Statin Drugs and High Cholesterol: A Story of Associations, Assumptions and Dogma

The love affair with statin drugs has turned from sizzle to fizzle as the irrational enthusiasm for these cholesterol-lowering drugs faces increasing scrutiny. While some would go so far as to put statins in the water supply, or sprinkled into every Big-Mac, research is drawing into question the success, and frankly the sanity of this idea.

Cholesterol Conundrum

This much is true, that high cholesterol levels are associated with an increased risk of developing heart disease and stroke, while lower levels are associated with less risk. However, association is not the same as cause and effect, and simply lowering cholesterol by any means necessary does not always succeed in lowering the risk of heart disease.

Consider the drug called Zetia, which lowers the “bad” LDL cholesterol quite well, but leads to little if any change the risk for heart disease. Also, studies such as ILLUMINATE and AIM-HIGH have shown using medications to raise the “good” HDL cholesterol does not translate to less heart disease.

The point is two-fold, that heart disease is much more complex than a simple cholesterol level, and lifestyle factors that lead to improvement in cholesterol also change many other factors involved in heart disease. As an example, about half the people dying from heart disease have normal cholesterol levels, while many people with high cholesterol have clean arteries without any plaque.

Statin Facts

Statin drugs have been shown to lower mortality in men that already have heart disease. That’s it. Yet statins are given to men, women, children and the elderly, with or without heart disease. Is this a good idea? Read on and draw your own conclusions…

What about statins lowering mortality in people with high cholesterol? Nope. There is no evidence of statin benefit in people with high cholesterol that don’t already have heart disease. Studies such as ASCOT and TNT show statins lead to significant reductions in heart disease but no benefit to all-cause mortality.

Do statins help women? Nope. Although studies show statins will lower the rates of heart disease in women that already have heart disease, again there is no reduction in overall mortality from heart disease or all-causes.

Surely statins help the elderly with high cholesterol? Again, it’s a resounding nope. The PROSPER trial showed a reduction in heart disease in the statin treated group, but that was offset by increases in cancer.

What is the point of lowering a serum marker such as cholesterol, or lowering the rate of events such as heart disease, if it does not lead to a reduction in the overall death rate?

Statin drugs work by blocking an enzyme that is involved in the production of cholesterol. They also block numerous other compounds, including a critical coenzyme used for cellular energy called Ubiquinol, Coenzyme Q10, or CoQ. Low levels of CoQ are observed in patients with diabetes, heart failure and some cancers.

Statin side effects are minimized in the results from the industry-sponsored studies and I certainly observe far more common problems than the studies report. From muscle aches and weakness, to joint pains, to memory loss, I routinely come across patients with statin induced maladies. Recent research shows statins cause diabetes when patients on statins tend to slack on healthy lifestyle factors, leading to weight gain.

The Latest Statin Guidelines

I’m pleased with the latest advice on just who should consider a statin as the latest guidelines are revamped from prior years and focus on recommendations for groups that have clear benefit from good studies.  The 2019 report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines specifies 4 groups where statin therapy is first-line treatment for primary prevention of vascular disease:  1) in patients with history of vascular disease, 2) those with elevated low-density lipoprotein cholesterol levels (≥190 mg/dL), 3) those with diabetes mellitus, and 4) those who are 40 to 75 years of age and determined to be at sufficient vascular risk after a clinician–patient risk discussion.

2019 ACC/AHA Guidlines

Physicians and patients should use a Heart Risk Calculator to estimate their risk of heart disease or stroke.  10-year risk for vascular disease is categorized as:  low-risk (<5%), borderline risk (5% to 7.4%), intermediate risk (7.5% to 19.9%), and high risk (≥20%).

Missing the Forest for the Trees

Although this article pertains to statin drugs, I think it really illustrates a bigger and more interesting issue regarding both our approach to research and treatment.

Health and disease is a complex matter, and as we observe the associations between certain diseases and biomarkers, we tend to make the assumption that these biomarkers cause the disease. Sometimes the biomarker is actually the result of the disease or a surrogate in that it simply changes along with the disease but does not cause the disease.

Next, we assume that if we do something to alter said biomarker it will lower the incidence of the associated disease. Sometimes that turns out to be true, sometimes not. And sometimes it matters how you alter the biomarker, such as with exercise versus with a medication. Only controlled research trials eventually sort out these issues.

The point is that we tend to oversimplify associations between biomarkers and disease, faithfully and naively extrapolate the data from studies that show a certain treatment works for certain patients, then dogmatically apply that treatment to patients for whom no benefit has yet been proven. It’s ok to work with associations, and do the best we can until research catches up, but we need to be very, very careful about this, particularly when the treatment also has the potential to cause significant harm.

Focus on What Works

Cholesterol is our friend, precursor to our steroid hormones, abundant in brain tissue and present in every cell membrane in the body. It is normal that cholesterol moves through artery walls and it ONLY makes plaque once it starts to oxidize and cause inflammation. Complex mechanisms control the processing of cholesterol and whether it turns to plaque.

I recommend a broader look at all the components needed for artery plaque to form, including cholesterol, but also markers of inflammation, oxidation, blood clotting, blood thickness and micronutrients. I also consider the role that toxic chemicals and heavy metals play in damaging the delicate protective cells that line our arteries.

While we should continue to examine the role of advanced biomarkers in heart disease and how manipulating those markers may help the lower the rate of disease, we also need to take a big step back and look at what works and what is easily observable.

Regular exercise lowers the risk of heart disease as much as 50%, independent of weight loss. Keeping your waist circumference less than 40 inches for men, or 36 inches for women also lowers the rate about 50%. A diet rich in fresh fruits and vegetables, and low in animal fats will just about eliminate the risk. Smokers have 2-4x the rate, while poor sleep and too much stress both correlate with significant increases in heart disease.

To prevent or reverse heart disease, focus on lifestyle factors. Eat right, exercise regularly, get good sleep, manage stress, maintain a good weight and don’t smoke. Screen for artery plaque with simple procedures such as a carotid ultrasound or cardiac CT scan. If you have plaque, then test for all the known biomarkers for plaque formation, not just cholesterol.

If you are unable to control lifestyle habits then seek help from your doctor, chiropractor, health coach, nutritionist, exercise trainer, or counselor. Consider complementary therapies such as yoga, tai chi, meditation or acupuncture.

When lifestyle efforts alone are not enough, seek knowledgeable guidance for using natural supplements for which there is proven safety and efficacy. At some point, medications such as statins are appropriate, but be wary of surrogate biomarkers and wonder drugs.


Author

Scott Rollins, MD, is Board Certified with the American Board of Family Practice and the American Board of Anti-Aging and Regenerative Medicine.  He specializes in bioidentical hormone replacement for men and women, thyroid and adrenal disorders, fibromyalgia and other complex medical conditions.  He is founder and medical director of the Integrative Medicine Center of Western Colorado (www.imcwc.com) and Bellezza Laser Aesthetics (www.bellezzalaser.com).   Call (970) 245-6911 for an appointment or more information.

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