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

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posted on 2024-07-18, 11:08 authored by Filip Stanicic, Dimitrije Grbic, Djurdja Vukicevic, Vladimir Zah

These are peer-reviewed supplementary materials for the article 'Serious treatment-emergent adverse events in chronic low back pain patients treated with buprenorphine or oral opioids: a retrospective commercial claims analysis' published in the Journal of Comparative Effectiveness Research.

Table S1: ICD-10-CM codes related to low back pain
Table S2: The relevant NDC codes related to CIII buprenorphine (Belbuca® and buprenorphine patch)
Table S3: The list of ICD-10-CM codes related to relevant TEAEs
Table S4: Demographic characteristics of non-matched patients (Primary Analysis: CIII Buprenorphine vs. CII Opioids)
Table S5: Clinical characteristics of non-matched patients (Primary Analysis: CIII Buprenorphine vs. CII Opioids)
Table S6: Demographic characteristics of non-matched patients (Sub-Analysis #1: Buprenorphine Buccal Film vs. CII Opioids)
Table S7: Clinical characteristics of non-matched patients (Sub-Analysis #1: Buprenorphine Buccal Film vs. CII Opioids)
Table S8: Demographic characteristics of non-matched patients (Sub-Analysis #2: Buprenorphine Buccal Film vs. Buprenorphine Patch)
Table S9: Clinical characteristics of non-matched patients (Sub-Analysis #2: Buprenorphine Buccal Film vs. Buprenorphine Patch)
Table S10: Demographic characteristics of matched patients (Primary Analysis: CIII Buprenorphine vs. CII Opioids)
Table S11: Clinical characteristics of matched patients (Primary Analysis: CIII Buprenorphine vs. CII Opioids)
Table S12: Demographic characteristics of matched patients (Sub-Analysis #1: Buprenorphine Buccal Film vs. CII Opioids)
Table S13: Clinical characteristics of matched patients (Sub-Analysis #1: Buprenorphine Buccal Film vs. CII Opioids)
Table S14: Demographic characteristics of matched patients (Sub-Analysis #2: Buprenorphine Buccal Film vs. Buprenorphine Patch)
Table S15: Clinical characteristics of matched patients (Sub-Analysis #2: Buprenorphine Buccal Film vs. Buprenorphine Patch)

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 postindex 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.