OBJECTIVE: Statins, among the most commonly prescribed medications, are 
associated with a wide range of musculoskeletal side effects. These include a 
progressive autoimmune myopathy with anti-3-hydroxy-3-methylglutaryl-coenzyme A 
reductase (anti-HMGCR) antibodies that requires immunosuppression. However, it 
remains unknown whether these antibodies are found in statin users with and 
without self-limited musculoskeletal side effects; this limits their diagnostic 
utility. The current work assessed the prevalence of anti-HMGCR antibodies in 
these groups of statin users.
METHODS: We determined the prevalence of anti-HMGCR antibodies in 1,966 
participants (including 763 current statin users) in a substudy of the 
community-based Atherosclerosis Risk in Communities (ARIC) Study and 98 French 
Canadian subjects with familial hypercholesterolemia, including 51 with 
documented statin intolerance.
RESULTS: No participant in the ARIC substudy, including those with past or 
current statin exposure at the time of sample collection, had anti-HMGCR 
antibodies. Similarly, none of 51 patients with self-limited statin intolerance 
or 47 statin-tolerant patients receiving maximal statin therapy were anti-HMGCR 
positive.
CONCLUSION: The majority of patients with and without statin exposure, including 
those with self-limited statin intolerance, do not develop anti-HMGCR 
antibodies. Therefore, anti-HMGCR antibodies are highly specific for those with 
an autoimmune myopathy.