The Vytorin Controversy One Year Later - An Update

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On January 8, 2009, the FDA issued the following safety review of Vytorin and concluded: “patients should not stop taking Vytorin or other cholesterol lowering medications and should talk to their [health provider] if they have any questions about these medications.”

Dear patient, you have been drawn into a medical slugfest that is being fought among leading cardiologists, so what are you to do? Read my prior post to get some background on the Vytorin controversy and then read this post to see where we are one year later.

The ENHANCE Study

In January of 2008 a study called ENHANCE was published and the cardiologists started swinging. This study showed the cholesterol drug Vytorin (which is a combination pill that contains two drugs – Zocor/simvastatin and Zetia/ezetimibe) did not reduce plaque in carotid arteries more than Zocor/simvastatin alone did.

In spite of The American Heart Association (AHA) and the American College of Cardiology (ACC) issuing a joint statement the very next day stating that Vytorin did not appear to be unsafe, calls flooded into millions of medical practices, including mine, from concerned patients. My estimate is that about 30% of the patients in my practice who had been taking Vytorin asked to be switched to another drug. I do not know how many just quit taking their medication altogether without calling or coming in to discuss it.

Now, one year later, the FDA’s safety review is complete and thier conclusion is “the levels of LDL (the bad) cholesterol decreased by 56% in the Vytorin group and decreased by 39% in the Zocor/simvastatin (alone) group. Patients should not stop taking Vytorin or other cholesterol lowering medications and should talk to their [health provider] if they have any questions about these medications.”

LDL is a known risk factor for cardiovascular disease and reducing LDL is a primary goal of cholesterol lowering medication. Plaque in the arteries is the result of years of increased LDL levels.

The primary purpose of cholesterol lowering medications is to prevent or slow the build-up of paque, it is not to get rid of plaque that’s already there. So dear patients, as Roseann Roannadanna would have said (and, according to the FDA this week), “Never mind.

My advice is continue to take your medication faithfully and get your cholesterol profile to target – nothing has changed.

The SEAS Trial

Later in 2008 a study called SEAS was published. In this study they were testing whether lowering LDL (the bad) cholesterol with Vytorin would reduce the risk of major cardiovascular events (in this study they were looking at aortic valve replacements, episodes of congestive heart failure, and heart attacks or strokes in individuals with aortic stenosis – a tight heart valve).

SEAS data showed there was more cancer diagnosed in patients taking Vytorin when compared to those taking a placebo (a pill with no medication in it). Another cloud was cast over this drug.

The IMPROVE-IT and SHARP Trials

So when the cancer findings became known, an independent analysis of two other studies of Zetia/ ezetimibe (the IMPROVE-IT and SHARP trials) was done to see if the cancer risk seen in the SEAS trial was real or chance. Those studies, which are still underway, showed no increased cancer risk.

One of the leading cardiologists in the slugfest was quoted as saying “the medical community will have to live with uncertainty regarding Vytorin based on the SEAS trial”. That is the medical community – and you – dear patient.

My Opinion as an NP

This whole controversy makes me angry. I firmly believe patients should be kept informed about their medications and treatments – both their risks and their benefits. But when leading physicians start playing “I’m a better expert than you” in the media over inconclusive and ongoing research, I think it is a disservice to both medical research and the patients it is meant to serve.

Nothing I have read over the last year about this controversy has led me to believe that Vytorin or Zetia pose a greater danger to patients than the high cholesterol they have been proven to effectively treat. I don’t have a crystal ball. I don’t know what will be discovered in the future about these or any other commonly prescribed drugs. I counsel my patients that nothing is without risk and we make the best decisions we can with the information that we have.

This whole controversy is just too much information about too few proven facts. So you world famous cardiologists out there – do us all a favor and thrash it out among yourselves before dragging the media and the public into it. Patients have enough to worry about without being frightened into believing they have problems they might not have.

Just for the record, I have no financial or clinical involvement with either the makers of Vytorin and Zetia or the any of above named studies. I’m a clinician who has followed this story in the clinical literature and the popular press over the last year. I haven’t seen anything yet that makes me think this is anything more than much ado about nothing.

Links I read to write this post:

American College of Cardiology Statement on ENHANCE Trial, January 15, 2008

Cleveland Clinic Journal of Medicine: Is ezetimibe/simvastatin no better than simvastatin alone? Lessons learned and clinical implications, July 2008

FDA Investigates a Report from the SEAS Trial, August 28, 2008

FDA Safety Update, January 8, 2009

CNN Money, FDA Completes Review of Clinical Trial for Vytorin, January 08, 2009

Debate about ezetimibe not over yet: Experts again weigh in on cancer risk, January 8, 2009

This information is offered for educational purposes only and is not intended to diagnose, prescribe or treat. For that please seek direct care from a health professional.

Permalink  ·  

#1 | On January 19, 2009, barry brader said:

Carla,
Thank you, thank you, thank you!
Barry

#2 | On March 04, 2009, Jean Rohrer said:

I just discovered you and I am SOOoo into what you are doing.  I want to join your bandwagon (Am a 11 yr veteran cardiology NP)  But I must comment on one sentence you made in this blog:

“So you world famous cardiologists out there – do us all a favor and thrash it out among yourselves before dragging the media and the public into it. Patients have enough to worry about without being frightened into believing they have problems they might not have.“

The cardiology community…all level of providers….would love it if the media was not able to grab hold of premature information and data that leaks from trials and other non medical sources. (believe me we try hard not to have premature conclusions get out….they are a nightmare for everyone involved except those causing the rumors.  At ACC meetings and conferences we recognize the lack of responsibility the media takes in what they rush to deliver all in the name of “news”.  I know ACC wasn’t prepared to make a stand so quickly after the ENHANCE data was misrepresented in the press.

Thanks for listening.

#3 | On March 04, 2009, Carla Mills said:

Jean,

Thanks very much for your thoughtful and educated comment.

I want to clarify, when I say “world famous cardiologists” I am referring to a couple of “world famous” ones. I am NOT referring to the cardiology community in general. I am not going to mention any names, but you probably know who I am referencing. These are doctors who have made a habit of rushing to the media prematurely. I don’t think it’s fair to blame the media for misrepresenting what “world famous” pundits eagerly present.

I want to be clear, I have nothing but respect and admiration for the cardiology community. The measured and balanced care and education of patients has made cardiology one the most sucessful and lifesaving areas of medicine.

But I stand by what I say, fame seeking pundits aren’t helping anyone but themselves.

Thanks for commenting.

Carla

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