Medical Insider Blog

From bad to worse (Part III)

  • Posted Nov 13, 2012
  • Alan Niederman, MD, FACC, FACP

So we have a conundrum.  Which is better: utilizing a new drug that works all the time and is easy to use but has a major drawback or an old drug that does not have the drawback but is impossible to use?   The answer is, "Who knows?"  I will  lay out the facts.

As I have mentioned before, only about 60% of the patients who are "supposed to be anti coagulated" because they have atrial fibrillation are actually anti coagulated.  Surprisingly, the use of the newer anticoagulants has not altered that number. Let me list some of the reasons that this happens.  At times doctors just don't realize that it is important. Sometimes there is a disagreement between doctors as to how to proceed, and the patient becomes confused.  Sometimes the patient refuses to use the drug regardless of their doctor's request.  You can do anything you want as long as you understand the issue and the possible consequences. Many of these patients are older and frail and have many co-morbities that make it almost impossible to anti coagulate them properly.  We as physicians just basically give up as the hassle for everyone just doesn't make sense.  If you the patient are trying, but we the physician never get you anti coagulated, you are not protected anyway.

Even in the best of hands anticoagulation is only correct 60% of the time.  How do I know this?  That is how often the "experts," who did the work of drug approval on these drugs, got it right.  This number has been replicated many times, and so it is not exact but pretty darn close.  How can people take a drug that is only dosed right 60% of the time?

Further, as reported in the Archives of Internal Medicine (Arch Intern Med 2012; DOI:10.1001/archintmed.2012.4485) in an article titled "Persistence with therapy among patients treated with warfarin for atrial fibrillation,"  more that 60% of the people who started taking warfarin stopped after five years.  It gets better.  8.9% didn't fill their second prescription.  31.8% stopped after one year.  43.2% stopped after two years.  61.3% stopped by five years.  More to the point, the mean stop time was 2.9 years.  That means that half the people had stopped by that time.  This group of people were in Ontario and were 66 years or older.  They all had insurance.  In this country I'm sure the numbers would be worse.

What to do?  My opinion, the one that I share with my patients, is that these new drugs are far easier to use than warfarin and provide a stable effect.  I prefer Xarelto because the pills are not fragile, and it is taken once a day.  The risk of difficulty when someone bleeds is real, but we as physicians make choices all the time that play the odds.  You can't live life worrying about all the "what ifs."  If you really need to be anti coagulated, then you should take the best drug possible to avoid the strokes associated with the condition.  I believe that patients who have had bleeds, or have a condition that might lead to bleeding, should not receive these newer drugs.

It is early in the game, and these real issues will be worked out over time.  No one is going to spend the money to find an antidote that no one will use.  Progress in this field will allow us to modify the bad effects and retain the better treatment results.

Progress in medicine is not a straight line.

From Bad to Worse (Part II)

  • Posted Nov 08, 2012
  • Alan Niederman, MD, FACC, FACP

Pradaxa is once again in the news.  Two very different stories about the drug were published on November 2, 2012.  The first was published in the New York Times, written by Katie Thomas and is entitled "A Promising Drug With a Flaw."  The second is a FDA Drug Safety Communication regarding Pradaxa.

The FDA undertook a review of the bleeding episodes of Pradaxa to follow-up on a FDA Safety Communication of December 7, 2011.  This new safety study concludes that "the results of this Mini-Sentinel assessment indicate that bleeding rates associated with new use of Pradaxa do not appear to be higher than bleeding rates associated with new use of warfarin, which is consistent with observations from the large clinical trial used to approve Pradaxa (the RE-LY trial)."

The data according to the FDA report shows that intracranial hemorrhage, which is the most dreaded bleeding complication, occurs 1.8 to 2.6 times higher in new users of warfarin than Pradaxa per 100,000 patient days at risk.  The rates of gastrointestinal hemorrhage were 1.6 to 2.2 times higher for new users of warfarin than Pradaxa per 100,000 patient days at risk.  The excess bleeding in warfarin users is likely due to physicians' inability to control the effect of the drug on patients and the multiple interactions of warfarin with other drugs that patients are often given without a full understanding of their medical conditions.

So what is the problem that has the New York Times so spun up?  The problem is that Pradaxa has no way to be reversed.  It just has to "wear off," and in that time, the bleeding may not be controllable, and the patient can die.  Some conditions like intracranial hemorrhage are so devastating and unpredictable that it often doesn't matter what we do.  Further, although there is an antidote for warfarin, let me lead you through the steps.

First ,we have to figure out that you are on warfarin and that you are actually anti-coagulated. The data shows that this only happens about 60% of the time.  Second, you have to be "typed and crossed" to find out what blood type you are.  Third, the fresh frozen plasma needs to be unfrozen.  It can't be placed in a microwave.  It is put in a warm water bath and gently rocked back and forth.  I am not kidding.  You can hop up and down all you want, but you the doctor and you the patient  are not getting the fresh frozen plasma until the blood bank is good and ready to give it to you.  Then you have to administer it.  All of this takes precious time.  In the meantime, physicians do what we can, just like always, to support the patient.

The data to approve Pradaxa and Pradaxa itself need to be better understood.  First, we physicians give Pradaxa to any patient, but the oldest patient in the study to approve Pradaxa was around 80 years old.  The mean age in the RE-LY  study to approve was 71.4 +/- 8.6 years.  The older you are, the more likely you are to have a poor outcome.  Second, as I have blogged about before, the FDA made up the 75 mg dose.  The RE-LY study used both a 150 mg does and a 110 mg dose.

More - and there is plenty more - next week.

From bad to worse (Part I)

  • Posted Nov 06, 2012
  • Alan Niederman, MD, FACC, FACP

I have blogged recently about the disaster of contaminated drugs and about Pradaxa; both topics remain in the news. First, the contaminated drugs: this event is nothing short of a disaster. The company New England Compounding Center and its sister company, Ameridose, are both shut down. When the FDA tested 50 vials from one of the lots of the drug, all 50 vials were contaminated. In one lot, 83 of 321 vials had visual contamination of "greenish black matter," and 17 vials had "white filamentous matter." 29 patients have died, and a total of 404 cases have been identified. Most of these relate to injection of the material in the spinal column, but some relate to injection of the material into other joints like knees and shoulders.

Now a second problem has been added to the devastation of the first one. This problem is the development of an abscess at the site of injection. This abscess can extend into the space around the spinal cord known as the epidural space. This is a devastating problem. Perhaps not fatal but it can lead to paralysis and chronic pain. It is possible that some of these patients may need treatment the rest of their lives as the fungus may be controlled but never cured. This second infection seems to be occurring in at least 30% of the cases.

Further complicating the picture is that these secondary sites are occurring in patients who have been receiving treatment for the fungus, which is called Exserohilum. These infections can only be identified by MRI scans. Not much has been heard from the FDA, and there is speculation that the reason is pending Federal indictments. Certainly, this problem will require hearings and new legislation to mandate further protection of the public who rely on medication. This is another cautionary tale for those people who believe that States and not the Federal government should take care of their own.

In my blogs last month on trying to expand the use of Pradaxa, I mentioned that a study was underway to evaluate the use of Pradaxa in the anticoagulation of mechanical valves. This study, known as RE-ALIGN, has two arms. The first arm randomized patients immediately after surgery, and the second arm three months or later after surgery. The first arm has just been discontinued after an excessive number of strokes occurred.

The second arm continues. No new patients are being enrolled. This work is taking place in Europe and Canada. The dose of Pradaxa is the same dose that is being used for atrial fibrillation. This may not be the proper dose. When we use warfarin for the purpose of anti-coagulating valves, the INR level we use is 3-4. The level for atrial fibrillation is 2-3. The dose of Pradaxa used may simply be too small. Although not done clinically, the levels of Pradaxa in your bloodstream can be identified. The levels found in the first arm were lower than those compared to the atrial fibrillation group. This is what research is about. Entering the maze and trying to find your way out. Next...more "bad" press for Pradaxa.

Transcatheter Aortic Valve Replacement (TAVR) at 10 years (Part II)

  • Posted Nov 01, 2012
  • Alan Niederman, MD, FACC, FACP

This transformational technology has now been carried out and followed for three years in the United States and longer in Europe.  In PARTNER B, which randomized patients to either TAVR or medical therapy at one year, the TAVR group had a mortality of 43.3% and the medical therapy group was 68%.  Cardiac death was TAVR 31% and medical therapy 62.4%.

PARTNER A was a randomization of TAVR vs. SAVR or surgical aortic valve replacement.  This revealed at two years that the all cause death rates were similar.  This meant that either approach was beneficial.

At the recent TCT meeting in Miami Beach, the three-year data were presented from the PARTNER B group.  At three years, 80.9% of the medical therapy group had died.  54.1% of the TAVR group had died.  The value over time went from a 20% reduction in death at one year, to a 25% reduction at two years, to a 26.8% reduction after three years.

Nonetheless, this is a very sick group of patients:
Rehospitalization:  75.7% vs. 42.3% \
Mortality or Rehospitalization: 93.1% vs. 66.3 %
Mortality or stroke: 80.9% vs. 57.5%

The take home message is that even with the benefit of this treatment, these patients are sick and need aggressive follow-up care.  The patients who are "too sick for TAVR" may represent a group of patients for which a new treatment model should exist, which is primarily that of comfort care.

This therapy continues to expand.  There are more than 10 new valves which are under development in Europe.  Some of these are quite innovative.  The largest technical hurdle is preventing leaks around the new valve because the "fit" of the new valve in the old valve is imperfect.  At open surgery, the leaks around the valve are minimal or nonexistent because the surgeon has exact control.  When the valve is implanted without that the imperfect fit, it sometimes causes problems.  This is being adjusted by a bigger "skirt" around the bottom of the valve.  This valve is undergoing trials in Europe (of course) and should be available here in the United States in two to three years.

Most recently, the second approach to the valve site has been approved in the United States.  Of course, they have been doing it this way in Europe for five years.  The standard approach is through the leg, but the patient needs an artery that is 9 mm or greater.  In elderly petite patients, who often have the problem of aortic stenosis, the arteries are just too small.  We are now allowed to implant the valves directly through the heart.  The tip of the heart, or apex, lies right under the breast, and a small one- to two-inch incision is made on the chest to access the tip of the heart.

Sutures are then placed in the heart while it is beating, the delivery device is placed directly in the heart, and the new valve is implanted.  The delivery device is removed and the sutures pulled tight.  This procedure has been around for several years and both delivery approaches are well-understood.  The patients who get the transapical approach tend to be sicker than the transfemoral cohort.

In one last example of our inadequate system, there are more elegant ways to implant the valve, but they are not allowed by Medicare.  Eventually, but not now.

At Holy Cross Hospital, we are allowed to perform TAVR in both ways.  We have had excellent results in our first 13 patients.  We have had no deaths, strokes or vascular problems.  We have an excellent team of surgeons and interventional cardiologists who are spending a great deal of time to ensure that we provide to best service to our community.  Our Valve Clinic is run by a full-time Nurse Practitioner who is dedicated to this group of patients. After 10 years, this technique is becoming available to a wider selection of patients.  I will continue to update you as we continue to advance this technique.

Transcatheter aortic valve replacement (TAVR) at 10 years (Part I)

  • Posted Oct 30, 2012
  • Alan Niederman, MD, FACC, FACP

Yes it has been 10 years. Actually, it was April 16, 2002 when the first aortic valve was replaced in man in the cath lab and not the operating room. It was done by one of the seminal thinkers in cardiology, Dr. Alain Cribier, who is Chief of Cardiology at Hôspital Charles Nicolle, University of Rouen, France.

The odyssey started in 1985 when he proposed and started to use a balloon to crack open the aortic valve. When I was at Emory University, I too participated in these first attempts. It made "sense" to us as we were enthusiastically opening everything with balloons at that time. Dr Gruentzig had died, and he wasn't around to supervise us. It became clear after about a year that the technique did not work as the valve quickly stiffened, and the procedure itself had at times catastrophic events such as stroke and death. Most of the world stopped but not Dr. Cribier. He went on to experiment in animals first by stenting open valves, which did not work, and then by developing a new type of valve that worked in animals. He did this in the form of a company called Percutaneous Valve Technology. This company was then purchased by Edwards Life Sciences and is the forerunner of one of the valves we use today.

The first case was done on a patient who was 57 years old and was desperately ill. The patient was in shock with low blood pressure and had a baseline ejection fraction of 10% (Normal is 60%). Further, he had no leg arteries to carry the valve, so the valve was implanted from the right femoral vein through the wall dividing the top chambers of the heart, into the left side of the heart through the mitral valve, and then out through the aortic valve. A true tour de force of cath skills. The valve worked well, but the patient died 17 weeks later from his baseline problems.

The work was published in Circ:2002; 106:3006-3008. Now the hard work started, and for the next year and a half, the only place that this work was done was in Dr. Cribier's lab. Several more years went by, and first one valve, then a second valve was available in Europe and Canada. To date, roughly 50,000 valves have been deployed mostly in Germany and Europe. This is another example of American technology that we in America did not get to use until much later.

In America, a trial was done called PARTNER. It had two parts labeled A and B. The medical problem here is aortic stenosis, which is a gradual closing of the aortic valve through which the heart empties. It is generally an aging phenomenon, and as it is a mechanical problem, it requires a mechanical solution. The valve must be opened for it to work. As our population ages, this problem will only grow over time. I have written about this trial before because it was the first study to show such a massive mortality benefit in patients. If no solution is provided to the patient, they inevitably die from it. The patients in this trial were inoperable. What this means in practice is that of course they could have an operation, but it is unlikely that they would survive it. PARTNER A randomized the patients to TAVR and surgery and PARTNER B randomized them to TAVR and medical management.

Next...what three-year follow up shows.

Our Inactivity (Part II): Our tax dollars at work

  • Posted Oct 25, 2012
  • Alan Niederman, MD, FACC, FACP

I often write that there are some studies that will just never get done because of the logistics and the cost.  They are studies that require funding without a financial reward.  The reward might be a decrease in costs to "society" but drug companies and Wall Street do not function on a society level, they function on a quarterly earnings level.

It takes the government to fund these studies and continue them over long periods of time.  We have seen in the recent months that one political party thinks that this is not "government's" job, so in the future I don't know how this will work.  In the meantime, I am reporting on a large (over 5,000) patient study that went on for 11 years and is now over.

This study looks at a group of patients that number over 24 million in the United States.  This is a societal problem.  The downstream costs are huge.  The human suffering involved is real.

This study named Look AHEAD relates to my previous blog.  It attempted to answer the question, "if you have non insulin diabetes and have intensive lifestyle intervention (i.e. diet and exercise), can you avert the complications of cardiovascular events?"  This is a worthy goal and points to one of the "urban(medical) legends" that I am so fond of.

The party line is that if you lose weight and exercise, you don't need medicine for the treatment of your diabetes and in fact may reverse your diabetic state.  We doctors spend a considerable amount of time cajoling patients to do what we want them to do.  In fact, in addition to the diet and exercise, all patients were treated in the routine way.  They were given whatever medications they needed to keep control of their diabetes.

This study enrolled 5,145 patients who were 45-76 years old, and 60% of whom were women.  37% were from varying racial and ethnic groups.  This is different from most of the white male studies that are conducted. The intensive group had lost 5% of their weight at year four. In contrast, the control group lost 1%.

Well....it doesn't work.  What?  The study has now been stopped at 11 years because it has been deemed "futile."  It will never show a difference between diet, exercise and the rest of us in the prevention of cardiovascular events.  This study has not been formally published.  All we have is the news release from the National Institutes of Health who ran the study for the government.

Two important points: what does it say about us that even when we are given intensive counseling, we can only lose and keep off 5% of our body weight?  Really?  If you weigh 200 pounds, 5% is 10 pounds.  Is that all we can manage?  What is now going to happen is that Medicare will never pay to have anyone discuss weight loss with anyone as it clearly does no good.

I am back to my last blog post.  It is frightfully clear that we eat too  much and get too little motion.  I think given our current understanding that it is not just exercise.  As my last blog post shows, if you exercise but then sit all day, you are only marginally better off.  We need an overhaul of our lives.  Medical care is bankrupting us, and much of it is self-inflicted.

I do not know how to accomplish this.  Clearly, neither does the government.   Somehow, we need to join together to figure it out.

Our Inactivity (Part I)

  • Posted Oct 23, 2012
  • Alan Niederman, MD, FACC, FACP

I have blogged in the past about a study which showed that watching TV leads to an increase in death.  Most of this work comes from Australia.  I don't know whether that is because they have better TV than we do or just less to do.  When I spent some time there, it seemed like everything on TV was from the United States.  Even the Today Show was broadcast, although because of the dateline, it wasn't "Today."

Two more articles have now been published.  One in the British Journal of Sports Medicine and another in the journal Diabetologia (2012; 55:2895-2905).  These articles are reviewed in an article in the New York Times published on October 17, 2012 titled "Get Up. Get Out. Don't Sit." The findings are somewhat misstated.  Basically the idea is correct, but the cause is misassigned. Remember in the style of reporting, "if it bleeds it leads," you must have a hook to get "eyeballs."  In today's overcrowded arena of things to do, the more sensational, the more eyeballs.

The discussion revolves around the calculation that if you watch one hour of TV, you shorten your life by 21.8 minutes.  This can be compared to smoking one cigarette, which shortens your life by 11 minutes.  If you smoke and watch TV, you are probably already dead and don't know it.  This parsing of data is interesting but beside the point.  It's not the TV, it is the inactivity.  If you watch TV when you are exercising, does that count?

The problem is not the TV. The problem is larger and more difficult to control.  It seems to be that sitting is killing us. This is entirely understandable.  In the past, most people did not sit. They had manual labor jobs, worked the fields or searched for food.  Recently, sitting seems to be the norm.  The act of standing, even in one place, is a muscle maintenance activity.  We stand up because we force our muscles to do it.  This muscle action requires food, and that food is glucose, so the more you move or stand the less likely it is that you will develop diabetes.  Most of us sit at work now, often at the computer.  This inactivity leads to the problem. The article points out that the highest inactivity caused " a 112% increase in diabetes, a 147% increase in risk for cardiovascular disease and a 49% risk of dying prematurely."

Here is the real kicker: even if you exercise 30 minutes or an hour a day, your risk is not offset by the amount of time that you spend sitting.  Six hours of sitting a day, in effect, will kill you. The solution seems to be standing up, but as of yet, this has not been tested.  The recommendations include that you stand while talking on the phone, buy a new desk to work standing up, take meetings standing up, drive standing up.  No, I made the last one up.  Basically, you need to stand up as much as possible during the day.  Those of you that have seen me eat in the doctors' dining room know that I generally eat standing up.  This goes back to my residency. Clearly, this does not work all the time as my next blog will show.

A First

  • Posted Oct 18, 2012
  • Alan Niederman, MD, FACC, FACP

I do not believe that this has ever happened. It does, however, point to the ongoing relationship between Medicine and everything else that happens in this country. Medicine is the 800 pound Gorilla that needs to be addressed but is still just sitting in the corner eating all the bananas in sight. The event I am blogging about is the publication of two opinion pieces in the New England Journal of Medicine published on October 11, 2012 (free articles). The first piece by President Obama and the second by Governor Romney. I would like all my readers to obtain and read the articles as I cannot do them justice here. I will summarize what I believe to be the high points.

From President Obama's Viewpoint

  • Americans who have health insurance from their employers will have more secure and affordable insurance.
  • Lifetime cap is lifted.
  • Preventive care without copays.
  • Forcing Insurance companies to use the money they take in to pay for care.
  • Closing the doughnut hole by $600 a year.
  • Covering children until age 26.
  • Removing preexisting conditions.
  • Costs to be evaluated by a board whose task it is to remove waste.
  • New models of healthcare like Holy Cross Physician Partners, which is an Accountable Care Organization.

From Governor Romney's Viewpoint

  • Repeal Obamacare.
  • Costs will come under control because "providers, insurers and patients have incentives to do it."
  • Employment-based insurance will still be there, but you will be able to also "shop" in the market for insurance. This will "drive down prices."
  • Expand Health Savings Accounts.
  • Malpractice reform
  • Streamline innovation by removing obstacles of regulatory oversight.
  • Each state will have the ability to solve its own problems.
  • The Grandaddy of them all: "Vouchercare." Pick what you want, and the government will "support" you depending on your net worth.

President Obama's piece had 27 comments. Governor Romney piece had 63 comments. The comments make for interesting reading on their own. This topic sure brings out some interesting exchanges. This is all for the good. Healthcare reform must occur, and we need everyone at the table and participating for all our good. I do not believe that will happen overnight, but I do believe that it will happen. We have the right to vote on this. These two views offer a stark difference. Educate yourself and go to the polls and choose. I do not know who will win. I do believe however that in the future, healthcare will look different than either of these two plans. They are both a starting point. This is not math. In healthcare 3 + 3 does not equal 6. At this point it equals different things for different people, and that is not the American way.


I thought China was bad

  • Posted Oct 16, 2012
  • Alan Niederman, MD, FACC, FACP

This blog post is about the declining environment in which we are obviously living. There is now a nationwide outbreak of fungal infections caused by a pharmacy that was compounding the steroid used to do spinal pain relief injections. 75 healthcare facilities in 23 states are affected, and people have already died from it. The number of patients affected continues to grow, and at the time of this writing, over 100 have been identified. I love the irony in our inability to understand a large and dangerous problem until it blows up in our faces. We babble on about generic manufacturing in China, India and wherever people get together to make a substance that physicians then give to humans and expect a result. It is obviously a daunting task to police this and to get it right. It needs to be right, but we will have to accept that the system is deeply flawed and clearly needs rapid rethinking. How this is to be accomplished with a group of people who believe that government has no purpose in our lives, I do not know.

How am I supposed to protect myself from fake or dangerous drugs? Start my own lab? How am I supposed to protect my patients? Honestly I, like you, had no idea that a "pharmacy" could "compound" a drug and then sell it all over the country. I thought, silly me, when I wrote a prescription that needed two components, the pharmacist at the corner store made it and handed it to you, the patient. Who is in charge here? It seems no one is - a classic loophole in the law.

It seems the FDA is not in control of pharmacies that make compounds containing drugs and sells them to any eligible person or entity across the country. It seems the states are in charge of pharmacies, and we know how that goes. It seems that this process is not manufacturing. Really? The most distressing thing is that in this flat world, we as physicians don't even know what the origin is or who created the substances that we are using to treat patients anymore. If you (the physician) think you do, you are fooling yourself. When I ask for a drug in the cath lab, I don't ask its pedigree. Where did it come from? Who made it? At a certain level, how are physicians supposed to work if we can't trust what we use? A race car driver gets into his car, a pilot gets into his plane with the expectation that the equipment works and has been manufactured according to a plan and has been vetted. How am I to know that anything works and won't kill someone anymore?

We as a nation went to the moon. We can do anything we want. As my readers know, I love the metaphor of the burning platform. This platform is a raging inferno, and we are now in deep trouble. We the people need to take up the call and respond. We need to email and write anyone and everyone: senators, congressman, the President, the FDA - everyone - and demand that we protect the integrity of the compounds we use to treat people. We will have to pay for it. We have to figure this out. Believe me, the next event is out there waiting. We have Homeland security. We need Medical-land security.

New toys and what the boys and girls of medicine do with them (Part III)

  • Posted Oct 11, 2012
  • Alan Niederman, MD, FACC, FACP

In keeping with my last several blogs regarding the use of the new antithrombins, an article was published in September in Circulation: Cardiovascular Quality and Outcomes.  As an aside, one of the recent trends has been subdividing our journals into sections.  In the past you received the Journal Circulation (Circ) or the Journal The Journal of the American College of Cardiology (JACC).  Now each of these Journals has expanded into five or six different Journals as I has mentioned above.  Although the Journals have expanded, my time has not expanded, so the feeling of helplessness in the face of exploding information worsens with every passing day.

The article "National trends in oral anticoagulation use in the United States" (Circ Cardiovasc Qual Outcomes 2012; 5:615-621) explores the use of Pradaxa in the United States after its approval. For all its hype and potential, how much of the market of anticoagulation for atrial fibrillation do you think Pradaxa has gained vs. warfarin?  10%?  50%?  Well, after five quarters (the last being the end of 2011), Pradaxa had 19% vs. 81% for warfarin of the market for atrial fibrillation anticoagulation.  This data is for Pradaxa only as the second drug Xarelto was not approved until November 2011.  The drug is mostly prescribed to patients 65- 84 years old.  53% of the drug use was by cardiologists.

One of the most interesting facts from the study is that in spite of all the fuss and all the need to protect patients from atrial fibrillation, by estimate, it seems that only 40% - yes that's not a typo - of the eligible patients are being treated with either warfarin or a newer agent.  The second interesting point - and the point of this blog post - is that over time, the percentage of this drug's use for purposes that it is not indicated for grows.

In the last quarter of 2011, 8% of the use of Pradaxa was for the treatment of venous blood clots, 9% was for coronary artery disease and 3% was for stroke.  Here is the clincher: according to the article, 13% of  the use of for Pradaxa is for "hypertensive heart disease." I don't even understand that.

A classic conundrum.  Why is Pradaxa - which should be used to treat a necessary and under-treated condition - being used to treat a whole slew of conditions for which it is not approved?  I do not know the answer, but we need to refocus our efforts to adequately treat patients with atrial fibrillation at risk for stroke.  It is true that in Europe and Canada Pradaxa is used for the treatment of any venous blood clot condition, such as deep venous thrombosis and pulmonary embolism.  Pradaxa and the other drugs in the group are also used for the prevention of venous blood clots after orthopedic surgery.  The studies of these subjects have been completed here and are awaiting the approval by the FDA of the expanded indications, but it seems that Christmas has come early for some, and they have unwrapped and are using their new shiny fire truck already.

Just an example of how physicians practice medicine.  As those of you who take this drug know, it is easier to use than warfarin, and I am a big fan of this group of drugs. The expense to the system should be considered before its use.  In the end, we are all paying for it.


About Holy Cross Hospital

Holy Cross Hospital is a nonprofit, Catholic hospital in Fort Lauderdale, Florida, dedicated to innovative, high quality and compassionate care. For nearly six decades, Holy Cross has continuously expanded its services to provide leading-edge care for their patients in Florida and for those from elsewhere in the United States. Holy Cross also offers an International Services program to ensure that patients from outside the U.S. receive the care they need.

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