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The following is a summary of “Safety of co-crystal of tramadol-celecoxib (CTC) in patients with acute moderate-to-severe pain: Pooled analysis of three phase 3 randomized trials,” published in the September 2024 issue of Pain by Viscusi et al.
Multi-modal analgesia is often preferred for acute pain management due to its effectiveness at lower doses and improved tolerability. A co-crystal of tramadol and celecoxib (CTC) offers adequate analgesia in acute pain models and potentially enhances tolerability by altering pharmacokinetics.
Researchers conducted a retrospective study to assess the safety and tolerability of CTC in patients with acute postoperative pain.
They performed a pooled analysis of safety data from 3 phase 3 randomized controlled trials involving adults with acute moderate-to-severe pain following oral surgery, bunionectomy, and elective abdominal hysterectomy. The data presented included CTC 200 mg twice daily (BID) and its comparators: tramadol 50 mg 4 times daily (QID) (1 trial), tramadol 100 mg QID (2 trials), celecoxib 100 mg BID (2 trials), and placebo (3 trials).
The results showed that in total, n=551 patients received CTC 200 mg BID, n=183 received tramadol 50 mg QID, n=368 received tramadol 100 mg QID, n=388 received celecoxib 100 mg BID, and n=274 received placebo. The prevalence of adverse events (AEs) associated with the study drug up to 48 hours was numerically lower with CTC 200 mg BID (35.9%) than with tramadol 50 mg QID (47.5%) and 100 mg QID (44.8%) but more significant than with celecoxib 100 mg BID (12.4%) and placebo (20.4%). The most frequent AEs related to the study drug up to 48 hours were drowsiness, nausea, dizziness, and vomiting, which occurred more frequently in patients receiving tramadol 100 mg QID than in those receiving CTC 200 mg BID.
They concluded that CTC 200 mg BID was better tolerated than tramadol 100 mg QID, likely due to reduced tramadol exposure, suggesting a more favorable benefit-risk profile for CTC as a potential treatment for acute pain.
Source: link.springer.com/article/10.1007/s40122-024-00655-w#Abs1