Affiliation:
1. Sidney Kimmel Medical College Thomas Jefferson University Philadelphia Pennsylvania USA
2. University of Buffalo/Roswell Park Cancer Institute Buffalo New York USA
3. Esteve Pharmaceuticals S.A. Barcelona Spain
4. Premier Research Reading UK
5. Chesapeake Research Group LLC Pasadena Maryland USA
6. Optimal Research LLC Austin Texas USA
7. JBR Clinical Research Salt Lake City Utah USA
8. Michael Kuss Consulting Austin Texas USA
Abstract
AbstractBackgroundIn 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).MethodsPatients (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.ResultsA 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.ConclusionCelecoxib‐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.
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