The New Controversy Over Blood Pressure and Cholesterol Guidelines – Part 2

Doc’s been running around like a chicken with his head cut off for the past month, but now I’m back and ready to give you the rundown on the new cholesterol guidelines, guidelines that are hot-off-the-press and, like their blood pressure brethren, are highly controversial. Published in Circulation: Journal of the American Heart Association, the new cholesterol guidelines are under attack for all sorts of reasons, and most of these reasons, in my opinion, are unfair and are largely coming from folks who don’t understand much of what we’ve learned in the past ten years with regards to treating hyperlipidemia (“high cholesterol”). So before we delve further, let’s take a step back and review the basics.

Cholesterol is a type of lipid (fat) that naturally occurs in the body and that is essential for making the membranes of the body’s cells and the protective sheaths of the axons of nerve cells, and for serving as the precursor to a plethora of essential hormones such as aldosterone (a salt-regulation hormone), estrogen, and testosterone. Unfortunately, cholesterol also plays an integral role in atherosclerosis, a disease that is characterized by the accumulation of fatty plaques in the walls of the blood vessels. Over time, these plaques can build up to such a degree that they narrow the blood vessels, causing a lack of blood flow to the peripheral organs. In severe instances, like in people with end-stage peripheral vascular disease, the blood flow can become so compromised that it results in the death of an organ (usually the legs in peripheral vascular disease).

Dry_gangene_4th_toe[1]

Dry Gangrene caused by peripheral artery disease. Atherosclerotic plaques have decreased the blood flow to this persons feet so much that the 4th toe is beginning to die from lack of oxygen (remember that oxygen is carried by the blood). Notice that this patient has already had a previous amputation of the 1st toe (aka: “big toe”), probably due to the same disease process.

Worse yet, these atherosclerotic plaques are often unstable and can suddenly rupture. When this occurs the body’s platelets, tiny cell fragment that form blood clots, rush to the ruptured plaque and form a clot over it, aka: a thrombus. A thrombus can suddenly and completely close off a blood vessel. If this occurs in one of the coronary arteries, the arteries that supply the myocardium (heart muscle) with blood, then a heart attack is the result. If plaque rupture, followed by thrombosis, followed by arterial occlusion, occurs in the brain then the result is a stroke.  A heart attack is the death of heart muscle due to a disruption of its blood supply whereas a stroke is the death of brain cells due to the same process – and this is why your doctor cares about your cholesterol levels.

Heart_attack-NIH[1]

A good illustration of how an atherosclerotic plaque can rupture–>thrombosis–>death of myocardium (heart muscle). This is medically called a “myocardial infarction” and is known in layman’s terms as a “heart attack.”

A few decades ago drug companies began discovering medications that lowered the levels of cholesterol in the blood. The thought at the time was that since cholesterol plays such an integral role in the formation of atherosclerotic plaques, and since people living in western/developed countries tend to have much higher levels of cholesterol in the blood than folks who live on rice and beans in the developing world, that lowering cholesterol levels would help prevent the development of atherosclerosis and its sequelae—heart attacks, peripheral vascular disease, strokes, aortic aneurysms, and more. This idea caught on rather quickly and before long everyone over the age of 40-50 was getting their cholesterol checked at least once a year by their doctor and being put on medication if their bad cholesterol (aka: LDL) was above 160mg/dL, with lower numbers like 130mg/dL, 100mg/dL, or even 70mg/dL being used as the goal for folks with known heart disease, diabetes, or who had suffered from a stroke. The problem is that while there are lots of drugs that lower cholesterol levels, only one category of these drugs has been scientifically shown to decrease the risk of death from atherosclerotic disease. These drugs are called statins.

Red_yeast_rice_wine2[1]

This is red yeast rice, a rice fermented with a specific mold that has been used medicinally and as a food substance in China for thousands of years. In the 1970’s the drug companies started investigating red yeast rice and they were able to isolate the cholesterol-lowering substance that it contains. This substance was patented under the name “Lovastatin” and the first statin drug was born. Lovastatin is a fairly low-potency statin and much more powerful derivatives have since been designed by the pharmaceutical industry. The most powerful statin drug is rosuvastatin (aka: Crestor), closely followed by atorvastatin (aka: Lipitor).

Niacin, the fibrates, bile acid binding resins, and more—all of these drugs significantly lower cholesterol, but this lowering of cholesterol has NOT been shown to lower mortality (risk of dying) from atherosclerotic disease. But the statins class of cholesterol-lowering drugs does decrease mortality from these atherosclerotic diseases, including in people who have had heart attacks and strokes in the past. How the heck does that make sense? All of these classes of medications lower cholesterol, but only the statins have a mortality benefit (decreased risk of death) from cholesterol plaque-induced diseases. Why?

450px-OahuCemetery-RevSamuelCDamon-tombstone[1]

Statins have been proven in study after study to prolong the inevitable trip to the grave for people with atherosclerotic disease or who are at high risk of atherosclerosis. None of the other cholesterol-lowering drugs have shown this benefit!

Physicians and scientists think that the reason statins are so beneficial for patients with atherosclerosis, while all of the other cholesterol lowering drugs are of dubious benefit at best (and of no benefit at worst), is because statin medications have other heart and blood vessel protective effects in addition to the lowering of cholesterol levels. The mechanism of this effect is still being investigated, but the most widely accepted theory is that statins also stabilize preexisting atherosclerotic plaques, the plaques that have been building up in the walls of every Western person’s arteries since childhood due to the unhealthy Western/American diet. These stabilized atherosclerotic plaques are less likely to rupture and it is the rupturing of these plaques, followed by thrombosis, that is responsible for the overwhelming majority of heart attacks and strokes.

Blausen_0227_Cholesterol[1]

This illustration shows the slow buildup of cholesterol and inflammatory cells in the walls of a small artery. The yellow substance is a combination of cholesterol and inflammatory cells — an atherosclerotic plaque. If you have lived in a Western/developed country for most of your life you almost certainly have at least some plaques in your arteries. We know this because even Western teenagers (who have died in car accidents, etc.) have been found to have some  plaque buildup. Most heart attacks and strokes are caused by the rupture of an unstable plaque–>thrombosis–>sudden and complete occlusion of an artery. Statins decrease the buildup of these plaques by lowering cholesterol levels in the blood but also probably stabilize preexisting plaques and make them less likely to rupture. Aspirin is heart protective because it inhibits the action of platelets, the cells responsible for thrombosis of ruptured plaques. The combination of a daily aspirin and a statin is more protective than either drug alone.

The new cholesterol guidelines are based on the recommendations of a joint panel of experts from the American College of Cardiology (ACC) and the American Heart Association (AHA) and these guidelines were published in November 2013. Before the publication of the new guidelines the cholesterol goals that your doctor was promoting were based on the findings of an older expert panel called ATP III (published in September 2002). The ATP III guidelines used an algorithm to determine how high risk a particular patient was for having atherosclerotic heart disease and then recommended a goal cholesterol level based on the calculated risk. Practicing physicians then used a variety of medications to attempt to achieve this cholesterol goal, reevaluating their progress by checking lots of cholesterol blood levels until the cholesterol blood level was in the goal range. The 2013 guidelines do away with most of this based on the best medical/scientific research currently available. And as we discussed above, the best and most current research essentially shows that statin drugs make you live longer if you have atherosclerotic disease and that none of the other cholesterol-lowering drugs have this effect.

Sprit_of_'76.2.jpeg[1]

So here’s the new ACC/AHA guidelines in simplified form — drum roll!

THE NEW ACC/AHA CHOLESTEROL GUIDELINES (simplified):

A)     You should be on a statin medication if you fall into one of these four groups:

1.       If you have atherosclerosis.

2.       If your LDL cholesterol (bad cholesterol) is >190mg/dL.

3.       If you are a diabetic who is aged 40-75.

4.       If your estimated 10-year risk of atherosclerotic heart disease is >7.5% based on this risk calculator: http://my.americanheart.org/cvriskcalculator.

B)      Instead of trending cholesterol blood levels, your doctor should use the new AHA/ACC algorithms to determine if you should be on a high-intensity statin, a moderate-intensity statin, or a low-intensity statin. In other words, instead of obsessing over a blood cholesterol goal we should instead be trying to reach a goal dose of a statin medication.

QUESTIONS/CRITICISMS REGARDING THE NEW GUIDELINES (also simplified):

QUESTION #1: My cholesterol is great on (insert medication name – niacin, fenofibrate, fish oil, etc.). Why the heck should I start taking a statin?

ANSWER: It’s nice that your cholesterol looks good on paper, but remember that your cholesterol level is only a number. Only statin drugs have been shown to decrease the risk of death from atherosclerotic disease. No one argues that you can lower cholesterol numbers with other medications, the question is whether that lowering of cholesterol is doing any good! I repeat, only statin medications have been scientifically proven to lower the risk of death from atherosclerotic disease. This is probably because statin medications have other protective effects besides just lowering cholesterol.

QUESTION #2: I see a lot of commercials on television from lawyers telling me how bad statin drugs are. Do you really think that I should be taking these medications?

ANSWER: Yes, if you fit into one of the four above listed categories, with the caveat that every patient is different and that I think even more strongly that you should follow your personal doctor’s advice (and I’m not your doctor). All medications have side-effects and statins are no exception. Statins can be hard on the liver and they can also cause myalgias (muscle pains) in susceptible people. If you have a predisposition to diabetes, they can probably can push you over into the official diabetic category faster than you would have gotten there otherwise. With that said, in people who have atherosclerosis or who are at very high risk for atherosclerosis the side-effects of not taking a statin medication are also very high and very dangerous, namely a substantially increased risk of heart attack, stroke, and death! In my experience, in the overwhelming majority  of patients with atherosclerosis or who are at high risk of atherosclerosis the risks of not being on a statin greatly outweigh the risks of taking one of these medications — I do know people who are exceptions, but they are few and far between.

CRITICISM #1: What’s the deal with this new risk calculator? I heard that it’s going to put a lot more people on statins.

REPLY: Yeah, no risk calculator is perfect, but a recent (March 2014) study in the Journal of the American Medical Association found that the new risk calculator works pretty well when used for Americans (in the same issue the calculator didn’t work so well when used for populations in Europe, but that’s not who its designed for). Yes, the new risk calculator does recommend statin therapy for lots of people who probably wouldn’t have been put on these medications under the old guidelines, but you have to remember that we’re talking about the disease (atherosclerosis) that is the #1 killer of Americans, so it’s not all that surprising that lots of people are found to be at risk by a good risk calculator!

CRITICISM #2: Isn’t this just a ploy by the drug companies to get lots of people to take their medications?

REPLY: Most statins are generic now, so in my opinion this isn’t a fair criticism.

QUESTION #3: I can’t tolerate statin drugs. Isn’t there an alternative medication?

ANSWER: This is anecdotal based on my personal experiences with patients, but the overwhelming majority of patients that I’ve treated who reported being “statin-intolerant” weren’t really. I have had a handful of (mostly) little old ladies who really couldn’t tolerate these drugs, but it is rare and in my experience most people with reported statin-intolerances are really “lawyer commercial intolerant.” Statins are a big business because the disease process that they treat is so prevalent. Most of the possible alternative medications also have a ton of potential side-effects, you just don’t hear about them on TV because statins are where the potential money is for the class action lawsuit attorneys. Remember, none of the alternative drugs have shown a mortality benefit (reduction in the risk of death) in patients with atherosclerotic disease. Only the statins are proven to do this!

QUESTION #4: What’s the deal with this “high-intensity, moderate-intensity, and low-intensity” statin therapy guideline?

ANSWER: Some statin drugs are more powerful than others. The new ACC/AHA guidelines have special algorithms that your doctor can use to determine how powerful of a statin you should be on. More powerful statins tend to be more heart and artery protective, but they also tend to have more side-effects. Examples of low-intensity statins are low-dose lovastatin and pravastatin while atorvastatin (in a high dose) and rosuvastatin are high-intensity drugs.

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REFERENCES:

1. Stone et al. 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic cardiovascular Risk in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. November 12, 2013.

2. Executive Summary of the Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). JAMA. 2001;285(19):2486-2497. doi:10.1001/jama.285.19.2486.

3. Muntner, et al. Validation of the Atherosclerotic Cardiovascular Disease Pooled Cohort Risk Equations. JAMA. 2014;311(14):1406-1415. doi:10.1001/jama.2014.2630.

4. Dry Gangrene: http://commons.wikimedia.org/wiki/File:Dry_gangene_4th_toe.jpg

5. Heart Attack: http://simple.wikipedia.org/wiki/File:Heart_attack-NIH.gif

6. Red Yeast Rice: http://commons.wikimedia.org/wiki/File:Red_yeast_rice_wine2.jpg

7. Tombstone: http://commons.wikimedia.org/wiki/File:OahuCemetery-RevSamuelCDamon-tombstone.JPG

8. Atherosclerotic Plaques: http://upload.wikimedia.org/wikipedia/commons/0/0e/Blausen_0227_Cholesterol.png

9. Drum Roll/Drummer Boys Image: http://en.wikipedia.org/wiki/File:Sprit_of_%2776.2.jpeg

I HAVE NO PERSONAL AFFILIATION WITH THE AHA/ACC EXPERT PANEL WHO MADE THESE RECOMMENDATIONS. I DO NOT OWN STOCK IN DRUG COMPANIES AND I DO NOT ACCEPT MONEY/BRIBES/INK PENS/ETC/ETC/ETC FROM DRUG COMPANIES. UNLIKE MANY OTHERS WHO COMMENT ON THIS SUBJECT, I HAVE ACTUALLY READ THE STUDIES/GUIDELINES THAT ARE DISCUSSED IN THIS ARTICLE. NONETHELESS, PLEASE REMEMBER THAT WWW.LEONARDONOTO.COM IS A GENERAL INFORMATION AND ENTERTAINMENT WEBSITE ONLY AND THAT YOU SHOULD NOT MAKE MEDICAL DECISIONS WITHOUT ASSISTANCE AND GUIDANCE FROM YOUR PERSONAL PHYSICIAN (WHO AIN’T ME!).

Dr. Leonardo Noto

DISCLAIMER: Remember to discuss all health concerns with your personal physician (I don’t count!) before making any medical decisions. www.leonardonoto.com is intended to present general medical information for entertainment purposes and not as specific guide to any medical treatment. The author has made every effort to present accurate information; however, due to the ever-changing nature of medicine and the intrinsic caveats that are inherent in any particular case, no medical decisions should ever be made based on information gleaned from the internet (duh!). The internet and self-education are great, but they don’t replace your Doc!

The opinions voiced on this medical blog are solely the author’s own and they do not reflect the opinions or values of Dr. Noto’s employers, past or present. Dr. Noto’s medical blogs should never be used as supporting evidence for legal testimony — this is of course obvious to anyone who isn’t a complete moron, but some people are rather stupid.

One thought on “The New Controversy Over Blood Pressure and Cholesterol Guidelines – Part 2

  1. This was an outstanding explanation of the new guidelines for dealing with the ‘silent killer.’ Thank you.

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