Don’t look now, but the updated clinical practice cholesterol guidelines from the American College of Cardiology, the American Heart Association and others are getting personal. Although the guidelines still contain their familiar approach — that I consider too aggressive with drug therapy — the latest 2018 version of the guidelines now includes an impressive update to emphasize lifestyle intervention, plus a more individualized approach for risk assessment.

MedPage Today: AHA: Revised Lipid Guide Boosts PCSK9s, Coronary Calcium Scans

Could this be the start of a progressive trend away from shotgun statin prescriptions? I sure hope so.

Prior guidelines emphasized the 10-year ASCVD risk calculator as the main determining factor for statin therapy. In the 2018 update, the guidelines acknowledge that the calculator frequently overestimates the risk in those individuals who are more involved with prevention and screening. (In other words, those patients more interested in and proactive about their health; I find many in the low-carb world fall into this category.)

The ensuing discussion with a healthcare provider should then focus on:

[T]he burden and severity of CVD risk factors, control of those other risk factors, the presence of risk-enhancing conditions, adherence to healthy lifestyle recommendations, the potential for ASCVD risk-reduction benefits from statins and antihypertensive drug therapy, and the potential for adverse effects and drug–drug interactions, as well as patient preferences regarding the use of medications for primary prevention… and the countervailing issues of the desire to avoid “medicalization” of preventable conditions and the burden or disutility of taking daily (or more frequent) medications.

I appreciate the attention the new guidelines bring to the depth of the discussion that should ensue between doctor and patient. Considering the treatment burden is equally as important as the burden of disease, and possibly even more important in patients who have not been diagnosed with heart disease, these individualized discussions about trade-offs are critical to personalized care.

Also worthy of mention is the increased use of coronary artery calcium scores (CAC) to help individualize risk stratification. The updated guidelines specify CAC may be useful for those age 40-75 with an intermediate 10-year calculated risk of 7.5%-20%, who after discussion with their physician are unsure about statin therapy. They specify that a CAC of zero would suggest a much lower risk than that calculated by the ASCVD risk formula, and thus take statins off the table as a beneficial treatment option.

This is huge. I cheered when I read this! I have been critical of prior guidelines that focused on ways to find more people to place on statins. The mention of finding individuals unlikely to benefit from statins is a giant step in the right direction.

The guidelines go even further: they mention that a CAC either over 100 or greater than the 75th percentile for age increases the CVD risk and the likely benefit of a statin. A CAC between 1-99 and less than the 75th percentile does not affect the risk calculation much and it may be worth following the CAC in five years in the absence of drug therapy. I would still argue that a CAC >100 does not automatically equal a statin prescription and we need to interpret it in context, but I greatly appreciate this attempt at a more personalized approach.

The guidelines also go beyond the limited risk factors included in the ASCVD calculator by introducing “risk modifying factors” such as:

• Premature family history of CVD
• Metabolic syndrome
• Chronic kidney disease
• Chronic inflammatory conditions such as rheumatoid arthritis and psoriasis
• Elevated CRP > 2.0 mg/L
• Elevated Lp(a) > 50 mg/dL or 125 nmol/L
• Elevated triglycerides > 175 mg/dL

Although they use these criteria to define an increased risk, the opposite would likely hold true. An absence of those criteria could define a lower risk situation.

Some changes deserve mention from a controversy standpoint as well. For instance, the new guidelines recommend checking lipid levels as early as two years old in some circumstances. Two!

They also recommend statin therapy for just about everyone with diabetes with no mention of attempting to reverse diabetes before starting a statin, a drug that has been shown to worsen diabetes and insulin resistance. In addition, the new guidelines do not mention the likely discordance between LDL-C and LDL-P in those with diabetes.

Last, the new guidelines define an LDL-C > 190 mg/dL as an absolute indication for statin therapy with a treatment goal of 190 mg/dL is in familial hypercholesterolemia populations (and even then has heterogenous outcomes). There is a clear lack of data supporting that same recommendation for metabolically healthy individuals with no other cardiac risk factors and no other characteristics of familial hypercholesterolemia. This is a clear example of when a guideline turns from “evidence based” to “opinion based.”

In summary, the guideline committee deserves recognition for its emphasis on an individualized care approach, its use of CAC, and its broader description of discussing potential drawbacks of drug treatment. It still combines opinion with evidence and believes all elevated LDL is concerning, but I for one hope it will continue its progression away from generalizations and someday soon see that individual risk variations exist, even at elevated LDL-C levels.

Thanks for reading,
Bret Scher MD FACC

Originally Posted on the Diet Doctor Blog 

I live in McAllen, Texas, where it’s difficult to find a doctor who’s knowledgeable on the benefits of a low-carb lifestyle. Because I battle a high A1C AND high cholesterol, I reached out to Dr. Scher for a consultation to monitor my blood work and develop a plan that will keep my heart healthy and my A1C in check. Before our video-consultation, he responded personally to every question I had via email. When I first reached out, I figured it would take at least a month or more to schedule our consultation, but to my surprise, it was planned just over a week from my initial email!

I like Dr. Scher’s commonsense approach to a healthy lifestyle. He came up with a very-easy-to-follow plan and agreed to review my bloodwork every 6-8 weeks to make sure I’m on the right track. Because of my family’s history, it’s comforting to know I have a cardiologist monitoring my health so that I can prevent a significant problem down the road.

Nicole Southwell

Can you find a more polarizing topic than statins? One article says they are miracle drugs that should be given to everyone. Then you turn the page, and you read how they are poison and you should stay away from them no matter what.  How can one drug cause such differing views? And which should you believe?

The statin debate has intensified ever since the 2013 ACC/AHA cholesterol treatment guidelines increased the number of people without heart disease who “should” take a statin to 43 million Americans. That is for primary prevention, meaning the individual has never had a diagnosis of cardiovascular disease, never had a heart attack, and never had any type of a heart problem.

As you can imagine, this has been a windfall for the drug companies. But are we healthier and better off as a result? That is unknown.

The problem is understanding the bias of whoever is writing the story.

Subtleties of Science

But wait, you say. Won’t the science tell us if statins are good or not? Isn’t it an objective fact if they are good for us?

Not so fast. Beauty is in the eye of the beholder, and so is the application of science.

Are you getting advice from someone who believes prescribing more medicine is better? Or someone who believes a more natural lifestyle is better? 

Are you reading a report sponsored by the pharmaceutical company that paid for the research?

Or are you getting advice from a scientist who is more focused on statistical benefits, or someone who is more concerned with the potential benefit for the one individual they are taking care of at the moment?

It is a confusing sea of conflicting information, and you have to find which approach resonates more with your beliefs and your life.

The Three Keys

Regardless of who you are and your beliefs, I promised you the three most important things you need to know about statins. Here they are:

1. All statin studies are worthless! That’s right. All statin studies that have been done to date are worthless and don’t apply to anyone who follows healthy lifestyle principles.
2. Statins will not prolong your life. Not at all. Not for a single day.
3. Statins DO reduce your heart attack risk, by about 0.7% over 5 years.

All of a sudden, statins don’t seem so powerful, do they? Let’s go deeper into these points to learn why.

1-All Statin Trials Are Worthless

When designing a trial, you have to decide what your control group is going to be. You have to show that the drug is better than something. The key is defining what that something is.

Therein lies the problem. In order to show beneficial effects, primary prevention statin trials need thousands of subjects, studied over years. That is very expensive to do. The vast majority of trials, therefore, rely on drug company funding.

Do you think they are going to fund a trial that makes it easier or harder to show a benefit? Of course, that was a rhetorical question.

Pharma companies don’t have an interest in your health and wellbeing. Their priority is to their stock holders and their bottom line. They are going to sponsor trials that are most likely going to benefit them.

How does this make the trials worthless? They compare statins to “usual care.” That means a brief, and ineffective attempt to educate people about healthy nutrition and physical activity.

In addition, the specific nutritional guidance that was used has always been a low-fat diet. As we now know, what does a low-fat diet usually include? Lots of sugars and simple carbohydrates. What does that diet do? Increase your risk of obesity, diabetes, inflammation, and eventually heart disease.

That’s setting the bar pretty low to show a benefit from statins. And that is exactly what the drug companies want.

What we need is a control group that is involved in a comprehensive lifestyle intervention program. A program that helps participants get regular physical activity. Helps them eat vegetable based, real food, low in added sugars and simple carbs, and high in natural healthy fats.

Since that is the way we should all be living, THAT is what the control group should be. I guarantee you, the results would be far different compared to the standard control groups used to date.

That is the trial the drug companies never want to see and will never fund. And that is why all statin trials to date are worthless.

If you can focus on proper lifestyle interventions, using healthy foods, physical activity and stress management as medicine, then we have no idea what effect, if any, statins would have. But I assure you it will be minimal if any benefit.

2-Statins Will Not Prolong Your life

You read that right. For people who have never had heart disease before, the multi-billion dollar drug won’t help you live longer. The overwhelming majority of primary prevention trials involving statins show no difference in overall mortality between those who took the drug and those who did not.

That surprises a lot of people. Statins are promoted as if they are wonder drugs that save lives left and right. That’s good marketing and good PR. Reality is far different.

If they don’t help you live longer, they must increase the quality of your life, right? Nope. In fact, 30-40% of people on statins will experience muscle aches and weakness causing them to exercise less and decreasing the overall quality of their lives.

So, if they don’t help us live longer, and they don’t increase the quality of our lives, why do we take them????

3-Statins DO Reduce Your Heart Attack Risk

If the news was all bad there wouldn’t be any debate about their use. But the truth is that statins do reduce the risk of heart attacks, and that is why in some cases it may be beneficial for you to take one.

But the big question is: How much do statins reduce your heart attack risk? The answer is not as much as you would think. Considering the recommendations keep getting more and more aggressive for statin therapy, you would think statins would be immensely powerful at reducing heart disease risk.

In reality, they reduce the risk of a heart attack by 0.7-1.5% over 5 years. That means you need to treat 66-140 people for 5 years to prevent one heart attack.  (as an aside, for people with pre-existing heart disease, so called secondary prevention, you need to treat approximately 40 people for 5 years to prevent 1 heart attack and 85 people to prevent 1 death)

When presented like that, it should certainly temper the enthusiasm for statin therapy. Again, it may still be the right choice for some people, but given the potential risks and side effects, I would hope for a much greater benefit.

Better Than Statins

A common response is that statins are “the best we have to offer” to reduce one’s risk of cardiovascular disease.  If you are talking about a drug manufactured in a laboratory, then that would be correct. But what else are options?

It turns out following a Mediterranean eating pattern with vegetables, fruit, fish, legumes, and lots of nuts, olive oil and avocados reduces the risk of cardiovascular events as well. For something as simple as nutritional choices the benefit must be much less than a statin, right?

That is what the drug companies would want you to believe. In reality, you need to “treat” 61 people with the Mediterranean diet for 5 years to reduce 1 cardiovascular event (a “combined endpoint” of stroke, heart attack or death).

To be fair, you cannot compare one trial to another as they have very different populations studied, and the outcome measures are different. So, it is not scientifically fair to say, “The Mediterranean diet has been proven to be more beneficial that statins.”  That would require a head-to-head trial. Unfortunately, that trial is unlikely to ever happen.

But it makes for an obvious answer when asked “If statins aren’t all that helpful, what else can I do to reduce my risk of cardiovascular disease?

• Follow a real food, vegetable-based, Mediterranean style diet, low in sugar and high in healthy fats.
• Maintain a physically active lifestyle.
• Exercise with some form of moderate cardio exercise, resistance training and higher intensity interval exercises.
• Practice stress reduction techniques.
• Don’t smoke.
• Manage your other risk factors such as diabetes and high blood pressure.

If you can follow these healthy lifestyle principles, you will be doing far more for your health than any pill you could take. And the best part? The only side effects are having more energy, feeling more empowered, and reducing your risk for chronic diseases.  Sounds like a good trade off to me!

Thanks for reading.

Bret Scher, MD FACC

Cardiologist, author, founder of Boundless Health

www.DrBretScher.com

I recently had a one-on-one Health Coaching Consultation with Dr. Bret Scher. I cannot adequately express the gratitude and respect I have for Dr. Scher. He took the time to consider all facets of my health and really listened to me and my concerns. He was not quick to insist I be on prescription medications, but rather he explored various avenues of suggested treatment/preventative measures I might consider taking…guiding, as opposed to dictating a plan of of action. The consultation was well worth my time and money! Loved his approach so much that my husband and I have decided to work with him long distance.

Jami Miltenberger
MS Counseling Psychology

45 million Americans “should” take statins. Are you one of them?

 It may surprise you to find out that you might be. When your doctor plugs your information into a cardiac risk calculator, he or she may tell you that you should to take a statin.

You may not feel bad. You may not have many other cardiovascular risk factors. Yet you may be labelled with the “disease” of elevated cholesterol.

“New” Guidelines- Questionable Sources, Questionable Guidelines

Why are so many more previously healthy Americans now being treated for high cholesterol? We can thank the 2013 ACC/AHA guidelines, which increased the intensity with which physicians prescribe statins.

Interestingly, these were not based on any new data. Instead, they were based on new interpretations of old data, much of which has not been made available for third party reviewers. None the less, it is now recommended that physicians consider prescribing a statin to anyone with a 5% 10-year risk of cardiac disease (increased from a previous 20% risk).

To me it seems that a recommendation to dramatically increase the use of these drugs should save lives left and right and have almost no down side.  Unfortunately, that is not the case.

Don’t get me wrong. Statins are not useless. They can reduce the incidence of heart attacks and strokes. For someone who has never had a heart attack (referred to as primary prevention) we need to treat between 60 and 104 people for 5 years to prevent one heart attack without any significant difference in the risk of dying.

That’s a little underwhelming, is it not? That seems like a “shotgun” approach where you send a hundred bullets out knowing that one will hit the right person (in this case getting hit by a bullet is a good thing). It doesn’t have to be this way.

In addition, statins are not perfect drugs. For every 50 people treated over five years there will be one new case of diabetes. There will also be at least 10% risk of muscle aches and pains with potential damage to the mitochondria (the energy producing part of the cell), and may even be linked to onset of dementia and memory dysfunction.

A system that potentially harms more people than it helps doesn’t seem like a viable solution to me. We can do better.

Better Define Your Risk

The problem is that our medical culture emphasizes prescribing drugs more than further defining your risk, and more than exploring alternatives to reducing your risk.

The current cardiac risk calculator uses:

• Age
• Gender
• Race
• Total cholesterol
• HDL
• Blood pressure or previous diagnosis of hypertension
• Diagnosis of diabetes
• Smoking status

Those are all reasonable initial risk factors to evaluate. But doesn’t it make sense that if we are using a drug that will only benefit one in 100, maybe we should try to further define those at high risk? To me that is a no-brainer.

For instance, one study showed that by measuring a coronary calcium score on statin eligible individuals, we could reclassify 50% of them so that they no longer “qualify” for statin treatment. We can avoid an enormous number of statin prescriptions with one simple test. A test that is readily available now. A test that has minimal risk (very low radiation dose, and a small chance of incidental findings), and is relatively low cost (about $100).

And we don’t have to stop there.

The Scripps Research Institute has developed an app to allow people to use their genetic information to better define their risks. This could potentially be used to define those who are not at high genetic risk for heart disease and therefore would likely not benefit from statin therapy.

Now we are starting to get somewhere. What if we could better define cardiac risk so that one in 5 people benefit from a statin, as opposed to the current 1 in 100? That is an admirable goal.

Even Better Than A Statin

Once we better define our risk, let’s not forget all the alternative to statins.

One recent study demonstrated that even those at the highest genetic risk for heart disease can cut their risk in half with healthy lifestyle habits (eating healthy, getting regular physical activity, not smoking and not being overweight). And that was the highest risk group! That’s likely just as good as, if not better than, a statin could do.

So why don’t we write prescriptions for intensive healthy lifestyle education programs instead of drugs?

Lifestyle changes are “harder.” Lifestyle changes take longer to see results. Lifestyle changes require more education, encouragement and follow up.

Do you know what else is associated with healthy lifestyle changes? Decreased risk of heart attack, strokes and death. Decreased risk of diabetes, high blood pressure and depression. And the only side effects are feeling better, having more energy, and being in control of your health.

That sounds like something that is well worth the extra work, the needed patience, and the more vigorous follow-up. Don’t you agree?

Start Asking Questions

So, what should you do if your doctor recommends a statin? Start asking questions. Lots of them.

• How high is your calculated cardiovascular risk?
• How much will a statin reduce that risk?
• What else can be done to better define your risk (i.e. coronary calcium score)?
• What else can be done to lower your risk (i.e. intensive lifestyle modifications)?

Ask yourself questions as well.

• How can I improve my nutrition to focus on a vegetable based, real food, Mediterranean style eating that focuses on healthy fats and appropriate proportions of high quality animal products?
• How can I improve my daily physical activities in addition to increasing my weekly exercise?
• How can I improve my stress management and sleep habits?

Remember, the benefits of statins are small. Not zero, but small.

Also, remember that statins have not been directly compared to healthy lifestyle habits. We don’t know if they add anything to a comprehensive lifestyle modification program. In fact, I would wager that if you have healthy eating habits, you get regular physical activity, you exercise regularly, and you practice regular stress management, then statins will not reduce your cardiovascular risk at all.

It may seem like a bold prediction, but to me it seems obvious.

Unfortunately we will likely never see a head-to-head study between statins and healthy lifestyle interventions (I discuss the specifics of the study I would like to see in my prior blog post here).

We can do better than a drug

In the end, remember that we can do better than drugs. We can be in control of our health. We can achieve real health that is not dependent on blood tests or medications.

So, don’t blindly accept a prescription for a statin (or any drug for that matter) without further defining your risk, and without further exploring your alternatives. You and your health deserve at least that much.

Thanks for reading.

Bret Scher, MD FACC

Cardiologist, author, founder of Boundless Health

www.DrBretScher.com

Action Item:

If you are on a statin, or any drug for that matter, make sure you ask your doctor why you are on it, exactly what benefit you should expect, and what the potential short- and long-term side effects are. Also, ask what the alternatives are, specifically regarding your lifestyle and healthy habits. If you aren’t getting adequate answers, ask me! info@drbretscher.com. I welcome your emails.