A benefit–risk assessment model for statins using multicriteria decision analysis based on a discrete choice experiment in Korean patients
Authors Byun J, Kwon S, Ha J, Lee E
Received 12 November 2015
Accepted for publication 9 April 2016
Published 13 June 2016 Volume 2016:12 Pages 965—974
Checked for plagiarism Yes
Review by Single-blind
Peer reviewer comments 2
Editor who approved publication: Professor Garry Walsh
Ji-Hye Byun,1 Sun-Hong Kwon,1 Ji-Hye Ha,2 Eui-Kyung Lee1
1School of Pharmacy, Sungkyunkwan University, Suwon-si, Gyeonggi-do, 2Ministry of Food and Drug Safety, Cheongju-si, Chungcheongbuk-do, South Korea
Purpose: 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.
Patients and 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.
Conclusion: A quantitative statin BRA model confirmed that the preference ranking of statins changed post approval because of the identification of additional benefits or risks.
Keywords: multicriteria decision analysis, statin, quantitative benefit–risk assessment, discrete choice experiment
This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License. By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.Download Article [PDF] View Full Text [HTML][Machine readable]