title: A benefit-risk assessment model for statins using multicriteria decision analysis based on a discrete choice experiment in Korean patients.
abstract: OBJECTIVE
  The benefit-risk balance for drugs can alter post approval owing to additional data on efficacy or adverse events. This study developed a quantitative benefit-risk assessment (BRA) model for statins using multicriteria decision analysis with discrete choice experiments and compared a recent BRA with that at the time of approval.
  
  
  METHODS
  Following a systematic review of the literature, the benefit criteria within the statin BRA model were defined as a reduction in the plasma low-density lipoprotein cholesterol level and a reduction in myocardial infarction incidence; the risk criteria were hepatotoxicity (Liv) and fatal rhabdomyolysis (Rha). The scores for these criteria were estimated using mixed treatment comparison methods. Weighting was calculated from a discrete choice experiment involving 203 Korean patients. The scores and weights were integrated to produce an overall value representing the benefit-risk balance, and sensitivity analyses were conducted.
  
  
  RESULTS
  In this BRA model, low-density lipoprotein (relative importance [RI]: 37.50%) was found to be a more important benefit criterion than myocardial infarction (RI: 35.43%), and Liv (RI: 16.28%) was a more important risk criterion than Rha (RI: 10.79%). Patients preferred atorvastatin, and the preference ranking of cerivastatin and simvastatin was switched post approval because of the emergence of additional risk information related to cerivastatin.
  
  
  CONCLUSIONS
  A quantitative statin BRA model confirmed that the preference ranking of statins changed post approval because of the identification of additional benefits or risks.
authors.affiliation: School of Pharmacy, Sungkyunkwan University, Suwon-si, Gyeonggi-do, South Korea.
authors.forename: Ji-Hye
authors.initials: JH
authors.lastname: Byun
authors.affiliation: School of Pharmacy, Sungkyunkwan University, Suwon-si, Gyeonggi-do, South Korea.
authors.forename: Sun-Hong
authors.initials: SH
authors.lastname: Kwon
authors.affiliation: Ministry of Food and Drug Safety, Cheongju-si, Chungcheongbuk-do, South Korea.
authors.forename: Ji-Hye
authors.initials: JH
authors.lastname: Ha
authors.affiliation: School of Pharmacy, Sungkyunkwan University, Suwon-si, Gyeonggi-do, South Korea.
authors.forename: Eui-Kyung
authors.initials: EK
authors.lastname: Lee
keywords: discrete choice experiment; multicriteria decision analysis; quantitative benefit–risk assessment; statin