Safety, Tolerability, and Effect on Opioid Use of Meloxicam IV Following Orthopedic Surgery

Kipling P Sharpe, Richard Berkowitz, William A Tyndall, David Boyer, Stewart W McCallum, Randall J Mack, Wei Du, Kipling P Sharpe, Richard Berkowitz, William A Tyndall, David Boyer, Stewart W McCallum, Randall J Mack, Wei Du

Abstract

Objective: A Phase 3 randomized multicenter, double-blind, placebo-controlled trial (NCT02720692) compared once-daily intravenous (IV) meloxicam 30 mg to placebo, when added to the standard of care pain management regimens, in adults with moderate-to-severe pain following major elective surgery and concluded that meloxicam IV had a safety profile similar to placebo and reduced opioid consumption.

Methods: In this post hoc subgroup analysis of orthopedic surgery subjects, 379 subjects received meloxicam IV 30 mg or IV-administered placebo every 24 hrs for ≤7 doses. Safety was assessed via AEs, laboratory tests, vital signs, and ECG, with an emphasis on specific AEs, including injection site reactions, bleeding, cardiovascular, hepatic, renal, thrombotic, and wound healing events. Daily opioid consumption was assessed during treatment.

Results: Among meloxicam IV-treated subjects, 64.7% experienced ≥1 AE versus 68.8% of placebo-treated subjects. Investigators assessed most AEs to be mild or moderate in intensity and unrelated to treatment. Total opioid consumption (36.8 mg versus 50.3 mg IV morphine equivalent dose; P=0.0081) and opioid consumption during time points 0‒24, 24‒48, 0‒48, and 0‒72 hrs were statistically significantly lower in the meloxicam IV group.

Conclusion: Meloxicam IV demonstrated no significant differences in the number and frequency of AEs versus placebo in subjects following orthopedic surgery. Opioid consumption was reduced in the meloxicam IV group versus placebo.

Trial registration: ClinicalTrials.gov (Identifier: NCT02720692).

Keywords: NSAID; meloxicam IV; orthopedic surgery; postoperative pain; safety.

Conflict of interest statement

Kipling P Sharpe is an employee of OrthoArizona who conducted this trial. He reports research funding for a separate study of the same drug. Richard Berkowitz is the owner/principal investigator of Phoenix Clinical Research who conducted this trial. William A Tyndall is an employee of University Orthopedics Center who conducted this trial and received clinical trials research support from Recro Pharma. David Boyer is an employee of Shoals Clinical Research Associates, LLC, who conducted this trial. Wei Du received consultancy fees from Baudax Bio formerly Recro Pharma, Inc., Malvern, PA, USA. Dr Du has been a consultant for Recro Pharma, Inc. since 2007. Randall J Mack and Stewart W McCallum are employees and security holders of Baudax Bio formerly Recro Pharma, Inc., Malvern, PA, USA. Mr Mack has multiple patents pending (application numbers 16/297,095; 16/297,020; 62/749,407; 62/755,003; all assigned to Baudax Bio, Inc). The authors report no other conflicts of interest in this work.

© 2020 Sharpe et al.

Figures

Figure 1
Figure 1
Total opioid consumptiona by time interval. aIntravenous morphine equivalent dose (mg). Abbreviations: IV, intravenous; SE, standard error.

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