Statin safety in children at increased risk for cardiovascular disease

Statins have been proven efficacious in reducing the incidence of atherosclerotic cardiovascular disease (CVD) in adults. However, the process of atherosclerosis commences early in childhood, especially when predisposing conditions are present, such as hypercholesterolaemia or the metabolic syndrome. Early initiation of treatment to reduce the risk for CVD is therefore warranted and several studies have evaluated the efficacy and safety of statin therapy in childhood. In this review, we sought to provide an overview of paediatric studies on statin therapy, with an important focus on safety. Studies for various indications, such as familial hypercholesterolaemia and cardiac transplantation, were identified. The data made us conclude that the efficacy of statins in children is largely similar to what is observed in adult populations. The only three studies on the pharmacokinetics and pharmacodynamics of these compounds also show a drug profile very similar to that found in adults. With respect to safety, a plethora of studies has so far evaluated adverse events and growth and maturation as well as liver and muscle toxicity. Although future studies should more firmly establish lifelong safety, our review supports the notion that statin therapy in childhood is safe.