title: Impact of the 2013 Cholesterol Guideline on Patterns of Lipid-Lowering Treatment in Patients with Atherosclerotic Cardiovascular Disease or Diabetes After 1 Year.
abstract: BACKGROUND
  The 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults emphasizes evidence-based treatment with moderate- to high-dose statins for patients at high risk for atherosclerotic cardiovascular disease (ASCVD). Whether this new guideline influenced patterns of treatment 1 year after its dissemination is unknown.
  
  
  OBJECTIVE
  To compare patterns of lipid-lowering treatment before and 1 year after the release of the 2013 cholesterol guideline in 2 high-risk groups: patients with ASCVD and patients with diabetes mellitus.
  
  
  METHODS
  Using pharmacy and medical claims from a large U.S. health insurance organization, 610,535 patients with ASCVD (n = 301,440) or diabetes mellitus (n = 309,095) were identified, and statin treatment rates and statin intensity were examined before and 1 year after the dissemination of the 2013 cholesterol guideline. A standardized difference of at least 10% was required to declare the effect size meaningful.
  
  
  RESULTS
  Overall, there was no change in statin treatment rates for patients with ASCVD (48.0% before guideline vs. 47.3% after, standardized difference 1.4%) or diabetes (50% vs. 51.5% after, standardized difference 2.4%). Statin initiation rates among patients not on statins before the 2013 guideline were 10.1% in patients with ASCVD and 14.3% in patients with diabetes, but these gains were offset by 13.0% and 12.2% statin discontinuation rates among ASCVD and diabetes patients, respectively. Among patients taking statins 1 year after the guideline was issued, 80% of patients with ASCVD and aged ≤ 75 years were not on guideline-recommended high-intensity statin therapy, whereas most patients with ASCVD and aged > 75 years or patients with diabetes were on moderate- or high-intensity statin treatment.
  
  
  CONCLUSIONS
  One year after dissemination of the 2013 cholesterol guideline, overall treatment rates with statins among patients with ASCVD and diabetes did not change appreciably, and many patients remained either untreated or undertreated.
  
  
  BACKGROUND
  No outside funding supported this research. Chan is supported by grants from the National Heart Lung and Blood Institute (1R01HL123980 and K23HL102224). Tran, Stockl, Lew, and Solow are employed by Optum. Kao and Caglar were employed by Optum when this study was conducted. Chan serves as an advisor and consultant to OptumRx but received no compensation for work on this manuscript. Stockl is also employed by the Journal of Managed Care & Specialty Pharmacy. Spertus reports personal fees from United Healthcare and grants from Lilly, outside of the submitted work. None of the authors have any other financial conflicts of interest to report. Tran and Chan supervised this study, had full access to all of the data in the study, and take responsibility for the integrity of the data and the accuracy of the data analysis. Study design and concept were contributed by Tran and Chan. Tran and Kao collected the data, with analysis and interpretation performed by all the authors. Statistical analysis was performed by Caglar and Kao, and Tran and Chan drafted the manuscript. All authors were involved in the critical revision of the manuscript.
authors.affiliation: 1 OptumRx, Irvine, California.
authors.forename: Josephine N
authors.initials: JN
authors.lastname: Tran
authors.affiliation: 1 OptumRx, Irvine, California.
authors.forename: Tzu Chun
authors.initials: TC
authors.lastname: Kao
authors.affiliation: 1 OptumRx, Irvine, California.
authors.forename: Toros
authors.initials: T
authors.lastname: Caglar
authors.affiliation: 1 OptumRx, Irvine, California.
authors.forename: Karen M
authors.initials: KM
authors.lastname: Stockl
authors.affiliation: 2 University of Missouri-Kansas City and Mid America Heart Institute, Kansas City, Missouri.
authors.forename: John A
authors.initials: JA
authors.lastname: Spertus
authors.affiliation: 1 OptumRx, Irvine, California.
authors.forename: Heidi C
authors.initials: HC
authors.lastname: Lew
authors.affiliation: 1 OptumRx, Irvine, California.
authors.forename: Brian K
authors.initials: BK
authors.lastname: Solow
authors.affiliation: 2 University of Missouri-Kansas City and Mid America Heart Institute, Kansas City, Missouri.
authors.forename: Paul S
authors.initials: PS
authors.lastname: Chan
mesh_terms: D000328:Adult; D000368:Aged; D050197:Atherosclerosis / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy; D002318:Cardiovascular Diseases / Q000097:blood* / Q000175:diagnosis / Q000188:drug therapy*; D015331:Cohort Studies; D003920:Diabetes Mellitus / Q000097:blood* / Q000175:diagnosis / Q000188:drug therapy*; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D000960:Hypolipidemic Agents / Q000627:therapeutic use; D008055:Lipids / Q000097:blood*; D008297:Male; D008875:Middle Aged; D017410:Practice Guidelines as Topic / Q000592:standards*; D012189:Retrospective Studies; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D000960:Hypolipidemic Agents; D008055:Lipids