Red Yeast Rice extract supplement, side effects, benefit for cholesterol, dosage, alternative to statin drugs by Ray Sahelian, M.D.
February 2 2014

Red yeast rice, a fermented product of rice on which red yeast ( Monascus purpureus ) has been grown, has been used for centuries in Chinese cuisine and as a medicinal food to promote healthy blood circulation. Red yeast rice extract is most often used by those who wish to have healthy cholesterol levels. There are quite a number of such supplements on the market from a number of nutritional product companies and it is quite likely that their chemical composition, along with their benefits and side effects, vary widely between different products. Try two or three different red yeast rice supplements from different companies to see which one(s) work best for you. Those who take these pills should consider taking a CoQ10 supplement a few times a week since some red yeast rice extract products may deplete CoQ10 levels.
Coq10 may be helpful for those on statin therapy used for lowering cholesterol levels. Red yeast rice may lower Coq10 levels although there are a number of different RYR products on the market and it is difficult to know what substances each one has and how they influence levels of coenzyme q10.
   
RYR may contains statin-like compounds called monacolins -- including one, monacolin K, which is structurally identical to the cholesterol drug lovastatin (Mevacor).

Benefit for heart and blood vessels
Maintaining healthy cholesterol levels is one of the benefits of red yeast rice extract. See cholesterol for natural ways to lower this lipid with diet and supplements. There are quite a number of dietary changes and supplement pills you can take to lower your cholesterol level. Eating less can also prevent a rise in cholesterol levels.

Nutr Res. 2013. Red yeast rice improves lipid pattern, high-sensitivity C-reactive protein, and vascular remodeling parameters in moderately hypercholesterolemic Italian subjects.

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Supplement Facts
Red Yeast Rice 600 mg (Monascus purpureus)

 

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Suggested Use: Take 1 red yeast rice capsule two  times daily with a meal or a glass of water, or as recommended by your health care professional. An additional daily use of 30 to 50 mg of Coenzyme Q10 is suggested a few times a week. Use this product only with supervision by your doctor.

Warning: Do not take red yeast rice capsule along with cholesterol medications such as statins without consulting with your physician.

Different products have different compositions
Dr. Ram Gordon of Chestnut Hill Hospital and the University of Pennsylvania tested 12 commercially available products and found great variation in how much active ingredient each actually contained. One-third of the products tested were contaminated with citrinin. Red yeast rice contains 14 active compounds called monacolins that slow the liver's production of cholesterol. The first statin, lovastatin, was based on red yeast rice. In 1998, the U.S. Food and Drug Administration ruled that a product called Cholestin was not a dietary supplement but an unapproved drug -- in essence, a source of lovastatin. Maker Pharmanex, now a subsidiary of Nuskin, removed red yeast rice from Cholestin. But consumers may be getting statins from the supplements anyway. To avoid being considered an unapproved drug by the FDA, red yeast rice manufacturers typically do not disclose levels of lovastatin or other monacolins in their products, and there is no standardization of these levels across manufacturers. Archives of Internal Medicine, October 25, 2010.

Red yeast rice is a potentially useful over-the-counter cholesterol-lowering agent. However, many formulations are non-standardized and unregulated food supplements, and there is a need for regulation of production.

Red yeast rice side effects - risk, caution
Rhabdomyolysis (breaking down of muscle tissue) is a known side effect of hepatic 3-methylglutaryl coenzyme A reductase (HMG-CoA) inhibitor (statin) therapy such as atorvastatin and other statin drugs. Since red yeast rice is supposed to work in a similar way as statins, such as LIpitor, it is possible that the risk of red yeast rice use in high doses or for prolonged periods could be similar to side effects as statins in terms of muscle tissue damage. One newly evaluated red yeast rice side effect is depletion of CoQ10. Perhaps supplementing with CoQ10 could prevent or reverse the myopathy due to the use of a red yeast rice supplement. The following are some reports found on the red yeast rice side effect of muscle tissue damage and depletion of coenzyme Q10.

Symptomatic myopathy due to red yeast rice. Mueller PS. Annals Internal Medicine. 2006 Sep 19;145(6):474-5. No abstract available.

Chinese red rice depletes muscle coenzyme Q10 and maintains muscle damage after discontinuation of statin treatment. Vercelli L, et al. Journal American Geriatric Society. 2006 April. No abstract available.

Acute administration of Monascus purpureus depletes tissue coenzyme Q10 levels in ICR mice.
Yang HT, et al. School of Pharmaceutical Science, Taipei Medical University, Taipei, Taiwan. British Journal of Nutrition. 2005.
In this study, we attempted to evaluate the effect of administration of a high quantity of red yeast rice on coenzyme Q10 ( CoQ10 ) synthesis in the tissues of mice. Eighty-eight adult male IC mice were housed and divided into control and experimental groups for red yeast rice treatment. Animals were gavaged with a low (1 g/kg body weight) or a high dose (5 g/kg body weight, approximately five times the typical recommended human dose) of red yeast rice dissolved in soyabean oil. Liver and heart CoQ10 levels declined dramatically in both groups administered red yeast rice, especially in the high-dose group, within 30 min. After 24 h, the levels of hepatic and cardiac CoQ10 were still reduced. A similar trend was also observed in the heart, but the inhibitory effect began after 90 min. The higher dose of red yeast rice presented a greater suppressive effect than did the lower dose on tissue CoQ10 levels. In conclusion, acute red yeast rice suppressed hepatic and cardiac CoQ10 levels in rodents; furthermore, the inhibitory effect was responsive to the doses administered.

Chinese red yeast rice induced myopathy.
South Med J. 2003.
A middle-aged man presented with joint pain and muscle weakness that had begun 2 months before presentation. Three months before presentation, he had begun to take the herbal preparation Chinese red yeast rice. Laboratory testing revealed a moderately elevated creatine phosphokinase level. Symptoms and laboratory abnormalities resolved with discontinuation of the Chinese red yeast rice. Eight months later, he resumed the red yeast rice product and his creatine phosphokinase level rose again. Lovastatin is a naturally occurring component of Chinese red rice and was the probable cause of his myopathy.

Rhabdomyolysis due to red yeast rice (Monascus purpureus) in a renal transplant recipient.
Transplantation. 2002.
We report a case of an herbal preparation-induced rhabdomyolysis in a stable renal-transplant recipient, attributed to the presence of red yeast rice (Monascus purpureus) within the mixture. The condition resolved when consumption of the product ceased. Rice fermented with red yeast contains several types of mevinic acids, including monacolin K, which is identical to lovastatin. We postulate that the interaction of cyclosporine and these compounds through the cytochrome P450 system resulted in the adverse effect seen in this patient. Transplant recipients must be cautioned against using herbal preparations to lower their lipid levels to prevent such complications from occurring.

My doctor is trying to help me lower my cholesterol level without prescription drugs and suggested I try red yeast rice supplements, which I purchased at an herbal store. The brand is Nature's Plus and 600 mg. After taking it for a week I began to develop a scalding red, itchy rash on the trunk of my body, which later went on to my arms and legs. It was as though someone had poured boiling water over me. I have always had an allergy to any kind of self tanning lotions and after having to go to my doctor each time I tried a new product, I decided I couldn't use any of these products, even the hypo-allergenic brands. I immediately associated the red yeast rice pills to my rash and stopped taking them and my rash gradually went away. Could there possibly be an association such as dyes in the products?
    I don't think dyes are the cause. If the skin rash was due to the supplement pills, most likely it is due to compounds that are normally found in this herbal product.

I have taken red yeast rice for over a year, 4 tablets a day. I now suddenly started having my bowel movements turn from brown to bright reddish brown. Could this be effected by the red yeast rice after prolonged periods of time. I had a rectal exam to see if there was blood in the stool, and there was not, also a blood test was done, and it came back fine. I'm thinking the red yeast rice is absorbed in my body and has turned the bowl movements bright reddish brown. Could this be correct?
    This is the first we have heard of a report regarding change in stool color from the use of red yeast rice. We don't know the answer.

I wanted to report a similar experience. I'm wondering if other people have since reported such an event. I have not done any blood work yet and I have been taking red yeast rice for the last 4 weeks.
    You are the second person to do so.

Red Yeast Rice Cholesterol research studies
Since different red yeast rice supplement products on the market may have different chemical compositions, it is difficult to know what benefits or side effects or how your cholesterol level will be influenced by taking such a product. The chemical composition of the product you are taking may be quite different than the ones used in research studies.

Med J Nutrition Metab. 2011. Clinical evidence of efficacy of red yeast rice and berberine in a large controlled study versus diet.

Dr. David J. Becker, a cardiologist at Chestnut Hill Hospital and the University of Pennsylvania Health System in Philadelphia randomly assigned 43 patients with high cholesterol to take either red yeast rice capsules or pravastatin every day for 12 weeks. The supplement group took four 600 milligram capsules twice per day, while the pravastatin group took 40 mg a day. By the end of the study, 1 of 21 patients on red yeast rice had stopped the treatment due to muscle pain, as had 2 of 22 patients on pravastatin. LDL levels fell by an average of 30 percent among supplement users, and by 27 percent among pravastatin users. Among statin medications, pravastatin and fluvastatin (Lescol) tend to cause less muscle pain. American Journal of Cardiology, 2009.

Together with lifestyle changes, red yeast rice can help reduce so-called "bad" cholesterol. Red yeast rice does not seem to have the side effects, including muscle pain, often experienced by those who cannot tolerate statin treatment. Dr. David J. Becker, from the University of Pennsylvania School of Medicine, Philadelphia, studied 62 patients with high cholesterol who had stopped taking statins because of muscle pain. The patients received either red yeast rice (1800 milligrams) or dummy pills twice per day for 24 weeks. All of the subjects also participated in a 12-week therapeutic lifestyle change program, including visits with a cardiologist, dietician, exercise physiologist, and several experts in relaxation techniques. After a few months, those who received the red yeast rice saw their LDL levels, and their overall cholesterol levels, fall more than those who took the placebo pills. By contrast, levels of other forms of cholesterol and fats in the blood did not change.
Annals of Internal Medicine, 2009.

Simvastatin vs therapeutic lifestyle changes and supplements: randomized primary prevention trial.
Mayo Clin Proc. 2008.
To compare the lipid-lowering effects of an alternative regimen (lifestyle changes, red yeast rice, and fish oil) with a standard dose of a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin). This randomized trial enrolled 74 patients with high cholesterol levels. All participants were randomized to an alternative treatment group (AG) or to receive simvastatin 40 mg/d. The alternative treatment included therapeutic lifestyle changes, ingestion of red yeast rice, and fish oil supplements for 12 weeks. The simvastatin group received medication and traditional counseling. There was a statistically significant reduction in LDL-C levels in both the AG and the simvastatin group. The AG also demonstrated significant reductions in triglycerides and weight compared with the simvastatin group. Lifestyle changes combined with ingestion of red yeast rice and fish oil reduced LDL-C in proportions similar to standard therapy with simvastatin.

Identification and chemical profiling of monacolins in red yeast rice using high-performance liquid chromatography with photodiode array detector and mass spectrometry.
J Pharm Biomed Anal. 2004.
Monascus purpureus-fermented rice ( red yeast rice ) was one of the food supplements that had the ability of lowering the blood-lipid levels, and monacolins have been proved to be main active constituents. In total 14 monacolin compounds such as monacolin K (mevinolin), J, L, M, X, and their hydroxy acid form, as well as dehydromonacolin K, dihydromonacolin L, compactin, 3alpha-hydroxy-3,5-dihydromonacolin L, etc. were identified in red yeast rice, using high-performance liquid chromatography with photodiode array detector and tandem mass spectrometry. A chemical fingerprint profiling method to display bioactive monacolins in red yeast rice was established and could be used for the quality control of the target material and its related products. Ten finish products labeled as red yeast rice from different manufacturers in marketing were traced using the chromatographic chemical profiling method, and the results show that only two of them were similar while the other eight were significantly different from the reference red yeast rice. All of these materials including raw material powder and finished products available were quantified and the contents of monacolins were calculated with reference of monacolin K (mevinolin) as the standard.

Monascus purpureus - Monograph.
Altern Med Rev. 2004.
Red yeast rice, a fermented product of rice on which red yeast (Monascus purpureus) has been grown, has been used in Chinese cuisine and as a medicinal food to promote blood circulation for centuries. In Asian countries, red yeast rice is a dietary staple and is used to make rice wine, as a flavoring agent, and to preserve the flavor and color of fish and meat. Red yeast rice forms naturally occurring hydroxymethylglutaryl-CoA reductase (HMG-CoA reductase) inhibitors known as monacolins. The medicinal properties of red yeast rice favorably impact lipid profiles of patients with high cholesterol levels.

New monascus metabolite isolated from red yeast rice (angkak, red koji).
J Agric Food Chem. 2002.
Red yeast rice (angkak, red koji) obtained as cultures of Monascus purpureus on rice was extracted and analyzed by HPLC. In addition to the known red, orange, and yellow pigments and the mycotoxin citrinin, a new Monascus metabolite was detected. It is present in the original red yeast rice and formed in higher amounts when red yeast rice is heated. High-resolution mass spectrometry indicated the molecular formula C(15)H(12)O(4). The chemical structure was elucidated by analysis of NMR data. The new compound, named monascodilone, is characterized by a propenyl group on a pyrone ring, an aromatic ring, and a gamma-lactone group.

Monascus purpureus is a destructive mold that grows on starch and silage. Red yeast rice is traditionally prepared by fermenting boiled non-glutinous rice with red wine mash, natural juice of Polygonum grass, and alum water. The fungus is cultivated on rice and then ground into a powder.

Weight control
Q. What effect does ref rice yeast supplement have on weight?
   A. Probably not major influence.

Emails
Q. I have been taking policosanol with coq10 now for nearly 2 months, it is a 10 mg dose (2 before bedtime). Prior to starting these treatments I weighed 235, with vegetarian diet and exercise I am now weighing 193. However my concern is that even though my weight is down, my overall cholesterol numbers concern me-total cholesterol 211-HDL-49-LDL-144. Im not sure what I can do to bring the LDL in range with the pills/diet/exercise the HDL went from 39 to 49 but I have not seen any reduction in LDL. I used to take Lipitor for 3 yrs, but my joints became so sore that I had to give it up. I dont want to save my heart at the expense of my liver. I am considering using red yeast rice in combination with the policosanol and want to know if these two are safe in tandem or is that dangerous.. So far I have not experienced any side effects using policosanol to speak of. Please let me know about the red yeast rice-policosanol or even possibly guggul combination.
   A. There has been hardly any research combining red yeast rice with guggul, policosanol, and the herbs and nutrients you mention, therefore it is very difficult for us to give any kind of recommendations regarding combinations, plus, each person is unique in their response.

Q. I was advised by my MD to trial red yeast extract product to reduce my cholesterol level. Starting on two tabs daily for the first 2 weeks then reduce down until 1 tab nocte. After taking only 6 tabs of red yeast extract, i have developed severe oedema of the face and neck and a generalised rash mainly over my trunk and arms - pale in colour, more visible by touch rather than sight. Could this be due to the red yeast extract as I have not had contact with any known viruses etc or consumed any different foods.
   A. This is the first we have heard of this. It could be the red yeast extract, one of the additives in the product, or a coincidence, caused by another unknown factor.

Q. 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 and statins have similar yet different molecular structures, and hence it is difficult to say whether red yeast rice causes muscle damage to the same extent as a statin. However, early reports now indicate that red yeast rice side effect is myopathy and hence one needs to inform their doctor if they plant to take this supplement.

Q. How much CoQ10 would you recommend to prevent the red yeast rice side effect of harm to muscle tissue?
   A. I am guessing that 30 to 50 mg a few times a week should be sufficient, but I cannot be sure without clear studies.

Q. I have just started using Solaray red yeast rice 600 mg. Is Solaray a good brand? I am concerned about the danger of red yeast rice to lower cholesterol.
   A. We have not analyzed the Solaray red yeast rice product, but in general, Solaray is a reliable brand. The danger of red yeast rice would occur from any brand, and it remains to be seen whether the use of coq10 could lessen the red yeast rice danger. The  benefit of red yeast rice to lower cholesterol has to be balanced with the danger of high cholesterol and the alternative of statin use. However, there are other natural options to lower cholesterol besides red yeast rice. There are many brands of red yeast rice including Rexall and KAL.

Q. Can guggul and red yeast rice pill be taken together?
   A. I have not seen studies regarding the combination of guggul and red yeast rice pill.

Q. Is red yeast rice a vitamin?
   A. It is not a vitamin.

Q. In reference to the letter concerning statins in Dr. Sahelian's January 2007 newsletter -- Red Yeast Rice is "Mevacolin" the very first statin synthesized by Merck and manufactured under the name Mevacor -- if one takes red yeast rice -- One is taking a statin. I would stop the red yeast rice and if I felt the need to lower cholesterol, would try to do so with natural products -- ie fish oil, vitamin b 6, folic acid, vita b 12. I am not a supplier of any products or supplements --am a spouse of an individual I feel developed Parkinson's after taking Lipitor for 4 plus yrs--hence my knowledge of red yeast rice and coq10 -- statins deplete not only coq10 but other prenylated products-- dolichol, selenoproteins including selenoprotein N, glutathione reductase to name just a few.

Q. After only 5 tablets of Red Yeast Rice, I developed a rash and swelling in the neck. It was actually a mixed product (Cholesterol Care from Healthy Choice Nutritionals - beta-sistosterol, guggul lipid, beta glucan, red rice extract and soy isoflavones). Don't know if it is the combination of supplements or just the Red Yeast Rice.
   A. It may be the red yeast rice or the combination. Thanks for letting us know.

I would like to know if taking red yeast rice capsules will cause me to gain weight I am on the jenny Craig diet and it is strict about calories and yeast is usually given to help people gain.
   We have no reason to believe that taking red yeast rice capsules will influence weight one way or the other.

Q. Dr. Sydney Spiesel wrote for Slate magazine in April 1007. He was questioning the FDA decision to withdraw support of Tigan suppositories in favor of the new drug Zofran. Tigan's patent had run out and he expressed his scepticism of the FDA and the drug maker of Zofran. He used a parallel story, of which I have been aware, as follows: For many years, "red rice yeast" had been available as a nutritional supplement in health food stores. Used in China for about 1,200 years, this product contains a statin, a cholesterol-lowering drug. As a nutritional supplement, red rice yeast was freely available and inexpensive. But then the pharmaceutical manufacturer of the same statin the yeast contains alerted the FDA. And the FDA decided that red rice yeast was no longer a cheap and unregulated nutritional supplement, but instead a medication, protected by patent and available only as an expensive prescription product. A modified form of red rice yeast is available again as a nutritional product— without the statin component. I have been intolerant of the statin drugs. Lipitor specifically...with muscle cramping and elevated liver enzyme panels. I have been using red rice yeast extract in combination with others, especially policosanols. This business of red rice being marketed without the statin component...it's only claim to health...is a surprise to me. Can you please comment about the veracity of Dr. Spiesels article. If correct, why would anyone advocate further use of red rice yeast extract?
   A. We have not studied this topic in enough detail to have an informed opinion but we are trying to find more information.
      Q. I am still able to purchase Solar Ray Brand Red rice yeast and it says it is in the 'pure' form. Up in Canada, they are aware of the lacking statin, and their suppliers have re-issued a substitute that contains NO red rice yeast extract at all.

I recently read that the FDA has mandated that Red Yeast Rice formulations eliminate the "naturally" occurring lovastatin ingredient. Apparently this is the active cholesterol lowering ingredient rendering the reformulated Red Yeast Rice ineffective. Please comment.
   See below.

Is there any research that indicates red yeast rice pills may help lower blood pressure in borderline cases?
   I have not seen research that has tested blood pressure effects of RYR.

I know each person is different, but are there any major concerns combining low dosages of RYR and curcumin, which has anti-inflammatory properties?
    Not that I am aware of.

For a few years my overall cholesterol has inched beyond the 200 range and according to one lab my doctor uses nearing 260. But my HDL is over 70 and the ratio of HDL to overall cholesterol is exactly 25% which is a good place to be and is the important ratio to consider. Another lab (for insurance) measured my overall cholesterol at 212 last summer so I have gotten conflicting data (all tests were with fasting). My doctor has wanted me to start statin drugs for some time now and comments how doctors discuss how our society has become ‘anti-prescription medication’ takers. My HS/CRP level is 1.5 and all other blood work looks very good for being 54. My triglycerides have dropped to a normal range also from 2 years ago. I don’t even appear to be in menopause with an 8.5 hormone test reading. I was having hot flashes last winter / spring though so who knows. Though I have started to exercise diligently and ‘try’ to eat healthy (it is the holidays you know) I have recently started taking Red Rice Yeast with Phytosterols (Weider brand via Costco). I am ‘giving in’ to this RRY supplement (as opposed to a statin drug) simply because I have a VERY demanding 12 hour a day kind of career and can’t always fit ‘healthy’ regimes into my days. The stress alone of my teaching career could be raising my cholesterol levels I suppose. My question is whether Red Rice Yeast product will have a negative, positive or stay the same effect on my HDL?
    This is not possible to predict since each person can react differently and different RYR products on the market may give different results.

I’ve previously self-experimented with RYR but, alas, with no beneficial effect and then discovered why. RYR contains lovastatin, an inhibitor of rate-limiting enzyme HMG-CoA reductase necessary for cholesterol production. However, in the US, RYR’s well-researched effectiveness on lipid-lowering is fully negated per FDA’s bowing to Big Pharma’s demands beginning mid-2007 and barring red yeast rice suppliers from supplying RYR with lovastatin. Shame on the FDA for bowing to Big Pharma. Can you shed some light on available RYR? I certainly would be interested in self-experimenting again to evaluate RYR effectiveness. I will likely add oat bran (½ cup 2x daily) as a 2nd component. Now, that’s a proven, jaw-dropping, beneficial effect when combining with a low dose statin per my self-experimentation.
    This whole issue is quite complicated. Different red yeast rice products on the market may have a different composition and it is difficult to know, even with same company product, what the actual composition is since it may vary from batch to batch. I prefer other dietary supplements for cholesterol reduction since they are more consistent in their effects and composition.

I have been taking RYR for about 2 years, while dieting and trying to take down my cholesteral. I have lost 114 pounds and still have a little more to go. I was reading that is has created problems with muscle mass. Is this correct? Also as a statin does it create problems with bowel movement – constipation?
    Different RYR products on the market have different compositions. Some may contain statin like substances while others may not. Without doing a chemical analysis of the product you are taking to know what it contains, it is not easy to say whether it will have an influence on muscle tissue or constipation.

August 2007 FDA warning letter
The U.S. Food and Drug Administration is warning consumers not to buy or eat three red yeast rice products. The potentially harmful products are: Red Yeast Rice and Red Yeast Rice / Policosonal Complex, sold by Swanson Healthcare Products, Inc. and manufactured by Nature’s Value Inc. and Kabco Inc., respectively; and Cholestrix, sold by Sunburst Biorganics. FDA testing revealed the products contain lovastatin, the active pharmaceutical ingredient in Mevacor, a prescription drug approved for marketing in the United States as a treatment for high cholesterol. These red yeast rice products are potentially harmful since lovastatin can cause muscle problems leading to kidney impairment. This risk is greater in patients who take higher doses of lovastatin or who take lovastatin and other medicines that increase the risk of muscle adverse reactions. These medicines include the antidepressant nefazodone, certain antibiotics, drugs used to treat fungal infections and HIV infections, and other cholesterol-lowering medications. FDA has issued warning letters advising Swanson and Sunburst Biorganics to stop promoting and selling the products. The FDA warning letters state that the products Red Yeast Rice, Red Yeast Rice / Policosonal Complex, and Cholestrix, sold on the firm’s websites, are unapproved new drugs that are marketed in violation of the Federal Food, Drug, and Cosmetic Act.
  
At least one raw material supplier that I know of sells Red Yeast Rice Extract 0.4%, 5% Lovastatin.

I would like to know if lovastatin still exists in red yeast rice purchased over the counter. I’ve read the FDA piece on certain distributors being prohibited from selling red yeast rice with lovastatin. My question is whether red yeast rice with lovastatin is still available anywhere in the United States or Canada?
    This is difficult to say since there are dozens of RYR products on the market and each one may have a different raw material ingredient source and each batch that is made may be different. The only way to know is to test each product by HPLC and this is not a practical thing to do for the consumer.

If a person gets good results with a red rice yeast product but the liver enzymes go up slightly, in general would they be better off taking a regular statin?
   This is not an easy question to answer since there are different types of statins, different dosages, and each person may have a unique response of benefits and side effects.

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