Statement of the International Task Force for Prevention of
Coronary Heart Disease on the use of statins
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September 2001
Because of the recent withdrawal of cerivastatin from the market of
cholesterol-lowering drugs, the Executive Committee of the International
Task Force for Prevention of Coronary Heart Disease, under the chair-manship
of Professor Dr. Gerd Assmann, FRCP, Director of the Institute of
Arteriosclerosis Research at the University of Münster, Germany, and
the International Atherosclerosis Society under the chairmanship of
Prof. Dr. Heiner Greten, Director of the Department of Internal
Medicine at the University of Hamburg, Germany, at a scientific
symposium at the Rockefeller University in New York on September
8-9, 2001, discussed issues of benefit and safety of statins. The
following conclusions were agreed upon:
Statins have been used for more than 10 years to lower blood cholesterol
levels. Large placebo controlled trials using the statins lovastatin,
simvastatin, and pravastatin in some 30,000 patients conclusively showed
that these drugs reduce the risk of myocardial infarction (heart attack)
and cardiovascular death both in patients with pre-existing coronary
heart disease and individuals at high risk of cardiovascular disease.
Together with the newer statins, atorvastatin and fluvastatin, these
drugs have been safely used by millions of patients all over the world,
demonstrating that serious side effects are rare. Doctors and patients
should remain confident that statins are an important and, indeed,
indispensable means to prevent cardiovascular disease. The withdrawal
of one drug from the class of statins (cerivastatin) should not result
in a failure to prescribe other statins for patients who need them
and who have no contraindications to statin use.
In order to guarantee maximum benefit from statin therapy, the following
guidelines should be followed:
- As stated in detail in previous documents of The International
Task Force for Prevention of Coronary Heart Disease (www.chd-taskforce.com),
therapy with statins should be targeted to patients at high risk of
coronary heart disease. High risk is indicated by the presence of
pre-existing atherosclerotic disease such as angina pectoris and
myocardial infarction. Treatment in patients with pre-existing
atherosclerosis is referred to as secondary prevention. Individuals
with no pre-existing disease, however, may nevertheless be at high
risk for near term clinical events. Their risk may be calculated
using socalled risk algorithms or risk scores derived from prospective
studies in large populations. The majority of patients with diabetes
mellitus are at high risk. Treatment in individuals without pre-existing
disease is referred to as primary prevention.
- As for all drugs, at the start of statin therapy, patients must be
made aware of the potential side effects of this treatment. Damage to
muscle known as myopathy or, in its rare severe form, rhabdomyolysis
may occur. Patients should be alerted to the tell-tale signs of
this side effect, muscle pain and weakness and darkening of the
urine which can take on a colour like coffee. Damage to the liver
known as hepatopathy and gastrointestinal problems may also occur.
- Statin therapy must be accompanied with laboratory checks on
effectiveness (by measuring LDL cholesterol) and side effects.
- In patients with other co-existing illness such as kidney failure
(renal insufficiency) and/or in patients who are being treated
with other drugs (e.g. fibrates, cyclosporin, erythromycin and
azole antifungals taken by mouth) doctors must consider the
problems of drug accu-mulation and interaction. Such patients
may require treatment with lower dosages or discontinuation of
combination treatment, special education on side effects and
additional laboratory testing. The ma-jority of such patients
on combination therapy with other lipid lowering drugs should
be referred to a specialist for initial treatment.
The International Task Force for Prevention of Coronary Heart
Disease is a non-profit organization and the members of the
executive board are scientists from various countries.
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