Review Shows Statins Safe, Effective
Risks of Side Effects Very Low for Most Patients
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
Her analysis is published in the latest online issue of The
“These are very safe drugs, overall, and they are very effective for
lowering stroke and heart attack risk,” she tells WebMD.
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,
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
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.
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
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
“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