Matching study design to prescribing intention: The prevalent new‐user design for studying abuse‐deterrent formulations of opioids

Author:

DiPrete Bethany L.12ORCID,Oh GYeon3456ORCID,Moga Daniela C.3456ORCID,Dasgupta Nabarun2ORCID,Slavova Svetla7ORCID,Slade Emily7,Delcher Chris34ORCID,Pence Brian W.1,Ranapurwala Shabbar I.12ORCID

Affiliation:

1. Department of Epidemiology, Gillings School of Global Public Health University of North Carolina Chapel Hill North Carolina USA

2. Injury Prevention Research Center University of North Carolina Chapel Hill North Carolina USA

3. Department of Pharmacy Practice and Science, College of Pharmacy University of Kentucky Lexington Kentucky USA

4. Institute for Pharmaceutical Outcomes & Policy, College of Pharmacy University of Kentucky Lexington Kentucky USA

5. Sanders‐Brown Center on Aging University of Kentucky Lexington Kentucky USA

6. Department of Epidemiology and Environmental Health University of Kentucky Lexington Kentucky USA

7. Department of Biostatistics University of Kentucky College of Public Health Lexington Kentucky USA

Abstract

AbstractPurposeIn 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.MethodsIn 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.ResultsWe 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.ConclusionsCareful consideration of the study design, comparator choice, and confounding by “indication” is crucial when examining ADF opioid use‐related outcomes.

Publisher

Wiley

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