Statin use and safety concerns: an overview of the past, present, and the future

Expert Opin Drug Saf. 2020 Aug;19(8):1011-1024. doi: 10.1080/14740338.2020.1796966. Epub 2020 Jul 31.


Introduction: Dyslipidemia is a significant risk factor for cardiovascular disorders and contributes to significant morbidity and mortality associated with CAD and stroke worldwide. Statins are the most commonly prescribed drugs for the prevention and management of dyslipidemia globally. Although they provide immense therapeutic benefit, they are associated with clinically significant adverse effects, predominantly muscle, nerve, liver, and cognition-related besides new-onset diabetes. This has sparked various controversies, bringing to the fore, ambiguities that continue to exist in the scientific evidence, in relation to statin-associated harms. Therefore, it becomes essential to have a better understanding of safety issues related to statin use in various populations.

Areas covered: This review describes the most common adverse effects of statins, examines available evidence and highlights the role of ethnicity, lipophilicity and other biological factors that could mediate and/or influence the relationship. MEDLINE was searched via PubMed to obtain relevant articles on dyslipidemia and statin safety.

Expert opinion: The effectiveness of statins is presently unmatched. Further research is warranted to gain insights into the diverse pharmacological effects of statins in various population subgroups. This would assist prescribers in making better informed decisions. Specific treatment strategies for vulnerable groups can significantly attenuate harms, improve risk-benefit ratios, and ultimately enhance patient experience.

Keywords: Statins; cognitive adverse effects; coronary artery disease; drug safety; muscle-related adverse events.

Publication types

  • Review

MeSH terms

  • Animals
  • Anticholesteremic Agents / administration & dosage
  • Anticholesteremic Agents / adverse effects*
  • Cardiovascular Diseases / prevention & control
  • Dyslipidemias / complications
  • Dyslipidemias / drug therapy*
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / administration & dosage*
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / adverse effects
  • Risk Factors
  • Stroke / prevention & control


  • Anticholesteremic Agents
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors