Hypercholesterolaemia is a chronic condition that often requires life-long
treatment, making the safety of lipid-lowering drugs a critical issue. 3-hy
droxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors ('statins'
) are commonly used as the pharmacotherapeutic treatment of choice for pati
ents with hypercholesterolaemia. These agents have consistently demonstrate
d a positive safety and tolerability profile, and are recommended by the US
National Cholesterol Education Program guidelines and by the European Join
t Task Force for Prevention of Coronary Heart Disease to be used after, or
in addition to, a first-line approach with diet. Several large-scale clinic
al trials have shown HMG-CoA reductase inhibitors to be efficacious and wel
l tolerated, and to be associated with a low rate of treatment withdrawal d
ue to adverse events. These studies included mortality and morbidity end-po
ints, and comprised both primary- and secondary-prevention trials. Hepatic,
renal and muscular systems are rarely affected during HMG-CoA reductase in
hibitor therapy and the few drug interactions that can occur with concomita
ntly administered drugs are well documented. There is no conclusive evidenc
e linking HMG-CoA reductase inhibitors to the development of cancer in huma
ns. In long term studies with various HMG-CoA reductase inhibitors, there w
as no increase in cancer rates compared with placebo. Thus, it can be concl
uded that HMG-CoA reductase inhibitors ale well tolerated, effective treatm
ents for hypercholesterolaemia.