By William L. Driscoll

Side effects from statins are “infrequent or rare” in clinical trials, and statin therapy is “usually well tolerated and safe,” according to the guideline on cholesterol management from the American College of Cardiology and the American Heart Association.

Statins are used to lower a patient’s LDL (“bad”) cholesterol, and thereby reduce the formation of plaques in the arteries, which can lead to heart attack, stroke, or dementia caused by mini-strokes.

The most frequent statin-associated side effects are muscle symptoms, usually muscle pain, reported in 5% to 20% of patients, the guideline says. In patients with muscle symptoms, a doctor should conduct a “thorough assessment” of symptoms, and conduct an evaluation for non-statin causes and predisposing factors.

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Statins “modestly” increase the risk of diabetes among those who have risk factors for diabetes, “but this should not be cause for discontinuation,” the guideline says.

Liver problems are infrequent, while rhabdomyolysis and other side effects are rare, and there is “no definite association” with cancer. The guideline’s Table 11 provides more detail.

Among those who experience side effects, the “large majority“ are able to tolerate an alternative statin or an alternative regimen, such as a reduced dose, or a reduced dose in combination with a non-statin drug, the guideline says.

The guideline recommends a doctor-patient risk discussion before starting statin therapy, to weigh the potential for reducing the risk of cardiovascular disease against the potential for statin-associated side effects and statin–drug interactions. In this discussion, the doctor should emphasize that “side effects can be addressed successfully.”

A doctor prescribing a statin should assess the patient’s “appropriate safety indicators” 4 to 12 weeks after starting a statin or adjusting the dose. The assessment should also review the patient’s adherence to any recommended lifestyle changes, and the patient’s LDL level. Assessments should be repeated every 3 to 12 months, based on the need to assess adherence or safety.

The “Guideline on the Management of Blood Cholesterol” is available free online from the Journal of the American College of Cardiology. It was prepared by the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines.