The Three Most Important Things You Need to know About Statins!

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

PCSK9 inhibitors- Hype or Hope?

Hot off the presses, just published today in NEJM. The new drug class PCSK9 inhibitors reduce heart attacks by 15%. Should we all rush out and start on one? Not so fast.

 

Initial studies demonstrated that Repatha (a PCSK9 inhibitor) dramatically reduced LDL cholesterol levels, but now we have evidence that they reduce the risk of heart attacks. Get ready for the barrage of commercials and ads for Repatha, and get ready for the experts to start proclaiming the benefits of this drug.

 

But as always, the truth may not live up to the hype.

 

For starters, the FOURIER trial focused on high risk patients who have already had heart attacks or strokes, and who were already on statins. This is called a secondary prevention trial. It is crucial to point out that it was not a primary prevention trial. The results do not apply to the millions of people with cardiovascular risk factors who have never had a heart attack or stroke (or peripheral vascular disease).

 

Second, the study did not show any difference in cardiovascular deaths. This is another important point as people frequently equate heart attacks with death. That is not the case. There was absolutely no difference in the risk of dying between the Repatha group and the placebo group.

 

Third, the reduction in heart attacks, although statistically significant, was small. Over 2.2 years, the risk of heart attacks was reduced by 1.2%. That means we need to treat 66 people for over 2 years to prevent 1 heart attack. Another way to look at it is that 65 people will not get the end benefit, and one will.

 

Last, the study was only 2.2 years long. The risk of side effects was similar between the two groups, suggesting that PCSK9 inhibitors don’t cause any adverse effects beyond statins. However, this is likely a big question mark regarding these drugs. These drugs drive the LDL lower than any other medication we have ever had. In this study, the average LDL for the Repatha group was 30. Our goal used to be 100, then 70, and now apparently 30. That’s quite a drop.

 

Is there reason to believe an LDL this low could be dangerous? You bet. LDL, although commonly known is the “bad” cholesterol, is vital for our health. We need it for neurologic and cognitive function. We need it for hormone production. We need it for cell membranes and for absorbing fat soluble vitamins.

 

Are you satisfied that the drug is harmless after this 2.2-year study? Neither am I. Stay tuned for the discovery of significant adverse effects over the next few years.

So far, I haven't even mentioned cost. If the drug was free, it would still be questionable if it was worth taking. But the drug is most certainly not free. In fact, it costs $14,000 per year.

Since we need to treat 66 people for 2.2 years to prevent one heart attack, that makes it $2.03million per heart attack saved. <Cough> That's a tough pill to swallow.

 

So why are so many experts going to promote it and extol its benefits? Most physicians believe that medicines are the path to health. The more we can alter our natural environment with drugs the better. Even minimal reductions in our risk are worth the minimal side effects from drugs. That seems to be a common bias in our healthcare system.

 

My bias is the exact opposite. We can achieve incredible benefits from purposeful lifestyle changes, and all without adverse effects! Drugs are largely unnecessary beyond that. Therefore, in my mind, any drug should have a dramatic benefit and a minimal long-term risk at an acceptable cost. After all, are you interested in lowering your heart attack risk for two-years? Or are you interested in lowering your risk over your lifetime?

 

Don’t get me wrong. There may still be a very limited role for PCSK9 inhibitors.

 

For very high-risk patients in whom you have tried everything (especially intensive lifestyle modifications) yet they are still likely to have another heart attack in the near future, then PCSK9 inhibitors could be a good option to reduce their heart attack risk by 0.6% per year, even though it won’t affect their risk of dying.

 

Beyond that, however, they have no proven benefit and no clear role in medical therapy. They are very expensive, and they are likely going to show significant long-term adverse effects when used for more than 2-years. Tread lightly with PCSK9 inhibitors. 

 

Action item:

When you read the headlines, and hear the news about the incredible benefits of PCSK9 inhibitors, please remember to put it all into context. Use this article as a guide to clarify where the trial has merits and where there are still unanswered questions. As always, if you have any questions, please do not hesitate to contact us at info@DrBretScher.com.

 

Thanks for reading.

 

Bret Scher, MD FACC

Cardiologist, author, founder of Boundless Health

www.DrBretScher.com

 

 

 

Statins- What do We Really Know?

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. 

Bret Scher, MD FACC

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