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By
Jay S. Cohen, M.D.
From
the MedicationSense
E-Newsletter
What is Crestor and What is the Problem?
Crestor is the newest statin and the strongest statin yet. Statins
are the highly touted drugs for reducing cholesterol. Studies clearly
show that statins improve cholesterol numbers (by lowering LDL and
raising HDL) and may reduce C-reactive protein. Statins impede atherosclerosis,
reduce heart attacks and strokes, and cardiac death. Thus, the statins
Lipitor and Zocor are not only the #1 and #2 top-selling drugs in
America, but also household names.
Other statins include Pravachol, Mevacor, and Lescol--and now ultra-potent
Crestor. Until 2001, there was another statin: Baycol. It was then
the newest statin and a potent statin--until it was withdrawn because
of dozens of deaths. Is Crestor another Lipitor or another Baycol?
Although Crestor has been on the market only a year, it has already
been linked to numerous cases of severe muscle breakdown, kidney
toxicity, and deaths. Public Citizen recently petitioned the FDA
to ban Crestor.
The Marketing of Super-Strong Crestor
Crestor's introduction in August 2003 provides a textbook example
of how marketing strategies can supersede medical science and common
sense. Taking a page from Lipitor's highly successful marketing
campaign in 1997, Crestor is now being aggressively marketed as
the strongest statin of all.
The manufacturer's recommended initial dose of Crestor is 10 mg/day
(except for people with kidney problems). This dosage is so strong
that Crestor's advertising can boast it is stronger than equivalent
doses of any other statin. This is quite a claim, because Lipitor
and Zocor are pretty strong themselves. Indeed, their top-selling
status has been built on their own advertising about their power
to reduce cholesterol and LDL-cholesterol (LDL-C) levels.
But more isn't necessarily better with most medications, including
statins. As I've written in medical journal articles and in my upcoming
book (What You Need To Know About Statin Drugs And Their Natural
Alternatives),1 the standard starting doses of Lipitor and Zocor
are often double or quadruple the amounts that millions of people
actually need, triggering many avoidable side effects.
So what can we say about super-strong Crestor, which is even stronger?
We can say that the drug company-recommended, super-strong initial
10-mg dose of Crestor has already been linked to severe toxicities.1A
This should not surprise anyone.
Excessive Doses = More Side Effects
One of my basic principles is: The best dose of any medication
is the least amount that works. Medical science agrees. Most people
with elevated cholesterol or LDL-C have mild-to-moderate elevations.
For many, dietary interventions are enough. For others, modest statin
doses are often plenty. But the recommended initial doses of Lipitor,
Zocor, and Pravachol are strong, yet that's what doctors prescribe
to most people, even to people who don't need such strong statin
therapy. This is the crux of the problem of statin side effects
such as muscle aches, joint pains, abdominal discomfort, memory
and cognitive impairment.2-6 Side effects are a major reason that
60 percent to 75 percent of people started on statins quit treatment.7,8
The average time until they discontinue treatment: eight months.
Many people quit within a few months.
Liver injury, liver toxicity, and death are also concerns with
statins. Like other statin side effects, these reactions are dose-related:
the greater the dose, the greater the risk. Dr. W.C. Roberts, the
editor-in-chief of the American Journal of Cardiology, warns:
"With each doubling of the [statin] dose, the frequency
of liver enzyme elevations [indicating liver irritation or injury]
also doubles.9"
Nerve injuries have now been documented in people taking statins
long-term.10, 11 The incidence is low, perhaps one in 2,000 to 5,000,
but with millions taking statins, this adverse effect will afflict
thousands of people each year. These injuries can be severe and
permanent, and even mild nerve injuries can take months to fade
away.
Doctors cannot anticipate who will develop a long-term side effect
with statins, but doctors should (but usually don't) anticipate
that they will occur in some people. The only defense: using the
least amount of medication you need.
Do We Need a Stronger Statin?
The standard starting dose of Crestor is 10 mg, which reduces LDL-C
a whopping 46 percent to 52 percent.12 Some people, especially those
with serious coronary disease, require this degree of LDL-C reduction,
but most people with elevated cholesterol require only 20 percent
to 30 percent reductions--and therefore much less medication.
Crestor's manufacturer does recommend a lower 5-mg dose for people
requiring "less aggressive LDL-C reductions.12" Yet, 5-mg
Crestor reduces LDL-C 42 percent, still far more than most people
with elevated cholesterol need.
And remember, this 42 percent LDL-C reduction represents the average
among study subjects. Many people get even greater reductions with
this dosage. In one study, 5 mg of Crestor reduced LDL-C as much
as 71 percent in subjects.13 This is an impressive number, but reducing
cholesterol too aggressively is believed to be a trigger for cognitive,
memory, and mood problems with statins. And too low cholesterol
levels aren't good either, because cholesterol is a necessary building
block in human cells and a substrate of many of our hormones.
So contrary to Crestor's marketing, we shouldn't be overly impressed
with which statin is strongest. You don't want the strongest statin.
You want the mildest statin that works for you.
Lower, Safer Doses of Crestor Work--But
Your Doctor Doesn't Know About Them
The lowest marketed dose of Crestor is 5 mg. Yet, studies show
that 2.5 mg of Crestor reduces LDL-C 40 percent, and just 1 mg reduces
LDL-C 34 percent, on average.13, 14 These doses are still stronger
than the standard initial doses of Pravachol, Mevacor, Zocor, and
Lescol, and they would certainly be strong enough for most people
with elevated cholesterol. Indeed, the lead author of one Crestor
study stated:
"Even at 1 mg/day, rosuvastatin [Crestor] reduced LDL-C
by 35 percent, the same percentage reduction seen with simvastatin
[Zocor] 20 and 40 mg.14"
Yet, you won't find any information about this in the Crestor package
insert,12 pharmacy slips, or the "Physicians' Desk Reference."2
Crestor's manufacturer isn't going to inform you or your doctor
about lower Crestor doses that aren't available, even if they are
effective--and safer.
This goes right to the heart of the issue of informed consent.
Your right of informed consent is denied if you aren't given enough
information to make an intelligent choice.15 You aren't alone: one
study showed that only 9 percent of office patients receive enough
information to fulfill their right of informed consent.16 No wonder
medication side effects continue to be one of the leading causes
of death in America.
Continue to Page 2 to read
the remainder of the story, as well as
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