March 1, 2012 -- Are the benefits of cholesterol-lowering statin drugs worth their risks?

It seems that every week there's news about statins. One week there's a scare about possible new or underappreciated risks. The next week, you hear they are the best thing ever.

What's the truth? To answer commonly asked questions, WebMD turned to Steven Nissen, MD, chair of cardiovascular medicine at the Cleveland Clinic, and to recent medical literature reviewing the latest research.

Cholesterol 101: What Your Levels Mean
What Are Statin Drugs?

The first statin drug, mevastatin, was isolated from a fungus. Red yeast rice contains mevastatin, although different batches of this natural product contain different amounts of mevastatin.

Several other statin drugs were derived from this fungal compound. Others are fully synthetic. All of them block an enzyme the body needs to create cholesterol. This lowers the amount of bad LDL cholesterol in the body.

Statin drugs include:

    Altocor, Altoprev, Mevacor (lovastatin)
    Crestor (rosuvastatin)
    Lescol (fluvastatin)
    Lipitor (atorvastatin)
    Livalo (pitavastatin)
    Pravachol (pravastatin)
    Zocor (simvastatin)

Clinical trials show that all of these cholesterol-lowering drugs cut the risk of heart disease by 25% to 30%, Nissen says.

In the U.S., an estimated 33 million adults are taking a statin drug.
Are Statin Drugs Too Risky?

"If you have heart disease, or are at very high risk of heart disease with high cholesterol, statins are one of the best classes of drugs we ever had," Nissen says. "When used thoughtfully and with good monitoring, they are safe and effective."

We all need to watch our cholesterol levels. But statin treatment is not for everyone.

"Some people are running around saying we should put statins in the water supply, and that is wrong. These are serious drugs," Nissen says. "Statins should be coupled with good diet and exercise. They are not a substitute for a healthy lifestyle."
Who Should Take Statin Drugs?

Statin drugs are for people who are at risk of heart disease.

Risk is defined by your age, your total cholesterol level, your good HDL cholesterol level, your blood pressure, and whether you are a smoker. Your blood level of C-reactive protein (CRP) and whether either of your parents had an early heart attack also are factors.

But the decision on whether or not to take a statin drug should be made in consultation with your doctor, who can take all your individual risk factors into account.

Statin drugs are not a cure-all. They should be used only along with proper exercise and a healthy diet.

And some people definitely should not take statins. Pregnant women, or women of childbearing age not using contraception, should not take statin drugs. And certain other drugs can have dangerous interactions with statins.
What Are the Risks of Statin Drugs?

Even the very best drugs carry risks. Statins are no exception.

Cholesterol-Lowering Statin Drugs: A WebMD FAQ
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What Are the Risks of Statin Drugs? continued...

In early 2012, the FDA told statin drugmakers to add a few of risks to the product label. These risks include memory loss, mental confusion, and a diagnosis of diabetes due to higher blood sugar.

Media reports of these risks alarmed many statin users. The Cleveland Clinic's Nissen says these risks are real, but not particularly worrisome.

The increase in blood sugar, he says, is small. But in people with already high blood sugar, this small increase may push them across the threshold of a diabetes diagnosis.

"It turns out that analyses of controlled trials show that those who cross the threshold into diabetes had exactly the same benefits of the statin," Nissen says. "So in terms of risk vs. benefit, there is no change."

As for the memory loss and confusion, Nissen says it is "rare and completely reversible." He notes that statins do reduce a person's risk of vascular dementia, which is considered to be the second leading type of dementia, behind Alzheimer's disease.

A more common risk seen with statins is muscle tenderness, which occurs in some 5% of patients. This can be extremely severe.

"A doctor should suspect a statin side effect in any patient who complains of muscle pain," Nissen says. "They can often switch to another statin. We can usually find a statin drug people can tolerate without too much difficulty."

There are several risk factors for muscle side effects linked to statins:

    Thyroid insufficiency
    Female sex
    Older age
    Liver and kidney problems
    Diabetes
    Excessive alcohol use
    Use of other medicines that affect statin metabolism

And while most people tolerate statins quite well, other common side effects include:

    Headache
    Difficulty sleeping
    Flushing of the skin
    Muscle aches, tenderness, or weakness
    Drowsiness/weakness
    Dizziness
    Nausea and/or vomiting
    Abdominal cramping and/or pain
    Bloating and/or gas
    Diarrhea
    Constipation
    Rash