Health & Medicine - Posted by Dennis O'Shea-JHU on Tuesday, December 7, 2010 14:06 - 10 Comments 
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(1 votes, average: 5.00 out of 5) Loading ...Statin side effect serious, but rare
While statins may trigger a rare, serious muscle disease in some patients, researchers say it can be treated and should not cause cholesterol patients to stop taking their medicine. (Credit: iStockphoto)
JOHNS HOPKINS (US) — Cholesterol-lowering statins, the most common class of medication in the U.S., appear to trigger a rare but serious autoimmune muscle disease in a small number of the 30 million Americans who take them.
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The text of this article by Futurity is licensed under a Creative Commons Attribution-No Derivatives License.
Statins, researchers say, can sometimes cause the body to produce antibodies against its own proteins, creating a condition that gets progressively worse—not better—even after the medication is discontinued.
The painful and debilitating disorder is uncommon and can be treated with steroids and other immune-suppressing drugs, so the researchers caution that people who must be on statins to reduce serious risk of heart disease and stroke should not avoid the drugs.
“We have long known that there must be environmental triggers to the development of autoimmune disorders,” says Andrew L. Mammen, assistant professor of neurology and medicine at the Johns Hopkins University.
“Now we have evidence that this medication is just such a trigger and, under certain circumstances, provokes a sustained autoimmune disease.”
Details of the study—published online in the journal Arthritis & Rheumatism—could lead to lab tests that identify early autoimmune muscle disease, guide treatment before symptoms escalate and, possibly, predict who is at risk before statins are prescribed.
Mammen cautions that the research describes a rare side effect, noting that statins are a “fantastic medication” that have proven value.
“No one who needs statins should be afraid to take them because of the slim risk of developing this autoimmune disease,” he says.
“Statins save a huge number of lives. They dramatically reduce the risk of strokes and heart attacks,” Mammen adds.
“The ultimate goal of our research is to determine before patients start taking statins who might be sensitive to the medication and who might be susceptible to its potentially toxic effects on the muscle. We want to prevent this autoimmune disease.”
Although statins are tolerated by most patients, about 5 percent who take them experience muscle pain and/or weakness severe enough to warrant stopping the medication. Most make a full recovery once they are off the drug.
But a small group who develop the progressive autoimmune muscle disease get weaker even after the medication is stopped. Some end up in wheelchairs and at least one has died. Immunosuppressive therapy with steroids or other drugs is effective in reversing the disease in most patients, Mammen says.
The target of the antibodies is HMG-CoA reductase, or HMGCR, the enzyme responsible for making cholesterol. It is the same enzyme that statins target.
Of more than 750 patients with muscle symptoms that participated in the study, 45 patients with HMGCR antibodies were identified. Of those older than 50, more than 90 percent had a prior statin exposure.
The younger patients, Mammen says, had not been on statins; how the disease is triggered in them has not been determined. It is suspected, however, that they may suffer from other cholesterol issues, a factor that could play a role in the development of the disease.
Antibodies are typically made by the body to recognize and destroy foreign invaders. But in patients with autoimmune diseases, the body makes auto-antibodies—antibodies that attack the body’s own proteins.
Mammen has developed a lab test that allows for near certain diagnosis of the disease. Some of his patients, however, continue to need the very medication that caused their pain. The test has not yet been approved by regulators,
“One of the questions that remain is: Can you safely restart statins? It’s important because some of our patients were put on statins for very good reasons, like they’ve had a heart attack,” Mammen says. “We would like to find out if there is a way for these patients to begin taking the medication again.”
The research was supported by the National Institutes of Health, the Passano Foundation, the Ira Fine Discovery Fund and the Dorothy and Donald Stabler Foundation.
More news from Johns Hopkins University: http://releases.jhu.edu/
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10 Comments
Sharon Pharms
mtflight
Autoimmune disease is horrible. My question is where is the data that supports that “statins save a huge number of lives. They dramatically reduce the risk of strokes and heart attacks”
Where are the studies that support this claim? Are they based on the assumption that high cholesterol is a risk for strokes (not) and heart attacks (weak link). This is probably along the lines of the Colbert Report’s keep fear alive campaign.
Diane
This is very frightening to me. I have already had several autoimmune diseases and am currently taken statins. I’ve not had a heart attack or stroke. I did have a triple bypass, yet was told my heart is normal. Do I continue taking this drug?
Marc Blasband
Who are the companies that produce Statins? Do they have any influence on these studies?
How independant are professor Andrew L. Mammen and Johns Hopkins University? This should be clearly stated by such studies.
emc2
I thought statin ads always state that there is no evidence to suggest they reduce the incidence of heart attacks and strokes. It’s not even clear that high cholesterol causes heart attack and strokes. What about triglycerides, which are lowered by prescription-grade fish oil. To promote long-term steroid use seems like a terrible idea.
Teresa Chandonnet
I have been on different statins for many years. I have been plagued with upper and lower extremity muscular pains that have progressively been getting worse for about a year. I stopped the statins for approximately 2 months and there was no change in the muscular pain. It seems to be worse in my lower extremities. I am back on a statin again. I really need some help because the pains are getting much worse. Maybe you can give me some information to bring back to my doctor and try to figure this problem out for me. I would be greatly appreciative for you help.
Thanks.
Mario
Teresa
Were you ever instructed to get on CoQ10 while on statins? The enzyme that statins act on is not only responsible for limiting the manufacture of cholesterol in the liver, but also some other important products like coQ10 which is a crucial cardiovascular antioxidant. Supplement it.
While most major authoritative institutions don’t discriminate the use of statins between the sexes, it is obvious from the scientific literature that the studies that villified cholesterol were only done on men! And that lowering cholesterol is not the mechanism by which statins work– they lower inflammation. You see, other drugs that successfully lower cholesterol have had sometimes lethal consequences. There are better ways to lower inflammation than with drugs.! Search for “cooling inflammation” blog which is written by Dr. Art Ayers for a basic primer. ( and take coQ10 in the meantime to see if your condition improves noticeably). I can tell you that most of the things that contribute to inflammation are not native to the human diet ( grains, oils).
Good luck.
Diane
Teresa
The way to start is by testing for creatine kinase (commonly called CK). If the level is too high you may have the autoimmune disorder talked about in this study. Then you need to find an immunologist who specializes in autoimmune disorders, not just allergies.
I have pain 24/7 and know how miserable life can become. I wish there was more I could suggest for you and for me.
If you want I’m adding my email addy. Maybe we can help each other?
Mario, I’m going to try CoQ10. Do you know what a typical dosage is?
Good luck,
Diane
dianecropper@gmail.com
mtflight
Diane,
I am not sure about the indicated dosage but in the case of someone taking statins, the CoQ10 deficiency could be similar to that of someone with a serious mitochondrial disorder that annotate produce it. Around 200 units a day minimum (it’s not inexpensive) and preferably as a capsule taken with fatty food, as it increases absorption, would be best.
For autoimmune disease look up “low dose naltrexone” as it is so far the only thing that has shown to arrest it. It has been tested clinically for multiple sclerosis and chrohns disease with great success.
Good luck
Mario .
Anita Mitchell
In 1999, a friend died while taking Lipitor. He went to see an allergist who prescribed an antifungal (ketoconizole, I believe) and something like Claritin (an anti-histamine) too. He only lived five days after he began taking all 3 drugs concurrently. Today, Statins and anti-histamines are “black boxed” (an after-introduction to market warning) not to take HMG CoA reductase inhibitors together and that means no antifungals (or azoles) and statins.
So, since the literature on these drugs seems to be “state of the art”, incomplete for years until enough info aggregates, who wants to be an unwitting part of the experiment?
I took blood pressure medicine (ACE inhibitors) and developed dry eyes and mouth that resemble the autoimmune disorder Sjogren’s syndrome. It seems that if you mess with the angiotensin/renin axis some people will develop these symptoms and they have not abated since the drugs were discontinued. Above it states that autoimmune disease can be triggered by the environment and drugs are included. Dry eyes and mouth and oral symptoms are in the literature for these drugs as possible side effects but nowhere did it suggest that discontinuing the drugs would not discontinue to adverse effects which appear to be permanent. Caveat emptor with the pharmaceutical industry folks. This is not as isolated or rare as “they” depict. Many cases go unreported because the connection to the drug is never made and other drugs just layered on to handle the new symptoms.
I’ve read the article above; however, my concern is what if a Patient already had an autoimmune disease (sarcoid or sarcoidosis) too be exact, already was on an immune-suppressive (Prednizone, then, Imuran); had a heart attack, then was placed on a stain, afterwards? How may, or may not, this affects this patient? Is being on a statin a good idea?