Treatment characteristics and safety profiles of Belbuca®, buprenorphine patch, and oral schedule II opioids among chronic low back pain patients without a positive history of opioid-use disorder: a retrospective US commercial claims analysis - Report - MDSpire
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Treatment characteristics and safety profiles of Belbuca®, buprenorphine patch, and oral schedule II opioids among chronic low back pain patients without a positive history of opioid-use disorder: a retrospective US commercial claims analysis
Clinical Report: Comparative Analysis of Treatment Features and Safety Profiles
Overview
This retrospective study evaluates the safety profiles of Belbuca®, buprenorphine patch, and oral Schedule II opioids in chronic low back pain patients without a history of opioid use disorder.
Background
Chronic low back pain (cLBP) is prevalent in the US, affecting approximately 40% of adults and contributing significantly to disability and economic burden. The management of cLBP often involves opioids, which carry risks of serious adverse events, including opioid use disorder (OUD). Understanding the safety profiles of different opioid formulations is crucial for optimizing treatment strategies in this patient population.
Data Highlights
Outcome
Belbuca®
Buprenorphine Patch
Oral CII Opioids
Serious opioid abuse/dependence
IRD −33.76
IRD −184.75
N/A
Osteoarthritis
IRD −78.77
N/A
N/A
Urinary discomfort
IRD −146.28
N/A
N/A
Seizures
IRR 0.11
N/A
N/A
Coronary artery disease
IRD 39.01
N/A
N/A
QT prolongation
N/A
IRD −52.78
N/A
Key Findings
Belbuca® showed a lower rate of serious opioid abuse/dependence compared to oral CII opioids (IRD −33.76 per 1,000 person-years).
Belbuca® was associated with significantly lower rates of osteoarthritis and urinary discomfort compared to oral CII opioids.
The buprenorphine patch cohort had higher incidence rates of serious QT prolongation and opioid abuse/dependence compared to Belbuca®.
Belbuca® demonstrated higher rates of serious coronary artery disease compared to the buprenorphine patch.
Overall, no serious treatment-emergent adverse events were more frequent in the Belbuca® cohort compared to oral CII opioids.
Clinical Implications
Clinicians should consider the safety profiles of different opioid formulations when prescribing for chronic pain management.
Conclusion
The study findings suggest that Belbuca® may have a favorable safety profile relative to oral CII opioids and buprenorphine patch treatments in cLBP patients without a positive history of OUD.
Phase 3 results showed longer progression-free survival with pembrolizumab plus sacituzumab govitecan-hziy than with pembrolizumab plus chemotherapy in previously untreated PD-L1-positive advanced triple-negative breast cancer.
A single case report described suicidal ideation that resolved after betahistine discontinuation and recurred after rechallenge, but the findings cannot establish causality or quantify risk.
