Statin enthusiasts have half jokingly suggested that statins are such marvelous medications that they should be introduced into the water supply, almost like fluoride. Their argument goes that if everyone got a daily dose of statins, they could dramatically reduce the risk of heart disease, and almost everything else for that matter.

Two studies just published in the New England Journal of Medicine (and an editorial titled “Statin Strikeout”) suggest that the statin juggernaut might be losing a little steam. This research was funded by taxpayer money and attempted to determine the value of statins for people with really severe breathing problems.

In one study, nearly 900 patients with chronic obstructive pulmonary disease (COPD) were recruited to receive either simvastatin (Zocor) or placebo. They were followed for roughly 641 days. The hypothesis was that patients taking simvastatin would have fewer flare-ups (“exacerbations” or serious breathing problems), hospitalizations or deaths compared to those on placebo.

The results were disappointing. Simvastatin (40 mg daily) did not improve lung function, did not enhance quality of life, did not reduce exacerbations and did not diminish deaths. The researchers pointed out that their results contradicted previous “observational” studies that demonstrated tremendous lung benefits from statins, thereby suggesting that such epidemiological research is often unreliable. This randomized controlled trial (RCT) put the brakes on the enthusiasts who were ready to start prescribing statins to patients with COPD.

The other study was equally disillusioning. Severely ill patients diagnosed with acute respiratory distress syndrome (ARDS) were the subjects in this trial. These are patients with a life-threatening lung condition sometimes called “shock lung.” It is life threatening and can be triggered by a respiratory infection such as pneumonia. People with ARDS have trouble breathing because of terrible lung inflammation and frequently have an accompanying systemic infection. Organ system failure often follows the profound inflammatory response called sepsis. Because statins have an anti-inflammatory effect, the researchers hoped rosuvastatin (Crestor) would “improve clinical outcomes.”

Au contraire. Here are the conclusions:

“Rosuvastatin therapy did not improve clinical outcomes in patients with sepsis-associated ARDS and may have contributed to hepatic and renal organ dysfunction.”

In other words the rosuvastatin did not reduce mortality from ARDS or improve other outcomes such as fewer days on a ventilator or improved lung function. There was also some suggestion that this statin had a negative impact on both kidney and liver function, not a good outcome for patients in a life-threatening situation already.

 

Other Statin Strikeouts: Alzheimer’s Disease

This is not the first time that epidemiological studies had suggested statin benefits for health conditions other than heart disease. There has been a drumroll of enthusiasm for using statins to prevent or treat Alzheimer’s disease and dementia. Again, the theory was that the anti-inflammatory effect of statins would be beneficial for the brain. A number of observational studies suggested that older people taking statins might be less likely to develop dementia.

http://www.ncbi.nlm.nih.gov/pubmed/23225700

Needless to say, this sort of finding created a lot of excitement within the statin-enthusiasts community. But epidemiological research doesn’t hold a candle to the gold-standard type of research in which one group of patients gets placebo and the other gets active drug (RCTs or randomized controlled trials). One such trial was conducted with atorvastatin (Lipitor). In this study 640 older people with mild to moderate Alzheimer’s disease were randomized to receive either 80 mg of atorvastatin daily or placebo. The statin did not slow cognitive decline.

Despite this negative finding, there is growing interest in prescribing statins to prevent Alzheimer’s disease. That is why the analysis by the independent experts at the Cochrane Collaboration is so important:

“There is good evidence from RCTs that statins given in late life to individuals at risk of vascular disease have no effect in preventing AD [Alzheimer's disease] or dementia. Biologically it seems feasible that statins could prevent dementia due to their role in cholesterol reduction and initial evidence from observational studies was very promising. Indication bias may have been a factor in these studies however and the evidence from subsequent RCTs has been negative.”

And this from the Cochrane Database of Systematic Reviews regarding treatment of cognitive decline:

“There is insufficient evidence to recommend statins for the treatment of dementia.”

The Statin Wars Continue

Just as there is polarization in politics these days, there is growing polarization within medicine when it comes to the benefits and risks of statins. The enthusiasts are quick to point out that statins have been shown to reduce the risk of recurrent heart attacks. That is to say, once a person has diagnosed heart disease, has a stent inserted in a coronary artery or has experienced a cardiac event, statins can reduce the risk of another event or death. This is called secondary prevention. There is little controversy about this.

What is far more contentious is whether statins do anything positive for people who are otherwise healthy. Some researchers are adamant that statins work to prevent cardiac events in so-called primary prevention. Others say not so fast. The number crunchers at TheNNT.com have analyzed the available data from randomized controlled trials. Their conclusions regarding people without known heart disease:

Taking a statin for 5 years:

1) did not prevent death

2) prevented a heart attack in 1.6% of subjects

3) prevented a stroke in 0.4% of subjects

4) provided no benefit in 98% of subjects

 

Statin Side Effects

Some physicians are relying on randomized controlled trials to demonstrate that statin side effects are insignificant and do not exceed side effects from placebos. A recent meta-analysis (The European Journal of Preventive Cardiology (March, 2014) concluded:

“At the doses tested in these 83,880 patients, only a small minority of symptoms reported on statins are genuinely due to the statins: almost all reported symptoms occurred just as frequently when patients were administered placebo. New-onset diabetes mellitus was the only potentially or actually symptomatic side effect whose rate was significantly higher on statins than placebo; nevertheless, only 1 in 5 of these new cases were actually caused by statins.”

In other words, except for a touch of diabetes, statins do not cause muscle pain, weakness, peripheral neuropathy (nerve damage), or any of the other side effects that have been widely reported on this website and even in the medical literature. One reason that the randomized controlled trials may not have identified side effects such as muscle pain is a lack of a shared definition. A recent report in the American Heart Journal (April 10, 2014) notes that in the real world of clinical practice, muscle problems are reported by 10-25% of people taking statins.

BOTTOM LINE:

The take home message from the New England Journal of Medicine articles is that both observational studies and randomized controlled trails have weaknesses. Epidemiology doesn’t do a good job of identifying how effective a treatment may be, which is why the researchers were a bit nonplussed when their expensive trials of statins for severe respiratory problems struck out. RCTs are not always well designed to detect side effects.

Tell your statin story below. Anecdotes are the least accurate scientific evidence, but they are not meaningless. If you have great success with statins, share your experience. If you have had trouble with side effects, please let us know too.

 

 

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  1. DJ
    Reply

    In 2013 I was diagnosed with Diabetes Type II and placed on Metformin 500 mg twice a day, which has worked great for me. Five months ago my Dr. put me on Simvastatin 10 mg once a day. My blood sugar level went from 88 to 131 in a matter of a month.
    This has me very depressed and now I am going to stop taking that statin drug or any other statin drug. I will discuss this with him on my next visit. In two years I have managed to reduce my cholesterol from 345 to 221 with a course of Red Yeast Rice, Niacin, Krill Oil and Flaxseed oil so why would I want to take this statin which has caused nausea, vomiting, and sometimes itching as well as an elevated blood sugar???????????????????????????

  2. GodofHellfire
    Reply

    You’re a nurse, of course I would listen to you! Good luck and I hope you live for another 90 years.

  3. ls
    Reply

    With all due respect I must ask what the government has to do with this hyperbole? Also, the medical profession and pharmaceutical industries are private, for profit organizations. It’s not the government that wants to “put this drug in the water supply”.

  4. Joyce E.
    Reply

    I was on Remeron/Mertazapine for depression and was one of the people whose triglycerides rose above 500. My MD put me on statins to reduce the triglycerides and high cholesterol. I was also put on Fenofibrate and a tiny amount of lisinopril to protect my kidneys. About two years later I developed type 2 diabetes. My sugar levels were quite high and I was put on Glipizide to help control the sugar levels.
    Well, for those of you who know about these drugs, looking back its obvious that I was given drugs to counteract the conditions caused (I believe) by the earlier drugs I was put on. This past March I have had excruciating sciatic nerve pain in my right hip and down my right leg. It has improved with chiropractic care and deep tissue massage, but is not completely healed. The chiropractor urged me to go off the statins and I decided that do that after reading about the side effects. So, I went off almost all the meds.
    I changed my diet to remove most of the sugars/carbohydrates, eating mostly proteins and vegetables with fruit and dairy, but almost no grains. I had already added a lot of excessive by starting back in Aikido and Tai Chi plus walking. The result was losing 20 lbs. Over the last year and a half, and sugar levels so normal that I don’t need the Glipizide. So, I hope the sciatic pain goes away, and I wont ever go on those meds again.

    • Joyce E.
      United States
      Reply

      I am back to say that I had blood work this week which was both good and bad news. The good news was that my sugar readings are normal and cholesteral are mostly of ok, but my triglycerides are way high, 511! So, I don’t know what to do next. My diet is still fairly low on carbs and sugar, and my weight has not increased (124lbs. and 5ft. 2in.).

      I would like advice on how to lower those extremely high triglycerides without going back on fenofibrates or simvastatin. Thanks
      P.S. Sciatic pain still here but, to be fair, I don’t necessarily think it is due to the statin I was taking.

  5. CG
    Reply

    After being on 80mg Lipitor for 2 years, my (R) shoulder had to be rebuilt. SLAP tear, bursitis, tendinitis, and 360 degree rotator cuff tear. I had a significant shoulder injury 10 years prior and I play tennis 3x/week, so I just assumed that was the cause.
    But now I wonder, could the Lipitor have been the cause of this health issue?

  6. CG
    Reply

    After a STEMI and 2 stents, I was put on Lipitor 80mg. They only thing MD was concerned about was making the cholesterol numbers as low as possible. Switched me to Crestor 40mg when they weren’t low enough. My knees starting getting progressively worse, to the point I was actively pursuing double knee replacement surgery. I mentioned this to MD, was told they only dealt with cardiac issues.
    Unrelated to this, we changed our diet to remove most animal products. We asked to reduce the statin dose to see if diet could maintain the numbers at an acceptable level. My knees started getting better, one is 100% and the other is 80+%. I also noticed my memory improving (had attributed to aging) and realized that I had had a hard time concentrating before, which had now cleared up.
    After researching side effects of statins, I am firmly convinced my physical issues were directly caused by statin and subsided when the dosage was reduced (now on 5mg). I will continue to reduce as much as possible, but stay on low dose for secondary prevention benefit.

  7. crandreww
    Reply

    Bs The header of this article notes the following: Taking a statin for 5 years:
    1) did not prevent death
    2) prevented a heart attack in 1.6% of subjects
    3) prevented a stroke in 0.4% of subjects
    4) provided no benefit in 98% of subjects
    What isn’t entirely clear is the number of people whose lives are devastated as a result of taking a statin or by artificially lowering their cholesterol. Watch this video from some of the WORLDS highest qualified experts on Statins and Cholesterol: https://www.youtube.com/watch?v=lzaHWNjEBO8#t=60
    We as a society have been browbeaten to believe that Cholesterol causes heart disease…we have had it drilled into our skulls so much, we actually believe a molecule, which is so absolutely crucial to hundreds of metabolic processes, including the production of CoQ10, Vit D, Dolichols, Testosterone, Steroid Hormones etc… I even as an RN, believed this, when I knew the basic physiology, which shows Cholesterol as an essential nutrient. Lowering your Cholesterol is as preposterous as lowering your Oxygen levels. High Cholesterol is not a disease.

  8. B s
    Reply

    Three years back I took Lipitor for three weeks and some new medicine six tablets three times a day it was Walchole I do not remember the spellings. For two weeks my biceps tendons from shoulder to elbow we’re ruptured with long tears. It was so horrible. When the therapist read the report she said you were in accident, I said no. Even for the last three years my insurance is telling me that I was involved in accident. Did I get any compensation? I cannot take any medicine. Till today I am suffering pain like bursitis and tendinitis. I cannot take any medicine for sugar or even a pain killer. May be I never took any medicine our mom always gave us home remedies and homeopathy.
    I only take cinnamon and life style to control my sugar. I request if anybody can give some information about home remedy or herbal or anything for cholesterol also, I spent lot of money and went to foreign country for special extensive therapy. That gave me relief to the extent I could have some normal life.

  9. kf
    Reply

    Hello, there was a newspaper maybe 2 years ago from the Peoples Pharmacy, someone had taken the Red Yeast Rice and it dropped their cholesterol 100 points. I think that is all they did, did not change diet dramatically. good luck!!!

  10. paulbyr
    Reply

    RAW requested that people who didn’t have trouble caused by statins write in. I have written in several times about my 20 mg of zocor + 1000 mg of niacin and not having pains. But, it occurs to me that many people who don’t have problems with statins wouldn’t want to spend time reading these reports from the people who do. (This isn’t a blind study or anything like that.)
    I don’t know why RAW and I are reading them – I think I am just curious. I’ve been taking zocor 40 mg since 1994 and only in 2012 reduced to 20 mg + the Niacin (with my Dr’s permission/suggestion). I had a mild TIA stroke in 2002 and didn’t dare quit zocor – I increased my Dog walk to 40 minutes a day and I lost from 210 lbs to 175 lbs rather quickly. For the last 6 or so years, my dog and I only walk 20 or so min. a day but it’s every day unless there is a continuous heavy rain all day long -don’t remember when that was.

  11. RAW
    Reply

    I would really like to hear from a few more people who aren’t having any problems caused by statins. I was starting to think something was wrong with me because I didn’t have any side effects.

  12. Jean
    Reply

    My doctor told me that my thoracic aneurysm was caused by cholesterol??? I am 72 and will not have surgery as I feel the results could be catastrophic..

  13. Ada L.
    Reply

    I started with Lipitor and suffered horrible aching in my knees, toes, and fingers, along with muscle pain and weakness in my arms and legs. At first, my doctor blamed it on my OA and spinal stenosis, but I knew it was the Lipitor and, sure enough, when I stopped it, all the additional pain and aches disappeared.
    My doctor was still concerned about my (moderately) high cholesterol and triglycerides, so put me on Simvastatin (sp?) and the aches and pains returned, though less intensely than with the Lipitor. Once again, when I discontinued the drug, the aches and pains went away.
    At that point, I told my doctor that I was “done” with the statins. I had started working to lower my cholesterol with dietary changes, and told her I would continue doing so. I’ve lowered my cholesterol from 246 to 209 – still struggling with my triglycerides, but working on that as well. But, for me, the pain and overall malaise caused by the statins were unbearable and I will never agree to take them again.

  14. VB
    Reply

    My husband had a heart attack in 2002 and had a stent put in. He was given simvistatin. I noticed a change in his cognitive function immediately. He loved to cook but suddenly developed problems following recipes or buying items he needed for large meals. My husband was always the main cook for large family dinners such as Thanksgiving and Christmas, but he would forget how to properly time the main course and side dishes.
    I kept after him to talk to his doctor and eventually they lowered his dose, but still he was lethargic and suffered memory lapses. He also developed diabetes. His doctor finally agreed that maybe he should take a hiatus from the statins. He has been off the statins for 3 weeks and is much, much better cognitively. We’ll see what his blood work reveals at his next check-up.

  15. RAW
    Reply

    reply to wb: Thank goodness someone isn’t having problems with statins. I have been taking Lipitor for almost a year and don’t seem to be having any problems. I am 82. Yes, sometimes I have pain in my hands and legs—that comes with age as far as I’m concerned. I am also a COPD patient and on oxygen 24/7. I can sit and watch TV all day and complain about my aches and pains or I can get up and go. I go! Hook my oxygen on my stroller and take off. I use the stroller so I can have my hands free to shop, eat or whatever. This sure beats sitting around worrying about having a stroke or heart attack.

  16. Nancy L.
    Reply

    Why do doctors insist on keeping patients on medications when a patient complains of side-effects? Do they think we are just complainers? I had to stop the generic Lipitor due to muscle pain despite my doctors objections.
    Now I am trying to get off of Atenolol for high BP and doctor refuses to change to something else. It has caused advanced arthritis in my feet + nerve pain in my lower right leg. Vascular MD says I have PAD but still primary care doctor sees no relationship with Atenolol. Problem with Betas is they cannot just be stopped. I am told it’s all a trade-off.

  17. JW
    Reply

    I tolerated Lipitor pretty well for 7-8 years except for constipation and being diagnosed with “polymyalgia rhumatica” which I think was caused by the Lipitor. Then the insurance company ordered generic. Over a period of years the doctor has prescribed three different generics, one after the other.
    I experienced the usual muscle and joint pain and spasms that others complain about. At one point I could hardly walk. Couldn’t play golf. I quit each generic and felt better within 1-3 months only to have problems recur with the next generic. Quit for the last time about six months ago and am doing fine. A friend who’s a retired M.D. also quit statins after similar miseries.
    I’m highly suspicious of the Indian company which manufactures generic statins. They’ve been criticized for quality control problems and have also been caught in financial irregularities. The FDA is clueless.
    Should I try to get my doctor to try to get Lipitor for me again? Nah.

  18. crandreww
    Reply

    MJ..Your Physician asst is correct…Red yeast rice will lower your cholesterol. Just know, red yeast rice works the exact same way statins do, by blocking the enzyme HMG CoA Reductase which is the precursor to a nearly 200 step pathway in which many many other vital substances are made, such as Vit D, Cholesterol, Dolichols, CoQ10, Steroid Hormones, Testosterone, Estrogen, etc. etc etc…all of which we manufacture, making these absolutely necessary. Being that Red Yeast Rice works the same way as statins, they have the potential carry the same risks. Be careful….Remember, lower cholesterol does NOT equal lower risk of heart attack. Read info above: Taking a statin for 5 years:
    1) did not prevent death
    2) prevented a heart attack in 1.6% of subjects
    3) prevented a stroke in 0.4% of subjects
    4) provided no benefit in 98% of subjects
    My Lipitor experience, being on Lipitor for 3.5 years, I suffered Neuronal Apoptosis (Brain Cell Death), Mitochondrial Mutations similar to Mitochondrial Encephalomyopathy with Lactic Acid Acidosis and Stroke-Like Episodes (MELAS), I developed Peripheral Neuropathy at the same time, as a result of the brain injury, have been disabled since oct 2002 due to severe cognitive impairment. Dr Beatrice Golomb of the UCSD statin effects study, informed me that per her study, Lipitor was the likely causal contributor to the MELAS findings. These Drugs are POISON!! I ended up firing my one neurologist and my Internist, both of whom vehemently denied any notion that the wonder drug Lipitor could do such a thing, and my internist kept pushing statins in spite of his speaking with dr Golomb…so he needed to go.
    I found a new primary care doc, who after reviewing my 28 day hospital records, told me after seeing what Lipitor did to me,that she will never ask me to take a statin, I told her, as long as we share the same feeling, she will be my doctor for a long time. We can no longer blindly accept what our doctors think as gold, but we have to discern for ourselves…man has been on this planet for a LONG time, and heart disease was essentially a non issue, until we started to eat garbage. Then we were told Cholesterol was the devil, and statins were born, with little to no effect of Mortality. But a huge jump in Congestive Heart Failure (Heart is hardest working muscle in the body, and needs an abundant supply of CoQ10, but statins BLOCK coQ10, therefore a spike in CHF.

  19. Torrence
    Reply

    First of all, we usually cause our own problems. Make sure you eat right and exercise. And don’t forget 200 is NOT a bad number. Even a little over that is OK. But, I’m quite sure you will be able to control it by changing your life style and get off the statins. They do more damage than good.

  20. Torrence
    Reply

    Your high cholesterol was probably from your life style. That being the case you would need a pill. Take a look at all the others comments and then do some research and see the BAD in statin pills that DO exist.

  21. Su
    Reply

    What you have experienced I have too. I went off Statins I feel great.
    After reading much on the literature, discussing how I felt with my doctor it was the best decision for me. I really have changed my diet, picked the right supplements etc. I have also included a doctor MD I now see that is into integrative health.

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