Document Type
Article
Publication Date
7-2-2024
Abstract
BACKGROUND: In the randomized, phase 3, SUSA-301 trial, celecoxib-tramadol co-crystal (CTC) provided significantly greater analgesia compared with celecoxib, tramadol, or placebo in adults with acute, moderate-to-severe, postoperative pain. This post hoc, secondary analysis further evaluated the use of rescue medication and the incidence of treatment-emergent adverse events (TEAEs).
METHODS: Patients (N = 637) were randomized 2:2:2:1 to receive oral CTC 200 mg twice daily (BID; n = 184), tramadol 50 mg four times daily (QID; n = 183), celecoxib 100 mg BID (n = 181), or placebo QID (n = 89). Post hoc analyses were conducted on the use of rescue medications up to 4 and 48 h post-study drug dose, stratified by baseline pain intensity (moderate/severe), and on the incidence of TEAEs, stratified by rescue medication use.
RESULTS: A significantly lower proportion of patients received any rescue medication within 4 h post-study dose with CTC (49.5%) versus tramadol (61.7%, p = 0.0178), celecoxib (65.2%, p = 0.0024), and placebo (75.3%, p = 0.0001); this was also seen for oxycodone use. Fewer patients in the CTC group received ≥3 doses of rescue medication compared with the other groups, irrespective of baseline pain intensity. In patients who did not receive opioid rescue medication, CTC was associated with a lower incidence of nausea and vomiting TEAEs versus tramadol alone. In patients who received rescue oxycodone, the incidence of nausea was similar in the CTC and tramadol groups, and higher versus celecoxib and placebo.
CONCLUSION: Celecoxib-tramadol co-crystal was associated with reduced rescue medication use and an acceptable tolerability profile compared with tramadol or celecoxib alone in adults with acute, moderate-to-severe, postoperative pain.
Recommended Citation
Viscusi, Eugene R.; de Leon-Casasola, Oscar; Cebrecos, Jesús; Jacobs, Adam; Morte, Adelaida; Ortiz, Esther; Sust, Mariano; Vaqué, Anna; Gottlieb, Ira; Daniels, Stephen; Muse, Derek; Kuss, Michael E.; Videla, Sebastián; Gascón, Neus; and Plata-Salamán, Carlos, "Celecoxib-Tramadol Co-Crystal in Patients With Moderate-to-Severe Pain Following Bunionectomy With Osteotomy: Secondary Analyses by Baseline Pain Intensity and Use of Rescue Medication of a Phase 3, Randomized, Double-Blind, Factorial, Active- and Placebo-Controlled Trial" (2024). Department of Anesthesiology Faculty Papers. Paper 104.
https://jdc.jefferson.edu/anfp/104
Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.
PubMed ID
38956758
Language
English
Included in
Analytical, Diagnostic and Therapeutic Techniques and Equipment Commons, Anesthesiology Commons
Comments
This article is the author’s final published version in Pain Practice, Volume 24, Issue 8, Nov 2024, Pages 1042-1050.
The published version is available at https://doi.org/10.1111/papr.13399. Copyright © 2024 Esteve Pharmaceuticals S.A and The Author(s). Pain Practice published by Wiley Periodicals LLC on behalf of World Institute of Pain.
Publication made possible in part by support through a transformative agreement between Thomas Jefferson University and the publisher.