A scientific statement by the American Heart Association (AHA) stated that the benefits of statins outweigh its risks, as they were associated with a low risk of adverse effects. The review was published in Circulation: Arteriosclerosis, Thrombosis and Vascular Biology.

At maximum dose, statins have demonstrated a mean reduction in LDL cholesterol of 55% to 60%. It has been shown that 25% of US adults aged >40 years take a statin to lower the risk of MI, ischemic stroke, and other atherosclerotic complications but up to 10% discontinue treatment because of adverse effects that may or may not be statin-related (eg, muscle symptoms).

For the statement, the Association analyzed multiple studies that evaluated the safety and tolerability of statins, including randomized-controlled trials with observational data where necessary. “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,” explained the authors. 

The data showed a <0.1% risk of statin-induced muscle injury, including rhabdomyolysis, and a ~0.001% risk of serious hepatotoxicity. Statin-induced newly diagnosed diabetes mellitus was a ~0.2% risk per year of treatment, depending on baseline risk in the patients studied. Treatment with statins produced a greater reduction in the risk of atherothrombotic stroke and other cardiovascular events in patients with cerebrovascular disease although they had a possibly higher risk of hemorrhagic stroke with using statins. 

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Muscle aches and pains are the most common adverse effects reported with statins. Data from randomized controlled trials showed the difference in occurrence of muscle symptoms without significantly raised creatine kinase, in statin-treated vs placebo-treated patients, was <1%. This incidence reduced to 0.1% for patients who discontinued statins because of these symptoms, suggesting “muscle symptoms are usually not caused by pharmacological effects of the statin.” 

The authors concluded, “Overall, in patients for whom statin treatment is recommended by current guidelines, the benefits greatly outweigh the risks.”

For more information visit ahajournals.org