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'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, 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, which was an acute coronary syndrome study, and another that was more recently done called SEARCH, 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.
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