Lipitor: Side Effects
effects have been reported for Lipitor and other
cholesterol-lowering drugs - the so-called statins - prescribed
to millions for preventive purposes. The prescription of these
drugs is based on the discredited hypothesis that high
cholesterol levels cause heart attacks. The cholesterol myth has
been one of the most long lived falsehoods around - probably
because it has been excellent business, both for large pharma
producers as well as for the food multinationals, who introduced
margarine telling us how much healthier it is than butter.
There is an easy,
widely available nutritional solution to heart attacks: Vitamin
C. Needless to say, taking more vitamin C has been opposed by
big pharma and its mainstream medicine followers for decades.
"preventive" medicine causes severe muscular degeneration as a
"common" side effect, something must be awfully wrong. Jonathan
Campbell examines the side effects and postulates a mechanism -
proposing an astonishingly simple remedy.
Lipitor - Reports
of Neuromuscular Degeneration
Campbell, March 16, 2004
side effect reports have implicated Lipitor as a possible cause
for severe neuromuscular degeneration. Some people who have been
using Lipitor for two years or more report symptoms similar to
multiple sclerosis or ALS - Lou Gehrig's Disease - in which they
are losing neuromuscular control of their bodies.
For instance, in
an article entitled "Life After Lipitor" that appeared in the
newspaper Tahoe World on January 27, 2004, Tahoe City
(California) resident Doug Peterson began having serious
neuromuscular problems after taking Lipitor for two years. He
began losing muscular coordination and slurring words when he
spoke. Then he lost balance, followed by loss of fine motor
skills - he had difficulty writing. He went from doctor to
doctor, trying to figure out what could be happening. Finally
one doctor suggested that he stop taking Lipitor, and the
downward health spiral stopped and his health is now slowly
effects have begun appearing in peer-reviewed medical journals,
and numerous people have reported similar symptoms at public
adverse effect reporting websites such as medications.com.
People have reported "trouble swallowing, trouble talking and
enunciating words, feeling fatigued all the time, neck aches,"
"motor neuropathy which mimics ALS," "Blinding headaches,
nausea, vertigo, disorientation, memory loss, extremely dry
eyes, pain and stiffness in my neck and calf muscles, abominal
pain," and "Muscle pain, weakness, spasms, buzzing in right leg.
Can't hold arms or head up in vertical position for 2 minutes
without extreme pain and weakness."
How could Lipitor
potentially cause this kind of harm to so many different parts
of the body? Lipitor is a "statin" drug which inhibits the
production of cholesterol in order to lower LDL cholesterol
counts. By limiting the production of cholesterol, Lipitor may
be indirectly causing membrane degeneration in neural and muscle
The problem is
this: cholesterol is essential in your body for many functions.
It forms part of what is called the cell membrane - the outer
layer of every cell in your body. It helps transport and pack
the major components of the cell membrane, called
"phospholipids," that are made from essential fatty acids
(EFAs). Without sufficient cholesterol we would die, because our
tissues are constantly being repaired and replaced with new
Our body produces
several thousand milligrams of cholesterol per day to carry out
these essential functions, and each day the excess of
cholesterol is supposed to be naturally recycled. If your body
doesn't have enough new cholesterol each day, you cannot repair
and replace your cell membranes and they will eventually
recycling of cholesterol happens naturally when you have
sufficient ascorbate, another name for vitamin C. Excess
cholesterol is naturally converted to bile acid and then
excreted. But if you don't consume enough vitamin C (about
2000-3000 milligrams per day for an adult), cholesterol builds
up in your bloodstream. It is here that doctors make a critical
error: instead of telling you to take more vitamin C, they
If Lipitor and
other similar statin drugs are in fact indirectly causing neural
and muscular degeneration, this is a very serious matter indeed.
There are twenty
million people in the
on Lipitor alone, and probably millions more on other statin
drugs (Zocor, Pravachol, Mevacor, Altocor, Lescol, Crestor,
etc.). Are they all going to become victims of cell membrane
degeneration and nervous system problems? There are few
long-term studies that bear out the safety of these drugs, and
side effects such as "muscle pain or weakness" are just
classified as a reason for some to stop the medication rather
than an indication of something very wrong with the drug.
What is most
horrifying about this problem is that cholesterol balance can be
achieved without drugs, simply and safely by taking 2000-3000
milligrams of vitamin C per day for an adult. Unfortunately,
vitamin C was misclassified as a micronutrient in the 1930s and
1940s, rather than an essential nutrient involved in dozens of
body processes. Our health authorities recommend that we take
only 60 milligrams per day, barely enough to prevent scurvy.
It is my hope
that people on Lipitor and other statins learn that they do not
need to take these potentially harmful drugs.
information about the connection between vitamin C and the
prevention of cardiovascular disease, see the article Natural
Therapy for Cardiovascular Disease, or visit the research
website of Dr. Matthias Rath.
Ascorbic acid in cholesterol and bile metabolism. Annals of the New York Academy
of Science. 258 (1975): 410-421
Lipitor Drug Information - Atorvastatin Calcium - Lipitor Side
Your online medication discussion resource. March 16, 2004.
Rath M, Pauling
L. Solution to the Puzzle of Human Cardiovascular Disease: Its
Primary Cause is Ascorbate Deficiency Leading to the Deposition
of Lipoprotein(a) and Fibrinogen/Fibrin in the Vascular Wall.
Journal of Orthomolecular Medicine 6 (1991): 125-134
Siig M. Life
After Lipitor: Is Pfizer product a quick fix or dangerous drug?
Residents experience adverse reactions. Tahoe World, January 29,
Atorvastatin-induced polyneuropathy. Ann Intern Med. 2003 Nov
Ziajka PE, Wehmeier
T. Peripheral neuropathy and lipid-lowering therapy. South Med
J. 1998 Jul; 91(7):667-8.
medical help if you have any of these signs of an allergic
reaction: hives; difficulty breathing; swelling of your face,
lips, tongue, or throat. Stop using atorvastatin and call your
doctor at once if you have any of these serious side effects:
muscle pain, tenderness, or weakness with fever or flu
symptoms and dark colored urine.
Less serious side
effects may include:
mild stomach pain, gas, bloating, stomach upset,
nausea, stomach pain or upset;
constipation, bloating, gas;
itching, skin rash; or
This is not a
complete list of side effects and others may occur. Tell your
doctor about any unusual or bothersome side effect.
Effects ( Atorvastatin Calcium )
With many years
of statin experience behind us, few clinicians would argue the
effectiveness of the statin class of drugs in reducing
cardiovascular disease risk.
The adverse side
effects from these drugs are another matter as the numbers of
people on Lipitor rapidly increase and the side effect reports
flood in. If you are on Lipitor or are planning to start taking
Lipitor, you must read my book. It is important that you know
Lipitor's true legacy.
Five years ago
when I started this research, reported side effects were
primarily "a few aches and pains and occasional liver
intolerance", arguably an acceptable price for society to pay
for such a beneficial class of drugs.
No longer does
this come even close to the truth. Of great concern today are
the growing numbers of adverse drug reports associated with the
use of Lipitor and the other stronger statin drugs, reflecting
dysfunction of many different body systems.
In my books, I
discuss the reasons for this broad range of devastating side
effects. The mevalonate pathway, critical to Statins inhibition
of cholesterol, is the pathway used by many other vital body
functions. From CoQ10, to dolichols, to normal phosphorylation
and to selenoprotein synthesis, all are affected by Statins'
broad reach. Side effects on muscle, nerve and memory functions
are not some extremely rare, almost unique, problem. They are
all but inevitable with the use of mevalonate inhibitors.
Here are a few of
the reports I have received from readers of my books and from
websites regarding personal experiences of Lipitor Side Effects.
1.) My father
(aged 56) has been taking Lipitor for about three years now. He
forgets telling us stories or events of the day and then tells
us the same story over and over (about ten times sometimes). If
I ask him to do something, he has forgotten about it within ten
minutes. It is progressively getting worse and my mother is
getting very worried. I heard a co-worker saying the other day
that Lipitor made him really depressed and then thought that
maybe Lipitor makes my father forget things. So, I went onto the
Internet and searched "Lipitor - amnesia" and was shocked at
what I found. I'm not sure that this is the problem, but could
it be from that?
2.) For some time
I've been concerned that Mum was becoming forgetful and becoming
more reliant on her diary to remember appointments, etc., and
that she was becoming increasingly confused. I am very concerned
that on top of her other concerns, she may now have dementia. I
did some research on dementia on the 'net, and began to consider
having a closer look at the drugs she is, and has been taking.
I've been gathering information on all the drugs she is
currently taking, and am seeking to have all her specialists
look closely at many concerning symptoms, including the confused
thinking, 'though I suspect it will be a long and frustrating
road. Somehow, for a period of approx. six weeks, Mum was taking
40mg Lipitor and 40mg Simvar daily. It was picked up when she
was recently admitted to the emergency department of our local
hospital with chest pain. I asked doctors if the doubling-up
could have caused some damage. I was told, if she had
experienced no severe pain in arms and legs, then probably no.
3.) I suffer now
from memory loss and am always tired dizzy - God, too many
things to mention. My Dr gave me so many drugs I can't remember
all their names but as a result of this Dr I now have all kinds
of things wrong with me. I take Lipitor now. Have been for about
2 years or so - before that Mevacor. I thought I was just
getting older and my memory was going. I'm 55. All my family and
friends told me something was wrong with me but I never thought
my meds would do that. What can I do to get my memory back? I
start to do something and it's like I don't remember what I was
doing. My 17-year old daughter tells me I have Alzheimer's
disease. She asks me did I do this or that today and I tell her
what because I forget so much. People think I'm real slow any
more. Just like driving - I was taking my son's baby to the Dr
and I forgot how to get there.
4.) I am a
business man, 42, good health, was 30 lbs over weight, and lost
30 lbs on a moderate Atkins and exercise program over 8 months.
Lipitor was prescribed 3 months ago; cholesterol came down
immediately to 170s but in the last 30 days have felt like my
brain is in a fog. I can't remember short-term things like; I
just picked up the phone now, who was I going to call or what
someone just told me hours or days earlier. I am going nuts
thinking I am going thru some type of midlife thing until I was
talking to a friend about it yesterday and he described that his
father (a very sharp guy) had experienced the same thing and had
narrowed it down to Lipitor being taken in the morning
5.) My 63 year
old wife has been on a max dose of Lipitor for over a year.
Since the increase in her dose she began experiencing constant
muscle soreness and increased short- term memory problems. She
brought this to her doctor's attention, but other than a check
to rule out Alzheimer's disease, nothing was done. A week ago
your site was brought to my attention and I sent her to the
doctor with a printout of your site. He seemed to already be
aware of the possible connection between Lipitor and her
symptoms and took her off the drug for six weeks. We'll see if
there's any change in her symptoms during these six weeks.
6.) I found your
web page when I decided to search out Lipitor. I have been on
Lipitor longer than I can remember. I started with Pravachol and
then went to Lipitor. I never associated my lack of energy and
muscle problems with the drugs though. I was having a series of
deep tissue massages with a massage person whom I have used
After the 3rd
session my neck muscles were just as tight as when I started.
She asked me if I was taking any cholesterol medications and I
had to say yes. She had told me she had seen a number of her
patients with close to the same problems and they all were
taking the cholesterol medicines. She asked me when I saw my
doctor next and I told her in October when I was due for my
blood work. She just suggested that I might want to consider
going off of the Lipitor till then and just see how I felt. She
gave me something to really think about. I only thought for a
very short period as I stopped taking it the next day. I went on
vacation and started having more energy and my neck pain was
minimal. I was amazed. I feel really great right now. I still
need to tell my doctor but might wait till I go back in October.
I just wanted to let you know that your web page really helped
me and all the other ones too.
7.) I have been
taking Lipitor 40mg. for approx. 1 year. For about six months I
have had severe pain in the muscles around my left elbow,
especially when twisting my thumb downward with my arm
outstretched. I am 47 years old, and an automobile technician by
trade. I went to my family physician and was told that I had
tennis elbow. In the last month the problem also began to show
up in my right elbow. This condition makes doing my job very
painful at times, depending on what I have to do. A few weeks
ago an insurance salesperson came to my shop to try to sell me
disability insurance. When she asked me if I was on any
medications, and I told her I was taking Lipitor, she asked me
if I have arm pain. I told her, "come to think of it, I do." She
said that her mother had experienced severe arm pain while on
Lipitor, and had to stop taking it. She told me that ever since
the problem with her mother, she now asks people if they
experience arm pain, if they tell her they are taking Lipitor.
She said that a large percentage of people she asks do, in fact,
experience pain in their arms. I stopped taking Lipitor about 2
weeks ago, and the pain in my arms is almost gone.
8.) I am 65 yrs.
old I've been taking Lipitor for over 8 yrs. then my Doctor
added Lopid for more than one year. From what I saw on the
internet you can not combine Lopid with Lipitor. It will cause
muscle problems, which I now have and feel like I'm going
cripple. I stopped taking Lipitor six months ago. I would like
to warn any one out there not to take Lipitor with Lopid. It's a
horrible pain to have muscle problems.
9.) The evolution
of my Lipitor problems. My right foot on the pedal was now at a
funny angle. My quad muscles became unusually sore. My libido
was now non-existent. At night in bed I was getting palpitations
and my heart rate rhythm was very irregular with the heart
stopping for about two/three
seconds about six
times a minute. My performances on the bike were getting
steadily worse. In June I raced a 25-mile time trial and barely
finished the distance totally exhausted. It was then that I
researched Lipitor on the internet. I am very angry to think
that the medical profession can proscribe a drug with these side
effects. I do not know whether or not there was a drug
interaction with the antibiotics or whether it made no
difference, anyway I stopped taking Lipitor immediately. That
was 42 days ago. My heart rhythm is now back to normal, the
palpitations stopped and libido back to normal, the soreness and
stiffness in my neck almost gone. When riding my bike the angle
of my foot on the pedal is now OK. My bike training is still
suffering as my recovery is still not very good. To aid recovery
I am taking 2000Mg Vitamin C 1000Mg Lysine 1000Mg L-Carnitine
120Mg CoQ10 and Vitamin B Complex supplements daily. Lipitor is
a poison. It will probably take me anything up to six months to
fully recover and with hopefully no permanent damage. Anything
you can do to prevent people taking Lipitor is OK with me.
10.) My mother,
age 84, lives with me, and has been taking Lipitor for 3 1/2
years, up until very recently. She's experienced a lot of muscle
pain, inflammation, and symptoms similar to muscular dystrophy
-- difficulty walking, rising from a seated position,
coordination, droopy eyelid on one eye, tremor in her right
hand, difficulty initiating walking, very dry eyes, and more. It
was only on August 17 when I ran across the article, "My Life
After Lipitor", that I suspected Lipitor could be causing these
symptoms and contributed to my mom's deteriorating health.
Having called her primary physician immediately after suspecting
this, they scheduled her for a CPK test. It was her first time.
Her reading was 174, on a scale from 30 to 135. So, they've told
her to stop Lipitor, and she should be fine in 2 weeks.
Meanwhile, I have contacted health consultant and have begun to
give my mom some of the recommended supplements as he advised.
Almost immediately, the tremor in her right hand was greatly
reduced, and is almost gone entirely. But it's a long road
ahead. She is so frustrated with her mobility issues, which
makes her frightened to be in the house alone. She depends on us
for assistance to dress, undress, toileting, showering and more.
Mostly, she's afraid that she'll fall. She's lost all her
confidence to be independent. She's frequently asked me, "did I
have a stroke?" She has not. Yet, she's felt so debilitated,
that she's concluded she must have. I'm so frustrated her
primary physician called her CPK results (174) only "mildly
elevated" and of no concern. When I asked her physician if she
recommended replacing Co-Q10 which her Lipitor had depleted, she
said she wasn't familiar with this, but added, "it couldn't
and Risk of Statin Side Effects
Research Institute of Tuft's
reported the results of a large study of the relationship of
statin side effects to the magnitude of lipid lowering achieved.
Common sense says
that the higher the statin dose with its resulting fall in
cholesterol, the greater the side effect problem, right? If you
said right, you are wrong and if you said wrong you are wrong.
The results of this study proved to be interesting.
appears that the benefit of statin drugs on atherosclerosis with
its stroke and heart attacks is not due to cholesterol reduction
but to the powerful anti-inflammatory effect of statins.
is now considered by most to be an inflammatory process.
Cholesterol, the former villain, is now felt to be irrelevant
and is there in the plaques solely as an innocent bystander to
the body's inflammatory response. And one of the concerns about
this new anti-inflammatory role of statins is that it is
mediated through inhibition of nuclear factor-kappa B, a
transcriptase vital not only to our body's inflammatory response
but also our entire immunodefence system. To inhibit
inflammation therefore must also inhibit the ability to
neutralize viruses, bacteria and mutagenic cells.
You cannot have
one without the other. It seems that if you lower heart attack
death rates by the use of statins, you increase cancer death
rates. And that is exactly what Alawi and his group found.
On the other
hand, if you are talking other statin side effects such as
rhabdomyolysis and hepatitis mediated through reductase
inhibition of the mevalonate metabolic pathway - the widely
stated mechanism of action of all statin drugs - the risk of
these side effects shows no correlation with lower cholesterol
reduction and these two conditions tend to occur just as
frequently with minimal cholesterol reduction and statin dose as
with the cholesterol hyper-responders and today's super dosing.
Some of the worst reports of these two side effects occur with
very modest cholesterol changes and statin doses.
If one goes to
the chart of the mevalonate pathway and finds the reductase step
in this long sequence of biochemical reactions, the first thing
you note is that the much touted reductase inhibition, common to
all statins, is at the very beginning of the mevalonate pathway.
The next thing you notice is that several other metabolically
vital pathways share the common mevalonate path. So to inhibit
cholesterol synthesis must affect everything else as well but
not necessarily to the same degree. This gives us a plausible
explanation for why a small cholesterol effect might be
associated with a large CoQ10 or dolichol effect. It is a matter
of different sensitivities of the different paths involved. And
likely, this is all a matter of inherent genetic variability.
I would like to
extend this discussion to cognitive effects and statin dose and
predict that it, too, is independent. In my own case of
transient global amnesia two months after Lipitor 10mg daily, a
worst case occurred the following year when at my insistence the
dose had been reduced to 5mg daily. This dose was miniscule by
any standards yet sufficient to wipe out my entire adult life
for a horrifying, in retrospect, 12 hours.
like these appear to be mediated by statin inhibition of glial
cell cholesterol manufacture. We have evolved with this glial
cell dependency but did not know this until Pfrieger's paper of
2003. If Alawi and his other authors had included this common
side effect of statin in their study, I am certain it would have
proven to be completely independent of statin dose and have to
do with the inherent sensitivity of the brain cholesterol
It is not every
day that a major study offers results so closely documenting
what I would suspect from my past seven years of statin side
The Dark Side of
Recently I have
received information from a former Navy flight surgeon, who
states, "You could not force a statin pill into my mouth."
Her story began
soon after her assignment to a Navy base as a flight surgeon,
when she began to encounter side effect complaints from patients
on Statins. As she researched this issue her attention was soon
drawn to CoQ10 and the fact that it was seriously inhibited by
the effect of statin drugs on the mevalonate pathway and no
doubt the cause of many of the problems
trials of CoQ10 were often successful but naturally she wondered
why CoQ10 was not given routinely with all statins since this
CoQ10 inhibition was inevitable. Meanwhile this new Navy flight
surgeon soon drew considerable attention to herself by not
giving statin drugs when her colleagues routinely were and by
insisting that all patients on statins should be on CoQ10.
bureaucracy of Navy medicine, flaunting standardized procedures
is not without its costs but her research continued. She found
that Merck had applied for and received two patents to help
offset the harmful effects of statin drugs on people by the use
But what followed
was even more surprising when she discovered that despite
Merck's obvious awareness of the CoQ10 deficiency problem, not
one word of this was disclosed by Merck to the doctors
prescribing this medicine.
Desk Reference on every physician's desk and inserts with every
pill package made no mention of the harm to come from statin
inhibition of CoQ10 synthesis. In other words, Merck was not
giving full and complete disclosure of the facts about statins
to the nation's doctors. Physicians were being forced to give
statins in accordance with established procedures despite
evidence of harm to come, not by possible reduction of CoQ10
from mevalonate blocking but inevitable inhibition of CoQ10
She then began to
conclude that fully 60% of statin side effects occurred because
of this. Insufficient CoQ10 was the basis not only of liver
inflammation but of statin associated heart failure, fatigue,
myopathy, neuropathy and rhabdomyolysis.
Meanwhile she was
being pressured to adhere to established medical guidelines with
respect to the use of statins. Needless to say, this doctor now
is pointing a finger at Merck, asking, "Blocking of CoQ10 is
commensurate with cellular suicide. Why did you not tell us?"
Hers is a very
appropriate question that organized medicine should have asked
back in 29 May, 1990 when Merck's request for Patent Number
4,929,437, explaining the cellular damage to come if CoQ10 was
not added to statins, was filed.
effects from Lipitor are not common, they can occur. Tell your
doctor if any of these symptoms are severe or do not go away:
stomach pain or cramps
rash or itching
If you experience
any of the following symptoms, call your doctor immediately:
muscle cramps or weakness with or without a fever.
Rare cases of muscle problems and liver problems have
been associated with the use of atorvastatin and other similar
medicines. Contact your doctor immediately if you experience
unexplained muscle pain, tenderness, or weakness, especially if
accompanied by a fever or flulike symptoms or yellowing of the
skin or eyes, abdominal pain, unexplained fatigue, dark colored
urine or pale colored stools. These may be early symptoms of
muscle or liver problems.
If you experience any of the following serious side
effects, stop taking atorvastatin and seek emergency medical
attention or contact your doctor immediately:
an allergic reaction (difficulty breathing; closing of
the throat; swelling of the lips, tongue, or face; or hives);
decreased urine or rust-colored urine; or
Other, less serious side effects may be more likely to
occur. Continue to take atorvastatin and talk to your doctor if
upset stomach or flatulence; or
Side effects other than those listed here may also
on side effects of Lipitol
UNPRECEDENTED CARDIOVASCULAR RISK REDUCTIONS IN DIABETES
PATIENTS WITH METABOLIC SYNDROME AND IN STROKE PATIENTS
- March 28, 2007
today that Lipitor?(atorvastatin calcium) Tablets 10 mg provided
a significant 61 per cent reduction in stroke in patients with
type 2 diabetes and metabolic syndrome but without heart
disease. In a separate study, patients who had suffered a
recurrent stroke or transient ischemic attack (TIA) during the
trial had a significant 53 per cent reduction in the risk of
major coronary events (death from cardiac causes, heart attack,
or resuscitation after cardiac arrest) with Lipitor 80 mg. These
analyses from two landmark clinical outcomes studies,
Collaborative Atorvastatin Diabetes Study (CARDS) and Stroke
Prevention by Aggressive Reduction in Cholesterol Levels
(SPARCL), were presented at the annual meeting of the
American College of Cardiology.
impressive is the magnitude of cardiovascular efficacy,
including a 61 per cent reduction in the risk of stroke, that
Lipitor offered these patients who were at high risk for
cardiovascular events," said Professor John Betteridge, a lead
author of CARDS and professor of endocrinology and metabolism at University College
add to the unique and robust body of evidence for Lipitor that
includes proven reductions in heart attacks and strokes,
impressive average LDL lowering of 39 per cent to 60 per cent,
and an established safety profile across a broad range of
patients," said Dr. Michael Berelowitz, senior vice president of
Pfizer's global medical division.
New Analysis of
the Collaborative Atorvastatin Diabetes Study (CARDS)
In a new analysis
of more than 2,200 patients with type 2 diabetes who met the
criteria for metabolic syndrome in CARDS:
Lipitor 10 mg provided a significant 41 per cent
reduction in the risk of major cardiovascular events (death from
coronary heart disease, heart attacks, strokes, certain types of
heart surgery, chest pain) compared with placebo.
Lipitor 10 mg provided a significant 61 per cent
reduction in the risk of stroke compared with placebo.
About the Overall
The CARDS study,
published in The Lancet in 2004, involved more than 2,800
patients with type 2 diabetes with no history of heart disease,
and relatively-low levels of cholesterol. The study showed that
patients who took Lipitor 10 mg had a 37 per cent reduction in
major cardiovascular events, which included heart attacks and
stroke. In fact, 48 per cent fewer Lipitor treated patients
experienced strokes compared to those who received placebo.
In CARDS, Lipitor
was well-tolerated. The overall frequency of adverse events or
serious adverse events did not differ between Lipitor and
syndrome was defined in this analysis using the International
Diabetes Federation criteria of central obesity and two or more
of the following conditions: diabetes, treated hypertension or
high blood pressure, high triglyceride and low levels of good
cholesterol (HDL). Metabolic syndrome is a condition that
affects thousands of Canadians, putting them at risk of heart
disease and stroke, especially those aged 50 and over.i
According to the
International Diabetes Foundation, a quarter of the world's
adults have metabolic syndrome and people with metabolic
syndrome are twice as likely to die from, and three times as
likely to have a heart attack or stroke compared with people
without the syndrome.
New Analysis of
the Stroke Prevention by Aggressive Reduction in Cholesterol
Levels (SPARCL) study
A new SPARCL
analysis was conducted to evaluate if treatment with Lipitor 80
mg was associated with significant protection from coronary
events after a recurrent stroke or TIA. In more than 850
patients who suffered a recurrent stroke or TIA during the
Lipitor 80 mg reduced patients' risk of experiencing
major coronary events (death from cardiac causes, heart attack,
or resuscitation after cardiac arrest) by 53 per cent compared
The benefits of
Lipitor 80 mg in patients with a recurrent stroke or TIA seen in
this analysis are consistent with the primary SPARCL results
which demonstrated the benefit of Lipitor 80 mg in reducing
stroke and coronary events among all patients in the study
About the Overall
The SPARCL study,
published in the New England Journal of Medicine in 2006, is the
first major study designed to examine the benefits of lipid
lowering therapy in stroke patients (n=4,731). Patients taking
Lipitor 80 mg who had a prior stroke or TIA reduced their
chances of having an additional stroke by 16 per cent, and major
coronary events, such as heart attack, by 35 per cent, compared
to placebo. In a post-hoc analysis of the SPARCL trial, there
was a higher incidence of hemorrhagic stroke in patients taking
Lipitor 80 mg compared with patients taking placebo. Despite the
current hypothesis that low cholesterol levels may be tied to
stroke, no significant increases in the incidence of hemorrhagic
stroke have been seen in lower LDL-C levels in other trials
involving Lipitor 80 mg. An analysis of three large clinical
trials involving more than 10,000 patients with coronary heart
disease (but who may not have had a previous stroke) treated
with Lipitor 80 mg, revealed that the rate of hemorrhagic stroke
was low (0.3%).ii Patients with prior hemorrhagic stroke at
study entry appeared to be at an increased risk of hemorrhagic
Lipitor was well-tolerated. The rate of side effects such as
elevated liver enzymes, muscle weakness or rhabdomyolysis were
low and consistent with the known safety profile.
Every year, an
estimated 15 million people worldwide suffer strokes. Stroke,
the fourth leading cause of death in
Canada, kills as many as 16,000
Canadians each year. Annually, 40,000 to 50,000 Canadians have a
stroke, and approximately 300,000 Canadians are living with the
effects of stroke, including paralysis and impaired cognitive
functioning. Often, those who have had a stroke are at increased
risk for stroke recurrence.
Lipitor is a
prescription drug indicated to lower LDL cholesterol and other
fats in the blood (such as triglycerides) when response to diet
and other lifestyle measures alone have been inadequate, in both
adults and pediatric patients (boys and postmenarchal girls, 10
to 17 years of age, with heterozygous familial
hypercholesterolemia). Lipitor is also indicated to reduce the
risk of myocardial infarction in adult hypertensive patients
without clinically evident coronary heart disease, but with at
least three additional risk factors (such as 55 years and older,
smoking and type 2 diabetes) for coronary heart disease.
Lipitor is also indicated to reduce the risk of myocardial
infarction and stroke in adult patients with type 2 diabetes
mellitus and hypertension without clinically evident coronary
heart disease, but with other risk factors such as age (55 years
and older) retinopathy, albuminuria or smoking.
Lipitor is the
leading cholesterol-lowering therapy in the world with more than
121 million patient years of experience. Since the introduction
of Lipitor ten years ago, its safety and effectiveness have been
supported through the Atorvastatin Landmark ProgramTM, an
extensive clinical program with more than 400 ongoing and
completed clinical trials involving more than 80,000 patients
around the world. Lipitor has demonstrated cardiovascular
outcomes benefits in a broad range of patients including the
entire risk continuum.
generally well-tolerated. Adverse reactions have usually been
mild and transient. The most common adverse events were
gastrointestinal complaints, headache, pain, muscle pain and
Inc. is the Canadian operation of Pfizer Inc, the world's
leading pharmaceutical company. Pfizer discovers, develops,
manufactures and markets prescription medicines for humans and
animals. Pfizer's ongoing research and development activities
focus on a wide range of therapeutic areas following our guiding
for a healthier world. For more information, visit
LescolTM, LipitorTM, MevacorTM, PravacolTM, and ZocorTM – are
the most widely used prescription drugs in the world. Over 20
million people worldwide take statins, and the resulting annual
sales exceeded 16 billion dollars in 2001.2 Why are they so
popular? People take statins to lower their cholesterol. Indeed,
these drugs can reduce blood serum cholesterol levels by 30 to
40% or more.
As described in
the previous chapter, experts have found that the incidence of
coronary heart disease (CHD) is essentially the same for people
with elevated and normal blood serum cholesterol levels. The
Cholesterol Risk Characterization Theaters (RCTs) shown in Chap.
8 suggest that the level of benefit from reducing cholesterol
levels may not support the contention that cholesterol is a
primary risk factor for CHD. Yet many of the people who take
statins to lower their cholesterol do so in the hopes of
reducing their risk of heart disease. Two key questions arise.
Do individuals taking statins have a lower incidence of CHD when
compared to individuals not taking these drugs? If so, are the
benefits due to lowering blood serum cholesterol levels, or are
they due to something else?
calcium) is a synthetic lipid-lowering agent. Atorvastatin is an
inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA)
reductase. This enzyme catalyzes the conversion of HMG-CoA to
mevalonate, an early and rate-limiting step in cholesterol
In adult patients
without clinically evident coronary heart disease, but with
multiple risk factors for coronary heart disease such as age >/=
55 years, smoking, hypertension, low HDL-C, or a family history
of early coronary heart disease, Lipitor is indicated to:
Reduce the risk of myocardial infarction
Reduce the risk for revascularization procedures and
as an adjunct to diet to reduce elevated total-C, LDL-C,
apo B, and TG levels and to increase HDL-C in patients with
primary hypercholesterolemia (heterozygous familial and
nonfamilial) and mixed dyslipidemia ( Fredrickson Types IIa and
as an adjunct to diet for the treatment of patients with
elevated serum TG levels ( Fredrickson Type IV);
for the treatment of patients with primary
dysbetalipoproteinemia ( Fredrickson Type III) who do not
respond adequately to diet;
to reduce total-C and LDL-C in patients with homozygous
familial hypercholesterolemia as an adjunct to other
lipid-lowering treatments (eg, LDL apheresis) or if such
treatments are unavailable;
as an adjunct to diet to reduce total-C, LDL-C, and apo B
levels in boys and postmenarchal girls, 10 to 17 years of age,
with heterozygous familial hypercholesterolemia if after an
adequate trial of diet therapy the following findings are
LDL-C remains >/= 190 mg/dL or
LDL-C remains >/= 160 mg/dL and:
there is a positive family history of premature
cardiovascular disease or
two or more other CVD risk factors are present in the