risk of clot-related strokes, bleeding in the brain and death compared to warfarin. The study also found an increased risk of major gastrointestinal bleeding with use of PRADAXA as compared to warfarin, but unlike in RE-LY, no increased risk of MI compared to warfarin.

BMJ also failed to inform its readers that earlier this month, an FDA director authored an article describing atrial fibrillation (AFib), the important role of anticoagulation and novel oral anticoagulants (NOACs) like PRADAXA, rationale behind why the NOACs were approved without an antidote and how the FDA conducts its post-marketing surveillance on all NOACs. The FDA director specifically stated that PRADAXA provides an important health benefit when used as directed.

As with any anticoagulant, there needs to be a balanced consideration of stroke risk reduction and bleeding risk. Patients should not stop taking their anticoagulant medication without first talking to their health care providers. Discontinuing anticoagulation therapy puts a patient at increased risk of stroke.


petey

I disagree with you completely. I don't even think we are talking about the same article I referred to. You and I probably don't look at these pharmacologist the same way. I am the type of person that takes everything they say with a grain of salt. I also don't trust the doctors that have jumped on this bandwagon too soon. The cardiologist that came to see me in the hospital just told me he wanted me to take Xarelto period. I told him I wanted to look in to blood thinners before making a decision so he gave me a prescription for enteric aspirin. I went to different cardiologist and he said the same thing: take Xarelto. I did it and ended up in the emergency room twice. Neither one of them suggested I take Coumadin. I told him that is what I wanted so he prescribed it. I don't know why you feel so secure in taking these drugs with such a short track record. I have been doing fine on warfarin. No problems at all and am glad I got it. Another thing that plays into my decision on any drug is the cost. These new drugs are just too expensive.

Same conversation is on-going in the Pulmonary Embolism group. After reading the Medpage article

(http://www.medpagetoday.com/Cardiology/Arrhythmias/46942)

and the comments section

(http://www.medpagetoday.com/Cardiology/Arrhythmias/46901)

I found that it didn't change my feelings about using Eliquis nor would it if I had chosen Pradaxa. I knew the drugs were new. New drugs sometimes have side-effects that don't come to light for years. The benefits of the new drugs far outweigh (for me) the risks.

My feeling is that whenever you take a drug, prescribed or otherwise, you are a guinea pig. No one can say that you are like the "average" person that takes the drug and won't have a reaction.

I do agree that having information is helpful when making a choice. I don't like it when information is withheld. But I didn't see anything in the article that led me to conclude that information was withheld.

Right now I'm very content with my choice. I wouldn't be if I only had warfarin as my choice.

Todd

And so many people have had horror stories and deaths on Warfarin. This is not a choice between NOACs and milk.

I didn't read the article. My cardiologist wanted me to take Eliquis because he said it had a better safety profile than aspirin or warfarin. The cost for me is not expensive. It's only $25/month but my cardiologist gave me a 6 week supply. I have been on it for three weeks now and no problem. I like that I don't have to monitor my INR and watch what foods I eat.

And by the way, Hi everyone. Woke up in AF this morning at 0415... always when I want to sleep. I must say all of your wise wisdom, comments and insights has REALLY helped me feel better about myself and this AF! I can't thank all of you enough! My prayers also go out to all of you who are having more challenges than I am with the AF.

kcarr: Pradaxa costs me $10 a month. Xarelto has a good safety/efficacy record. Why did you wind up in the hospital twice? What kind of bleeds? Coumadin has a terrible record of bleeds and emergency room incidents. It had the highest amount of adverse events in ERs of any drug for decades. They don't report old drugs as much for adverse events any there is less money in lawsuits for drugs when there are generics. Coumadin/Warfarin didn't get suddenly safe. The problems with Pradaxa involved very old patients. I don't believe just doctors and drug companies, I look at informed websites like stopafib.org. If you like Coumadin, take it. petey

Petey I do as much research as you seem to do but I guess we see what we want to see regarding the dangers of each of the drugs including warfarin. I ended up in the emergency room twice with severe intestinal problems and after cat scans, etc. they couldn't find anything that could be causing the problem other than possibly the Xarelto. After stopping the Xarelto the pain went away. Also the Xarelto cost me $95,00 per month. As I said the warfarin works fine and I feel better than there is a reversal method for bleeds. I just found a chart that shows the history of Pradaxa. It shows that the FDA started a safety review of excess reported bleeding with Pradaxa and found that Pradaxa was lined to 542 patient deaths and 2,367 reports of hemorrahage vs 72 deaths on Warfarin in 2011.

I guess we will have to agree to disagree on this subject.

Is Pradaxa the blood thinner that should not be take be folks over 75?

"Reported" deaths. This topic has been discussed for years.

Missd: 80 or 75 and "frail" would have to be monitored on Pradaxa. 80 was the age they used to define elderly when talking about Pradaxa appropriateness and dosage.

kcarr: The deaths that occurred were where patients, especially elderly, were given the wrong dose of Pradaxa by their doctors.
That was in Australia, New Zealand, and Japan, where elderly were often given the 150 mg dose instead of the 110 mg dose approved for those with low renal clearance (kidney issues) and the elderly.

In the US, some elderly were given the 150 mg dose rather than the 75 mg dose the FDA approved for those with low renal clearance and the elderly. (That was based on the FDA's computer modeling that said that the 75 mg dose was more appropriate than the 110 mg dose).

So many of the problems were where doctors didn't prescribe properly. For whatever reason, the FDA didn't approve the 110 dose, that could be used here.

I have researched this topic and have gotten feedback from the experts. I am sure I have researched it more than you, or as you say, I "seem" to do. Fear mongering is not good for people on a support website. Particularly when it is uninformed.

Coumadin and all anticoagulants have potentially serious side effects. Newer drugs always are reported more frequently than old drugs.

In 2011, Coumadin was the drug associated with the most emergency room visits for older Americans:

"The blood thinning medication warfarin (Coumadin, Jantoven), which is used to treat blood clots, was involved in 33 percent of emergency hospitalizations."

http://usatoday30.usatoday.com/news/health/medical/health/medical/treatments/story/2011-11-25/Four-common-meds-send-thousands-of-seniors-to-hospital/51397208/1

So anyway, I believe in science and evidence based medicine. I don't chose to believe what I chose to believe.