Statins Have Few Side Effects, But Should More People Be Taking Them?

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Statins lower cholesterol, reduce inflammation and may be responsible for saving thousands of lives. Should everyone be taking the wonder drug?

In the latest study investigating the side effects o statins, researchers report in the journal Circulation: Cardiovascular Quality and Outcomes, that the best-selling drugs are relatively safe. And as evidence builds that statins can lower inflammation, the process responsible for many chronic illnesses, from Alzheimer’s to cancer and heart disease, some experts are suggesting that more people should be taking advantage of the prescription medication to slow down aging.

The results of the Circulation paper may bolster that idea. The study’s lead author, Huseyin Naci, a research fellow at Harvard Medical School in the department of population medicine, pooled 135 studies involving 250,000 participants and all seven of the currently available statin medications and analyzed the risk of side effects. The studies were those that drug makers submitted to the Food and Drug Administration to demonstrate the safety of their medications for approval. Naci and his colleagues found a 9% increased risk of diabetes among those who used statins compared to those who were assigned placebo pills. The rates of other side effects, including muscle pain, cancer, and changes in liver enzymes were not statistically significant.

MORE: Who Should Take Statins? The Debate Continues

Such a relatively safe side effect profile could reignite the debate over whether more people should be taking statins – or, as some researchers in the UK and US have suggested, whether everyone over age 40 or 50 should be on the medication.  Dr. David Agus, professor of medicine at the University of Southern California Keck School of Medicine, recommends that everyone over 40 should discuss statins with their doctor, even if they haven’t had heart problems or are at increased risk for heart disease or diabetes. He says that inflammation is driving a number of aging-related conditions, both in the body and brain, and since studies have shown that statins are a powerful way to dampen the inflammatory response, more people might be living longer if they take advantage of statins. Rory Collins, an epidemiologist at Oxford University, caused an uproar last year when he addressed the European Society of Cardiology with a talk entitled, “The Case for Statins In a Wider Population,” and argued that more people should be availing themselves of the medications, just as they do aspirin.

Not everyone agrees with that view, however, despite the favorable side effect profile of the drugs. “It’s a wonderful medication, but we shouldn’t be putting statins in the water supply,” says Dr. Steven Nissen, chair of cardiovascular medicine at Cleveland Clinic. Naci also says that although his analysis showed that the drugs were relatively safe, “we don’t know the long term effects of statins. If we give it everyone, then after ten or 15 years we don’t know what the slight increased risk of diabetes will amount to.” Statin drugs have been linked to an increased risk of muscle weakness as well, which was severe enough for one medication to be pulled off the market.

MORE: Should You Take Statins? Study Says Heart Benefits Outweigh Diabetes Risk

There’s no argument that patients who have already had a heart attack or heart disease can lower their risk of further heart problems by taking a statin. What’s less clear is whether people who are otherwise healthy could lower their risk enough to justify their exposure to the side effects of the medications. And to answer that question, scientists are turning to statins’ ability to reduce inflammation.

Currently, national guidelines recommend that patients start on statins based on their cholesterol levels. But doctors are investigating whether people with low cholesterol levels but high inflammation levels could benefit from statins. A recent trial showed that these patients, who under existing guidelines would not be advised to take statins, could lower their risk of a heart attack or stroke by 50% if they were taking the drug. To confirm the association between inflammation and a lower risk of heart events, Dr. Paul Ridker, director of the center for cardiovascular disease prevention at the Brigham and Women’s Hospital and a pioneer in understanding inflammation’s role in heart disease, is spearheading two trials involving heart patients on statins. Half will be randomly assigned to take another anti-inflammatory agent on top of their statin, while half will be assigned a placebo; if the group taking the anti-inflammatory agent ends up with a lower rate of heart problems, then that would support the idea that inflammation indeed plays a critical role in heart disease, and that controlling it with a statin might save more lives.

MORE: Statins: Evidence of Broader Benefits

“We already know that the risk associated with elevated inflammation is as large as the elevated risk patients have from having either high cholesterol or high blood pressure,” he says. “The question is, just as lowering blood pressure reduces risk, can we generate evidence that reducing inflammation reduces the risk of heart disease.”

Even if the results of those trials show that lowering inflammation also lowers risk of heart problems, that won’t mean that everyone should be taking a statin. “One has to be cautious about for whom we recommend [statin] therapies,” says Dr. Sidney Smith, professor of medicine at the University of North Carolina Chapel Hill and past president of the American Heart Association. “We are going to have to do a better job of identifying patients at risk who might benefit from medical therapies to reduce their risk of heart disease at a dosage that minimizes the side effects.”

That’s especially true for the youngest patients – children – who are increasingly being tested for high cholesterol levels and even prescribed the medications that most associate with middle-age. In 2008, I wrote about the American Academy of Pediatrics’ recommendation to broaden cholesterol testing to include toddlers as young as two and to consider prescribing statins for youngsters with a history of abnormally high cholesterol levels:

While the guidelines target kids with a genetic risk of abnormally high cholesterol, called hyperlipidemia, they could lower the bar for prescriptions–not just for these children but for any overweight youngster whose cholesterol is not in check. Within hours of the AAP announcement on July 7, parents took to the blogs, expressing shock and unease over the aggressiveness of the guidelines. Statins are not without risks; in adults, in rare cases, they can cause muscle weakness and kidney problems, and there are limited data on how statins affect children.

The Academy defended its position, maintaining that the benefits of addressing cholesterol in children, which can lower their risk of diabetes and heart disease, outweighed the risks of the medications. Making such risk-benefit calculations about statin use for non-heart patients continues to be a work-in-progress, says Smith, but new national guidelines may help doctors to make those calculations in the coming year. “We still need to carefully define the groups that will benefit,” he says. “I think we will do a better job of that based on studies like this and others that have come out in the past few years. Hopefully within the next year we will be able to pull some things together that will allow us to move forward and do good things for our patients.”

56 comments
BradSoverty
BradSoverty

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bvogler
bvogler

My doctor put me on simvastatin in 2005. In 2006 I was told I was now a type II diabetic. Statin drugs will raise your blood sugar and HCA1 levels. Avoid them if you are not already a diabetic. The monthly cost for diabetic supplies, and the hassle of monthly lab testing, doctor visits are not worth it. If I had known taking a statin drug would have, could have caused diabetes I would have told my doctor to stick it.

I'd like to sue my doctor and the drug companies for giving me diabetes, but then I would probably have to enroll in Obama care to find a new doctor.

wjohnatty
wjohnatty

Very badly written piece - you need to do more research Time! Go see Scientific American's take on this topic - "The Stats on Statins: Should Healthy Adults Over 50 Take Them?" They expose the flaws, biases, and miscalculations of the work quoted here.

Orator
Orator

These days lots of Medicine Reference Guides are Available on Apps-Catalog, Doctors can check the dosage and the content of the latest medicine through the Apps!

some medical Apps can help doctors to take the reference:

http://apps-catalog.com/products/medical-apps

 


aliberaldoseofskepticism
aliberaldoseofskepticism

In simple terms: It's diminishing returns. If your cholesterol is above 5 mmol/L (approximately 190 mg/dL), then yes, you should consider a statin. But if not, then the diabetes risk is more dangerous.

dgarmster53110
dgarmster53110

I agree with johnwagoner and jcornelius. Drug company studies don't prove anything when the participants are hand-picked and the studies are very short in duration. I took a low-dose statin for 1 year and 8 months, and now I'm a wreck. I already had osteoarthritis but now I'm almost ready for disability at age 60. Diabetes also looms large in my future, and I don't think there's anything I can do about it. I can barely move, let alone exercise. Statins may be good for a small percentage of men, but they wreck bodies and lives in ways that medical science doesn't understand and can't do anything about. Since most medical professionals are in utter denial over this, as this article shows, statin victims are truly SOL.

aliberaldoseofskepticism
aliberaldoseofskepticism

@dgarmster53110 It's not the study itself. It's that they're not required to release all their data.

In addition, statins are a wide class of drugs. Someone like me, with a total cholesterol of 143 mg/dL, is unlikely to need a statin. They're best used for familial hypercholesterolemia, meaning your high cholesterol is connected to genetics. (In simple terms, statins interfere with cholesterol synthesis.)

The nice thing is, you can see a few big pharma tricks. Note that these tricks are also used by the appropriately-acronymed "supplements, complementary, and alternative medicine" industry. Even more so, actually, since something like homeopathy or dietary supplements or mesmerism has been repeatedly shown not to work and can't even conceivably work.

Texas sharpshooter fallacy Basically this is defining what your experiment means to test after doing your experiment. Sorry, unless you're the Doctor, you can't do this. Okay, the Master can, too, and is more prone to doing so. ;)

"Best of 3! No, 5! No, 9001!" If a study starts and stops at the author's whim, it probably indicates "I got the results I wanted. Now to stop it before regression to the mean kicks in." In general, extreme results occur earlier or with small numbers. Speaking of which...

Small numbers Studies with small numbers are always dangerous in and of themselves. The clustering illusion can create issues. (To look at this effect, flip a coin 1000 times. You're unlikely to get alternating heads and tails, since that's only two possibilities out of 2^1000. In fact, you'll often get twenty or more heads or tails in a row. Zooming in on that sequence, you get all heads or all tails. But it's just as random as the other coin flips.)

Split the trial Another trick is to split one trial into multiple trials. You might do this to make yourself better-represented in the literature when it comes time for a Cochrane review. Beyond scientific gerrymandering, you can also do this, wait for it, so you don't have to reveal all your data from the trial.

Continually studying the same thing for decades This is actually the entire way the Burzynski clinic stays open. Most people would say that after the first dozen trials, try something else. Not Stan! He continues his "trials", which (in a serious breach of ethics) his patients have to pay to take part in. Why? Because as long as it's considered "experimental", it doesn't go through the same rigorous review as established treatments. This one is more found in "alternative" clinics than in real medicine, but you should be aware of it.

In addition to all that, be aware of the usual logical fallacies.

nzstatinalert
nzstatinalert

In New Zealand there appears to be the same zealous attack on cholesterol, so much so it is a large part of government funding. However, many thousands of people being placed on a medication for primary care seems irresponsible. Certainly I hope children are never screened for these deadly drugs. Like KFARADY my husband was given simvastatin and seven weeks later nearly died with rhabdomyolysis, renal failure and stroke. AND the doctor didn't recognise the problem until it was too late. Now he has permanent damage through more than 60% of his body. I have spent the last 11 years trying to understand why  everyone  should have low cholestrol and yet the media machine and advertisers paid by pharmaceutical companies keep on the same old out of tune song.

http://www.naturalmedicine.net.nz/readers-stories/a-near-fatal-adverse-drug-reaction-to-a-cholesterol-lowering-medication/

Feel free to read the above article written by me to our family and friends.

paulgeorges
paulgeorges

The only purpose to laboratory is to scare people to get us to use statins.Why ?   Money at all cost with the help of some lobbies for example : newspapers  !

paulgeorges
paulgeorges

@aliberaldoseofskepticism @paulgeorgesSome scientists believe the statins are overused. Their use has expanded into areas where they provide lesser benefit, and lesser evidence of benefit. The lower the risk of cardiovascular events, the lower the ratio is of benefits to costs. The US market for statins nearly tripled when the National Cholesterol Education Program revised its guidelines to recommend statins as primary prevention. Although the panel cited randomized trials to support statin therapy for primary prevention of occlusive cardiovascular disease, a report inLancetnotes, "not one of the studies provides such evidence."[16]Journalists have questioned the interests of the doctors who made such recommendations, as eight of the 9 doctors on the panel were discovered to have been paid by statin manufacturers.[17]

A smaller group of scientists, The International Network of Cholesterol Skeptics, question the lipid hypothesis and argue that elevated cholesterol has not been adequately shown to cause heart disease. These organizations maintain that statins are not as beneficial or safe as suggested.[18] The beneficial effects of statins are suggested to be due to their working as vitamin D analogues.

aliberaldoseofskepticism
aliberaldoseofskepticism

@paulgeorges

Yeah, I wish people would stop using the word "skeptic" that way. As Rebecca Watson put it, "I'm a skeptic. Not the kind that believes the 9/11 attacks were the product of a grand Jewish conspiracy—we hate those guys. "Stop stealing the word 'skeptic,'" we tell them, but they don't listen to us because they assume we're just part of the grand Jewish conspiracy too."

kfarady
kfarady

While taking statins eight years ago, I became very ill, with symptoms in several organ systems.  At one point, I was taking 7 different medications and had seen 8 specialists over 2 years, costing me thousands of dollars and lost productivity.  The irony is that I am a physician.  Neither I nor any of my specialists recognized my problems as related to the statin. After 2 years of misery, I stopped the statin and started feeling better.  Then the lightbulb went on.  And yet, when I tell any of my colleagues this story, they give me a blank stare.  They do not believe me.  It makes me wonder if they listen to their patients either.  


I have a few comments on this piece:  aside from the obvious problem that the studies reviewed in this paper were all funded by pharmaceutical companies, I have several problems with the views and thinking espoused here.  First, statin side effects tend to be insidious, with onset at 6 months or even years after starting the drugs.  At that point, patients tend to get diagnosed with a whole new problem and prescribed more medications, or their symptoms are written off as “aging.”  Physicians seem to have a particular blind spot when it comes to recognizing statin side effects, which can go way beyond the typical muscle aches that everyone is familiar with.  I am an example of that.  And if these side effects aren’t recognized, you can be sure they are not getting reported.  Most statin trials are of short duration and may not be long enough to catch the long term side effects.  And these are drugs that are being prescribed to healthy people for life!


Second, although statins may have some anti-inflammatory activity, they have also been implicated in some autoimmune disorders, which means that we have a long way to go before we truly understand how these drugs interact with the immune system.  


Third, how can a drug that interferes with the production of cholesterol, a molecule so crucial to life and the health of all cells, be possibly thought to have antiaging effects?  In fact, statins, through their inhibition of Co-Q-10 synthesis, result in mitochondrial damage, which accelerates cellular aging.


I urge anyone who is prescribed a statin to ask a lot of questions, such as, “Will this drug prolong my life?”  For the majority of people, the answer is “No.”


justmeint
justmeint

Alice Park

This is the most outrageous and incorrect load of rubbish regarding the positive benefits of statin drugs that I have read in quite some time. One really does have to wonder which pharmaceutical company you are being paid by Dear Lady.

I represent a group of over 750 people who could claim to be Statin Victims. This is only one small group of people, there are many thousands of others who claim to have been damaged by this class of drugs. And yet you have the gall to write that few suffer side effects and these drugs save lives. I say show me the positive outcomes, show me the lives that have been saved. I will point you to seriously ill people, People who have become diabetic. People who have lost the use of body parts and can no longer function with the zest and zeal of healthy individuals. I will point you towards people who are now perpetual patients on a multiplicity of other medications necessary simply to get from day to day. These drugs are not the saviour of humankind, and the companies and promoters of them, like yourself are cruel and money hungry swine's.

Instead of writing headlines to grab attention and bring in income, why not take yourself off and do some serious research on the destructive power of this class of drugs. There is no proof what-so-ever that any woman or any age will benefit from these drugs, and for men, ONLY a very small percentage of men within a certain age bracket MIGHT - notice that word please MIGHT benefit. Millions of unnecessary prescriptions have been issued. Millions of patients are suffering because of the known side effects of these drugs..... and you have the nerve to promote their health benefits? You ought to be ashamed!

paulgeorges
paulgeorges

@justmeint You are right because now the first and only purpose of laboratories is to get  more average people taking drugs lowering for instance cholesterol rate .Best way is to exercize more and to eat a better way with less sugar,less GLUTEN,less salt ,less meat....And more and more fruits and vegetebles .  Some newspapers and journalist  often  agree with the power of laboratories. We live in democratics countries and we are proud of that ,but we forget something.  The power of big money ,with some monopoly can control us better than any dictatorial countries . Are  there for instance big talking about danger of statine,industrial food industry,dangerous drugs,gluten item everywhere with intolerence of many people,cancer rate up for some kind,nitrate ......And above all if someone kill he must go to jail but if with autorisation of the law he sold a legal product (food,drug...) he can freely sold everything untill law change and oblige him . And without any penalty of any kind !

aliberaldoseofskepticism
aliberaldoseofskepticism

@paulgeorges How does gluten have anything to do with it?

Okay, to explain: Gluten is a protein in wheat, barley, rye, oats, and hybrids thereof (such as triticale). It's actually fairly easy to avoid, if you know what to look for. In some people, the inability to digest gluten, or an autoimmune response to gluten, causes digestive issues known as celiac disease.

Here's the best part: Only about 1 in 3 people who think they have celiac disease actually do.