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American Journal of Cardiovascular Drugs

, Volume 8, Issue 6, pp 373–418 | Cite as

Statin Adverse Effects

A Review of the Literature and Evidence for a Mitochondrial Mechanism
  • Beatrice A. Golomb
  • Marcella A. Evans
Review Article

Abstract

HMG-CoA reductase inhibitors (statins) are a widely used class of drug, and like all medications, have potential for adverse effects (AEs). Here we review the statin AE literature, first focusing on muscle AEs as the most reported problem both in the literature and by patients. Evidence regarding the statin muscle AE mechanism, dose effect, drug interactions, and genetic predisposition is examined. We hypothesize, and provide evidence, that the demonstrated mitochondrial mechanisms for muscle AEs have implications to other nonmuscle AEs in patients treated with statins. In meta-analyses of randomized controlled trials (RCTs), muscle AEs are more frequent with statins than with placebo. A number of manifestations of muscle AEs have been reported, with rhabdomyolysis the most feared. AEs are dose dependent, and risk is amplified by drug interactions that functionally increase statin potency, often through inhibition of the cytochrome P450 3A4 system. An array of additional risk factors for statin AEs are those that amplify (or reflect) mitochondrial or metabolic vulnerability, such as metabolic syndrome factors, thyroid disease, and genetic mutations linked to mitochondrial dysfunction. Converging evidence supports a mitochondrial foundation for muscle AEs associated with statins, and both theoretical and empirical considerations suggest that mitochondrial dysfunction may also underlie many nonmuscle statin AEs. Evidence from RCTs and studies of other designs indicates existence of additional statin-associated AEs, such as cognitive loss, neuropathy, pancreatic and hepatic dysfunction, and sexual dysfunction. Physician awareness of statin AEs is reportedly low even for the AEs most widely reported by patients. Awareness and vigilance for AEs should be maintained to enable informed treatment decisions, treatment modification if appropriate, improved quality of patient care, and reduced patient morbidity.

Notes

Acknowledgments

The authors have no conflicts of interest to report. Work that contributed to this paper was funded by a Robert Wood Johnson Generalist Physician Faculty Scholar award to Dr Golomb. The study sponsor did not participate in study design; in the collection, analysis, or interpretation of data; in the writing of this report; or in the decision to submit this paper for publication. The authors would like to thank Hanh Nguyen and Jersey Neilson for kind assistance securing articles; and Sabrina Koperski for excellent editorial and administrative assistance.

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