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Research Article
16 July 2024

Serious treatment-emergent adverse events in chronic low back pain patients treated with buprenorphine or oral opioids: a retrospective commercial claims analysis

Authors: Filip Stanicic https://orcid.org/0000-0003-2293-8940, Dimitrije Grbic https://orcid.org/0009-0005-4962-4396, Djurdja Vukicevic https://orcid.org/0000-0001-9591-1111, and Vladimir Zah https://orcid.org/0000-0003-1368-4491 [email protected]Author Info & Affiliations
Volume 13, Number 8
https://doi.org/10.57264/cer-2023-0183
PDFFormats

Abstract

Aim: Explore the safety of Belbuca® (buprenorphine buccal film), buprenorphine transdermal patches and oral opioids for chronic low back pain (cLBP) treatment. Methods: The retrospective analysis of the MarketScan Commercial database (2018–2021) included treatment-naive cLBP adults. The first date of buprenorphine (Belbuca and transdermal patch) or opioid prescription was index date. Cohorts were defined based on the index medication. Observation included a 6-month pre-index period, while post-index lasted until the end of continuous insurance coverage. There were 44 relevant treatment-emergent adverse events (TEAEs) identified in the literature. Incidence rate ratio (IRR) and incidence rate difference (IRD) were used to compare serious TEAE rates (in 1000 person-years) between cohorts. Propensity-score matching minimized the selection bias. Results: Buprenorphine had lower rates of 15 serious TEAEs than oral opioids (all p ≤ 0.037), while higher rates only for serious dizziness (IRR 2.44, p = 0.011; driven by Belbuca), opioid abuse/dependence (IRR 3.13, p = 0.004; driven by patches) and cholecystitis (IRD 20.25, p = 0.044; an outlier). Additionally, a comparison between Belbuca and oral opioids showed lower rates of 13 serious TEAEs (all p ≤ 0.024) and a higher serious dizziness rate (IRR 3.17, p = 0.024). Although the rates of serious opioid abuse/dependence were similar (24.60 vs 26.93, p = 0.921), all Belbuca patients and none of the opioid patients had a positive history of these events. Belbuca also had lower rates of five serious TEAEs than transdermal patches (all p ≤ 0.018), including a serious opioid abuse/dependence (IRR 0.04, p < 0.001), but higher rates of serious cholecystitis (IRD 52.17, p = 0.035; an outlier) and suicidal ideation (IRD 156.50, p < 0.001; an outlier). Conclusion: Buprenorphine had a better safety profile than oral opioids in cLBP treatment. Belbuca showed a more favorable TEAE profile than buprenorphine transdermal patches and oral opioids.

Shareable abstract

#Belbuca (#buprenorphine buccal film) used for chronic #lowbackpain showed a better #safety profile than buprenorphine transdermal patches or oral #opioids. Also, buprenorphine (Belbuca and transdermal patch) was associated with fewer serious #adverseevents than oral opioids.

Plain language summary

Serious harmful effects of treatment for long-lasting low back pain

What is this article about?

This study explored how safe is to use the drugs prescribed for chronic low back pain – buprenorphine and opioids. Researchers analyzed insurance data of patients with long-lasting low back pain and explored the occurrence of serious medical problems that may be caused by the treatment they take. Buprenorphine was compared with opioids and also different forms of buprenorphine were compared with each other – the patch that adheres to the skin versus the film that sticks to the inner cheek (buccal film).

What were the results?

We laid out 44 different types of harmful effects while taking the drugs and tracked their frequency in the patient insurance records. The most relevant results were:
•
Fifteen out of the 44 medical problems occurred less often when taking buprenorphine than opioids. Only three illnesses were more frequent with buprenorphine
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Patients with buccal films felt serious dizziness more commonly than those with opioids but they less often experienced 13 other illnesses
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Five serious harmful effects were observed less frequently in the buccal film than in skin patches
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Two harmful effects were more common when using the buccal film than the skin patch. These effects were not related to the treatment but rather to the patient's disease history.

What do the results mean?

Buprenorphine treatment for long-lasting low back pain may be a safer option than opioids. Also, patients had fewer serious harmful treatment effects when using buccal film than skin patches and opioids.

Supplementary Material

File (supplementary data.docx)

References

Papers of special note have been highlighted as: • of interest; •• of considerable interest
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