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Buprenorphine alone or with naloxone: Which is safer?
Erin Kelty1,2, Craig Cumming2,3, Lakhhina Troeung2
11 Division of Psychiatry, University of Western Australia, Sir Charles Gairdner Hospital, Nedlands, WA, Australia.
Journal of Psychopharmacology (Oxford, England)
|February 14, 2018
Summary
The addition of naloxone to buprenorphine (BUP-NLX) did not improve patient safety compared to buprenorphine (BUP) alone. Post-treatment mortality and hospital admissions were higher for BUP-NLX patients.
Area of Science:
- Pharmacology
- Public Health
- Addiction Medicine
Background:
- Concerns exist regarding the intravenous diversion of buprenorphine.
- A combined buprenorphine-naloxone (BUP-NLX) formulation was developed to mitigate diversion risks.
- Opioid dependence treatment outcomes require continuous evaluation.
Purpose of the Study:
- To compare health outcomes between opioid-dependent patients treated with buprenorphine (BUP) and buprenorphine-naloxone (BUP-NLX).
- To assess the safety profile of BUP versus BUP-NLX in a real-world clinical setting.
Main Methods:
- A retrospective cohort study of 3455 patients in Western Australia (2001-2010).
- Data linkage between prescribing records and state mortality, hospital, and emergency department records.
- Statistical analysis using Cox Proportional Hazard Models and Generalized Estimating Equations.
Main Results:
- No significant difference in mortality rates during treatment between BUP and BUP-NLX groups.
- Significantly higher mortality rates after treatment cessation for BUP-NLX patients (aHR: 1.59).
- Elevated hospitalization rates for BUP-NLX patients (aOR: 1.17), particularly for opioid poisoning post-treatment (aOR: 1.59).
- Lower rates of skin/subcutaneous diagnoses hospitalizations for BUP-NLX patients (aOR: 0.65).
Conclusions:
- The addition of naloxone to buprenorphine does not appear to enhance the overall safety profile.
- Buprenorphine-naloxone treatment is associated with increased post-treatment mortality and hospital admissions.
- Further research is needed to understand the long-term implications of BUP-NLX treatment.

