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Virtues of Statin Therapy






Why all the Fuss about Cholesterol?


Cholesterol is a waxy substance used by the body in small quantities to make essential tissues. In larger quantities the excess cholesterol is used to make the blockages which form in our arteries: atherosclerotic plaque. Excess cholesterol gets into the body in two ways: some people get their extra cholesterol from a diet rich in animal fats, some people get their extra cholesterol because their bodies simply make too much cholesterol. 

No matter how we get the extra cholesterol, it is one of the major causes of the blockages in our arteries that cause heart attacks, strokes and poor circulation. Your likelihood of developing these problems depends on how high your cholesterol level is. Many studies have now shown that lowering your cholesterol level will help to prevent these complications of atherosclerosis. Whether you lower your cholesterol by diet, exercise or drug therapy, this effort will help to prevent future heart attacks, strokes and poor circulation.

Measuring Cholesterol

There are many ways to measure the cholesterol levels in our blood. Previously, total cholesterol was the most common measure. Now cholesterol is divided into good and bad portions based on the direction that they carry fats. LDL or ėbad cholesterolî carries fats to the artery wall. HDL or ėgood cholesterolî carries fats away from the artery wall. Many recent studies have confirmed that the ratios of these types of cholesterol is a better predictor of heart disease than total cholesterol alone. 

More sophisticated measures sub-fractions of the good and bad cholesterols are now available. Although they are not yet commonly available, studies now show that they may be even better predictors of atherosclerosis. Most adults should have their cholesterol measured every five years. Those who have suffered atherosclerotic problems like heart attack or stroke and those with diabetes require more strict control of their cholesterol. These patients need more frequent testing.

How Low Should My Cholesterol Be?

Current recommendations treat those who already have blocked arteries or diabetes differently than those who do not have these problems. People without these problems are advised to maintain their total cholesterol less than 200, their bad cholesterol (LDL) less than 160 mg% and their good cholesterol (HDL) greater than 40 mg%. Patients who are diabetic or already have blocked arteries are treated more aggressively. These patients are advised to keep their bad cholesterol (LDL) less than 100 mg%.

How Do I Lower My Cholesterol?

A good diet and exercise program are the first step in any cholesterol lowering program. Many patients will require drug therapy as well in order to reach the goals stated above.

There are three components to a cholesterol lowering diet: 

  • decreased calories, 

  • decreased fat consumption, and 

  • decreased cholesterol consumption. 

Reducing the amount of food (calories) until you have reached your ideal body weight will also help you lower your cholesterol. If you are not sure what your ideal weight should be you should ask your doctor. For many people their weight at age 18 is close to their ideal body weight. The amount of fat and cholesterol you are allowed may be determined by your physician or by a dietitian. Generally, fat should represent only 25-35% of your daily calorie intake. Everyone should consume less than 200 mg of cholesterol daily.

A good exercise program will not only condition your cardiovascular system and help you reach your ideal body weight, but it will also lower your cholesterol level. Patients with heart disease should ask their doctor how much exercise will be acceptable for them. Others should aim for 45 minutes of aerobic exercise daily. Walking, jogging, swimming and bicycling are all forms of aerobic exercise.

Drug Therapy

Many patients will require drug therapy in order to reach their cholesterol treatment goals. Your physician may choose a drug for you based on your underlying cholesterol disorder and his goal for your cholesterol levels. Among the available drug therapies are:

Drug Name Statins Resins Fibrates Other
Atorvastatin (Lipitor) l      
Fluvastatin (Lescol) l      
Lovastatin (Mevacor) l      
Pravastatin (Pravachol) l      
Simvastatin (Zocor) l      
Rosuvastatin (Crestor) l      
Colestyramine (Questran)   l    
Cholestipol (Cholestid)   l    
Colesevalam (Welchol)   l    
Fenofibrate (Tricor)     l  
Gemfibrozil (Lopid)     l  
Ezetimibe (Zetia)       l


What is a Statin?

Statins are drugs that reduce your cholesterol level by blocking the major enzyme responsible for manufacturing the substance.  When this enzyme is blocked, the liver begins to clear cholesterol from the circulation and the blood levels fall.  Among all the possible therapies to control elevated cholesterol levels, statins have distinguished themselves and become the most popular treatment. 

Statins are popular because in major studies they have been shown repeatedly to be the most effective way to lower cholesterol and to prevent heart attacks.  Even more important, statins are extremely well tolerated with very few patients complaining of side effects or intolerance.  The safety profile of statins is irrefutable and they are currently the number one class of new prescriptions written daily.  

Despite this rare patients may develop a toxic muscle reaction to statins.  An increase in such rare reactions caused by the statin "Baycol" or Cerivastatin led to the withdrawal of this drug from the market by the FDA in 2001.  This withdrawal has caused both patients and physicians to become more interested in muscle toxicities associated with statin use.


What are the Symptoms of Muscle Toxicity?

As we age it is common to experience more muscle aching and tiredness.  Many muscle symptoms are in fact due to aging have no relation to statin therapy.  In large controlled trials as many patients had muscle complaints in the groups that were taking no drug as in the groups on statin therapy.  Nonetheless, some symptoms in some patients appear to be related to the statin therapy.  

Patients in our research studies who could repeatedly identify when they were receiving statin therapy shared certain complaints.  Their muscles ached during and after exercise.  In particular many patients noticed burning in their legs when climbing stairs.  Some of these patients experienced easy breathlessness during exertion and complained of fatigue.  A very small group of patients may develop a serious muscle disorder called "rhabdomyolysis" while taking statins.  This term means breakdown of muscle which is actually what occurs in this rare condition.  These patients have severe tenderness of most muscle groups in addition to weakness and a sense of fatigue.  They may develop dark or tea-colored urine.


What is Myopathy?

Myopathy means muscle sickness. There are many different kinds of myopathy.  Some myopathies are inherited like muscular dystrophy.  Others are due to an acquired inflammatory illness like polymyositis or inclusion body myositis.  Some myopathies are due to a toxic reaction like the statin associated myopathy that is the focus of this web site. Most, but not all, muscle illness or myopathy results in symptoms of muscle pain or weakness. Some patients have frequent muscle cramping and others may complain of fatigue or energy loss.

Many muscle disorders that involve destruction of muscle tissue can be detected by measuring the muscle enzymes that are released into the blood. Creatine Kinase is a muscle enzyme that is released into the blood by damaged muscle.  It is measured to screen for these disorders. Many other muscle disorders do not destroy muscle tissue but simply cause it to function poorly. These myopathies do not result in the release of muscle enzymes like Creatine Kinase into the blood stream. 

As a consequence, these disorders may be harder to detect and diagnose. Examples of myopathies that may not result in the release of Creatine Kinase are the disorders due to hormonal or metabolic imbalances (e.g. Cushingís Syndrome and CPT deficiency) and disorders due to defects in the cells energy producing units the mitochondria. Statin associated myopathy is one such disorder that doesnít necessarily cause muscle damage or elevation of Creatine Kinase. This is why this disorder may be difficult to diagnose.

Myopathy can be due to many things including recent infections, hormonal changes due to aging, or even due to other drugs and vitamins a person may be taking.

Drugs and Vitamins Associated With Muscle Toxicity

Steroids/Cortisone/ Prednisone

Vitamin E in doses over 400 IU daily

Alcohol (more than 2 drinks daily)

Valproate (Depakote)


Thyroid preparations

Labetolol (Normodyne)

Amiodarone (Cordarone, Pacerone)

Cyclosporine (Neoral, Sandimmune)

Antimalarial drugs

Chemotherapy for cancer

Protease inhibitors for HIV disease and AIDS


Why You Should Continue Your Cholesterol Lowering Therapy

Statin therapy has saved thousands of lives by preventing heart attacks and strokes (see ėVirtues of Statin Therapyî). In major studies of thousands of patients on statin therapy, as many patients had muscle complaints on placebo or nothing as on statin therapy!  This means that when patients are not sure whether they are receiving sugar pills (placebo) or statin therapy, they are as likely to have muscle complaints on the sugar pills as they are on the statin therapy. Therefore many patients with muscle complaints on statins are not having a reaction to the drugs and they should continue this important therapy.

The vast majority of patients receiving statin therapy tolerate it without any side effect.  Statins have been shown to be safer than aspirin in studies of over 80,000 patients.  There is some evidence that patients with heart and vascular conditions who stop their statin therapy abruptly may be at increased risk of having medical problems.  Statins save lives by reducing cholesterol and decreasing the complications of atherosclerosis.  They also seem to have benefits beyond cholesterol lowering such as in reducing inflammation.  A list of the other potential benefits is available on the virtues of statins page.

If you think that you may be having a reaction to your therapy, discuss this with your doctor before discontinuing the therapy. Your doctor may choose to perform tests while you are still on the statin to see if you are having a reaction.  Some of these tests must be performed while you are still taking the medicine. Read further to discover what symptoms to report to your physician (see below).


What to do if You Think You are Having a Reaction to Your Statin Therapy

If you believe you may be having a reaction to your statin therapy, you should talk with your physician before you do anything else.  The majority of patients with minor muscle complaints while taking statins are not having any reaction to their medication.  Your physician can evaluate your symptom and perform tests to discover whether your symptoms are related to statin therapy.   Some of these tests need to be performed while you are on the medicine so stopping it prematurely may confuse or delay the evaluation.


The following websites have regularly updated information on cholesterol management:

National Cholesterol Education Program, National Heart, Lung and Blood Institute

Information on Statins

Statins: Powerful Drugs for Lowering Cholesterol, by Antonio M. Gotto Jr., M.D., Circulation, American Heart Association

Information on Rhabdomyolysis and muscle reactions to statins

Baycol: Questions and Answers, U.S. Food and Drug Administration,  Center for Drug Evaluation and Research

Information on the Mediterranean Diet

The Mediterranean Diet: Setting The Record Straight, by Sarah Yang, WebMDHealth

Mangia Mediterranean, by Andrew Weil, M.D., DrWeil.Com

The Mediterranean Diet, by Anna Rita Mazzoli, Biologist and Nutritionalist, Italian Website

A Primer on Fats and Oils, American Dietetic Association

Wanted: More Fruits and Vegetables, American Dietetic Association

Fats, the Good, Bad and Neutral, American Dietetic Association


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