title: Implications of the US cholesterol guidelines on eligibility for statin therapy in the community: comparison of observed and predicted risks in the Framingham Heart Study Offspring Cohort.
abstract: BACKGROUND
  Concerns have been raised that the 2013 atherosclerotic cardiovascular disease (ASCVD) risk estimator overpredicts risk in contemporary cohorts. Whether suboptimal calibration will lead to overtreatment with statins is unknown. We investigated the numbers of people eligible for statin treatment in the Framingham Heart Study Offspring Cohort, based on the 2013 cholesterol guidelines, and estimated the proportion that may be overtreated as a result of potential miscalibration of the ASCVD estimator.
  
  
  RESULTS
  During a median follow-up of 10 years, we observed 285 ASCVD events (8.4%; comprising ischemic stroke, myocardial infarction, and coronary artery disease death) among 3396 men and 112 events (2.9%) among 3838 women. Hosmer-Lemeshow chi-square statistics were 16.3 in men (340 predicted versus 285 observed events) and 29.1 in women (166 predicted versus 112 observed events). Overprediction predominantly occurred among women in the highest risk decile and among men in the ≥7th risk deciles, for which observed ASCVD event rates were ≥7.5%. In total, 2615 participants (36%; 867 women) were eligible for statins based on the new guidelines. Of these, 171 women (20%) and 154 men (9%) were reclassified downward (as not eligible for statin therapy) using a recalibrated ASCVD estimator. In the latter group, 18 women (10.5%; 95% CI 5.9% to 15.2%) and 11 men (7.1%; 95% CI 3.0% to 11.3%) experienced ASCVD.
  
  
  CONCLUSIONS
  The risk estimator overpredicted ASCVD risk but did so mainly among high-risk participants who would be considered eligible for statin use anyway. Our findings may mitigate concerns regarding the potential impact of miscalibration of the ASCVD estimator in contemporary cohorts.
authors.affiliation: Framingham Heart Study, Framingham, MA (C.A., D.E., M.G.L., V.X., R.S.V.) Department of Cardiology, Gentofte Hospital, University of Copenhagen, Denmark (C.A.).
authors.forename: Charlotte
authors.initials: C
authors.lastname: Andersson
authors.affiliation: Framingham Heart Study, Framingham, MA (C.A., D.E., M.G.L., V.X., R.S.V.) Department of Mathematics and Statistics, Boston University, Boston, MA (D.E., M.G.L.).
authors.forename: Danielle
authors.initials: D
authors.lastname: Enserro
authors.affiliation: Framingham Heart Study, Framingham, MA (C.A., D.E., M.G.L., V.X., R.S.V.) Department of Mathematics and Statistics, Boston University, Boston, MA (D.E., M.G.L.) Department of Biostatistics, Boston University School of Public Health, Boston, MA (M.G.L., R.S.V.).
authors.forename: Martin G
authors.initials: MG
authors.lastname: Larson
authors.affiliation: Framingham Heart Study, Framingham, MA (C.A., D.E., M.G.L., V.X., R.S.V.) Sections of Preventive Medicine and Cardiology, Department of Medicine, Boston University School of Medicine, Boston, MA (V.X., R.S.V.) Department of Epidemiology, Boston University School of Public Health, Boston, MA (V.X.).
authors.forename: Vanessa
authors.initials: V
authors.lastname: Xanthakis
authors.affiliation: Framingham Heart Study, Framingham, MA (C.A., D.E., M.G.L., V.X., R.S.V.) Department of Biostatistics, Boston University School of Public Health, Boston, MA (M.G.L., R.S.V.) Sections of Preventive Medicine and Cardiology, Department of Medicine, Boston University School of Medicine, Boston, MA (V.X., R.S.V.).
authors.forename: Ramachandran S
authors.initials: RS
authors.lastname: Vasan
mesh_terms: D000328:Adult; D000368:Aged; D002318:Cardiovascular Diseases / Q000517:prevention & control*; D002784:Cholesterol / Q000097:blood*; D003324:Coronary Artery Disease / Q000401:mortality; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology; D017410:Practice Guidelines as Topic; D018570:Risk Assessment / Q000379:methods; D012307:Risk Factors; D020521:Stroke / Q000453:epidemiology / Q000517:prevention & control; D014481:United States / Q000453:epidemiology
chemical_list: D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D002784:Cholesterol
keywords: primary prevention; risk prediction; statin