Safety, Tolerability, and Effect on Opioid Use of Meloxicam IV Following Orthopedic Surgery
Authors Sharpe KP, Berkowitz R, Tyndall WA, Boyer D, McCallum SW, Mack RJ, Du W
Received 23 May 2019
Accepted for publication 21 December 2019
Published 21 January 2020 Volume 2020:13 Pages 221—229
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Dr Michael Schatman
Kipling P Sharpe, 1 Richard Berkowitz, 2 William A Tyndall, 3 David Boyer, 4 Stewart W McCallum, 5 Randall J Mack, 5 Wei Du 6
1OrthoArizona, Gilbert, AZ, USA; 2Phoenix Clinical Research, Tamarac, FL, USA; 3University Orthopedics Center, Altoona, PA, USA; 4Shoals Clinical Research Associates, LLC, Florence, SC, USA; 5Baudax Bio, Inc., Malvern, PA, USA; 6Clinical Statistics Consulting, Blue Bell, PA, USA
Correspondence: Randall J Mack
Baudax Bio, Inc., 490 Lapp Road, Malvern, PA 19355, USA
Tel +1 484 395 2470
Fax +1 484 395 2471
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: meloxicam IV, NSAID, orthopedic surgery, postoperative pain, safety
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