A safety look at currently available statins.

In this mini-review, the evidence for safety and efficacy of currently available statins is discussed. Large-scale, long-term clinical studies have documented an outstanding efficacy and safety profile for statin monotherapy when used at pharmacological doses. Non-life-threatening side effects may occur in up to 15% of patients receiving one statin. Sporadic reports show possible adverse effects of statins on nervous system function including mood alterations. More serious side effects may also occur but at much lower rates. Significant elevations in the activity of serum aminotransferase and creatine kinase alone or in combination with muscle pain in statin-treated patients should be taken seriously; under these conditions, monitoring the statin dose or its discontinuation must be considered. Unlike monotherapy, combination therapy is more problematic. Particularly, combination of the statins with gemfibrozil results in higher rates of drug toxicity. Co-administration of statins with other drugs, especially those which may interfere with the cytochrome P450 system, should be considered carefully. Special attention must be paid to the tolerability of the statins in elderly and transplant patients. The safety of statins in children and adolescents has not yet been well-documented, thus, statin therapy is not routinely recommended in this group of hyperlipidaemic subjects. Future clinical studies and surveillance information will warrant long-term safety of each member of this class of lipid-lowering agents.