Statins

A recent article in the British Medical Journal suggested no association between low density lipoprotein (LDL) cholesterol levels and mortality in individuals over 60 years of age. Unfortunately, the study was weak and not powered to give a definitive answer regarding causal effects of a lab value or treatment and could mislead some individuals. Some think this study means they do not require preventive measures to reduce their risk of heart and vascular disease, or forbid, another related event. National guidelines continue to recommend statins (HMG-CoA Reductase Inhitors) based on an individual's risk for heart and vascular disease and related events. Strokes and heart attacks can have disabling and devastating effects. When I meet with a 50 year old man who has suffered a heart attack without warning and he admits to heavy tobacco use, a high stress lifestyle, sedentary lifestyle and getting most of his meals through a fast food window, I can see the pattern of behavior that contributed to his developing heart disease. Guidelines regarding his treatment will be followed to give him the best odds possible to avoid further progression of disease, optimal recovery and hopefully avoid another event. Treatments should be like crutches. We only use them until our knee or other joint has healed from injury or surgery. We should rehab the knee and then progress to running again. My concern is that we tend to start and never stop medications. That may be where people have grown frustrated. It is easier for us to prescribe a medication without taking the time for lifestyle modification. Genetics plays a role, though often it is the individual's behavior that is contributing the most to heart and vascular disease.

Prevention is about determining where you are on the timeline. Perhaps you don't have any heart and vascular disease. When I am talking to someone who just suffered a heart attack, I will discuss with them the current recommendations for treatment. I will discuss the appropriate use of aspirin and statin therapy. It is always interesting when a smoker wants to review everything he has read about the risk of statins and never once read the copious documents regarding the dangers of tobacco. I have to weigh risk and benefits of statin therapy for each patient. I am not a fan of the term side-effects since drugs simply have effects, both good and bad. Even food has side-effects. If the dose is too high, we get fat, and if we are allergic to a particular molecule in our food, then we can suffer anaphylaxitic death. "All things in moderation" should be considered when prescribing medications, food, alcohol and even exercise.

When my client's risk for heart and vascular disease is moderate to high, I will discuss the use of statins; however, people continue to ask me everyday whether there is a link between diabetes, cancer and dementia risk and statin use. There is no doubt that statins can cause muscle pain and weakness. The site UpToDate notes the incidence of severe muscle issues (myopathy) is about 0.1 % and we are continuing to learn about the etiology of statin-related side-effects. The less severe muscle issues are much more common than that number and statin use must be closely monitored. If someone has muscle pain or weakness, then it requires evaluation to determine if related to the statin therapy. Statin-related muscle pain and weakness is real and not the current discussion, but there are individuals who cannot tolerate statins and must avoid.

It has been shown that the benefits of statin therapy outweigh the risks in those individuals with established cardiovascular disease (coronary artery plaque, heart attack, stent, bypass surgery, stroke, peripheral arterial disease or other atherosclerotic related diagnosis). Statins should be used with nutritional modification and exercise. The ACC/AHA 10-year ASCVD risk calculator is used to determine an individual's risk and treatment strategy. Low risk and elderly individuals are not typically offered statins based on studies indicating less benefit, but must be determined by your healthcare provider. It is important to treat the individual, not numbers and not the population.

Just be aware there are meta-analysis of persons at low risk for vascular disease where statins reduced the risk of major vascular evens by 21% per each reduction of 38.7 mg/dL in LDL-C and the risk of death from vascular-related causes was reduced by 12%. There was no increase in the incidence of cancer or cancer-related death. Allison B. Goldfine, M.D., Joslin Center, Boston, MA, wrote in the 2012 in an issue in the New England Journal of Medicine that:

"Even among participants with estimated 5-year event rates of less than 5%, there was a 38% reduction in the rate of major vascular events, a 43% reduction in the rate of major coronary events, and a 48% reduction in the rate of revascularization.

The effect of new-onset diabetes attributable to statins is 2% of the absolute benefit in terms of protection against major vascular events. This conclusion is based on a frequency of new cases of diabetes of about 1% annually (as seen in the primary-prevention trials), an observed excess risk of new cases of diabetes associated with statins of 10% (equal to an absolute risk of 0.1% per year), and an immediate doubling of the risk of death from vascular causes in persons with diabetes."

It is important to balance therapies with lifestyle modification. Continuing to smoke tobacco, avoiding exercise and eating unhealthy foods and depending on a statin is not smart. The InterHeart Study demonstrated the balance of bad to good lipid particles ( ApoB/ApoA1 ratio ) was the number one finding associated with heart risk, followed by smoking, psychosocial stress and diabetes. If you can make lifestyle changes and get your lipids to goal without medications, that is in your favor; however, treatment has to be based on individual risk.

One of my patients followed the recommendations in Joel Fuhrman's The End of Diabetes and lost 40 lbs and went from 40 units to 4 units of insulin daily. This was not one of my young, motivated and professional clients, this was a local rancher who was tough to convince. Not everyone can achieve this, but for him it has worked very well. Is he free of diabetes? Of course not. His CT calcium score was 700; however, his stress test was low risk. He has advanced, silent coronary artery disease and is at risk. His primary care physician recommended he start a statin based on current guidelines. He asked about the Finnish study indicating a possible 46% increase in diabetes in individuals on statins, but had not read anything else.

These are important questions and one must recognize that diabetes-related heart and vascular disease are silently developing for the 10 years prior to the diagnosis of diabetes. We know that many of these individuals in the prediabetes phase (metabolic syndrome, insulin resistance, etc...) have lipid disorders and often require statin therapy to control their lipids based on their risk factors. It may be that these individuals require statin therapy for significant lipid abnormalities and risk factors and have not yet manifested their diabetes. Once their diabetes is diagnosed, we may incorrectly associate a causal link between the statin and the diabetes. We must continue to follow the research and I would prefer it not be sponsored by the drug companies. It can be tough finding unbiased results. It is my role to give my clients options and help them better understand the treatments that are available. Statins reduce cardiovascular events about 25% across a number of studies. If you look through my website, you will find studies demonstrating about 90% reduction in cardiovascular events on optimal lifestyle therapy, 50% reduction with meditation, about 50% reduction with habitual exercise and even studies showing regular sex can reduce heart attack rates in men.

I want to be clear that healthcare providers must follow guidelines when making recommendations. These guidelines are not always written in stone. The patient must be given these recommendations and they can decide if they want to accept this as part of their treatment. It should never be an argument. Your healthcare provider is making recommendations based on his or her training, interpretation of the studies and the regional standard of care. Once an individual is diagnosed with diabetes, the American Diabetes Association recommends the following since there is strong association between diabetes and heart disease:

"Because people with diabetes are already at high risk for heart disease, the revised Standards of Medical Care call for all people older than 40 years of age with diabetes to take statins," said Richard W. Grant, MD, MPH, Research Scientist, Kaiser Permanente Division of Research and Chair of the Association’s Professional Practice Committee. They recommend people with diabetes who are between the ages of 40 and 75 with no additional cardiovascular disease risk factors take a moderate-intensity statin, while those of all ages who have cardiovascular disease, or those ages 40-75 who have additional cardiovascular risk factors, take a high-intensity statin."

I find it interesting that clients now come to see me to discuss using statins for other issues. Please understand that I am a physician who cannot tolerate statins. I understand the benefits and risks better than most. Statins cause me significant muscle weakness and yet, I have familial hypercholesterolemia and would benefit the most. I took my weight from an appropriate 170 lbs to 155 lbs only to find my lipids still high. Statins, when tolerated, seem to reduced cardiovascular events by about 25% when combined with lifestyle modification. I don't know of any studies where individuals were simply given a statin without lifestyle modification. I personally question whether they work as well without other behavior modification. That being said, I find recent studies regarding statin benefits to be quite interesting. This information should not be ignored.

European studies have recently found statins associated with a 50% reduction in the progression of multiple sclerosis and a similar reduction in the recurrence of breast cancer in women. Statins certainly have pleotrophic effects. Anti-inflammatory effects. They do more than simply reduce cholesterol levels and seem to make arterial plaque more stable and less prone to rutpure. They are not without "side-effects" and we continue to learn. Recently the FDA removed its approval for the combination of niacin and fibrates with statins. They did not see a beneficial risk to benefit ratio and thus recommended these agents not be used in combination with statins. Newer agents are now available called PSCK9 inhibitors that offer another option for those with heart and vascular disease when statins and other therapies fail to get lipids under control or are not tolerated.

This is just for information and an opinion. It is my opinion that lifestyle modification and optimal nutrition is key. It has been shown; however, that only about 4% of those participating in large studies on optimal risk factor modification could actually achieve the 90% reduction in cardiovascular events. Motivation is the key. It is more than a cholesterol value. LDL-C is not the only answer and people still suffer heart attacks with LDL-C levels in the "normal" range. Perhaps it (LDL-C) is an innocent bystander of our poor, inflammatory lifestyles. Sleep, nutrition, stress-reduction and exercise are all very imporant and often not prescribed since their importance is not realized. It is estimated that about 70% of Americans are on at least more prescription medication. That seems very high to me. Obesity is epidemic and we live off energy drinks since sleep is not given priority. Time to make a change!

I have included the link to the University of Texas Southwestern Prevention website regarding statins:

:

http://www.utswmedicine.org/stories/articles/year-2016/statins-answers.html

Cholesterol Treatment Trialists' (CTT) Collaborators. The effects of lowering LDL cholesterol with statin therapy in people at low risk of vascular disease: meta-analysis of individual data from 27 randomised trials. Lancet 2012 May 16

Sattar N, Preiss D, Murray HM, et al. Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials. Lancet 2010;375:735-742

http://www.diabetes.org/newsroom/press-releases/2014/new-standards-of-care-provide-guidelines-for-statin-use-for-people-with-diabetes-to-prevent-heart-disease.html?referrer=https://www.google.com/#sthash.nO28vMK7.dpuf