Detailed study overview at the full project site OpioidData.org
This document contains information on comparator choice in research of abuse-deterrent formulations (ADF) of opioids.
What is the best comparator for an ADF? Is it other medicines with the same active ingredient? Or, would it be better to consider a patient pool of similar patients as the comparator?
Considerations in comparator selection are discussed at length in D’Arcy et al 2018 _____
Active comparators are drugs (or drug class) that have similar indication and formulation as the treatment. Studies with active comparators restrict to patients initating treatment with medications that have similar indications, and thus have less potential for confounding than studies that make use of inactive comparators or studies that use non-initators as the comparison group (D’Arcy et al 2018).
| Class | Ingredient | ER/LA or IR | Form | Documentation | Comments | |
|---|---|---|---|---|---|---|
| Opioid | Morphine | ER | Tablet, Capsule | Primary comparator in OxyContin postmarketing studies Stable market share |
||
| Opioid | FentanylER | Transdermal Patch | Primary comparator in OxyContin postmarketing studies Stable market share |
Consider route of administration |
||
| Opioid | Methadone | LA | Tablet, Capsule | Primary comparator in OxyContin postmarketing studies Stable market share |
Declining use |
|
| Opioid | Oxymorphone | ER | Tablet | Secondary comparator in OxyContin postmarketing studies Stable market share |
Reformulated in 2012, low market share, FDA requested to remove from market in 2017 |
|
| Opioid | Oxycodone | IR | Tablet | Secondary comparator in OxyContin postmarketing studies Stable market share |
IR instead of ER, often used to treat acute pain Often dispensed with OxyContin |
|
| Opioid | Hydromorphone | IR | Tablet | Secondary comparator in OxyContin postmarketing studies Stable market share |
IR instead of ER, often used to treat acute pain |
|
| Opioid | All non-ADF schedule II opioids | IR & ER/LA | Any |
Inactive comparators are drugs (or drug class) that are not indicated/used for the same purpose at the treatment of interest. Inactive comparators should have no known association with the outcome.
References:
D’Arcy M, Stürmer T, Lund JL. The importance and implications of comparator selection in pharmacoepidemiologic research. Curr Epidemiol Rep. 2018 Sep;5(3):272-283. doi: 10.1007/s40471-018-0155-y. Epub 2018 Jul 6. PMID: 30666285; PMCID: PMC6338470.