One in 4 Americans >40 years of age takes a
statin to reduce the risk of
myocardial infarction,
ischemic stroke, and other complications of atherosclerotic disease. The most effective
statins produce a mean reduction in
low-density lipoprotein cholesterol of 55% to 60% at the maximum dosage, and 6 of the 7 marketed
statins are available in generic form, which makes them affordable for most patients. Primarily using data from randomized controlled trials, supplemented with observational data where necessary, this scientific statement provides a comprehensive review of
statin safety and tolerability. The review covers the general patient population, as well as demographic subgroups, including the elderly, children, pregnant women, East Asians, and patients with specific conditions such as
chronic disease of the kidney and liver, human immunodeficiency
viral infection, and organ transplants. The risk of
statin-induced serious muscle injury, including
rhabdomyolysis, is <0.1%, and the risk of serious hepatotoxicity is ≈0.001%. The risk of
statin-induced newly diagnosed
diabetes mellitus is ≈0.2% per year of treatment, depending on the underlying risk of
diabetes mellitus in the population studied. In patients with
cerebrovascular disease,
statins possibly increase the risk of
hemorrhagic stroke; however, they clearly produce a greater reduction in the risk of atherothrombotic
stroke and thus total
stroke, as well as other cardiovascular events. There is no convincing evidence for a causal relationship between
statins and
cancer,
cataracts,
cognitive dysfunction,
peripheral neuropathy,
erectile dysfunction, or
tendonitis. In US clinical practices, roughly 10% of patients stop taking a
statin because of subjective complaints, most commonly muscle symptoms without raised
creatine kinase. In contrast, in randomized clinical trials, the difference in the incidence of muscle symptoms without significantly raised
creatinine kinase in
statin-treated compared with placebo-treated participants is <1%, and it is even smaller (0.1%) for patients who discontinued treatment because of such muscle symptoms. This suggests that muscle symptoms are usually not caused by pharmacological effects of the
statin. Restarting
statin therapy in these patients can be challenging, but it is important, especially in patients at high risk of cardiovascular events, for whom prevention of these events is a priority. Overall, in patients for whom
statin treatment is recommended by current guidelines, the benefits greatly outweigh the risks.