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(BETHESDA,
MD, and DALLAS)—In light of recent patient
concerns over the safety of cholesterol-lowering
drugs commonly known as statins, the American
College of Cardiology (ACC) and the American Heart
Association (AHA) are reassuring patients that
these drugs are safe and very effective for most
patients. More than a decade of medical research
has shown that statins prolong lives and prevent
heart disease by effectively lowering serum cholesterol
levels.
Coronary
heart disease continues to be the leading cause
of death in the United States. Physicians have
been encouraged to step up efforts to prevent
heart disease, including an important focus on
reducing patients' cholesterol levels through
changes in their diet and regular exercise. In
many patients, cholesterol-lowering drugs, including
statins, are also part of treatment and prevention.
"While
statins, like all drugs, have side effects, the
benefits of using statins to manage patients'
cholesterol far outweigh the risks of serious
side effects from their use," said ACC President
Douglas P. Zipes, MD.
Recent
media reports about the August 8 voluntary withdrawal
of Baycol (also called cerivastatin), have prompted
some patients to stop taking their statins. Many
others have expressed serious concern about whether
they are safe. In addition, one consumer group
has called for a "black box" warning to be added
to the labels of all statins.
"Patients
are understandably concerned," said Dr. Zipes.
"We want to reassure patients that statins have
proven to be safe and very effective drugs, and
we urge patients who are taking a statin and who
have had no side effects to continue taking the
drug and to consult their physicians." As for
the black box warning on labels, "We feel that
is a decision best left to the Food and Drug Administration
(FDA) to make based on the available clinical
data," Dr. Zipes said.
Baycol
was withdrawn because of a reported 31 deaths
and significant muscle damage caused by the drug.
Any patients still taking Baycol should immediately
consult their physician about switching to another
drug. Patients taking Baycol who are experiencing
muscle pain or dark urine, or taking it in combination
with another drug called gemfibrozil (Lopid or
generic equivalents), should stop using Baycol
immediately and contact their physician.
There are five other FDA-approved statins with
a proven track record of effectiveness and safety
despite the withdrawal of Baycol.
"Statins significantly reduce the risk of heart
attack and stroke," said AHA President David Faxon,
MD. "Overall, multiple large studies have found
that statins significantly reduce the risk of
death in patients with heart disease by as much
as 30 percent."
Even
with this strong efficacy record, Dr. Faxon continued,
"Patients on any statin who have experienced side
effects such as muscle aches or dark urine should
stop taking the drug and immediately consult their
physician."
If
caught early, problems from side effects can be
quickly and effectively treated. Physicians can
also perform tests, including those for liver
function and markers of muscle inflammation, to
look for signs of problems possibly related to
the drugs.
Serious
side effects of statins—including
the muscle damage, or rhabdomyolysis, reported
in the Baycol withdrawal—are
rare, and appear to be more common with Baycol.
In general, the risk of a fatal reaction to a
statin drug is very low. As is the case with all
prescription drugs, however, patients should talk
to their physician about potential side effects
and how to properly use the medication.
"Patients who are having side effects can be taken
off of a statin or switched to one of the other
approved statins," explained Dr. Faxon. Patients
can also be switched to a different cholesterol-lowering
drug that can help them effectively manage their
cholesterol, he added.
Both
Drs. Zipes and Faxon stressed that statins and
other cholesterol-lowering drugs are meant to
be an adjunct to lifestyle changes such as diet
and exercise.
The
American College of Cardiology, a 26,000-member
nonprofit professional medical society and teaching
institution, is dedicated to fostering optimal
cardiovascular care and disease prevention through
professional education, promotion of research,
leadership in development of standards and guidelines,
and the formulation of health care policy.
The American Heart Association is a nonprofit,
voluntary health organization, with almost 2,000
community organizations in all 50 states, Washington,
DC, and Puerto Rico, dedicated to fighting heart
disease and stroke. Its mission is to reduce disability
and death from cardiovascular disease and stroke.
Copyright © 2001 American College of
Cardiology
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