NLA refines statin intolerance definition, management

Andara Puchino


Maki KC. Session V: Scientific Statements. Presented at: National Lipid Association Scientific Sessions; June 2-5, 2022; Scottsdale, Arizona (hybrid meeting).

Maki reports no relevant financial disclosures.

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The National Lipid Association updated its scientific statement on statin intolerance with a revised definition of statin intolerance and new guidance on how to manage patients with true or partial statin intolerance.

The scientific statement, presented at the NLA Scientific Sessions and published in the Journal of Clinical Lipidology, defines statin intolerance as “one or more adverse effects associated with statin therapy which resolve or improve with dose reduction or discontinuation and can be classified as a complete inability to tolerate any dose of a statin, or partial intolerance with inability to tolerate the dose necessary to achieve the patient-specific therapeutic objective.”

Guidelines discussion

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The document also addresses the prevalence of statin intolerance in clinical practice and the evidence for use of nonstatin therapies to lower atherogenic lipoproteins and reduce adverse CV events, Kevin C. Maki, PhD, CLS, FNLA, president and chief scientist of Midwest Biomedical Research, adjunct professor at Indiana University School of Public Health, incoming president of the NLA and co-chair of the scientific statement, said during a presentation.

By saying statin intolerance is defined as adverse effects associated with statin therapy, “we are not necessarily saying that these side effects are due to the pharmacodynamic effects of statins,” Maki said during the presentation.

“To classify a patient as statin intolerant, a minimum of two statins should have been attempted, one at the lowest approved daily dosage,” he said.

The definition differs from that in the NLA’s 2014 scientific statement in that “there is a continuum; you can have complete statin intolerance with a patient who can’t tolerate any statin therapy, or partial intolerance which prevents the patient and clinician from reaching the therapeutic objective” which requires a clinician-patient discussion, he said.

Statin intolerance is most often associated with statin-related muscle symptoms, but there can be other reasons for it, Maki said, noting that addressing modifiable risk factors could improve statin intolerance, but the writing committee did not assess that literature and make formal recommendations.

The document encourages clinicians to find alternatives, including changing agents and doses, “because complete statin intolerance is uncommon in clinical practice, less than 5% of patients in randomized controlled trials,” Maki said during the presentation. “In most cases, it is possible to find a regimen of statin therapy. It may not be sufficient to reach the therapeutic objective.”

He added that in patients at high or very high risk for CVD, “clinicians need not employ various unconventional methods before initiating nonstatin therapy, to limit the time of exposure to atherogenic lipoproteins. A lot of time can be wasted trying to find a regimen while the elevated levels of atherogenic lipoproteins are driving an increase in risk.”

Statin intolerance has been reported in 5% to 30% of patients, depending on the population studied, Maki said.

“Many patients are experiencing muscle symptoms while taking placebo, which indicates it is very likely that some of what we are seeing of statin-related muscle symptoms is not related to the pharmacodynamic effects of the drug,” he said.

If a patient cannot achieve their therapeutic objective with statins and lifestyle, then they should be considered for nonstatin lipid-lowering therapies, Maki said.

There is evidence that ezetimibe, PCSK9 inhibitors, gemfibrozil, icosapent ethyl (Vascepa, Amarin) and cholestyramine all reduce CV events by lowering levels of atherogenic lipoproteins, he said.

“In general, the evidence from randomized controlled trials as well as Mendelian randomization studies supports the view that adverse cardiovascular event risk is lowered by reduction of the plasma atherogenic lipoprotein level, and that benefit is proportionate to both the degree of reduction and the length of time that the lower level is maintained, so lower for longer is better,” Maki said.


  • Cheeley MK, et al. J Clin Lipidol. 2022;doi:10.1016/j.jacl.2022.05.068.

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