학술논문
Matching study design to prescribing intention: The prevalent new-user design for studying abuse-deterrent formulations of opioids.
Document Type
Academic Journal
Author
DiPrete BL; Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina, USA.; Injury Prevention Research Center, University of North Carolina, Chapel Hill, North Carolina, USA.; Oh G; Department of Pharmacy Practice and Science, College of Pharmacy, University of Kentucky, Lexington, Kentucky, USA.; Institute for Pharmaceutical Outcomes & Policy, College of Pharmacy, University of Kentucky, Lexington, Kentucky, USA.; Sanders-Brown Center on Aging, University of Kentucky, Lexington, Kentucky, USA.; Department of Epidemiology and Environmental Health, University of Kentucky, Lexington, Kentucky, USA.; Moga DC; Department of Pharmacy Practice and Science, College of Pharmacy, University of Kentucky, Lexington, Kentucky, USA.; Institute for Pharmaceutical Outcomes & Policy, College of Pharmacy, University of Kentucky, Lexington, Kentucky, USA.; Sanders-Brown Center on Aging, University of Kentucky, Lexington, Kentucky, USA.; Department of Epidemiology and Environmental Health, University of Kentucky, Lexington, Kentucky, USA.; Dasgupta N; Injury Prevention Research Center, University of North Carolina, Chapel Hill, North Carolina, USA.; Slavova S; Department of Biostatistics, University of Kentucky College of Public Health, Lexington, Kentucky, USA.; Slade E; Department of Biostatistics, University of Kentucky College of Public Health, Lexington, Kentucky, USA.; Delcher C; Department of Pharmacy Practice and Science, College of Pharmacy, University of Kentucky, Lexington, Kentucky, USA.; Institute for Pharmaceutical Outcomes & Policy, College of Pharmacy, University of Kentucky, Lexington, Kentucky, USA.; Pence BW; Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina, USA.; Ranapurwala SI; Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina, USA.; Injury Prevention Research Center, University of North Carolina, Chapel Hill, North Carolina, USA.
Source
Publisher: Wiley Country of Publication: England NLM ID: 9208369 Publication Model: Print Cited Medium: Internet ISSN: 1099-1557 (Electronic) Linking ISSN: 10538569 NLM ISO Abbreviation: Pharmacoepidemiol Drug Saf Subsets: MEDLINE
Subject
Language
English
Abstract
Purpose: In drug studies, research designs requiring no prior exposure to certain drug classes may restrict important populations. Since abuse-deterrent formulations (ADF) of opioids are routinely prescribed after other opioids, choice of study design, identification of appropriate comparators, and addressing confounding by "indication" are important considerations in ADF post-marketing studies.
Methods: In a retrospective cohort study using claims data (2006-2018) from a North Carolina private insurer [NC claims] and Merative MarketScan [MarketScan], we identified patients (18-64 years old) initiating ADF or non-ADF extended-release/long-acting (ER/LA) opioids. We compared patient characteristics and described opioid treatment history between treatment groups, classifying patients as traditional (no opioid claims during prior six-month washout period) or prevalent new users.
Results: We identified 8415 (NC claims) and 147 978 (MarketScan) ADF, and 10 114 (NC claims) and 232 028 (MarketScan) non-ADF ER/LA opioid initiators. Most had prior opioid exposure (ranging 64%-74%), and key clinical differences included higher prevalence of recent acute or chronic pain and surgery among patients initiating ADFs compared to non-ADF ER/LA initiators. Concurrent immediate-release opioid prescriptions at initiation were more common in prevalent new users than traditional new users.
Conclusions: Careful consideration of the study design, comparator choice, and confounding by "indication" is crucial when examining ADF opioid use-related outcomes.
(© 2024 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.)
Methods: In a retrospective cohort study using claims data (2006-2018) from a North Carolina private insurer [NC claims] and Merative MarketScan [MarketScan], we identified patients (18-64 years old) initiating ADF or non-ADF extended-release/long-acting (ER/LA) opioids. We compared patient characteristics and described opioid treatment history between treatment groups, classifying patients as traditional (no opioid claims during prior six-month washout period) or prevalent new users.
Results: We identified 8415 (NC claims) and 147 978 (MarketScan) ADF, and 10 114 (NC claims) and 232 028 (MarketScan) non-ADF ER/LA opioid initiators. Most had prior opioid exposure (ranging 64%-74%), and key clinical differences included higher prevalence of recent acute or chronic pain and surgery among patients initiating ADFs compared to non-ADF ER/LA initiators. Concurrent immediate-release opioid prescriptions at initiation were more common in prevalent new users than traditional new users.
Conclusions: Careful consideration of the study design, comparator choice, and confounding by "indication" is crucial when examining ADF opioid use-related outcomes.
(© 2024 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.)