title: Individualized Statin Benefit for Determining Statin Eligibility in the Primary Prevention of Cardiovascular Disease.
abstract: Current guidelines recommend statins in the primary prevention of cardiovascular disease on the basis of predicted cardiovascular risk without directly considering the expected benefits of statin therapy based on the available randomized, controlled trial evidence.
  
  
  
  We included 2134 participants representing 71.8 million American residents potentially eligible for statins in primary prevention from the National Health and Nutrition Examination Survey for the years 2005 to 2010. We compared statin eligibilities using 2 separate approaches: a 10-year risk-based approach (≥7.5% 10-year risk) and an individualized benefit approach (ie, based on predicted absolute risk reduction over 10 years [ARR10] ≥2.3% from randomized, controlled trial data). A risk-based approach led to the eligibility of 15.0 million (95% confidence interval, 12.7-17.3 million) Americans, whereas a benefit-based approach identified 24.6 million (95% confidence interval, 21.0-28.1 million). The corresponding numbers needed to treat over 10 years were 21 (range, 9-44) and 25 (range, 9-44). The benefit-based approach identified 9.5 million lower-risk (<7.5% 10-year risk) Americans not currently eligible for statin treatment who had the same or greater expected benefit from statins (≥2.3% ARR10) compared with higher-risk individuals. This lower-risk/acceptable-benefit group includes younger individuals (mean age, 55.2 versus 62.5 years; P<0.001 for benefit based versus risk based) with higher low-density lipoprotein cholesterol (140 versus133 mg/dL; P=0.01). Statin treatment in this group would be expected to prevent an additional 266 508 cardiovascular events over 10 years.
  
  
  
  An individualized statin benefit approach can identify lower-risk individuals who have equal or greater expected benefit from statins in primary prevention compared with higher-risk individuals. This approach may help develop guideline recommendations that better identify individuals who meaningfully benefit from statin therapy.
authors.affiliation: From Preventive and Genomic Cardiology, Department of Medicine, McGill University Health Center and Research Institute, Montreal, QC, Canada (G.T., A.D.S.); KenAnCo Biostatistics, San Antonio, TX (K.W., K.K.); Department of Medicine, University of Texas Health Science Center at San Antonio (K.W.); Duke Clinical Research Institute, Durham, NC (M.J.P.); and Harvard Clinical Research Institute and Brigham and Women's Hospital, Boston, MA (C.P.C.). george.thanassoulis@mcgill.ca.
authors.forename: George
authors.initials: G
authors.lastname: Thanassoulis
authors.affiliation: From Preventive and Genomic Cardiology, Department of Medicine, McGill University Health Center and Research Institute, Montreal, QC, Canada (G.T., A.D.S.); KenAnCo Biostatistics, San Antonio, TX (K.W., K.K.); Department of Medicine, University of Texas Health Science Center at San Antonio (K.W.); Duke Clinical Research Institute, Durham, NC (M.J.P.); and Harvard Clinical Research Institute and Brigham and Women's Hospital, Boston, MA (C.P.C.).
authors.forename: Ken
authors.initials: K
authors.lastname: Williams
authors.affiliation: From Preventive and Genomic Cardiology, Department of Medicine, McGill University Health Center and Research Institute, Montreal, QC, Canada (G.T., A.D.S.); KenAnCo Biostatistics, San Antonio, TX (K.W., K.K.); Department of Medicine, University of Texas Health Science Center at San Antonio (K.W.); Duke Clinical Research Institute, Durham, NC (M.J.P.); and Harvard Clinical Research Institute and Brigham and Women's Hospital, Boston, MA (C.P.C.).
authors.forename: Kathleen Kimler
authors.initials: KK
authors.lastname: Altobelli
authors.affiliation: From Preventive and Genomic Cardiology, Department of Medicine, McGill University Health Center and Research Institute, Montreal, QC, Canada (G.T., A.D.S.); KenAnCo Biostatistics, San Antonio, TX (K.W., K.K.); Department of Medicine, University of Texas Health Science Center at San Antonio (K.W.); Duke Clinical Research Institute, Durham, NC (M.J.P.); and Harvard Clinical Research Institute and Brigham and Women's Hospital, Boston, MA (C.P.C.).
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Pencina
authors.affiliation: From Preventive and Genomic Cardiology, Department of Medicine, McGill University Health Center and Research Institute, Montreal, QC, Canada (G.T., A.D.S.); KenAnCo Biostatistics, San Antonio, TX (K.W., K.K.); Department of Medicine, University of Texas Health Science Center at San Antonio (K.W.); Duke Clinical Research Institute, Durham, NC (M.J.P.); and Harvard Clinical Research Institute and Brigham and Women's Hospital, Boston, MA (C.P.C.).
authors.forename: Christopher P
authors.initials: CP
authors.lastname: Cannon
authors.affiliation: From Preventive and Genomic Cardiology, Department of Medicine, McGill University Health Center and Research Institute, Montreal, QC, Canada (G.T., A.D.S.); KenAnCo Biostatistics, San Antonio, TX (K.W., K.K.); Department of Medicine, University of Texas Health Science Center at San Antonio (K.W.); Duke Clinical Research Institute, Durham, NC (M.J.P.); and Harvard Clinical Research Institute and Brigham and Women's Hospital, Boston, MA (C.P.C.).
authors.forename: Allan D
authors.initials: AD
authors.lastname: Sniderman
mesh_terms: D000328:Adult; D000368:Aged; D002318:Cardiovascular Diseases / Q000175:diagnosis* / Q000517:prevention & control*; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009749:Nutrition Surveys; D057285:Precision Medicine / Q000379:methods*; D011322:Primary Prevention / Q000379:methods*; D016032:Randomized Controlled Trials as Topic / Q000379:methods
chemical_list: D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors
keywords: guidelines as topic; hydroxymethylglutaryl-CoA reductase inhibitors; lipoproteins; primary prevention; risk