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.

IF 2.5 3区医学 Q2 ANESTHESIOLOGY Pain Practice Pub Date : 2024-07-02 DOI:10.1111/papr.13399

Eugene R Viscusi, Oscar de Leon-Casasola, Jesús Cebrecos, Adam Jacobs, Adelaida Morte, Esther Ortiz, Mariano Sust, Anna Vaqué, Ira Gottlieb, Stephen Daniels, Derek Muse, Michael E Kuss, Sebastián Videla, Neus Gascón, Carlos Plata-Salamán

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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.

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塞来昔布-曲马多联合晶体治疗拇趾外翻截骨术后中度至重度疼痛患者：根据基线疼痛强度和抢救药物使用情况对一项第 3 期随机、双盲、因子、活性和安慰剂对照试验进行二次分析。

背景在SUSA-301随机3期试验中，与塞来昔布、曲马多或安慰剂相比，塞来昔布-曲马多联合晶体（CTC）为急性、中度至重度术后疼痛的成人患者提供的镇痛效果明显更佳。这项事后二次分析进一步评估了抢救药物的使用情况和治疗突发不良事件（TEAEs）的发生率：患者（人数 = 637）按 2:2:2:1 随机分配，分别接受口服 CTC 200 毫克，每天两次（BID；人数 = 184）、曲马多 50 毫克，每天四次（QID；人数 = 183）、塞来昔布 100 毫克，每天两次（BID；人数 = 181）或安慰剂 QID（人数 = 89）。根据基线疼痛强度（中度/重度）分层，对研究用药后4小时和48小时内抢救药物的使用情况进行了事后分析；根据抢救药物的使用情况分层，对TEAEs的发生率进行了事后分析：使用四氯化碳（49.5%）与曲马多（61.7%，p = 0.0178）、塞来昔布（65.2%，p = 0.0024）和安慰剂（75.3%，p = 0.0001）相比，研究用药后 4 小时内接受任何抢救药物治疗的患者比例明显降低；使用羟考酮的患者也是如此。与其他组相比，无论基线疼痛强度如何，CTC 组中接受≥3 次抢救药物治疗的患者人数较少。在未接受阿片类药物抢救的患者中，CTC与单独使用曲马多相比，恶心和呕吐TEAEs发生率更低。在接受羟考酮抢救的患者中，CTC组和曲马多组的恶心发生率相似，而塞来昔布组和安慰剂组的恶心发生率更高：结论：与单独使用曲马多或塞来昔布相比，塞来昔布-曲马多联合晶体可减少成人急性、中度至重度术后疼痛患者的抢救用药，其耐受性也可接受。

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来源期刊

Pain Practice ANESTHESIOLOGY-CLINICAL NEUROLOGY

CiteScore

5.60

自引率

3.80%

发文量

审稿时长

6-12 weeks

期刊介绍： Pain Practice, the official journal of the World Institute of Pain, publishes international multidisciplinary articles on pain and analgesia that provide its readership with up-to-date research, evaluation methods, and techniques for pain management. Special sections including the Consultant’s Corner, Images in Pain Practice, Case Studies from Mayo, Tutorials, and the Evidence-Based Medicine combine to give pain researchers, pain clinicians and pain fellows in training a systematic approach to continuing education in pain medicine. Prior to publication, all articles and reviews undergo peer review by at least two experts in the field.