HEALTHCARE RESOURCE UTILIZATION (HRU) ASSOCIATED WITH PREOPERATIVE MELOXICAM IV IN COLORECTAL SURGERY
Conor P. Delaney4, Jennifer D. Silinsky3, Vamshi R. Anupindi2, Swapna U. Karkare5, Drishti R. Shah2, Randall J. Mack1, Stewart W. McCallum1, Wei Du6,1, Alex Freyer1, Teresa Galas1, Libby K. Black*1
1Baudax Bio, LA CONNER, WA; 2IQVIA, Falls Church, NJ; 3Tulane University, School of Medicine, New Orleans, LA; 4Cleveland Medical Center, Cleveland, OH; 5Janssen, Tutusville, NJ; 6Clinical Statistics Consulting, Blue Bell, PA
To date, clinical studies of Meloxicam IV have evaluated post-surgical dosing to quantify reductions in moderate to severe pain after administration. This study assessed HRU with perioperative dosing, replicating current clinical practice by utilizing a standardized Enhanced Recovery After Surgery (ERAS) protocol incorporating multimodal analgesia.
This was a prospective economic sub-study of a Phase 3b, randomized, double-blind, placebo-controlled trial in subjects undergoing open or laparoscopic colorectal surgeries. Subjects followed a standardized pre-, peri-, and postoperative ERAS protocol (e.g. diet, medication, recovery activities). Subjects were randomized 1:1 to meloxicam IV 30 mg or placebo, with the first dose administered 30 minutes prior to surgery, then every 24 hours thereafter. Opioids were used postoperatively for analgesia as required. Safety and efficacy were evaluated in addition to HRU (total hospital costs and length of stay, LOS). A subject-level database was developed to capture quantity of service, charges and date of service from UB-04 forms (from admission date to discharge), captured in the clinical trial. A national cost:charge ratio was applied to convert ‘charges’ to ‘costs’. Total costs and LOS were reported descriptively (mean, median and SD) for each group. Comparisons (unadjusted) were made using Wilcoxon rank-sum tests and generalized linear models (adjusted).
A total of 55 subjects (mean age: 60, female: 43%) were treated in the trial, with 54 subjects included in HRU analysis (n=27 per treatment; 1 excluded due to missing UB-04). Total mean costs of hospital stay among meloxicam IV subjects was similar to placebo subjects ($23,115 vs. $22,682; p=0.3370). Mean hospital length of stay (LOS) was significantly lower for meloxicam IV vs. placebo (86.2 vs 111.7 hr; p=0.0162). Every 1 mg increase in opioid consumption was associated with a 0.77% increase in in LOS in days (p=0.0003). Proportion of subjects with ≥1 opioid related adverse drug event (ORADE) was higher for placebo (63%) than meloxicam IV (41%). Presence of >1 ORADE was associated with a significant increase in LOS (exp (β)=1.303, p=0.0238) in hours (exp(β)=1.264, p =0.031) as compared to not having any ORADEs.
This sub-study demonstrated a favorable impact of meloxicam IV 30 mg compared with placebo on HRU. Hospital LOS was significantly shorter for meloxicam IV compared to placebo. Total mean costs of hospital stay were similar among meloxicam IV and placebo subjects. Observed reductions in HRU in this analyses were associated with reductions in opioid use and ORADEs in meloxicam IV vs. placebo subjects. This study demonstrates that perioperative administration of meloxicam IV 30 mg in subjects undergoing colorectal surgery results in reductions in HRU.
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