Statins are the number 1 selling class of drugs in the United States today.  In fact, according to the annual report put out by Blue Cross Blue Shield, Crestor (Rosuvastatin) was the second most prescribed drug in 2014. There were 22,557,735 prescriptions covered under just this one insurance company.  With this kind of popularity it is prudent to consider the current literature regarding the safety and efficacy of this drug class.

The safety of Statins has been the subject of much research over the last few years. As so, much evidence has come to surface regarding our current understanding.  Though we have been well aware of the most common side effects including muscle pain, rhabdomylosis, and abnormal Liver Function Test, post-marketing research has expanded the side effect profile of these drugs.

One of the most important side effects that must be brought to the forefront is Central Nervous System dysfunction. Post-marketing studies have revealed that statins are associated with memory loss, forgetfulness, amnesia, confusion, and memory impairment. It has been established that statins do cross the blood brain barrier. Thus they decrease the amount of circulating cholesterol in the brain. It is postulated that this causes a downstream effect of progressive demyelination of CNS nerves (cholesterol is an essential component of the myelin sheath that protects all nerves) leading to the aforementioned CNS side effects.

Outside of CNS dysfunction statins also have been associated with two very important nutritional deficiencies: CoQ10 and selenium. To review, Coenzyme-Q10 is a very important part of the energy cycle. Without it none of the organs including the heart, muscles, liver would be able to create ATP.  Selenium on the other hand functions as a very important co-factor in many enzymatic reactions involving anti-oxidant activity. Further recent literature suggests that it may be involved with glucose regulation via insulin mimetic activity. Statin induced depletion of these two micronutrients can cause significant effects on major organs and can potentially cause Diabetes.

Still there is one critical association that must be addressed: increased risk of cancer.  There have been several trials in the past few years that have explored this concern. At least 9 well-controlled RCTs have pointed to statins as a factor in cancer generation. One trial in particular showed that women taking statins for more than 10 years had twice the incidence of breast cancer.

As with any therapy decision, we must weigh the risks versus benefits. Thus the question remains do the risks of CNS dysfunction, essential micronutrient depletion, cancer, and various other side effects outweigh the potential benefits of statin therapy?

To answer this question we need to answer another simple question does lowering cholesterol actually decrease the risk of Cardiovascular death? Major organizations have published guidelines to address this issue with no consensus. In fact, as recently as this year the American Diabetes Association revised its recommendations in regards to statins proclaiming that there is a major evidence gap related to the benefits for patients under the age of 40 and above 75. Further The American Heart Association and the American College of Cardiology have revised their guidelines to recommend that no statins should be prescribed for patients under the age of 40 in lieu of additional CVD risk factors. And lastly Johns Hopkins Medicine put out a report entitled “To Statin or Not Statin.”  In this report they also acknowledged that in some patients Statins may not be appropriate and that the patient should be given a choice of whether they would like to be on lifelong therapy.

As you can see the limbo between benefits and risks is quite complicated. Many studies have revealed the potential deleterious effects of Statins and I anticipate that more diligent research will reveal the true consequences of long-term statin use. The potential benefits are also being labeled “controversial” at best by major organizations. 

Unfortunately this leaves physicians and patients confused on how to handle high cholesterol. If you still have concerns despite the evidence presented that you or your patient has risk of CVD death this is where Therapeutic lifestyle changes can play a major role. 

The following is a list of safe alternative interventions that should be considered in lieu of statin therapy:

1.     Getting blood sugar under control – Decreasing sugar intake, and high glycemic carbohydrates will decrease the amount of glucose that is available to be stored as triglycerides

2.      Implementing an exercise program – increasing muscle will allow excess glucose to be used as energy, exercising leads to more insulin sensitivity, increases blood flow to the heart and other vital organs

3.     A good quality Fish oil at 2-4g daily – will help raise HDL (takes cholesterol from peripheral tissue back to the liver to be broken down) and decrease triglycerides by 15-30%

4.     High dose Niacin (Vitamin B3) at 1g daily – reduces LDL, increases HDL, decreases Triglycerides

This all being said in the functional medicine model we don’t see high LDL as an issue in general, however we are concerned with LDL particle size and Triglycerides. When both of these values are out of range this denotes underlying metabolic dysfunction that must be resolved. Implementing the aforementioned changes is a start. If other cardiovascular symptoms still arise such as angina, erectile dysfunction, syncope it is prudent that you find the root cause by contacting a functional medicine practitioner who can do further testing.

The cholesterol and statin controversy will be the subject of much debate for years to come. Only time will tell what new research will reveal.

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