Review Shows Statins Safe, Effective

Risks of Side Effects Very Low for Most Patients

From the WebMD Archives

June 6, 2007 -- The benefits of taking cholesterol-lowering statin drugs far outweigh the potential risks for the vast majority of patients with heart and vascular disease, a new review of the research suggests.

Longtime statin researcher Jane Armitage, MD, of the University of Oxford, found the incidence of serious side effects to be very rare in patients taking standard doses of the drugs, although the risks rose with higher doses.

She estimated the risk for myopathy (muscle symptoms such as pain or weakness) to be less than one in 10,000 for patients on standard doses of the drugs.

Her analysis is published in the latest online issue of The Lancet.

“These are very safe drugs, overall, and they are very effective for lowering stroke and heart attack risk,” she tells WebMD.

Best-Selling Drugs

In just two decades, statins have become the world’s best-selling class of drug, with sales of Pfizer’s Lipitor alone approaching $13 billion last year. Other statins include Zocor, Mevacor, Pravachol, Lescol, and the newest statin, Crestor.

Another statin, sold as Baycol, was removed from the market in 2001 when its use was linked to an unacceptably high incidence of serious muscle damage.

Patients taking the statins on the market today are routinely warned that muscle pain or weakness can be a side effect of the drug, and Armitage says many erroneously attribute routine muscle issues to its use.

Muscle pain is one of the main reasons patients cite for abandoning statin therapy.

When Armitage reviewed studies comparing statin users with patients with similar characteristics who were not taking the drugs, she found no evidence of an increase in muscle pain and weakness in the former group.

"When you look at the objective evidence there is very little to suggest that muscle pain is a common problem with statins,” she says.

She adds that there is even less evidence linking standard doses of the cholesterol-lowering drugs now in use to a life-threatening liver disease caused by muscle breakdown.

Standard doses were considered those that typically reduce low-density lipoprotein (LDL), or bad, cholesterol levels by 30% to 45% -- 10 milligrams to 20 milligrams daily for Lipitor, 40 milligrams to 80 milligrams for Lescol, 40 milligrams for Mevacor, 40 milligrams for Pravachol, 10 milligrams for Crestor, and 20 milligrams to 40 milligrams for Zocor.

Continued

Treatment with statins is known to raise levels of potentially problematic liver enzymes in some patients, but that has not been clearly linked with liver failure, American Heart Association spokesman Gerald Fletcher, MD, tells WebMD.

A preventive cardiologist at the Mayo Clinic in Jacksonville, Fla., Fletcher was among a group of cardiovascular disease experts who conducted a separate review of the research assessing statin safety, published two months ago in the American Journal of Cardiology.

Like Armitage, Fletcher’s group found little evidence of risk in the published studies.

“The side effects and complications with these drugs are so rare, they are miniscule,” he says. “But the potential benefits are great for people with any kind of vascular disease, whether or not they have had a heart attack or stroke.”

Unanswered Questions

Armitage concedes that not all of the safety questions regarding statins have been answered.

Though her review found little evidence of problems in groups considered to have the highest risk for side effects, including the elderly and alcoholics, she acknowledges that these people are often excluded from clinical trials.

She adds that there is also not enough long-term safety data on newer cholesterol-lowering drugs like AstraZeneca’s Crestor to fully understand their safety profile.

“With a few caveats, and while awaiting good-quality randomized data for the newer drugs, statins seem to be a remarkably safe group of drugs when used at their usual doses,” she writes.

WebMD Health News Reviewed by Louise Chang, MD on June 06, 2007

Sources

SOURCES: Armitage, J., The Lancet, vol 369; online edition. Jane Armitage, MD, Clinical Trials and Epidemiological Studies Units, University of Oxford, England. Gerald Fletcher, MD, preventive cardiologist, Mayo Clinic, Jacksonville, Fla.; and spokesman, American Heart Association. WebMD Medical News: “Lipitor Safety Questioned in Lawsuit." Fletcher, G. American Journal of Cardiology, March 27, 2007; vol. 99.

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