New Guidelines for Cholesterol Treatments Represent “Huge Change”

  • Share
  • Read Later
Getty Images

New guidelines would double the number of Americans on cholesterol-lowering drugs.

Dr. Sanjay Gupta of CNN wondered on Twitter whether we are “waving the white flag” when it comes to helping Americans avoid heart disease. Dr. Eric Topol, a cardiologist and chief academic officer of Scripps Health, tweeted that the doubling of patients on statins, which can lower cholesterol by up to 50%, was “not good.”

But the American Heart Association and the American College of Cardiology remained convinced that the 2002 federal recommendations for when to start people on the drugs needed to be updated. About 33% of U. S. adults have high cholesterol, and less than half are receiving proper treatment, despite the fact that elevated cholesterol levels double the risk of heart disease, the number one killer of adults in the U.S.

Under the new guidelines, people without a history of heart disease can start taking statins if they have a 7.5% higher risk of developing heart problems or stroke in the next 10 years, based on their cholesterol levels, blood pressure, weight, gender, race and smoking status. (You can calculate your 10-year risk here. Warning: it’s a little complicated.) That’s a dramatic change from the 20% higher risk that previous guidelines advised.

The new advice also recommends statins for anyone with type 1 or type 2 diabetes, regardless of whether they have additional heart disease risk factors, between the ages of 40 and 75 years old. Diabetes carries a higher risk of heart disease, in part because of the changes in cholesterol levels.

The lower threshold for statin prescriptions is certainly welcome news for their manufacturers; the drugs have been among the most prescribed class in the U.S. in recent years, and in 2013, rosuvastatin (Crestor) topped the list, earning AstraZeneca $5.4 billion in sales, according to IMS Health.

But the dramatic shift also has some heart experts nervous about how the guidelines will translate in doctors’ offices around the country. For those with a history of heart disease, there is little debate about how beneficial statins can be in preventing second events; studies show that the drugs can significantly lower risk of death from heart events. But for healthy individuals who may have some risk factors for future heart trouble, doctors have always been reluctant to prescribe medications when so much of heart disease is preventable, with proper diet and exercise. “For people with no history of heart disease, but who are trying to prevent heart disease, there is already a tremendous amount of overuse of statins in my view in this country,” says Topol. “So my concern is that the new guidelines will lead to potentially even more promiscuous use of these statins than already exists.”

And as unscientific as the target numbers were, at least they provided patients with a goal, and motivation for changing their diet and exercise habits to lower their cholesterol and potentially reduce their dose or get off their statin medications entirely. “I have worries about how to motivate patients when they don’t have numbers as goals,” says Dr. Steven Nissen, department chair of cardiovascular medicine at the Cleveland Clinic. “The targets served a purpose for sure even though they weren’t scientific.”

But since the last federal guidelines for cholesterol treatment were issued in 2002, two things have happened. First, all but one of the currently approved statins came off patent, so the cost of the medications has plummeted; a three-month supply can cost as little as $10.

Second, more studies have emerged indicating the various ways that statins can help the heart. Not only do the drugs restrict cholesterol production in the liver, but they can also lower levels of inflammation, a process that researchers now believe is the final player in the several-act play that is a heart attack, by aggravating unstable plaques in heart vessels that then send clots to constrict blood flow.

And last summer, a team at Harvard Medical School published the most comprehensive analysis on the safety of statins to date. Based on 135 studies submitted by manufacturers of all seven statins to the Food and Drug Administration to earn approval for their medications, the scientists found that compared to placebo pills, statins raised the risk of diabetes by just 9%; other side effects, including muscle pain, cancer and changes in liver enzymes were not statistically significant.

So while most heart experts welcome the fact that cholesterol-level targets are no longer used to determine who should and shouldn’t be on statins, they need to be convinced that the new calculator will be a better tool for making that decision. “It will be a huge educational challenge,” says Nissen. “How do you now tell patients and doctors that you don’t need to know your [cholesterol] numbers any more, that it’s not about getting to a specific goal? Now it’s you either take a statin or you don’t. Everything else goes out the window.”

The new recommendations inch closer to the idea of putting everyone on a statin, a controversial scenario that a few bold scientists have proposed in recent years. As I reported earlier this year:

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.

Nissen notes that the guidelines are guidelines, and not binding, although many primary-care physicians may turn to then for help in determining how best to treat their patients.

For doctors who don’t quite know what to do about the new advice, Nissen suggests having discussions with their patients to make individual decisions about whether they need statins. Depending on how high that individual risk is, both doctor and patient can reach some consensus on whether they are comfortable with using statins.

And the recommendations don’t replace diet and exercise, still the best ways to avoid heart disease. It’s just that they aren’t as easy for patients as popping a pill.

27 comments
robert.h.mercer
robert.h.mercer

This is not a concerted effort to reduce cholesterol.

It is a conspiracy between the WHO, FDA, Medical practioners et al to ensure an obscene increase in the profits of the pharmaceutical companies. One may ask why the WHO and others would do this. Well WHO receives large donations from most of the pharmaceutical companies as does the the FDA and medical fraternity.

People who believe the rubbish dished out over "high cholesterol" should seek psychiatric help.  My cholesterol has always been below the recommended maximum.  Now, thanks to the greed of many, it is just above the maximum although the actual level has not changed.   As far as I am concerned the meds are not for me.

glutathionepro
glutathionepro

Statins are such a farce. They deplete the body of a key nutrient, CoQ10. An antioxidant found in great concentrations in the heart, liver and kidneys. By depleting the heart of this vital, energy producing nutrient, you are leaving yourself extremely vulnerable to heart failure and numerous cardiac problems.
Avoid Statins altogether, if you are on a Statins drug, be sure to supplement your CoQ10 levels to help counteract the detrimental side effects of this big pharma drug.

Ripmonben
Ripmonben

America!  Research why your Cholesterol levels are elevated!  What do the standard tests really show? They are using old tainted clinical trial.  You'd be surprised at  what really raises your cholesterol!

rosepo
rosepo

I have tried many statins and invariably they cause muscle pain especially in my upper arms.  The last time I tried it took less than a month for my arms and shoulders to begin hurting.  

I was told at a physicians meeting with the public that  I, and everyone else, must take statins (I do have above average cholesterol & tryglycerides).  The fact that they caused me pain was of no consequence to him.  

At the next group meeting I was told I must take aspirin.  When I responded that they made my nose bleed, he wasn't helpful in suggesting a solution either.  It seems to be always "You must do this" with no alternatives.

drstephensinatra
drstephensinatra

While many aspects of these new guidelines concern me, one of the biggest is the concerns I have is the recommendation to use statin in people with diabetes. First off, statins can actually contribute to type 2 diabetes. In fact, last year the FDA began requiring statin manufacturers to put a diabetes warning on their labels. So giving statins to people who already have diabetes doesn’t make sense.

Plus, the data demonstrates that for men with diabetes statin drug use can lead to calcification of the coronary arteries. There’s also documented evidence that cataracts are more common in those taking statin drugs. And since people with diabetes are already more prone to cataracts, the use of statins for this population can be harmful.

A far better intervention for people with type 2 diabetes, or pre-diabetes, is lifestyle changes—including diet therapy; weight reduction; avoidance of sugars; exercise; use of raw foods, particularly vegetables; and targeted nutritional supplements.

On my blog I actually went through each of the guidelines one-by-one outlining my concerns: http://ow.ly/qN2vv.

Dr. Stephen Sinatra
Board Certified Cardiologist
Assistant Clinical Profession, Connecticut University School of Medicine

brianedwardhunt
brianedwardhunt

You can all do this by yourself. Go to any risk calculator (American Heart Association, National Heart Lung and Blood Institute, etc) and put your information in. I just did. I'm 52 years old, and in good general health. I do have high cholesterol. My risk of developing heart disease is 8%. That is about 1 in 13 people with my profile will develop heart disease over the next 10 years. If I had extremely high cholesterol levels (over 280 mg/dl), my risk would increase to 12%, or about 1 in 8 people. However, if I were a smoker, my current risk would double to 16%.

All to say that while cholesterol is one important predictor of developing heart disease, it is just one, and not the most important. I would suggest that those that revised their recommendations regarding statin use would do more good by recommending that insurance companies or the government simply supply smokers with the new electronic cigarettes.

FrankM
FrankM

For all of you talking about how easy it is to control with diet and exercise - my cholesterol shot up *after* I improved my diet, lost 30 lbs. and cranked up my exercise to 50 mins 5x/week. So, explain that.

Let's face it, once you hit your 40s certain people have livers that like to crank out the cholesterol, no matter what we eat or how much we exercise.

So, we're not supposed to give our money to "big pharma". What do we do then?

ruthgfeldman
ruthgfeldman

Of course it is all about money, for Big Pharma.  Doctors don't know any better; they are taught about diseases and drugs to treat them with, in medical school. That is all they know and they trust the pharmaceuticals. If someone's cholesterol is astoundingly high, it would be better to find out what is causing that rather than just treat the symptoms, the way doctors are taught to do. Besides, high cholesterol may be good for some patients. Years ago I read that researchers were confused, as they could find no connection between cholesterol level, heart attacks, strokes, in people over 65.  More recently I saw the results of research on 70+ year old men in Japan.  The men with high cholesterol lived while the men with low cholesterol died. Cholesterol is necessary for health; your hormones are made with it.   Just say no to drugs. 

EndDave
EndDave

In man's pursuit for immortality it only makes it easier for these pharmaceutical companies  to grow richer beyond anyone's expectations.

Soon people will be taking a pill to stop the urge to take a pill. It's all money in the bank because they are only looking out for your well being after all. 

wenchypoo
wenchypoo

<i>all but one of the currently approved statins came off patent, so the cost of the medications has plummeted</i>

 That about says it all--if they don't have fancy expensive new drugs in the pipeline, then they want to make just about EVERYBODY buy the generics (which they own stock in).  Anything to keep making money...and never mind the heart disease risk math!

TomRidgley
TomRidgley

Well, i hope all the people involved with this do go on a statin if it's "indicated" I took 80mg of Zocor for 8 mo, 4 years ago and  I have continuing myopathy and type 2 diabetes that began 6 weeks after starting. Good luck.

JoelDavis
JoelDavis

Well, they have done it again!  Not enough humans in our country are taking enough pills. Hey while we are at it, lets lower the threshold to put people on blood pressure meds - oh, wait already did that. Big Pharma Rejoice!

How about a vaccine for stupid...

MartinFlynn
MartinFlynn

More statins? Is everybody insane?
BigPharma would like nothing better than to help you "manage" your chronic conditions, most all of them by the way, are reversible and preventable.
And don't get me started on cardiac stents.


billthegrunt
billthegrunt

About the American College of Cardiology's CEO:

WASHINGTON, April 22, 2013 /PRNewswire-USNewswire/ -- The American College of Cardiology Board of Trustees today announced that Shalom "Shal" Jacobovitz has been selected as the college's chief executive officer.

Jacobovitz comes to the ACC from Actelion Pharmaceuticals U.S., a biopharmaceutical company specializing in cardio-pulmonary therapies, where he has served as president since 2004. At Actelion, Jacobovitz developed a strong patient- and customer-centered corporate strategy, which he implemented globally.

Prior to Actelion, Jacobovitz held positions at F. Hoffmann La Roche, where he served as general manager for Central Americaand the Caribbean, led the Pharmaceutical, OTC and Diagnostic divisions, and served as the global lifecycle leader for cardiovascular products in Basel, Switzerland. He also held positions with Abbott Canada, Nordic Labs and Marion Merrill Dow(now known as Aventis) in Canada. Jacobovitz earned his Bachelor of Science degree in biology at the University of Western Ontario in Canada.

http://www.prnewswire.com/news-releases/shalom-jacobovitz-named-ceo-of-american-college-of-cardiology-204089131.html

suhanthi
suhanthi

A Harvard analysis of studies by manufacturers of statins...does anyone wonder about the built-in bias here, and does it make it any better if it's a Harvard analysis?

sonik555
sonik555

This is great news. Pretty soon we will be recommending statins to newborns. Where are the incentives to exercise and eat healthy. more money for big pharma. 

DPSaint
DPSaint

Although the medical reasons seem a bit debatable, has anyone looked into how big Pharma throws around its

weight including funds? The advantages to them mentioned in passing (why?) deserve more treatment. There is a history here.  Do some investigative reporting. Something smells fishy and it's not fish oil pills.

Truth_Seeker
Truth_Seeker

All 0ur problems stem from people not knowing the truth of life.  

It is time to separate the wheat from the chaff (the truth from the deception.)  If you are a truth seeker,  go to TruthContest'  com and open "The Present." What it says will change the way you see and live your life. ... 

aliberaldoseofskepticism
aliberaldoseofskepticism

@drstephensinatra This is indeed a real concern. Another concern is what it means. While I'm not diabetic, I have a family history of diabetes. My LDL cholesterol is also very low, I'm at my normal weight, and I go to the gym regularly. (Also, I don't smoke.) In short, statins wouldn't do a thing for me. But one doctor I went to wanted me on them, despite the possibility of diabetes, or liver damage.

The problem is, a panacea really doesn't work, whether it's given to you by a drug rep, the classic medicine show, an "alternative" scaremonger on Dr Oz, or some dude in your email, in decreasing order of honesty.

IUQ
IUQ

@FrankM You should read "Good Calories, Bad Calories" by Gary Taubes. Cholesterol really isn't the problem they make it out to be.

MarkDemma
MarkDemma

@FrankM I'm curious what the parameters you followed in your diet.  There is a growing number of folks that have found that what is sold to the public as a "healthy diet" is anything but.  Specifically, the notion that we need to eat more "healthy whole grains" and avoid saturated fats.  Your personal experience mirrors the experience we've encountered as a society that has been getting sicker and sicker on what has been 50 years of the wrong dietary advice.  Back when people were eating lard not vegetable oils heart disease was rare.

wenchypoo
wenchypoo

@sonik555 No--prenatally!  We'll have moms take them in their third trimester whether they need them or not.  :)

aliberaldoseofskepticism
aliberaldoseofskepticism

@IUQ @FrankM I'll be quick about this: Given the nature of human diversity, it's unlikely one diet serves everyone. And he cites his personal experiences; in other words, n=1.

stefkagoil
stefkagoil

@MarkDemma @FrankM A high protein, low carbohydrate diet actually works to lower cholesterol. Counter-intuitive, I know, but it worked for me. And it's been reported elsewhere. But it's not going to make any money for Big Pharma...