Abstract
Since the first approval of lovastatin in 1987, hydroxy-methyl-glutaryl CoA (HMG CoA) reductase inhibitors, or statins, have been effective and widely popular cholesterol-lowering agents with substantial benefits for the prevention and treatment of cardiovascular disease. Not all patients can tolerate these drugs, however, and statin intolerance is most frequently associated with a range of side effects directed toward skeletal muscle, termed statin-associated muscle symptoms or SAMS. SAMS are particularly difficult to treat because there are no validated biomarkers or tests that can be used to confirm patient self-reports of SAMS, and a number of patients who report SAMS have non-specific muscle pain not attributable to statin therapy. This review summarizes the most recent evidence related to diagnosis and management of SAMS. First, the range of skeletal muscle side effects associated with statin therapy is described. Second, data regarding the incidence and prevalence of SAMS, the most frequently experienced muscle side effect, are presented. Third, the most promising new techniques to confirm diagnosis of SAMS are explored. Finally, the most effective strategies for the clinical management of SAMS are summarized. Better diagnostic and treatment strategies for SAMS will increase the number of patients using these life-saving statins, thereby increasing statin adherence and reducing the costs of avoidable cardiovascular events.
Highlights
Hyperlipidemia is a major public health problem
Data from STOMP, CoQ10, and GAUSS-3 support that there is a high percentage of false positive muscle complaints associated with SAMS, suggesting that 30 to 50% of patients who report SAMS may have another source of muscle pain besides their statin drug
In our CoQ10 in Statin Myopathy Trial, we found no relationship between vitamin D levels, pre- and post-statin therapy, or clinical vitamin D deficiency and insufficiency, on the development of SAMS [70]
Summary
Hyperlipidemia is a major public health problem. Approximately 30% of US adults have elevated low-density lipoprotein cholesterol (LDL-C), which doubles their heart disease risk [1]. In our more recent Coenzyme Q10 in Statin Myopathy study, we used a double-blind, placebo-controlled, crossover protocol to confirm SAMS in 120 patients with a history of statin-associated muscle complaints [21].
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