Simvastatin 80 mg: If You Can't Go Lower, Go Elsewhere

Howard S. Weintraub, MD


June 22, 2011

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Hi, I'm Howard Weintraub. I'm a cardiologist from New York University (NYU) Medical Center, where I'm the Clinical Director for the NYU Center for the Prevention of Cardiovascular Disease, and a clinical associate professor of medicine. I also have 2 lovely daughters and a great wife.

I'm here to discuss an interesting alert that the Us Food and Drug Administration (FDA) just came out with last week, where they advised against the utilization of 80 mg of simvastatin except in select groups of patients. Simvastatin, for those of you not familiar, used to be called Zocor®. It was a very popular medication when it was branded, and even now that it's generic it has become the most widely utilized statin.

There are some very, very good efficacy studies that have been associated with this drug. Most notably, the Heart Protection study,[1] which proved that almost regardless of your LDL level, the use of the statin, here it was 40 mg of simvastatin -- this is important to remember -- 40 mg of simvastatin was associated with safe, effective, lowering of cardiovascular events in a wide group of patients.

However, in 2 other studies that were done, one called A TO Z,[2] which was an acute coronary syndrome study, and another that was more recently done called SEARCH,[3] which was kind of a convoluted study that also involved looked at homocystine, there were disturbing data about the development of myopathy when 80 mg of simvastatin was used.

For this reason, the FDA, about a year ago, hinted that maybe it wouldn't be such a good idea if we continued to use 80 of simvastatin. And now, they came out and said, "Yeah, we made our mind up; you should not be using 80 mg of simvastatin." The only place where they think it might be okay is in those patients who have already been taking the drug for over a year and have been obviously tolerating it.

So, what does this mean? Well, it means that the FDA doesn't think we should be prescribing 80 mg of simvastatin out of the shoot. Now, that's not a recognized starting dose, but certainly we're even talking about people who are not controlled on 40 mg of simvastatin. What do you do? Clearly the answer here is that you should not be graduating to 80 mg of simvastatin. So now, what can happen?

Well, my great concern is that physicians may not be comfortable in escalating to branded statins because of the resistance that they get from managed care, and sometimes the necessity for this widely loved thing called a prior authorization. And then, the other problem comes when patients may vocalize their distaste for this because of the added cost that they have to spend. But, I think that physicians need to be aware that there are very, very good branded alternatives that are safer and have had very good efficacy data in their highest dose when used for long periods.

And, ultimately I think the cost of the drug is one thing, but we need to recognize that using the drug to get the event reduction that is desired in the kind of patient that you're treating is ultimately our goal.

So, I think it's important for physicians to recognize that if a patient is on 40 mg simvastatin, and they need considerably more low-density lipoprotein (LDL) reduction, then their choices are now limited to doing one of several things. One is to add a drug to [simvastatin], which may be even more distasteful to some patients, because both of [these additional drugs] are branded, and one of them would be ezetimibe (Zetia®). I don't think I need to tell you about some of the controversy that swirls around ezetimibe. And, the other is to add a drug like colesevelam (Welchol®), which really has some quite good data associated with it,. Although there are some other issues that patients sometimes find distasteful, actually I think this drug is underutilized.

The alternative is to keep it at only 1 pill a day, and that would be switching to either atorvastatin (Lipitor®) or rosuvastatin (Crestor®).

These drugs have been shown to be very well tolerated and highly effective in their maximal doses. And, I think that you can get considerably greater LDL reduction in the range of about another relative 20%. So, instead of getting about 45% [reduction] with 80 mg with simvastatin, you can get a little over 50%, particularly when you're using a drug like rosuvastatin, where you can get in the low 50th on 40 mg of rosuvastatin a day.

So, it's important for physicians to recognize this new warning. It's important that they try to avoid harming their patients by utilizing the 80 mg of simvastatin. It also has more drug-drug interactions posted in their product insert than the other prominent branded statins, such as atorvastatin and rosuvastatin.

And, I think it's important that ultimately we think of the one thing, which is getting LDLs, triglycerides, and high-density lipoprotein to the appropriate goal, so that our patients experience the lowest possible cardiovascular risk. I'm Howard Weintraub, thank you very much.


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