Real-World Effectiveness and Safety of Imrecoxib Across Diverse Pain Conditions: A Multicenter, Retrospective Cohort Study of 30,214 Patients.

Background: Imrecoxib, a selective COX-2 inhibitor approved for osteoarthritis pain, has shown therapeutic potential in various inflammatory conditions. However, real-world evidence of application patterns and effectiveness in routine practice remains limited. Methods: A non-interventional, registry-based real-world study was performed from August 2023 to January 2025 at 95 centers in China. Patients with at least one record of imrecoxib treatment were enrolled. Data on demographics, clinical characteristics, treatment patterns, pain scores (numeric rating scale, NRS), and adverse events were collected. Descriptive analyses were performed for baseline characteristics, while inferential statistics (including Wilcoxon signed-rank test and chi-square test) were used to compare pre- and post-treatment outcomes. Subgroup analyses were conducted to evaluate treatment effects across different patient characteristics, and linear mixed-effects models were applied to adjust for potential confounders (baseline NRS, age, sex, and pain category). Effective pain control was defined as achieving an NRS score of ≤3 (successful pain relief), or a decrease in pain severity category (pain alleviation). Results: A total of 30,214 patients were included. Orthopedic settings accounted for 50.8% of prescriptions, with osteoarthritis (17.2%), bone fracture pain relief (17.1%), and perioperative pain control (16.5%) being the primary indications. Additional use was observed in lumbar/cervical spondylosis (12.2%), rheumatoid arthritis (2.6%), and gout (1.6%). Notably, the recorded prevalence of comorbidities (24.0%) appeared lower than that reported in the general population. The majority of patients (96.0%) received the standard dosage (100 mg twice daily), with a median treatment duration of 8 days (interquartile range: 5-12). Monotherapy was predominant (71.83%), while concomitant use with other analgesics was uncommon. Post-treatment NRS pain scores showed a significant reduction compared to baseline. Successful pain relief was achieved in 75.8% of patients, and treatment effectiveness was rated at 76.1%. Adverse events (AEs) were infrequent (95 cases, primarily mild cardiovascular or gastrointestinal events). Conclusion: In this large, multicenter real-world study, imrecoxib was widely prescribed for various pain conditions. The results suggest favorable effectiveness and a generally favorable safety profile in routine clinical practice.