{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T16:20:08Z","timestamp":1782836408371,"version":"3.54.5"},"reference-count":30,"publisher":"Becaris Publishing Limited","issue":"8","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J. Comp. Eff. Res."],"published-print":{"date-parts":[[2024,8]]},"abstract":"<jats:p>\n            <jats:bold>Aim:<\/jats:bold>\n            Explore the safety of Belbuca\u00ae (buprenorphine buccal film), buprenorphine transdermal patches and oral opioids for chronic low back pain (cLBP) treatment.\n            <jats:bold>Methods:<\/jats:bold>\n            The retrospective analysis of the MarketScan Commercial database (2018\u20132021) 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.\n            <jats:bold>Results:<\/jats:bold>\n            Buprenorphine had lower rates of 15 serious TEAEs than oral opioids (all p\u00a0\u2264\u00a00.037), while higher rates only for serious dizziness (IRR 2.44, p\u00a0=\u00a00.011; driven by Belbuca), opioid abuse\/dependence (IRR 3.13, p\u00a0=\u00a00.004; driven by patches) and cholecystitis (IRD 20.25, p\u00a0=\u00a00.044; an outlier). Additionally, a comparison between Belbuca and oral opioids showed lower rates of 13 serious TEAEs (all p\u00a0\u2264\u00a00.024) and a higher serious dizziness rate (IRR 3.17, p\u00a0=\u00a00.024). Although the rates of serious opioid abuse\/dependence were similar (24.60 vs 26.93, p\u00a0=\u00a00.921), 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\u00a0\u2264\u00a00.018), including a serious opioid abuse\/dependence (IRR 0.04, p\u00a0&lt;\u00a00.001), but higher rates of serious cholecystitis (IRD 52.17, p\u00a0=\u00a00.035; an outlier) and suicidal ideation (IRD 156.50, p\u00a0&lt;\u00a00.001; an outlier).\n            <jats:bold>Conclusion:<\/jats:bold>\n            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.\n          <\/jats:p>","DOI":"10.57264\/cer-2023-0183","type":"journal-article","created":{"date-parts":[[2024,7,16]],"date-time":"2024-07-16T15:05:02Z","timestamp":1721142302000},"source":"Crossref","is-referenced-by-count":1,"title":["Serious treatment-emergent adverse events in chronic low back pain patients treated with buprenorphine or oral opioids: a retrospective commercial claims analysis"],"prefix":"10.57264","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2293-8940","authenticated-orcid":false,"given":"Filip","family":"Stanicic","sequence":"first","affiliation":[{"name":"Health Economics &amp; Outcomes Research Department, ZRx Outcomes Research Inc., Mississauga, ON L5A 2X7, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-4962-4396","authenticated-orcid":false,"given":"Dimitrije","family":"Grbic","sequence":"additional","affiliation":[{"name":"Health Economics &amp; Outcomes Research Department, ZRx Outcomes Research Inc., Mississauga, ON L5A 2X7, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9591-1111","authenticated-orcid":false,"given":"Djurdja","family":"Vukicevic","sequence":"additional","affiliation":[{"name":"Health Economics &amp; Outcomes Research Department, ZRx Outcomes Research Inc., Mississauga, ON L5A 2X7, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1368-4491","authenticated-orcid":false,"given":"Vladimir","family":"Zah","sequence":"additional","affiliation":[{"name":"Health Economics &amp; Outcomes Research Department, ZRx Outcomes Research Inc., Mississauga, ON L5A 2X7, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"36897","reference":[{"issue":"10137","key":"e_1_3_8_3_2","doi-asserted-by":"crossref","first-page":"2356","DOI":"10.1016\/S0140-6736(18)30480-X","article-title":"What low back pain is and why we need to pay attention","volume":"391","author":"Hartvigsen J","year":"2018","unstructured":"Hartvigsen J, Hancock MJ, Kongsted A What low back pain is and why we need to pay attention. 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Disord."},{"issue":"11","key":"e_1_3_8_31_2","doi-asserted-by":"crossref","first-page":"2517","DOI":"10.1097\/j.pain.0000000000000670","article-title":"Efficacy and tolerability of buccal buprenorphine in opioid-experienced patients with moderate to severe chronic low back pain: results of a Phase III, enriched enrollment, randomized withdrawal study","volume":"157","author":"Gimbel J","year":"2016","unstructured":"Gimbel J, Spierings ELH, Katz N, Xiang Q, Tzanis E, Finn A. Efficacy and tolerability of buccal buprenorphine in opioid-experienced patients with moderate to severe chronic low back pain: results of a Phase III, enriched enrollment, randomized withdrawal study. 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