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

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 painTable 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 TEAEsTable 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.

本数据集为发表于《比较有效性研究杂志》的论文《使用丁丙诺啡或口服阿片类药物治疗的慢性下腰痛患者中严重治疗相关不良事件：一项回顾性商业索赔分析》的同行评审补充材料。表格 S1：与下腰痛相关的 ICD-10-CM 代码；表格 S2：与 CIII 类丁丙诺啡（Belbuca® 和丁丙诺啡贴片）相关的相关 NDC 代码；表格 S3：与相关治疗相关不良事件（TEAEs）相关的 ICD-10-CM 代码列表；表格 S4：不匹配患者的人口统计学特征（主要分析：CIII 类丁丙诺啡 vs. CII 类阿片类药物）；表格 S5：不匹配患者的临床特征（主要分析：CIII 类丁丙诺啡 vs. CII 类阿片类药物）；表格 S6：不匹配患者的人口统计学特征（子分析 #1：丁丙诺啡颊片 vs. CII 类阿片类药物）；表格 S7：不匹配患者的临床特征（子分析 #1：丁丙诺啡颊片 vs. CII 类阿片类药物）；表格 S8：不匹配患者的人口统计学特征（子分析 #2：丁丙诺啡颊片 vs. 丁丙诺啡贴片）；表格 S9：不匹配患者的临床特征（子分析 #2：丁丙诺啡颊片 vs. 丁丙诺啡贴片）；表格 S10：匹配患者的人口统计学特征（主要分析：CIII 类丁丙诺啡 vs. CII 类阿片类药物）；表格 S11：匹配患者的临床特征（主要分析：CIII 类丁丙诺啡 vs. CII 类阿片类药物）；表格 S12：匹配患者的人口统计学特征（子分析 #1：丁丙诺啡颊片 vs. CII 类阿片类药物）；表格 S13：匹配患者的临床特征（子分析 #1：丁丙诺啡颊片 vs. CII 类阿片类药物）；表格 S14：匹配患者的人口统计学特征（子分析 #2：丁丙诺啡颊片 vs. 丁丙诺啡贴片）；表格 S15：匹配患者的临床特征（子分析 #2：丁丙诺啡颊片 vs. 丁丙诺啡贴片）。研究目的：探究 Belbuca（丁丙诺啡颊片）、丁丙诺啡透皮贴片及口服阿片类药物在慢性下腰痛（cLBP）治疗中的安全性。研究方法：对 MarketScan 商业数据库（2018–2021）中的治疗初治慢性下腰痛成人进行回顾性分析。丁丙诺啡（Belbuca 和透皮贴片）或阿片类药物处方的首次日期为索引日期。根据索引药物定义队列。观察期包括索引日期前 6 个月的预索引期，索引日期后持续至连续保险覆盖结束。文献中确定了 44 项相关治疗相关不良事件（TEAEs）。使用发生率比（IRR）和发生率差异（IRD）比较队列间严重 TEAE 的发生率（以 1000 人年计）。倾向得分匹配最小化了选择偏差。研究结果：丁丙诺啡的 15 项严重 TEAE 发生率低于口服阿片类药物（所有 p ≤ 0.037），而严重眩晕的发生率较高（IRR 2.44，p = 0.011；由 Belbuca 引起），阿片类药物滥用/依赖（IRR 3.13，p = 0.004；由贴片引起）和胆囊炎（IRD 20.25，p = 0.044；异常值）。此外，Belbuca 与口服阿片类药物的比较显示 13 项严重 TEAE 的发生率较低（所有 p ≤ 0.024）和严重的眩晕发生率较高（IRR 3.17，p = 0.024）。尽管严重阿片类药物滥用/依赖的发生率相似（24.60 vs 26.93，p = 0.921），所有 Belbuca 患者和所有阿片类药物患者均无这些事件的阳性史。Belbuca 与透皮贴片相比，5 项严重 TEAE 的发生率较低（所有 p ≤ 0.018），包括严重的阿片类药物滥用/依赖（IRR 0.04，p < 0.001），但严重的胆囊炎（IRD 52.17，p = 0.035；异常值）和自杀意念（IRD 156.50，p < 0.001；异常值）的发生率较高。研究结论：在慢性下腰痛治疗中，丁丙诺啡的安全性优于口服阿片类药物。Belbuca 的治疗相关不良事件（TEAEs）表现优于丁丙诺啡透皮贴片和口服阿片类药物。