ASSOCIATION BETWEEN RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEINS AND POST-OPERATIVE OPIOID USE IN LUMBAR FUSION PROCEDURE PATIENTS- A PROPENSITY-SCORE MATCHED ANALYSIS
Author(s)
Murimi IB1, Ghambaran A2, Decker R3, Lu X3, Segal R3, Loyo-Berrios NI2, Marinac-Dabic D4, Hartzema A3
1Johns Hopkins Bloomberg School of Public Health, Center for Drug Safety and Effectiveness, Baltimore, MD, USA, 2United States Food and Drug Administration, Silver Spring, MD, USA, 3University of Florida, Gainesville, FL, USA, 4U.S. Food and Drug Administration, Silver Spring, MD, USA
OBJECTIVES: To investigate the association between Recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) use during lumbar fusion procedures and the demand for opioid analgesics in the first post-surgical year. METHODS: We conducted retrospective study using the Multi-Payer Claims Database (MPCD) 2007-2010. Patients aged > 20, who received a Degenerative Disc Disease-indicated lumbar fusion procedure and had at least one opioid prescription filled in the three months prior to surgery, were identified. Propensity score matching (1:1) of rhBMP-exposed and unexposed patients was used to mitigate the effects of confounding. Outcomes of interest were opioid independence and decreases in opioid doses as measured in morphine equivalents assessed at 3-6 and 9-12 months post-procedure. Logistic regression and Analysis of Covariance models were used to examine the association between rhBMP-use and post-operative opioid use patterns. RESULTS: A total of 318 patients were included in the propensity score matched cohort; most were female (61%) and under 65 years old (68%). Few patients achieved opioid independence at either the 3-6 (n=71, 22.3%) or 9-12 months (n=115, 36.2%) post-surgical windows. During the 3-6 months window, patients who received rhBMPs reduced their opioid use rates (Estimated Mean Difference: -28.4 vs. -19.5, p value= 0.69) and achieved opioid independence (21.4% vs. 23.3%, OR=0.92, 95% CI, 0.54-1.56, pvalue = 0.74) at rates that were statistically comparable to their matched comparators. Similar patterns were observed during the 9-12 months window. CONCLUSIONS: We found no evidence to suggest that rhBMP use during spinal fusion procedures is associated with either the discontinuation or decrease of opioid analgesic therapy. Given the significant morbidity associated with prolonged opioid therapy, the high prevalence of continued opioid use after surgery warrants further study.
Conference/Value in Health Info
2017-05, ISPOR 2017, Boston, MA, USA
Value in Health, Vol. 20, No. 5 (May 2017)
Code
PMD17
Topic
Clinical Outcomes, Epidemiology & Public Health
Topic Subcategory
Comparative Effectiveness or Efficacy, Safety & Pharmacoepidemiology
Disease
Musculoskeletal Disorders, Systemic Disorders/Conditions