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.