How safe is statin therapy?

The National Lipid Association just released a report addressing six safety issues related to statin therapy, including the effects of statins on cognition, diabetes risk, liver function, muscle symptoms, interactions with other drugs, and statin intolerance. The report, published in the Journal of Clinical Lipidology, is an update to a consensus report published by the organization in 2006.

“With the number of new patients now eligible to receive statin drugs under the new 2013 ACC/AHA Cholesterol guidelines, this [update] will provide welcome reassurance about the safety of these agents, particularly given recent negative media reports,” according to Terry A. Jacobson, MD, professor of medicine at Emory University, and the chairman of the NLA Statin Safety Expert Panel that examined the safety issues related to statins.

The Statin Cognition Task Force noted that despite reports of cognitive problems in patients who have taken statins, “there is no definitive evidence that statins as a class have adverse effects on cognition,” the report stated. The task force does not recommend that cognitive function be assessed before starting statin therapy. Individuals who use statins and have cognitive complaints should be assessed for other possible causes, especially as the incidence of cognitive impairment increases as one ages.

Statin users do have a small increased risk of developing diabetes-about 10% to 12%, and the high-intensity statins may be associated with a higher risk than moderate-intensity statins, according to meta-analyses. However, these individuals may already be at high risk for developing diabetes, according to the Statin Diabetes Safety Task Force.

“Clinical trial data strongly confirms the superior benefit of statins on cardiovascular disease risk reduction in diabetes patients, and this effect outweighs the much smaller risk of new onset diabetes,” the task force said. “The panel recommends that statin treatment should continue in patients who develop diabetes on therapy, and that enhanced lifestyle/behavioral changes be instituted to control weight, increase physical activity, and improve diet quality.”

The Statin Liver Safety Task Force explained that statin therapy may cause modest increases in liver enzymes, however, typically this doesn’t indicate liver damage. The task force has developed a table describing possible non-statin causes of increased liver enzymes and offers clinicians a diagnostic and statin management algorithm in the case of increased liver enzyme and bilirubin levels.

Muscle-related adverse events have been seen in individuals taking statins, and myalgia (muscle pain) is the most common, with approximately 1% to 5% reporting them in controlled clinical trials and approximately 11% to 29% in observational cohorts, according to the Statin Muscle Safety Task Force.

“Many patients initially intolerant to one statin can tolerate a different statin, possibly with alternative dosing strategies,” the task force noted.

In the Clinician’s Guide to Statin Drug-Drug Interactions report, each of the seven statins and the potential drug interactions have been covered, including the effects on plasma concentration AUC.

The Statin Intolerance Task Force has agreed on a definition of statin intolerance: “adverse symptoms, signs and/or laboratory abnormalities attributed by the patient and/or provider to a statin and perceived by the patient to interfere with daily life activities.” Statin intolerance is usually a temporary state and will resolve when individuals discontinue statin therapy. About 10% to 20% of individual patients can be described as statin intolerant.

“Because statins are safe, the Panel recommends that the clinician and patient should keep trying to adjust doses and type of statin in order to maintain statin therapy at some level when cardiovascular risk is high,” the report suggested.