Experts Warn Statin Drug Trend Puts Lives at Risk

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August 09, 2017 | 47,989 views

Story at-a-glance

  • The number of people suffering from heart disease and stroke continues to rise, despite pharmaceutical interventions, including statin medications recommended for high cholesterol levels
  • Statins focus on reducing cholesterol your body produces naturally; the process also depletes your body of CoQ10, potentially the trigger behind many of the significant side effects associated with the drug, including neuromuscular disease and cardiovascular death
  • Non-drug strategies can help you manage your heart health and include quality sleep, stress reduction, adequate amounts of vitamin D, and consuming a good portion of your food raw

By Dr. Mercola

The number of people continuing to suffer from heart disease and stroke rises each year, despite advancements in pharmaceutical intervention. Unfortunately, the misguided recommendation to eat a low-fat diet is only making matters worse. Cardiovascular disease was listed as the underlying cause of death in 33 percent of all deaths in the U.S.1 and remains the No. 1 cause of death.

Someone has a stroke every 40 seconds and a stroke kills someone every four minutes. According to the American Heart Association (AHA), seven factors are associated with an increased risk of heart disease and stroke, including smoking, inactivity, diet, high cholesterol, blood pressure and blood sugar.2 While some of these factors are straightforward, such as smoking or not smoking, others are more complicated than a simple measurement.

Like saturated fat, cholesterol has been vilified despite 60 years' worth of research having failed to demonstrate a correlation between high total cholesterol and heart disease. Cholesterol is actually one of the more important molecules your body uses to build cells and produce hormones and vitamin D. Low levels of cholesterol that may occur with pharmaceutical intervention are linked to memory loss and Alzheimer's disease,3 and may increase your risk of depression,4 stroke and violent behavior.

Cholesterol is often divided into HDL/"good" and LDL/"bad" cholesterol, but the division is really based on how the molecule combines with protein. LDL and HDL are lipoproteins, or fat molecules combined with protein. Fat must be transported in your blood with a protein, which is classified by density. Large LDL molecules are actually not harmful, but small dense LDL particles may squeeze out of the lining of your arteries and trigger damage and inflammation.

Some groups, such as the National Lipid Association, are now starting to shift the focus toward the size of the LDL particle instead of total cholesterol and LDL cholesterol, in order to better assess your risk of heart disease. While a potentially more accurate method of assessing risk, the process has not yet been embraced by the mainstream, and requires more complex blood testing than currently done for cholesterol levels.5

New Study Defends Statin Drug Use

A recent study released in the Annals of Internal Medicine6 triggered a flurry of media attention when it recommended patients continue — or start — taking statin drugs.7 According to Cleveland Clinic chairman of cardiovascular medicine, Dr. Steven Nissen, holistic practitioners are hyping side effects associated with statin drugs and have concocted unfounded assertions against the medication.

However, many studies have shown statins fail to live up to the promises of lowering your cardiovascular disease risk. In fact, this class of drug may actually raise your risk.

The study from Brigham and Women's Hospital that sparked this attention evaluated 28,266 people who reported an adverse event or reaction to taking the statin drug.8 Of those who had already experienced an adverse reaction, 70.7 percent continued their medication. After four years, the researchers found those who continued the drug had a 12.2 percent rate of cardiovascular events. Those who discontinued the medication had a 13.9 percent rate of adverse cardiovascular events.

In other words, those who continued taking the drug after suffering some form of adverse effect experienced a mere 1.7 percent reduced rate of cardiovascular problems over four years. In an editorial in the same publication, Nissen laid a substantial portion of the blame for stopping statin drugs on the doorstep of dietary supplements, lifestyle-based approaches and benefits from these that have not been confirmed in formal clinical studies.9

Statin Benefits Are Weak at Best

Interestingly, the AHA places a strong emphasis on lifestyle-based approaches that include quitting smoking, getting exercise, normalizing weight, reducing blood pressure and reducing blood sugar.10 In other words, while Nissen is not convinced lifestyle-based approaches are very helpful, the AHA doesn't appear to agree.

Moreover, the potential benefit of statins must also be weighed against its drawbacks, and many cardiologists and even professional organizations have warned that statins seem to do more harm than good.11

According to an analysis from the U.S. Preventive Services Task Force,12 to prevent a single person from dying of any cause, 250 people would need to take statin medications for six years; 100 people need to take a statin as a primary preventive for five years in order for one or two people to avoid a heart attack, but none will actually live longer.13 Other studies have also failed to find any kind of mortality benefit from statin medications, even in at-risk groups.14

Unfortunately, statin medications are not just recommended for individuals who have had a cardiovascular event in the past and considered at high risk. They're now recommended to any person who has a 7.5 percent risk of having a heart attack in the following 10 years, based on a risk profile created by the AHA, which takes into account gender/age/race, cholesterol, blood pressure, diabetes and smoking.

Using this calculator, an amazing 26.4 million Americans become candidates for statin treatment.15 However, as discussed in previous articles,16,17 researchers have warned the AHA's risk calculator overestimates your heart disease risk by anywhere from 75 to 150 percent. This means even healthy people at low risk for heart problems are being put on these risky drugs.

Statin Drugs Focus on the Wrong Factor

Your risk of heart attack and stroke is not related to a simple number, but rather to a complex interaction of the different weight densities of lipoproteins in your blood. For years Americans were misinformed and told to eat a low-fat diet to reduce their risk of heart attack. However, research does not support this recommendation, and even a general look at the difference between potential risk in people from the U.K. and France demonstrates something quite different.

The average French person receives 15.5 percent total calories from saturated fat, while a person from the U.K. receives 13.5 percent. However, the rate of death from heart disease in France is one-third that of that in the U.K.18 And, like saturated fat, Americans have been advised to eat a diet low in cholesterol to control the cholesterol in their body, until the Dietary Guidelines Advisory Committee said:19 "Cholesterol is not considered a nutrient of concern for overconsumption."

Heart disease is triggered by damage to your artery walls and blood clotting. When the endothelial wall of your artery is damaged, your body begins the repair process and essentially creates a "scab." To prevent the scab from dislodging, your endothelial wall grows over it, causing the wall to thicken, which you know as atherosclerosis.

In other words, cholesterol is not clogging your arteries; rather, the arterial walls are thickened as a result of a natural repair process. One of the primary culprits of the initial damage to the arterial walls is sugar (fructose). This means that eating a diet high in sugar is the way to increase your risk of heart disease, not a diet high in cholesterol or saturated fats.

Statin drugs are designed to lower your total cholesterol levels, which tell you virtually nothing about your risk of heart disease unless it is exceptionally elevated. A total cholesterol above 330 or so would be suggestive of familial hypercholesterolemia, which, in my view, would be about the only time a cholesterol-reducing drug would be appropriate.

While cholesterol numbers may be indicative of an increased risk of heart disease, they aren't the numbers you're used to seeing. Two ratios that are far better indicators of heart disease risk are:

Statin Side Effects Far From Minor

In an interview with CBS News,20 Nissen said that most side effects associated with statins are minor and can be addressed by adjusting the dose or switching to another type of statin. The side effect primarily discussed were muscle aches. Dr. Donald Lloyd-Jones, professor of preventive medicine and cardiology at Northwestern University School of Medicine, downplayed the matter further by suggesting the muscle aches typically associated with statins may simply be due to the age of the individual taking the drug.21

However, muscle pain is only one of the common side effects attributed to statin medications. Health professional information for atorvastatin (Lipitor) ranks side effects as very common (10 percent prevalence or greater), common (1 to 10 percent), uncommon (0.1 to 1 percent), rare (0.01 to 0.1 percent) and very rare (less than 0.01 percent). Side effects from statins reported to health professionals as very common, common and uncommon include:22

Neuromuscular and Cardiovascular Side Effects Are Devastating

The problem with using statin drugs is they address only the surface issue of total cholesterol levels in a simple manner inside a complex organism. The drugs work by blocking the enzyme in your liver that naturally produces cholesterol your body needs to function. This essentially reduces your total cholesterol without addressing the different densities of lipoproteins, namely HDL, LDL, VLDL (very low-density lipoproteins) or your triglyceride levels.

By altering just one aspect of your cholesterol production, statin medications have a significantly negative effect on your total body health. Rarely mentioned is the link between cardiovascular death and statin medications. It's important to realize that the medication you're using to prevent heart disease has a common side effect of cardiovascular death, occurring in up to 10 percent of patients.23

Another less publicized side effect is a progression of muscle wasting that may lead to a diagnosis of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease. The World Health Organization Foundation Collaborating Centre for International Drug Monitoring has noted a disproportionately high number of patients with upper motor neuron lesions, like ALS, among those taking statin medications.24

Researchers from Johns Hopkins Medical School countered these disturbing findings25 saying the condition can be treated with steroids and other immunosuppressive drugs; hence, there's no need to fear this popular "fantastic medication." Considering you can dramatically lower your cardiovascular disease risk with lifestyle changes alone, this hardly seems like a reasonable recommendation for most people.

What Is the Statistical Effectiveness of Statin Medications?

When the risks of taking a medication include neuromuscular disease and a "common" side effect of cardiovascular death, you would hope the effectiveness of the drug outweighs the risks. However, in this case, the risks far outweigh any benefit from using the drug. In a report published in the Expert Review of Clinical Pharmacology, the authors concluded statin advocates used a statistical tool called relative risk reduction (RRR) to amplify what amounts to trivial benefits.26

The same report states clinical trials have also succeeded in minimizing the significance of a large number of adverse effects that patients experience. When you consider the absolute risk for adverse side effects listed above the use of statin drugs, that benefits just 1 percent of the population, appears ludicrous. A 1 percent benefit means that out of 100 people treated with the drug, one person will have one less heart attack.

By changing the statistic to a relative risk, the benefits of statins suddenly help 30 to 50 percent of the population. To understand this better, imagine you have a study of 200 men, half of whom take a drug and the other half a placebo, to examine the effect on prostate cancer. After five years, two men in the group taking the drug get prostate cancer, compared to four in the group taking the placebo.

Using this data, researchers could claim the drug cut the risk by 50 percent, or that there was a mere 2 percent drop in risk — and both would be correct. The first claims relative risk reduction and the second uses absolute risk.

In a second study published in Expert Review of Clinical Pharmacology, researchers found that not only were statins not as effective as commonly communicated, but they may also contribute to cardiovascular disease,27 which would account for the common cardiovascular side-effect associated with the drug. Several physiological mechanisms associated with statins were discussed that show how the drug may be associated with making your heart health worse, including but not limited to the following:28

Reduction in CoQ10 May Be Trigger Behind Statin Side Effects

One of the known effects of statin medications is that it depletes your body of CoQ10, used for energy production in every cell of your body. Hence, CoQ10 is vital for your good health, energy levels, longevity and general quality of life. Although there was a proposal to add a black box warning on statin medications regarding the depletion of CoQ10, the U.S. Food and Drug Administration decided against it in 2014.

The reduced form of CoQ10 is ubiquinol, also a critical component in cellular respiration and the production of adenosine triphosphate (ATP). Considering your heart demands the most energy of the organs in your body, you may see how potentially devastating it may be to diminish your body's main source of cellular energy.

If you are taking a statin drug, it is essential you also take a CoQ10 or ubiquinol supplement. I strongly recommend the latter as it is more effectively absorbed by your body.

Dr. Steven Sinatra, cardiologist and founder of the New England Heart Center, recommends taking at least 100 milligrams (mg), but preferably 200 mg of high-quality CoQ10 or ubiquinol daily. Using ubiquinol improves the mechanism that prevents LDL cholesterol from damaging your body and effectively rescues cells from the damage done by the statin, protecting muscle cells from myopathies.29

Protect Your Heart Health Using Drug-Free Strategies

It is important that you don't just stop a medication without first putting other strategies into place to help manage your heart health. If you are looking for a non-drug way to boost your heart health, here are some of my top recommendations:

Reduce, with the plan of eliminating, grains and sugars in your diet. It is vitally important to eliminate gluten-containing grains and sugars, especially processed fructose.

Consume a good portion of your food raw.

Make sure you are getting plenty of high-quality, animal-based omega-3 fats from fatty fish low in mercury. Good examples include sardines, anchovies, herring and mackerel. Alternatively, take a high-quality omega-3 supplement such as krill oil. Research suggests that as little as 500 mg of krill per day may improve your total cholesterol and triglycerides and will likely increase your HDL cholesterol.

Replace harmful vegetable oils and synthetic trans fats with healthy fats, such as olive oil, butter and coconut oil (remember olive oil should be used cold only; use coconut oil for cooking and baking and source your butter from certified grass fed, organically raised dairy cattle).

Include fermented foods in your daily diet. These will not only optimize your intestinal microflora, which will boost your overall immunity, but will also introduce beneficial bacteria into your mouth. Poor oral health is another powerful indicator of increased heart disease risk.

Optimize your vitamin D levels, ideally through sensible sun exposure as this will allow your body to also create vitamin D sulfate — another factor that may play a crucial role in preventing the formation of arterial plaque.

Check your iron level at least once a year, and donate blood two to three times a year if your ferritin level is above 80 ng/mL. An ideal level for adult men and non-menstruating women is somewhere between 40 and 60 ng/mL. You do not want to be below 20 ng/mL or above 80 ng/mL.

Another valuable test is the gamma-glutamyl transpeptidase (GGT) test. GGT measures liver enzymes. Not only will this tell you if you have liver damage, it can also be used as a screening marker for excess free iron and is a great indicator of your sudden cardiac death risk.

For women, a healthy GGT level is around 9 units per liter (U/L) whereas the high ends of "normal" are generally 40 to 45 U/L. For men, 16 U/L is ideal, while the normal lab range can go as high as 65 to 70 U/L.

Exercise regularly. Make sure you incorporate high-intensity interval exercises, which also optimize your human growth hormone production.

Stop smoking completely and don't drink alcohol excessively.

Be sure to get plenty of high-quality, restorative sleep.

Practice regular stress-management techniques.

[+]Sources and References [-]Sources and References

  • 1, 2, 10 American Heart Association, Heart Disease and Stroke Statistics 2017
  • 3 Journal of the American Medical Association Neurology 2014;71(2):195
  • 4 Annals of General Psychiatry, 2017;16:20
  • 5 American Association for Clinical Chemistry, LDL – Particle Testing
  • 6 Annals of Internal Medicine, July 25, 2017
  • 7, 20, 21 CBS News July 25, 2017
  • 8, 9 MedPage Today, July 24, 2017
  • 11, 13, 15 CNN April 18, 2017
  • 12 Journal of the American Medical Association, 2016;316(19):2008
  • 14 Journal of the American Medical Association, 2010;170(12):1024
  • 16 Mercola.com November 23, 2016
  • 17 Mercola.com May 3, 2017
  • 18 Heart, 2004;90(1):107
  • 19 Dietary Guidelines Advisory Committee December 15, 2014
  • 22, 23 Drugs.com, Atorvastatin
  • 24 Drug Safety, 2007;30(6):515
  • 25 Johns Hopkins Medicine, December 7, 2010
  • 26 Expert Reviews of Clinical Pharmacology 2015;8(2):201
  • 27 Expert Reviews of Clinical Pharmacology 2015;8(2):189
  • 28 Wellness Resources, February 16, 2015
  • 29 European Journal of Pharmacology, 2013;711(1-3):1