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.
CONCLUSIONS: 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.
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.
CONCLUSIONS: 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.
摘要：
背景：在随机分组中，SUSA-301试验的第三阶段，与塞来昔布相比，塞来昔布-曲马多共晶（CTC）提供了显着更高的镇痛作用，曲马多,或安慰剂在成人急性，中度至重度,术后疼痛。这个posthoc，次要分析进一步评估了抢救药物的使用和治疗引起的不良事件(TEAE)的发生率.
方法：患者（N=637）随机分为2：2：2：1，每天两次（BID；n=184）口服200mgCTC，曲马多50毫克，每日4次（QID；n=183），塞来昔布100毫克BID（n=181），或安慰剂QID（n=89）。对研究药物剂量后4小时和48小时内使用救援药物进行了事后分析，按基线疼痛强度（中度/重度）分层，关于TEAE的发生率，按抢救药物的使用进行分层。
结果：在研究后4小时内使用CTC（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）；这也适用于羟考酮的使用。与其他组相比，CTC组接受≥3剂量抢救药物的患者较少，与基线疼痛强度无关。在没有接受阿片类药物治疗的患者中，与单独曲马多相比，CTC与恶心和呕吐TEAE的发生率较低相关。在接受羟考酮抢救的患者中，CTC和曲马多组的恶心发生率相似，与塞来昔布和安慰剂相比更高。
结论：塞来昔布-曲马多共晶体在成人急性、中度至重度,术后疼痛。
方法：患者（N=637）随机分为2：2：2：1，每天两次（BID；n=184）口服200mgCTC，曲马多50毫克，每日4次（QID；n=183），塞来昔布100毫克BID（n=181），或安慰剂QID（n=89）。对研究药物剂量后4小时和48小时内使用救援药物进行了事后分析，按基线疼痛强度（中度/重度）分层，关于TEAE的发生率，按抢救药物的使用进行分层。
结果：在研究后4小时内使用CTC（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）；这也适用于羟考酮的使用。与其他组相比，CTC组接受≥3剂量抢救药物的患者较少，与基线疼痛强度无关。在没有接受阿片类药物治疗的患者中，与单独曲马多相比，CTC与恶心和呕吐TEAE的发生率较低相关。在接受羟考酮抢救的患者中，CTC和曲马多组的恶心发生率相似，与塞来昔布和安慰剂相比更高。
结论：塞来昔布-曲马多共晶体在成人急性、中度至重度,术后疼痛。
