The use of structured data elements to identify ASCVD patients with statin-associated side effects: Insights from the Department of Veterans Affairs

J Clin Lipidol. Sep-Oct 2019;13(5):797-803.e1. doi: 10.1016/j.jacl.2019.08.002. Epub 2019 Aug 9.


Background: Accurate identification of patients with statin-associated side effects (SASEs) is critical for health care systems to institute strategies to improve guideline-concordant statin use.

Objective: The objective of this study was to determine whether adverse drug reaction (ADR) entry by clinicians in the electronic medical record can accurately identify SASEs.

Methods: We identified 1,248,214 atherosclerotic cardiovascular disease (ASCVD) patients seeking care in the Department of Veterans Affairs. Using an ADR data repository, we identified SASEs in 15 major symptom categories. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were assessed using a chart review of 256 ASCVD patients with identified SASEs, who were not on high-intensity statin therapy.

Results: We identified 171,189 patients (13.71%) with documented SASEs over a 15-year period (9.9%, 2.7%, and 1.1% to 1, 2, or >2 statins, respectively). Statin use, high-intensity statin use, low-density lipoprotein cholesterol, and non-high-density lipoprotein cholesterol levels were 72%, 28.1%, 99 mg/dL, and 129 mg/dL among those with vs 81%, 31.1%, 84 mg/dL, and 111 mg/dL among those without SASEs. Progressively lower statin and high-intensity statin use, and higher low-density lipoprotein cholesterol and non-high-density lipoprotein cholesterol levels were noted among those with SASEs to 1, 2, or >2 statins. Two-thirds of SASEs were related to muscle symptoms. Sensitivity, specificity, PPV, NPV compared with manual chart review were 63.4%, 100%, 100%, and 85.3%, respectively.

Conclusion: A strategy of using ADR entry in the electronic medical record is feasible to identify SASEs with modest sensitivity and NPV but high specificity and PPV. Health care systems can use this strategy to identify ASCVD patients with SASEs and operationalize efforts to improve guideline-concordant lipid-lowering therapy use in such patients. The sensitivity of this approach can be further enhanced by the use of unstructured text data.

Keywords: Adverse drug reaction; Atherosclerotic cardiovascular disease; Electronic medical record; Statin-associated side effects; Statins.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Atherosclerosis / blood
  • Atherosclerosis / drug therapy*
  • Cholesterol, HDL / blood
  • Cholesterol, LDL / blood
  • Female
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / adverse effects*
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / therapeutic use*
  • Male
  • Predictive Value of Tests
  • Sensitivity and Specificity
  • United States
  • United States Department of Veterans Affairs*
  • Veterans*


  • Cholesterol, HDL
  • Cholesterol, LDL
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors