Abstract
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.
