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Statin Intolerance Transcript

Video by Michael Rocco, MD

Medical Director of Cardiac Rehabilitation and Stress Testing, section of Preventive Cardiology and a staff cardiologist, Section of Clinical Cardiology and Preventive Cardiology in the Tomsich Family Department of Cardiovascular Medicine

Specialties: clinical cardiology, stress testing and cardiac rehabilitation, coronary artery disease/cardiac catheterization, lipid disorders and prevention

Hello, I’m Dr. Michael Rocco, and I’m Medical Director of Cardiac Rehabilitation and Stress Testing, section of Preventive Cardiology and a staff cardiologist, Section of Clinical Cardiology at the Miller Family Heart & Vascular Institute. Today I would like to put in perspective for you potential side effects to a commonly prescribed class of medication used for the treatment of cholesterol.

Cardiovascular disease which encompasses diseases of the heart and the blood vessels of the brain and other organs is the leading killer in our country striking men and women equally and responsible for approximately 40% of deaths each year. Half of these deaths or 20% of all are due to heart attacks and its complications. In women for example, this represents more than the next 5 leading causes of death combined. Therefore, it’s important to identify factors that contribute to the development of heart disease and treat them appropriately.

The relationship between elevations in cholesterol, particularly the LDL cholesterol, commonly referred to as bad cholesterol, is well known. And many clinical studies have demonstrated that lowering cholesterol can reduce the risk of heart attacks, stroke, and death. In addition, elevated cholesterol is quite common. More than 50 million men, and 50 million women, that’s about half of the adult population have cholesterol levels that are considered too high. Therefore lowering cholesterol is a very important step in our battle against heart disease.

A class of medications commonly referred to as statins which includes such brand names as Lipitor, Zocor, Pravachol, Crestor and others has been shown to be most effective in reducing LDL cholesterol and consistently has been shown to be associated in reduction in heart and vascular disease risk. Guidelines now recommend very aggressive lowering of cholesterol in high risk individuals to LDL or bad cholesterols at least under 100 and often under 70. Statins which are very potent are often necessary to achieve these very aggressive goals. Consequently millions of individuals are currently prescribed statins. While well tolerated in most as with any medications, there are side effects we need to be aware of.

The most common side effects of statins include gastrointestinal intolerance such as constipation, nausea, or indigestion. Headache and upper respiratory type symptoms, muscle symptoms and liver abnormalities. Fortunately these side effects are not common, occurring in only in up to 3% of people on statins and most are not serious, but some do require a few comments. Let’s speak first about liver abnormalities, these tend to occur in less than 1% of all individuals taking statins in the broad range of stains doses and choices. These are usually unassociated with symptoms and are manifested by abnormalities in blood tests, liver enzyme tests. And these rarely lead to liver failure and usually these are reversible and may even improve with continuation of statin drug at the same dose or a reduced dose.

Recently more attention has been turned to muscle symptoms. Myalgia is the most common, and is defined as muscle soreness or tenderness or aching without associated muscle injury and occurs in 1.5-3.5% of patients taking statins. Myopathy, which is muscle soreness or symptom associated with evidence a muscle injury, such as an elevation in blood muscle enzyme test, is less common, occurring in less than 1/10th of a half of percent of patients. Rhabdomyolysis, which is the most severe form of myopathy, fortunately is very infrequent only occurs 5 in very 10,000 patients taking statin drugs.

It’s important to know that statin intolerance may be more common in certain situations. And in these situations, we need to watch more closely for side effects or maybe even use reduced doses of statins. These situations include being elderly, over 75 to 80 years. Having a small body frame or being frail, or having other medical conditions like kidney disease or liver disease. Also large amounts of grapefruit or grapefruit juice consumption, or other medications like certain types of drugs used to treat fungal infection, some antibiotics, and some heart medications such as (medications-can you listen to see what he says) may increase the levels of stain in the blood and therefore be associated with a higher risk of side effects, so it’s important to let your doctors know any other medications or supplements you are taking.

Now, how do we follow for side effects over time? Your doctor will typically will check a blood test to measure liver enzymes before starting statin drug, approximately 12 weeks after starting the medication, and with every dose increase. Once a stable dose is present, yearly blood tests are sufficient. If you develop any type of muscle pain, soreness, or weakness after starting a statin, let your doctor know immediately. He or she will likely obtain a blood test to exclude muscle injury and may consider a change in the statin type or dose. And remember to report any type of symptoms when starting a new medication. If side effects or muscle symptoms do develop it’s important to exclude other causes. Not all side effects or symptoms that develop after starting a medication are due to that medication. If it’s believed by your physician that the statin is the likely cause, he or she may elect a trial off of a statin to see if the symptoms resolve. If they do, it’s very common to rechallenge with the statin at a lower dose or to consider using a different statin. It’s important to remember that if you develop a symptom on one statin if very likely you will be able to take a different statin and not have the same symptoms, so it’s worth trying other medications. If you are truly intolerant after a trial of multiple statins, other medications such as cholesterol absorption inhibitors such as Zetia, resin drugs like Welchol, or Niacin that are less effective in lowering cholesterol than a statin may be prescribed.

Now lifestyle changes and diet are a very important with any program to lower cholesterol but may need to be emphasized even further if there are limits to medication use. Regular aerobic exercise, maintaining ideal body weight and reducing cholesterol and saturated fat or animal fat in the diet are all important.

Now while we talk a lot about what not to eat, additions to the diet may also be helpful. Foods containing plant stanols and sterols which include spread like Benecol and Take Control, Minute Maid Heart Wise Orange Juice, and certain yogurts and granola bars, ground flax seed added to the food, and increasing soluble fiber to the diet should also be considered as an aid in lowering cholesterol.

Coenzyme Q10 has been suggested as an aid in reducing muscle symptoms with statins. There is a theoretical basis for this although there are not large well controlled studies demonstrating definite benefit. However the downsides to Coenzyme Q10 are small and this is something you may want to discuss with your doctor as a way to continue on a statin drug, or increase the dose if symptoms develop. Be cautious of non-prescription supplements such as red yeast rice. This contains an active ingredient similar to the statin Lovastatin, and therefore should only be used only under your doctor’s supervision, especially if you’ve experienced side effects to prescription statins.

In conclusion, lowering cholesterol is a key component to preventing heart disease. For every 1% reduction in LDL cholesterol, you can expect 1% reduction in cardiac and vascular disease risk. The best approach to lowering cholesterol and reducing your risk is a combination of sensible diet, regular exercise, and when appropriate medications. Statins are well proven to reduce cholesterol and the risk of death, heart attack, and stroke. In the majority of individuals, statins are effective and very well tolerated. If you are prescribed a statin and suspect that you are intolerant, speak with your physician before stopping the medication, or taking any other additional supplements. Remember, work in partnership with your physician to determine the best and safest treatment for you. Thank you.

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Reviewed: 04/11

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