[Statins under fire: justified or not?]

Abstract

Statins inhibit the synthesis of cholesterol in the liver resulting in a decrease of LDL cholesterol and triglycerides, and a limited increase in HDL cholesterol. Statins also have pleiotropic effects, such as stabilisation of atherosclerotic plaques. The 4S-study was the first trial that demonstrated a significant benefit with statins in secondary prevention. The WOSCOPS-study was the first to prove the efficacy of statins in primary prevention. diseases approximately 10 years later than men. Therefore, it looks as if women are protected against cardiovascular diseases. Hence, they were underrepresented in large clinical trials. If there is no limited life expectancy, elderly--even older than 85 years--do not have to be treated differently for the secondary prevention than younger people. For primary prevention, the situation of the patient has to be evaluated, paying attention to additional risk factors. Type 2 diabetic patients that already have had a cardiovascular incident are considered to be at high risk and are eligible for an intensive therapy. Primary prevention in diabetic patients is often compared with secondary prevention in non-diabetic patients. The use of statins in children is controversial due to possible interference with the development of the child. New guidelines decrease the age for starting a therapy from 10 years old to 8 years old. For all patients a good safety profile is very important, given the long duration of therapy. Statins are used increasingly in high dose and accordingly the risk of adverse effects increases. Muscle toxicity is the most frequent side effect. The risk is strongly intensified by drug interactions through CYP3A4 (for simvastatin and atorvastatin), high doses, and combination therapy with fibrates. The use of statins during pregnancy is contra-indicated. Pharmacists are well placed to give advice about the risks of the use, or non-use, of statins. A high cholesterol level and the accompanied risk of cardiovascular disease, is something that one cannot really sense. The well-established effects of statins have to be explained to patients, together with a healthy life style. It is important to mention that the effects of statins in high--risk patients are largely proven. For primary prevention the risk factors have to be evaluated individually. Compliance is often low and pharmacists can play a major role in the pharmaceutical care of cardiovascular patients.