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.
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