Statins are among the most widely prescribed drugs in the United States, with more than $12 billion in annual sales and tens of millions of patients. However, many doctors and their patients do not realize the potential serious side effects from statin use. Doctors are prescribing these drugs too casually, not recognizing the potential dangers. Furthermore, there is no proof that patients taking statin drugs will live longer. See my discussion in the March 2008 newsletter. Therefore, why should a doctor prescribe such an expensive and potentially harmful drug when there is no proof of increased lifespan? Plus, there are many natural ways to lower cholesterol levels that are much safer.
   The medical community, and the drug companies keep pounding the consumer and physicians with promotional material that cholesterol must be lowered with statin drugs. However, natural supplements and functional foods are also good options to lower cholesterol levels. See cholesterol for a thorough discussion. Many patients on statins may need to take a CoQ10 supplement to counteract the myopathy that occurs from statin drug use.

Statins and mortality
Primary Prevention of Cardiovascular Diseases With Statin Therapy: A Meta-analysis of Randomized Controlled Trials.
Arch Intern Med. 2006 Nov 27;166(21):2307-13. Thavendiranathan P, Bagai A, Brookhart MA, Choudhry NK. Department of Medicine, University of Toronto, Toronto, Ontario.
While the role of hydroxymethyl glutaryl coenzyme A reductase inhibitors (statins) in secondary prevention of cardiovascular (CV) events and mortality is established, their value for primary prevention is less clear. To clarify the role of statins for patients without cardiovascular disease, we performed a meta-analysis of randomized controlled trials (RCTs). Seven trials with 42 848 patients were included. Ninety percent had no history of CV disease. Mean follow-up was 4.3 years. Statin therapy reduced the RR of major coronary events, major cerebrovascular events, and revascularizations by 29%, 14%, and 33%, respectively. Statins produced a nonsignificant 22% RR reduction in coronary heart disease mortality. No significant reduction in overall mortality or increases in cancer or levels of liver enzymes or creatine kinase were observed. In patients without cardiovascular disease, statin therapy decreases the incidence of major coronary and cerebrovascular events and revascularizations but not coronary heart disease or overall mortality.
   Dr. Sahelian comments: Statins are currently the most widely prescribed drugs in many countries. There are hundreds of thousands of doctors in the USA, and many more in the rest of the world, who prescribe statin drugs to their patients and have been doing so for the past decade or so. Most of these doctors are well meaning and do think they are helping their patients. But, unfortunately, they have been misguided by the drug companies and by the medical journals they read and trust. These medical journals have repeatedly reinforced the notion that lowering cholesterol is a good thing. I don't dispute the fact that studies show those with high cholesterol levels have a higher rate of cardiovascular conditions. However, I do dispute the fact that lowering cholesterol with statin drugs is a good thing when there are natural options available..
     This is what a CNN article says: Statins are prescribed to lower excessive levels of artery-clogging "bad" cholesterol and to lessen inflammation in blood vessels. But the latest study casts doubt on the benefits of prescribing statins to prevent cardiovascular disease in individuals with healthy cholesterol levels. While statins lessen the risk of heart attacks and strokes in people already at risk because of heart disease or high cholesterol, routine use of such drugs by otherwise healthy adults produces such limited benefits that it may not be cost-effective. For example, an analysis of seven previous trials involving nearly 43,000 adults aged 55 to 75 found that the average adult had a nearly 6 percent chance of suffering a heart attack or stroke over a 4 year period, compared with a 4 percent risk among those who took statins. Therefore, 60 patients would need to be treated for an average of 4 years to prevent one major coronary event," the study's author, Dr. Paaladinesh Thavendiranathan of the University of Toronto, wrote in the article. To prevent a single stroke, 268 people would need to undergo statin treatment, and to prevent one nonfatal heart attack 61 would have to take the drugs, he added. Moreover, statin use did not improve the overall risk of dying from cardiovascular disease or from other causes.

Why was this the headline of an article as opposed to "Statin use does not improve mortality"?
Statins Reduce Risk of Heart Attack and Stroke in Those Without Heart Disease
CHICAGO, IL -- November 28, 2006 -- Among individuals without cardiovascular disease, taking statins regularly may reduce the risk of major heart and cerebrovascular events such as heart attack and stroke but not coronary heart disease or overall death, according to a meta-analysis of previously published studies, reported in the November 27 issue of Archives of Internal Medicine, one of the JAMA Archives journals. Statins have been shown to reduce death and other negative outcomes associated with heart and cerebrovascular disease among those who already have these conditions, according to background information in the article. It is less clear whether these medications benefit those without cardiovascular disease. Current national treatment guidelines recommend the use of statins in these patients based on their cardiovascular risk profile and LDL-C or "bad cholesterol" level. For patients without cardiovascular disease and with normal LDL-C levels, statins are recommended only for individuals with diabetes or with two or more other cardiac risk factors that raise their 10-year risk of a heart attack or other heart event to at least 10%. Paaladinesh Thavendiranathan, MD, MSc, University of Toronto, Ontario, and colleagues analyzed the results of seven previously published clinical trials that assessed the benefits of statins in a total of 42,848 patients, 90% of whom had no history of cardiovascular disease. In each study, patients were randomly assigned to receive either statins or another form of care and were followed for at least one year, at least 100 major cardiovascular events occurred and 80% or more of the participants did not have cardiovascular disease. In total, 21,409 patients in the trials took statins and 21,439 were assigned to placebo. The average follow-up period for the studies ranged from 3.2 to 5.2 years; average age of the participants ranged from 55.1 to 75.4 years; and the proportion of men included ranged from 42% to 100%. In patients on statin therapy, there were 924 major coronary events such as heart attack compared with 1,219 among those in control groups -- a 29% reduction in risk. Major cerebrovascular events, including stroke, occurred in 440 patients taking statins and 517 controls, a 14% lower risk. Statin treatment was also associated with a 31.7% reduction in risk for non-fatal heart attacks and a 33% reduction in the number of revascularization procedures, which restore blood flow and include angioplasty and bypass surgery. There were no statistically significant differences between the statin and control groups in the rates of patients who died from cardiovascular disease or from all causes. Assuming that individuals not taking statins have a 5.7% chance of having a major heart event over a 4.3-year period, statins can reduce that risk to 4%, the authors write. "Therefore, 60 patients would need to be treated for an average of 4.3 years to prevent one major coronary event." Similarly, 268 patients would need to be treated to prevent one stroke or other major cerebrovascular event; 61 to prevent one non-fatal heart attack; and 93 to prevent one revascularization procedure. Statins are expensive and other therapies also may work to reduce risk, the authors conclude. "Therefore, even though universal lipid-lowering therapy appears attractive, especially in an intermediate-risk primary prevention population, further studies are needed to clarify the cost-effectiveness of therapy in this group." SOURCE: American Medical Association
 

Research on statin drugs and alternatives
Assessment of the longer-term effects of a dietary portfolio of cholesterol-lowering foods in hypercholesterolemia
American Journal of Clinical Nutrition, Vol. 83, No. 3, 582-591, March 2006
Cholesterol-lowering foods may be more effective when consumed as combinations rather than as single foods. Our aims were to determine the effectiveness of consuming a combination of cholesterol-lowering foods (dietary portfolio) under real-world conditions and to compare these results with published data from the same participants who had undergone 4-wk metabolic studies to compare the same dietary portfolio with the effects of a statin medication. For 12 months, 66 hyperlipidemic participants were prescribed diets high in plant sterols (1.0 g/1000 kcal), soy protein (22.5 g/1000 kcal), viscous fibers (10 g/1000 kcal), and almonds (23 g/1000 kcal). Fifty-five participants completed the 1-y study. The 1-y data were also compared with published results on 29 of the participants who had also undergone separate 1-mo metabolic trials of a diet and a statin. Results: At 3 mo and 1 y, mean (±SE) LDL-cholesterol reductions appeared stable at 14 and 13, respectively. These reductions were less than those observed after the 1-mo metabolic diet and statin trials. Nevertheless, 31% of the participants had LDL-cholesterol reductions of >20% at 1 y. The LDL-cholesterol reductions in this group were not significantly different from those seen after their respective metabolically controlled portfolio or statin treatments. More than 30% of motivated participants who ate the dietary portfolio of cholesterol-lowering foods under real-world conditions were able to lower LDL-cholesterol concentrations >20%, which was not significantly different from their response to a first-generation statin taken under metabolically controlled conditions.

Statin drugs damage mitochondria
The mitochondria are structures in cells that make adenosine triphosphate, or ATP, which helps power cells. Statins lower ATP levels and interfere with the mitochondria. Three statin drugs (fluvastatin, lovastatin and simvastatin) produce strong decreases in cellular ATP levels and mitochondrial) activity. Fluvastatin is sold by Novartis under the brand name Lescol, lovastatin is sold under the brand name Mevacor, and simvastatin is sold as Zocor. Three others -- atorvastatin, made by Pfizer under the brand name Lipitor, pravastatin, sold as Pravachol, made by Bristol Myers Squibb and rosuvastatin, sold under the Crestor brand name by AstraZeneca -- have little effect on mitochondria.
Other drugs that are similar to statins in their activity in mitochondria include propranolol, amoxapine, cyclobenzaprine, griseofulvin, pentamidine, paclitaxel, propafenone, ethaverine, trimeprazine and amitriptyline.

Statin drug questions
Q. Is it okay to take serrapeptase or nattokinase enzymes the same day as statin drugs?
   A. This is a good question. I don't know, but my first impression is to be cautious and not to combine statins and these proteolytic enzymes.

Q. Thanks for this writeup in your August 2006 newsletter regarding statin use and muscle damage. In your opinion, would the same be true for red yeast rice which has statin -like properties?
   A. Red yeast rice has many substances in it, one of them being similar to a statin drug. Plus, different red yeast rice supplements on the market may have different compositions. it is difficult to say whether red yeast rice causes muscle damage. We have not had this reported to us yet, but we keep an open mind.

Q.  I am new to your medical newsletter and I like what I read.. you can add me to the list of leg muscle pain taking the statin Lipitor. i took this statin medication for 2 yrs and stopped 3 months ago.

Q. I am a medical doctor. I was placed on Crestor after my cholesterol became elevated. I had also become diabetic -- both after being on many medications for various illnesses. I developed so-called diabetic peripheral neuropathy. I say "so called" because there was a possibility I had plantar fasciitis, and I insisted that all other possible causes of the neuropathy be ruled out. Internists and neurologists insisted that the statin Crestor was not a possible cause. I subsequently "googled" "statins and peripheral neuropathy"...Needless to say, much was found. I insisted that I be taken off the Crestor, and received PT for possible plantar fasciitis. During this time, I wrote Dr. Lam at his web site, asking if red yeast rice, as a "natural" statin, could also cause peripheral neuropathy. He replied, "Yes". He suggested alternatives, which I cannot remember at this time. I am writing out of concern that perhaps the red yeast rice could cause similar problems as the pharmaceutical statins. Also wondering if CoQ10 supplementation might also be necessary for the red yeast rice!
   A. I have not seen any research regarding the role of red yeast rice and muscle tissue damage.

Q. Dr. Sahelian, I've been following your advice and even though I'm 75, my health has been improving. In Jan 2001, a cardiologist rushed me into heart surgery and then prescribed statin drugs, one of which caused me to cough 24 hours a day, I got off of it, then heard it was taken off the market due to causing deaths The statin drug was Baycol manufactured by Bayer. Thank you for your reliable information. My friend's husband is 60 and has had heart surgery, has diabetes, and is in terrible health; I've forwarded your information to her in hopes it will be as much help to her has it has to me.

Q. Are there special risks associated with discontinuing statin use, as opposed to not starting it in the first place. I've noticed a lot of muscle fatigue in my legs since starting to take Lovastatin ( Mevacor ), although I hadn't previously associated the pain with the drug as a statin side effect. I stopped taking the lovastatin and the pain in my legs went away immediately! Now I need to figure out if I should take it every other day, once a week, or not at all . .
   A. There have not been any problems mentioned in the medical literature with abrupt discontinuation of statin drugs, you could consider at first using it every other day after discussing with your doctor until you implement natural ways for cholesterol reduction. I think statin drugs are being overused and are less safe than doctors think.
      Q. I'm thinking that I'll get more exercise without taking this statin drug, since the pain was keeping me away from dancing and other activity that would exercise my joints- I was assuming it was arthritis-related, and that I should reduce stress on my joints to prevent it from getting worse! I could live with high cholesterol levels- it was never something I was particularly concerned about in the past. I'm amazed that the information on statin drug use and muscle aches hasn't gotten wider exposure- I've mentioned it to a few friends who also said they had cut down or discontinued cholesterol medication!

Q. This is my Kaiser general internist's (tee hee) reply to the message I sent him - a quote from your newsletter. "Those of you who are regular readers of my newsletter http://www.raysahelian.com (he makes sense about enough
stuff that I'm forwarding you a comment of his) have heard me repeatedly say that, even though statin drugs such as
Lipitor and Zocor reduce cholesterol levels, there is no proof that statin drugs help people live longer. A recent medical journal article appears to validate my viewpoint. Fortunately, this journal article from Archives of Internal Medicine, November 27, 2006 got picked up by the news media. The CNN.com headline said, " Study doubts benefits of universal statin drug use." The CNN article begins, "Cholesterol-regulating statin drugs slightly lower the risk of heart attack and stroke in people with no history of cardiovascular disease but may do little to reduce their risk of death." My doctor replied, This is not a good statin study; the author's themselves in the conclusion of it note that they did not break the subjects into groups with varying levels of risk. Other statin studies show a clear benefit for diabetics. Also, this study only addresses primary prevention (ie those people who have never had a stroke or heart attack); the authors note that these people benefit from statins. Lastly, while the death rate was not decreased, the risk of heart attack and stroke was. I think most people would not like to have a nonfatal heart attack or stroke. So I don't think this statin study really changes anybodies recommendations about statins.
   A. Perhaps future research will further clarify the statin controversy, but for the time being it is the doctor's duty to provide proof that a 1000 or 2000 dollar a year statin drug will be of significant benefit to the patient and enhance lifespan and quality of life with few side effects before haphazardly prescribing it. I'm not sure dying of other causes besides a stroke or heart attack is any more pleasant.  Your doctor's answer does not seem rational.

Q. I just finished reading your article on the infamous statin drugs! My cholesterol always hovered around the 180 mark which is fine by all the standards, and my LDL, bad cholesterol, was always around 100, again ok, and my triglycerides hovered around the upper range at150 - 160 or so!...About 6 months ago, I started taking flush free niacin (over the counter!) to see what would happen to my cholesterol levels, added 2 grams of fish oil, and a garlic supplement!. I DID "NOT" CHANGE MY DIET!!...To the astonishment of both my Dr. and to myself last week, the following results came back. TOTAL CHOLESTEROL, 138, LDL, 86, TRIGLYCERIDES, 90..... My HDL, well, I've always had a bit of a problem with that being around 36 or so and have tried everything, went to 40....My point being that one should explore 'every possible option' before putting the dangerous statins into their systems. Additionally, statins deplete the body of CoQ10. Doctors don't tell you to supplement with CoQ10 if you are on a statin drug. My best to
you,. Chuck Kelley, llcarlos48@yahoo.com. You may use my name if you wish, and I have 'documentation' if you wish
also.
 

Q. I am a retired drug rep. My cardiologist could not believe my lipid profile without the use of statins. I take 1 tbls. of pharmaceutical grade fish oil each day. My triglycerides dropped by 40%!
 

Q. After 7 months of various statin protocols I completely stopped in March 06 due to extensive pain in the thighs and calfs and started a daily regiment of 2400mg of red yeast rice. The muscular discomfort has slowly decreased. Last month I added 200mg of Co Q10 to my daily regimen. The lingering muscular discomfort has gone. I credit CoQ10 for the relief. I wish to continue CoQ10 along with the Red Yeast Rice and would appreciate your comments, recommended dosage and frequency.
   A. There is no standard nutritional regimen that will apply to everyone. As a rule, the best option is to use the lowest amount of supplements that work. Personally, I prefer to use less than 60 mg of CoQ10 a day, and there have been cases of muscle aches with red yeast rice hence the lowest amount that works in reducing cholesterol.

Q. I really am glad to see that someone is writing the TRUTH about statin drugs. I was diagnosed with high cholesterol, at age 25, that was 20 years ago. One of the cardiologist that I worked with at the time, told me that my condition was most likely genetic. He left it up to me as to whether or not to take meds for the condition. I opted not to, despite my cholesterol of 285, because I felt uneasy about the liver implications. The last time I had my cholesterol checked, was a couple of years ago and it was 308. It has stayed in that range for the past ten years. One doctor prescribed statin Lipitor, which I did NOT take; I never filled the prescription! However, the information went on my chart, and now I am self-employed, and honest, and due to the fact that this statin drug was prescribed, I have been denied health insurance. I wonder how many people realize that once they begin taking statin drugs that they are considered a "high risk" for heart attack or bypass surgery? Do they know that if they ever attempt to obtain private insurance, they can be denied based on this "high risk" categorization? To dispute this presumption of CAD, I had a an echo-cardiogram and a treadmill test. My echo was good, and I did exceptionally well on the treadmill test; better than 70% of women my age (or so I was told). Even with this information, I still cannot get health insurance! Because of this, and my desire to lower my cholesterol, I recently started taking policosanol and I am hoping to see a drop in my cholesterol. I will keep you posted. I may drop dead tomorrow of a massive MI, however, at least I will not have died a slow painful death from my liver being destroyed because of statin drugs!  I know people, who despite taking statin drugs, still had to have stents or bypass surgery, or died.

Q. I am suffering from a severe case of rhabdomyolysis caused by statin drugs which were used to lower my cholesterol.

Q.  I've had high cholesterol all of my life , some 240 plus and last year increased to the 270 plus level. I've tried all diets, supplements to no effect. Doctor had me on simvastatin 40 MG but I just felt ill , weak and poor balance on them and only took them a couple of weeks before quitting. This I did for three different times. I obtained a copy of Dr Duane Graveline book, Statin Drugs Side Effects; The last thirty days I have been taking 6 to 10 grams of vitamin C and equal amounts of Omega 3 Fish Oil. The reason the amounts vary is that I forget to take them at times. I had a checkup at the VA clinic yesterday and cholesterol has dropped to 221, some 50 points. This has been the lowest I have ever had. I had took the last statin in Nov. last year. I expect the level to drop more. The ratios are out but hopefully they will improved in the future. I has a Carotid Artery screening a couple of months ago and Plaque build up was rated mild / moderate range which is "insignificant", so I must be doing something right. Also I am 67 years old.

Q. I have been diagnosed with cfids chronic fatigue and immune dysfunction syndrome since 2001. I am 55 years old now, I suffer greatly. My doctor doesn't know what to do for me. I take tramadol everyday. After I do any physical work, about 5 hours later my entire body (muscles) are killing me...I am getting worse ...Just before I came down with this I was put on pravachol statin drug for high cholesterol, I then had muscle weakness and my doctor took me off of it. To this day we wonder if this was a pravachol side effect that did this to me. I can't take this, the body pain is awful.
   A. It's difficult for us to say whether the pravachol statin drug was the cause, but it is a possibility. Statin drugs can unmask neuromuscular diseases. See the link towards the top of the page regarding neuromuscular damage and conditions that statin drugs may induce or aggravate.

Q. I have read recommendations that the appropriate dosage of CoQ10 for those who are on statin drugs is 300 mg. Is this true?
   A. We don't know for sure what the right CoQ10 dosage would be for those on statin drugs, but 300 mg is too high and can cause side effects. For now, we prefer 30 to 50 mg a few times a week.

Q. I have had several patients report to me that they have developed tremors after taking statins to lower cholesterol; and these tremors persist even after stopping the statins. They also report their doctors say this is a possible side effect. I have not seen this statin drug side effect reported in any literature I've read. Do you have any knowledge of this statin side effect?
   A. I have not come across in any medical journal publication tremors as a side effect of stating drug use. However, I have come across two patients who thought the use of statin drugs caused tremors. I await further studies and case reports before having more confidence in this possible statin drug side effect.

Q. I was prescribed a statin drug about a week ago (Simvastatin which is generic Zocor). I am having muscle cramps, diarrhea, and stomach cramps every morning. I just threw the prescription in the trash today after using for 6 days. My total cholesterol is 253, LDL is 179. Triglycerides are OK at 122, and HDL at 50. I take fish oil - 1200 mg, CoQ10 - 50 mg, and alpha lipoic acid -100 mg. daily in addition to a multivitamin and chondroitin / glucosamine plus MSM.

Q. Thanks for your recent news letter on statin drugs. With the article on statins I had to write with my experience. The VA put me on simvastatin 40 mg a day. I don't like to take any drugs and find that I'm very susceptible to any drug. I found a article by a Dr Duane Graveline, and purchased his book "Statin Drugs Side Effects and the misguided war on cholesterol" I took 6 grams of vitamin C and a equal amount of Omega 3 fish oil per day. In 60 days my cholesterol dropped from 270 to 220. Don't have the ratios handy. I've since threw my statins away. Dr Duane Graveline maintains that most people are deficient in Vitamin C.
   A.  Thanks for the feedback. I was not aware of a book by Dr Duane Graveline, "Statin Drugs Side Effects and the misguided war on cholesterol."

Q. I am a doctor. My wife, 67, never smoked, no alcohol, very active physically (non stop gardening and ceramicist who hunks and throws clay up to 10kg at a a time) was started on 20mg Pravastatin ten weeks ago for high cholesterol / LDL. Two weeks ago she felt sensitivity at upper right abdomen; unabated for 7 days. Then weakness / loss of appetite/ reduced drinking during a day. Early that day a GP muttered about Gall bladder after consulting current diagnosis software: she proposed ultrasound; queue, 4 weeks. Later in day, weaker and weaker, no temp. yet, back to a different GP (same practice). He was concerned: to ER. Passed out sitting! amylase already 3300 + temp (37.4)! Statin stopped immediately; no food, no statin, pain stopped in 15 hours. Four days in ward; starvation, iv water/salts - ie wide metabolic 'rest'. After four days amylase down to 100. Liver function fine apart from elevated LDH; slight rise in blood urea / also normal after 4 days; ultrasound was negative as also CT, no sign of biliary deposits problem. Other exclusions: hepatitis etc etc. As in 20-30% of cases of pancreatitis, the doctors have no suggestions. After 3 days back home wife seems herself, eating carefully; we hope that this is first/last time My comments: Statins can have very wide 'light' effects over a range of systems. So damage can be slight but slow, unnoticed till the cart tips suddenly. This is a particularly dangerous kind of situation. My wife is lucky - we hope ....; another week to diagnosis and the pancreatitis could have led to permanent pancreatic damage (at least cartilage and muscle effects are noticeable). Not only is the public very unaware of the danger to the pancreas, but it seems most GPs too! This is unacceptable. Is the FDA unaware too? Thanks for keeping an eye out for an unsatisfactorily protected public.
 

This statin medication page was last updated June 2008.