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Statement of the International Task Force for Prevention of Coronary Heart Disease on the use of statins
 
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:

  1. 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.
  2. 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.
  3. Statin therapy must be accompanied with laboratory checks on effectiveness (by measuring LDL cholesterol) and side effects.
  4. 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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