Background: Abuse-deterrent formulations (ADFs) of extended-release (ER) opioids are manufactured to address opioid abuse. However, little is known about characteristics of patients who initiate ADF opioids, which is important to identify appropriate comparators to address confounding by indication.
Objectives: To describe demographics and medical characteristics of patients prescribed ADF and non-ADF ER opioids in two sources of commercial claims.
Methods: Using IBM Marketscan commercial claims (Data A) and a large private insurance provider in North Carolina [USA] (Data B) (both 2009-2018), we conducted a retrospective cohort study to examine patterns of ADF opioid use compared to non-ADF ER opioid use. Patients who initiated ADF and non-ADF ER opioids (18-64 years-old) were selected using both a traditional new user design (no opioid claims during the washout period, defined as six-months prior to ER opioid initiation) and a prevalent new user design (allowed non-ER opioid claims during the washout period and excluded the patients with no six-months eligibility prior to the first immediate-release (IR) opioid claim). Patient characteristics including demographics, medications (gabapentin, benzodiazepine, antidepressants, IR opioids), pain-related symptoms, and cancer were measured during the washout period for patients with ADF and non-ADF ER opioids.
Results: Among eligible ER opioid initiators in Data A (N=330,728) and B (N=20,992), 31% and 34% initiated with ADF opioids, respectively. Among these patients, demographics were as follows (Data A and B): age [mean (SD)] = 49.4 (11.8) and
48.4 (11.8); male sex = 51.2% and 55.4%. Among patients with non-ADF ER opioids, demographics were as follows (Data A and Data B): age [mean (SD)] = 49.2 (11.4) and 47.8 (11.3); male sex = 45.8% and 50.4%. About 50% and 62% of patients with ADF opioids initiated with IR opioids, whereas 29%and 34% of patients with non-ADF ER opioids initiated with IR opioids in Data A and B, respectively. In both data sources, the prevalence of several types of pain was higher among patients with ADF opioids than in non-ADF ER group, including acute pain (Data A: 54.5% vs. 40.3%; Data B: 56.7% vs. 41.5%), arthritis pain (35.7% vs. 20.1%; 36.4% vs. 22.7%), and chronic pain (84.8% vs. 76.3%; 89.5% vs. 85.3%). The prevalence of use of medications and cancer was higher in patients with non-ADF ER opioids than in patients with ADF opioids in both data sources.
Conclusions: Both data sources revealed differences in characteristics between patients with ADF and non-ADF ER opioids. The implications for research design include identifying appropriate comparator groups when examining ADF opioid use related outcomes
