Rate of Statin-Linked Muscle Woes Unclear, Study Suggests

FRIDAY, April 27 (HealthDay News) — It’s been long known that
people on high doses of statins, cholesterol-lowering medications taken by
millions of Americans, are at risk for a rare yet serious muscle
condition. However, new research suggests that the frequency of the
condition, called rhabdomyolysis, is a bit less clear due to confusion
with the codes health professionals use to classify and report such
problems.

Statins include such bestselling drugs as Crestor, Lipitor, Pravachol
and Zocor. Muscle ailments have long been cited as a rare but possible
side effect of statin use, particularly at higher doses.

In the new study, University of Washington researchers evaluated the
use of the diagnostic code for “statin-related rhabdomyolysis,” a serious
condition involving achy muscles that is sometimes accompanied by kidney
problems. The code was introduced in 2006 as a way of tracking how many
cases of the potentially serious condition — which can be confirmed using
a blood test — were related to high-dose statin use.

But using coding data alone doesn’t appear to accurately track how many
people are stricken, according to the researchers.

“We did this study to see if we could identify cases of rhabdomyolysis
using billing data. But the way things are billed doesn’t tell you
anything about a case,” said study co-author Dr. James Floyd, a senior
fellow in epidemiology and a general internist at the University of
Washington, in Seattle.

Floyd, whose research was reported this month in the Journal of the
American Medical Association
, said he and his colleagues used
computerized pharmacy data to review electronic medical record reports of
statin users between 2006 and 2010.

Out of 292 statin users with an International Classification of
Diseases, Ninth Revision
(ICD-9) code for rhabdomyolysis, 22 actual
cases of the statin-related condition were picked up. Another seven cases
were identified using other methods. Of these 29 validated cases, 26 were
hospitalized, and no one died, the researchers reported.

Floyd said the results confirm an earlier U.S. Food and Drug
Administration warning against the use of high-dose statins. But he said
the best way to confirm true cases of rhabdomyolysis is to also use
information from evaluating patient charts.

“The conclusion is that if you’re going to do a study of an adverse
drug reaction, it is difficult to do with billing data alone,” Floyd
said.

So just how common might statin-linked rhabdomyolysis be? Cardiologist
Dr. Carl Lavie said that while lesser muscle aches are common in
statin-using patients, rhabdomyolysis is much rarer.

“We see a lot of patients with muscle aches, where all tests are okay
except that they swear that the muscle aches are bad and sometimes
unbearable, and an occasional patient with myopathy, but we hardly ever
see a true rhabdomyolysis [case],” said Lavie, who is medical director of
Cardiac Rehabilitation and Prevention and director of the Stress Testing
Laboratory at John Ochsner Heart and Vascular Institute, in New
Orleans.

Speaking of the new study, he added that “this is the kind of data that
the FDA based their warnings on from the SEARCH Trial, and both these data
and the SEARCH [study] suggested that the ICD-9 code data was misleading.”
SEARCH is the abbreviated name of the Study of the Effectiveness of
Additional Reductions in Cholesterol and Homocysteine.

In any case, “the lay public really shouldn’t be panicked about this,”
added Robert Bonow, director of the Center for Cardiovascular Innovation
at Northwestern University Feinberg School of Medicine and Northwestern
Memorial Hospital, and past president of the American Heart Association.
“It’s very common for people to have muscle pain. In clinical trials,
[even] people on [inactive] placebos said they had muscle aches,” he
noted.

“My words of advice: talk to your physician if you’re worried,” Bonow
said.

More information

Find out more about statins at the U.S.
National Library of Medicine
.

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