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Lipitor: Side Effects


Serious side 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.

When a "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

by Jonathan Campbell, March 16, 2004

Numerous adverse 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 improving.

These adverse 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 tissue.

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 cells.

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 degenerate.

The continual 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 prescribe Lipitor.

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 U.S. 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.

For more 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.


Ginter E. Ascorbic acid in cholesterol and bile metabolism. Annals of the New York Academy of Science. 258 (1975): 410-421

Medications.com. Lipitor Drug Information - Atorvastatin Calcium - Lipitor Side Effects.

Medications.com - 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, 2004

Silverberg C. Atorvastatin-induced polyneuropathy. Ann Intern Med. 2003 Nov 4;139(9):792-3

Ziajka PE, Wehmeier T. Peripheral neuropathy and lipid-lowering therapy. South Med J. 1998 Jul; 91(7):667-8.



Atorvastatin side effects

Get emergency 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, heartburn;

           nausea, stomach pain or upset;

           constipation, bloating, gas;

           stuffy nose;

           itching, skin rash; or

           muscle pain.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.



Lipitor® Side 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 before.

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 hurt.

Duane Graveline MD MPH

Former USAF Flight Surgeon

Former NASA Astronaut

Retired Family Doctor



Lipid Lowering and Risk of Statin Side Effects

The Molecular Research Institute of Tuft's New England Medical Center 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.

It increasingly 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.

Atherosclerosis 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.

Cognitive effects 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 synthesis capability.

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 effect study.

Duane Graveline MD MPH

Former USAF Flight Surgeon

Former NASA Astronaut

Retired Family Doctor



The Dark Side of Statins

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

Therapeutic 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.

In the 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 of CoQ10.

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.

The Physician's 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 synthesis.

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.

Duane Graveline MD MPH

Former USAF Flight Surgeon

Former NASA Astronaut

Retired Family Doctor



Possible Side Effects

Although side 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





           blurred vision


           rash or itching

           upset stomach

If you experience any of the following symptoms, call your doctor immediately:

§         muscle pain

§         tenderness

§         muscle cramps or weakness with or without a fever.

More Information

§         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

§         blurred vision.

§         Other, less serious side effects may be more likely to occur. Continue to take atorvastatin and talk to your doctor if you experience

§         headache;

§         upset stomach or flatulence; or

§         a rash.

§         Side effects other than those listed here may also


Personal reports on side effects of Lipitol





New Orleans - March 28, 2007

Pfizer announced 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.

"What's 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 London Hospital.

"These results 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 CARDS Study

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 placebo.

About Metabolic Syndrome

Metabolic 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 trial:

           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 with placebo.

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 (n=4,731).

About the Overall SPARCL Study

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 stroke.

In SPARCL, 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.

About Stroke

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.

About Lipitor

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.

In addition, 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.

Lipitor is generally well-tolerated. Adverse reactions have usually been mild and transient. The most common adverse events were gastrointestinal complaints, headache, pain, muscle pain and fatigue.

About Pfizer Canada Inc.

Pfizer Canada 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 aspirationorking for a healthier world. For more information, visit www.pfizer.ca.

http://www.pfizer.ca/english/newsroom/press releases/default.asp?s=1&releaseID=227

Statins – 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?




Lipitor® (atorvastatin 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 biosynthesis.

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 angina


Lipitor is indicated:

1.         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 IIb);

2.         as an adjunct to diet for the treatment of patients with elevated serum TG levels ( Fredrickson Type IV);

3.         for the treatment of patients with primary dysbetalipoproteinemia ( Fredrickson Type III) who do not respond adequately to diet;

4.         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;

5.         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 present:

a.         LDL-C remains >/= 190 mg/dL or

b.         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 pediatric patient