Treatment Efficacy of Single Topical NSAID (S-Flurbiprofen Plaster) for Knee Symptoms and Locomotive Dysfunction in Knee Osteoarthritis Patients.

OBJECTIVE

The aim of this study was to demonstrate the non-inferiority of S-flurbiprofen plaster (SFPP) monotherapy for treating knee osteoarthritis compared with the combination of conventional oral and topical non-steroidal anti-inflammatory drugs (NSAIDs).

METHODS

A total of 222 participants (114, SFPP group; 108, control group) were treated for 4 weeks. The primary endpoint was the change in the degree of pain felt while rising from a chair after 2 and 4 weeks of treatment as determined using the visual analog scale (VAS) . The secondary endpoint was the change in functional scores and test results. Safety was evaluated in terms of the adverse effects.

RESULTS

The VAS score significantly decreased in both groups after 2 and 4 weeks of treatment. Non-inferiority in the VAS score was established only at 2 weeks. There were no significant differences in the secondary endpoints between the groups. Skin disorders were more frequent in the SFPP group; however, there was no difference in gastrointestinal (GI) adverse effects.

CONCLUSIONS

The therapeutic efficacy of SFPP monotherapy for knee OA, with respect to changes in the VAS, was not shown to be non-inferior to conventional treatment at 4 weeks; however, non-inferiority was established at 2 weeks. The functional improvement in the SFPP group was comparable to that of the control group. No severe GI adverse effects associated with SFPP administration were observed; however, it is necessary to pay more attention to the occurrence of skin disorders with SFPP than with conventional topical NSAIDs.