Features June 2010 Issue

What You Should Know About Statin Side Effects

The benefits of these drugs far outweigh the risks.

Media reports questioning the safety of statins are raising concerns about side effects such as muscle pain. These reports alarm Cleveland Clinic physicians, who worry people will stop taking the drugs.

"Statins are incredibly safe. They reduce the rate of heart attack and stroke, and save more lives than almost any other drug. Sure, side effects can occur, but the risk is very low, and the benefits far outweigh the risks," says Stanley Hazen, MD, PhD, co-section head of Preventive Cardiology and Rehabilitation at Cleveland Clinic.

Common side effects

The primary side effect of statins is myopathy (muscle pain, tenderness or weakness). A review of studies involving several hundred thousand patients found the risk of myopathy to be one to three in every 100.

"The risk is smalló97 out of 100 statin users have no side effects; furthermore, in the vast majority of the small percent that do have side effects, the muscle stiffness or aches disappear rapidly when the drug is stopped," says Dr. Hazen.

The study found the risk of side effects is similar with all statins and is dose-related: The higher the dose, the greater the risk of myopathy.

Reducing side effects

Myopathy generally resolves over time and reverses when the statin is discontinued. Lowering the dose or switching statins may eliminate symptoms also.

Because statins deplete a nutrient called coenzyme Q-10 (CoQ-10), replacing this with over-the-counter CoQ-10 supplements may also provide relief.

"There are no good randomized trials of CoQ-10, but many observational studies suggest muscle aches and stiffness improve in over 50 percent of statin-intolerant patients who use it. We suggest patients try it, and if they benefit, continue," says Dr. Hazen.

As a caveat, he warns that
CoQ-10 is not FDA-regulated, so the amount listed on the label may not correspond with the amount inside the tablet. That means all brands may not work equally well, and the amount that is effective in one brand may not be effective in another.

Uncommon side effects

Rhabdomyolysis is a serious form of myopathy that can cause kidney failure. Fortunately, the side effect is rare, affecting only 1 in 20,000 statin users, and is reported most often with high doses of statins.

Rhabdomyolysis is associated with severe muscle pain, weakness and often brown or dark color changes in urine. If you experience any of these symptoms, discontinue taking your statin immediately and call your doctor.

When to continue therapy

If you experience side effects from statins, itís important to determine your need to continue the therapy and at what level. The decision is particularly important for people with cardiovascular disease.

"Statins have been shown to decrease the risk of heart attack, stroke and death in patients who have suffered a previous heart attack or stroke," says Dr. Hazen.

He adds, "If you need a statin for secondary prevention, we suggest you work with your physician to find a regimen you can tolerate. We often work with patients with statin intolerance and in some cases have tried a low dose of every statin, or a non-traditional regimen, such as a pediatric dose or even low doses given less often than once a day."

If you do not have coronary artery disease, but have high levels of "bad" LDL cholesterol, less aggressive measures for cholesterol lowering if statins cause adverse side effects may be appropriate.

"You can also try boosting your Ďgoodí HDL cholesterol levels with niacin, which also helps lower LDL" says Dr. Hazen.

Donít forget to exercise

Whether or not you take a statin, Dr. Hazen recommends you exercise regularly, but to pay attention to the signals your body sends you.

"Routine exercise is one of the best things anyone can do to help reduce the risk of coronary artery disease. If you are statin intolerant, it is even more important," he says. "If you know your normal exercise tolerance, you can tell if you are becoming muscle fatigued more quickly or are less able to lift as much weight. This prevents statin side effects from sneaking up on you."