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Topical loxoprofen sodium hydrogel patch is non-inferior to oral loxoprofen tablets in improving symptoms of knee osteoarthritis.
According to the outcomes of a randomized controlled trial, loxoprofen sodium hydrogel patch (LX-P) is as effective and safe as oral loxoprofen sodium tablets (LX-T) for knee osteoarthritis (OA) management.
The study enrolled 169 patients with knee OA, who were randomly assigned to receive either LX-P or LX-T for 4 weeks. The primary efficacy endpoint was the proportion of patients attaining at least a 50% overall improvement, while secondary endpoints assessed the proportion of patients with at least a 25% improvement from baseline across seven key OA symptoms. Designed with 80% statistical power, a 2.5% significance level, and a non-inferiority margin of −10%, the trial illustrated that LX-P met non-inferiority criteria.
In both intention-to-treat (ITT) and per-protocol (PP) analyses, the topical patch exhibited comparable efficacy to the oral formulation for the primary endpoint. In the ITT analysis, the between-group difference was 12.6%, with a 95% confidence interval ranging from −1.7% to 26.9%. No prominent differences were noted between LX-P and LX-T in any of the secondary efficacy outcomes. From a safety perspective, adverse events occurred less frequently in the LX-P group, although the difference did not reach statistical significance.
Importantly, no serious adverse events were observed in those using the topical patch, whereas 1 serious adverse event occurred in the oral tablet group. Overall, the findings indicate that topical loxoprofen sodium hydrogel patch is non-inferior to oral loxoprofen tablets in alleviating knee OA, offering a comparable therapeutic effect with a favorable safety profile.
Clinical Rheumatology
Efficacy and safety of loxoprofen hydrogel patch versus loxoprofen tablet in patients with knee osteoarthritis: a randomized controlled non-inferiority trial
Rong Mu et al.
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