The Vytorin Controversy: What’s a Patient to Do?

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This post was originally published on May 15, 2008 and updated updated on January 16, 2009. Click here to read the update. This has remained one of the most frequently read posts on this blog.

When all the controversy about Vytorin hit the popular press in January 2008, patients immediately began calling my office for more information. They are asking a lot of good questions. They want to know whether they should stay on the drug or stop it; whether it is doing them any good – or more importantly, whether it is doing them any harm. I’m going to try to explain what the controversy is all about and give you some information that will help you figure out what to do.

About These Drugs

Vytorin is a cholesterol lowering drug that combines two drugs in one pill – Zocor (also now available as a generic – simvastatin) and Zetia.

Zocor (simvastatin) is from a class of drugs called statins. Other drugs in the statin class are: Lipitor (atorvastatin), Pravachol (pravastatin), Mevacor (lovastatin), Crestor (rosuvastatin), and Lescol (fluvastatin). These medications work in the liver to decrease the amount of cholesterol produced there. We actually make most of cholesterol in our bodies ourselves to digest fat – that’s why a high fat diet raises cholesterol. Only part of the cholesterol in our bodies comes from food.

Zetia, on the other hand, is a drug that works in the gut to block the absorption of cholesterol there and it lowers total cholesterol more than a statin alone. It has been used primarily as an add-on drug along with statin to achieve greater overall reductions in cholesterol levels – though it is occasionally used alone.

About the Controversy

This whole controversy is part grandstanding, part muck-raking, part politics, part marketing and part witch-hunting – none of which is helpful to patients trying to figure out what they should be doing.

I went poking around the Internet and found this post on the Wired Science blog called The Vytorin Controversy for Dummies. I think it unmasks much of the skullduggery surrounding this issue quite nicely. It also makes the point that for all the media bluster and all the ink that’s been spilled, patients have no better information on which to base their treatment decisions now than they did before the controversy. In fact, like with most of these pharmaceutical disputes, they create more confusion than clarity.

Poor Richard

I was particularly moved when I read this comment to the Wired Science article posted by: Richard on Apr 11, 2008 at 2:09:53 PM:

I think one of the most obvious aspects of this drug problem has been overlooked.
Vytorin is a combination drug of Zocor and Zetia. Zocor is a statin, Zetia is not a statin.
So, what is the issue with Vytorin?
Is the issue with statin alone; is the issue with Zocor; is the issue with Zetia; is the issue with statin in combination with Zetia; is the issue with Vytorin alone?
I was taking Vytorin for a while prescribed by my then cardiologist. My internist, who is not the most informed pharmacologist, decided that Lipitor is better and switched me to that. When my cholesterol numbers still didn’t come down enough my new cardiologist prescribed Zetia. So at this point I am taking Zetia and Lipitor. On my next to last visit to the cardio he says why don’t you take Vytorin?
Meanwhile I didn’t tell you about how I went between 20 40 mgs on the statin in both drugs—relevant?
Duh! So I switch back to Vytorin.
PLEASE HELP (I mean it)

Answers to Richard’s Questions

CARLA: Richard, I wish I knew how to reach you so I could send you a link to this post. I think you are asking great questions! So I am going take them one by one and try to answer them. Here goes:

RICHARD: I think one of the most obvious aspects of this drug problem has been overlooked. Vytorin is a combination drug of Zocor and Zetia. Zocor is a statin, Zetia is not a statin. So, what is the issue with Vytorin?

CARLA: The issue is whether the combination of Zocor (a statin) and Zetia together reduce plaque in the arteries less than, the same as, or more than Zocor (or another statin) alone. Critics say if Vytorin either causes an increase in plaque (which has neither been proven nor disproven) or doesn’t reduce plaque any more than a statin alone then there is no point in taking it. The rub comes because it’s well known that this drug combination lowers both total cholesterol and LDL (the bad cholesterol) more than a statin will alone. So, the answer to your question is: the issue is the degree of plaque reduction in the blood vessels. What makes this confusing is that plaque that’s already in the blood vessels got there as a result of long term high cholesterol in the bloodstream. So the other question that needs to be answered is: Will overall reduction of cholesterol decrease plaque deposition even if it doesn’t decrease the plaque that’s already there? (Sorry to answer your question with another question – but I’m trying to explain where the tipping point is here.)

RICHARD: Is the issue with statin alone; is the issue with Zocor; is the issue with Zetia; is the issue with statin in combination with Zetia; is the issue with Vytorin alone?

CARLA: The issue is whether Zetia combined with any statin will increase, decrease or make no difference in the effectiveness of the statin. It is known that statins do reduce plaque somewhat (though to different degrees depending on which statin and at what dose). What is being questioned is whether adding Zetia interferes, adds to or has no effect on statins ability to reduce plaque.

RICHARD: I was taking Vytorin for a while prescribed by my then cardiologist. My internist, who is not the most informed pharmacologist, decided that Lipitor is better and switched me to that. When my cholesterol numbers still didn’t come down enough my new cardiologist prescribed Zetia. So at this point I am taking Zetia and Lipitor. On my next to last visit to the cardio he says why don’t you take Vytorin?

CARLA: Here is how I would help you decide for yourself. Let’s look at three patients on Vytorin and you see where you fit into these scenarios:

Patient #1: Has a history of having already had a heart attack, has had coronary artery bypass surgery, and a family history of high cholesterol just like the people in the ENHANCE study that started all this controversy. This patient’s cholesterol is well controlled to target numbers on Vytorin 10/40 mgs. In light of the questions the controversy has raised, it would be reasonable to switch this patient to Zocor/simvastation at 80mg (or another statin at an equivalent dose) and watch their cholesterol and liver function tests. If both remained normal and to target, based on what we now know, this person might get slightly better reduction of plaque on a higher dose of the statin alone than with the combo therapy. But if the cholesterol numbers went up, restarting the Zetia would be reasonable. Remember high cholesterol is what grew the plaque in the first place.

Patient # 2: Is middle aged, has no history of cardiovascular disease, but cholesterol levels are too high in spite of three months of lifestyle modifications to a low fat/low cholesterol diet and regular aerobic exercise. This patient is prescribed Zocor/simvastatin 20 mg alone (or an equivalent dose of another statin) and encouraged to continue the lifestyle modifications. After three months, this patient’s cholesterol numbers still do not reach goal. At this point, adding Zetia to the Zocor (which is Vytorin 10/20 – Zetia 10 mg/Zocor 20 mg) would be reasonable. If, after another three months, the cholesterol levels are not to goal, increasing Vytorin to 10/40 could be tried and three months after that increasing it again to 10/80 if necessary.

Patient #3: This patient has no insurance and pays cash for all prescriptions. There is a family history of cardiovascular disease and the patient’s cholesterol profile is too high in spite of lifestyle modifications. Going with generic simvastatin or pravastatin (the only two generic statins on the market) and increasing the dose every three months while following liver function and cholesterol numbers will be the most cost effective, safe and aggressive therapy to prevent a future cardiovascular accident. And it would be a respectful way to prescribe given the patient’s lack of insurance.

RICHARD: Meanwhile I didn’t tell you about how I went between 20-40 mgs on the statin in both drugs—relevant?

CARLA: Take whatever dose is necessary to achieve target numbers. Don’t be afraid of higher doses if your numbers are not to target. Many treatment failures occur because maximum therapeutic doses are not reached, so don’t stop short of reaching your goal. Your health provider should be following your liver function tests with each dose change and you should report any side effects you have. According to a joint report by the National Heart. Lung, and Blood Institute; American Heart Association; and the American College of Cardiology these medications are under-prescribed and safe for the overwhelming majority of people who need them.

RICHARD: Duh! So I switch back to Vytorin.

CARLA: If it gets your numbers to target, don’t worry about it. Take your medicines properly, follow a healthy lifestyle and see your health provider regularly – that’s your best chance for avoiding problems.

RICHARD: PLEASE HELP (I mean it)

CARLA: I hope this answers Richard’s questions – and yours. Do you have any comments, information to add, or other questions?

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 August 11, 2009, Jim Bass said:

Colesterol over 300 following triple bypass 9/87. Put on a variety of meds until Internist put me on Zocor then later vytorin.  Then and only then did cholesterol fall below 200 mostly 180’s.  After vytorin scrare, primry Dr put me on Crestor. Stats still good but Dr ****of best pills worst pills says Crestor worst cuse of kidney failure and recommends not to take it.  I’m going back to vytorin!

#2 | On August 11, 2009, Carla Mills said:

Thanks for your comment.

Stay tuned, I think you will find Vytorin and it’s ingredient, Zetia, will be making a comeback in coming months as we rethink and learn more about how best to manage high cholesterol.

I’ll be writing more about this later in the fall.

You might also want to check out the post I wrote to follow up on this one:

http://www.maverickhealth.com/blog/entry/the-vytorin-controversy-one-year-later-an-update/

Carla

#3 | On January 04, 2010, joe said:

I seem to be having trouble with an irregular heart beat and was wondering if anybody else has this problem?I am going to see my primary doc. tomorrow.But it seems like when I stop taking the vytorin I feel better,I Know what the doc. is going to say….I shouldn’t have stopped taking it.But when you hear stories like the ones that have been out there,it makes you stop and think.JOE ZITO

#4 | On January 04, 2010, Carla said:

Hi Joe,

An irregular heart beat is called an arrythmia and can be caused by many things. You are doing exactly the right thing to see your primary care provider. Let your provider know you do not feel well on Vytorin. I believe a good drug is one that meets 3 criteria:

1) It does not cause side effects.
2) It achieves its desired result.
3) It’s affordable.

If Vytorin is not working for you in any one of these ways let your provider know. Good luck.

Carla

#5 | On February 10, 2010, gail adinolfi said:

I am so glad to have seen this explanation. I tried and had problems with all of the statins. I have taken Vytorin for a few years and was delighted to find something that worked and didn’t give me any side effects.  Then, I read some of the bad press about Vytorin and was concerned. I believe I will stay with Vytorin after reading your insightful commentary..

#6 | On February 21, 2010, Carla Mills said:

Hi Gail,

I’m glad this helped. If you didn’t see it I also recommend you read the follow-up to this post at http://www.maverickhealth.com/blog/entry/the-vytorin-controversy-one-year-later-an-update/ which I wrote in January 2009.

It’s now February 2010 and there have been other updates which deserve their own post one of these days. NPR posted an update in November 2009, here’s a link (and don’t miss the only comment - it makes the point I want to share with you in replying to your comment): http://www.npr.org/blogs/thetwo-way/2009/11/vytorin_zetia_heart_drugs_ques.html

Thanks for commenting.

Carla Mills, ARNP

#7 | On May 21, 2010, Pat Adams said:

My husband had taken Vytorin for several years when he switched to simvastatin (40 mg) to save on the co-payment.  When you say that vytorin is a combo of simvastatin and zetia does that mean that there is not difference in the chemistry of the zocor and simvastatin.  My husband started losing the pigmentation in his hands after a day in the sun using a spray on sunscreen some time after starting the simvastatin.  Since one of the side affects of simvastatin can be discoloration of the skin…could this be related?  The dermatologist said it is not known what the cause of this ailment is.

#8 | On September 12, 2010, Rainer said:

I have taken every Medication to date to help keep my cholesterol levels at Bay. Everyone of those Statins have given me problems to a point where it affected my quality of life. The worst was Lipitors. In the mean time I did end up having to have a triple bypass. Vytorin is the latest for me to try. This one also as I suspected is giving me enough dramas to want to stop using it too. My Head feels unwell most times. I can’t remember the last time I felt focused enough let alone not feeling tired. My Legs feel wobbly at times and achy too. My Liver produces too much Cholesterol. There for natural alternative are not suitable to stop my Liver from simply producing too much Cholesterol.
Yes! What is one to do from here? I am between a hard Rock and the Ocean. I need to take some thing or I end up on the operating table again. but! What is around is giving me too much of a problem with side effects and affects my quality of life. Guess I am doomed?

#9 | On September 13, 2010, Carla Mills said:

Rainer,

So sorry to hear of the troubles you have had. If it is any comfort you are not alone. Statin drugs are well tolerated by the vast majority of people - but not all. I have a number of patients who just don’t do well on them.

Given your risks and history of bypass surgery, I would suggest you work closely with your cardiologist or primary care provider and get your cholesterol measured at 3 month intervals.

Have you tried all statins at least once to see if you react badly to all of them - simvastatin (in Vytorin), Lipitor, Pravachol, and Crestor? If you’ve failed all of those I’d try Zetia alone (also in Vytorin) and/or Wellchol (a totally different type of cholesterol drug).

In addition to drug therapy, there is diet and exercise, which even for those who over-produce cholesterol in their livers can help. Have you read Dean Ornish’s books about reducing cardiovascular risks with lifestyle? They might be helpful.

Good luck to you.

#10 | On September 13, 2010, Rainer said:

Thank you for your reply” The answer is yes” I have tried pretty much all of them. Zocor. Lipitor (being the worst of them), Crestor,Provachol,Lopid e.t.c I did think about Zetia and I wonder if it is even available here in Australia? I never heard of Welchol. I will read up on this one and ask my Doc. My diet is good and excercise but could do a little more of it. grin
Thanks!

#11 | On October 01, 2011, georgette GRAY said:

My total cholesterol was measures for the first time at age 41,and normal weight.It was 500.It is familial(My mother had hers measured for the first time at age 82 it was 400.It never bothered her .I tried diet and exercise but i could never get below 380with HDL 65.Mevacor 40mg reduced it some.Lipitor 80mg a little more and vytorin 10/80brought it a little over 200 when I watched my diet.But now my HDL is only 40 and my glucose 125,the triglycerides are up too.% years ago I had an abnormal EKG with mild cardiac problems.My cardiologist suggest Crestor but I do not want to take 80mg of crestor.at 77 I weighed 215lb,the dietician put me on a low carb diet amd I lost 20lbs.Will see if it affected the cholesterol.

#12 | On October 01, 2011, Carla Mills said:

This summer the FDA published new warnings about high dose simvastatin/Zocor/Vytorin - specifically the 80 mg dose. Here’s a link: http://www.fda.gov/Drugs/DrugSafety/ucm256581.htm.

Crestor is actually more potent than simvastatin so talk to your cardiologist. Maybe Crestor 40 mg will do a better job than simvastatin 80mg - even at a lower dose.

Good luck and congrats on the diet and weight modifications. Everything helps!

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