Efficacy and safety of loxoprofen hydrogel patch versus loxoprofen tablet in patients with knee osteoarthritis: a randomized controlled non-inferiority trial

Mu, Rong; Bao, Chun de; Chen, Zhi wei; Zheng, Yi; Wang, Guo chun; Zhao, Dong bao; Hu, Shao xian; Li, Yu jun; Shao, Zeng wu; Zhang, Zhi yi; Xiao, Wei guo; Zhang, Weiya; Li, Zhan guo

Abstract

© 2014, Clinical Rheumatology. This study is aimed at comparing the efficacy and safety of loxoprofen sodium hydrogel patch (LX-P) with loxoprofen sodium tablet (LX-T) in patients with knee osteoarthritis (OA). One hundred sixty-nine patients were enrolled in a randomized, controlled, double-blind, double-dummy, multicenter, non-inferiority trial of LX-P. Patients were randomly assigned to either LX-P or LX-T groups for a 4-week treatment. The primary efficacy endpoint was the proportion of patients with an overall improvement of ≥50 %, and the secondary efficacy endpoint was the proportion of patients with an improvement of ≥25 % from baseline in each of the seven main symptoms. The non-inferiority trial was based on a power of 80 % and significance level of 2.5 % with a non-inferiority margin of −10 %. In both intention-to-treat (ITT) and per-protocol (PP) analyses, LX-P was as effective as LX-T in regard to the primary endpoint. In the ITT analysis, the difference between the two groups was 12.6 % [95 % confidence interval, −1.7 to 26.9 %]. No significant differences were found between the two groups in any of the secondary efficacy outcomes. A lower incidence of adverse events was observed in LX-P group; however, the difference was not statistically significant. No serious adverse events were reported in the LX-P group, whereas one case was reported in LX-T group. Based on the present study, topical loxoprofen patch was non-inferior to oral loxoprofen in patients with knee osteoarthritis.

Citation

Mu, R., Bao, C. D., Chen, Z. W., Zheng, Y., Wang, G. C., Zhao, D. B., Hu, S. X., Li, Y. J., Shao, Z. W., Zhang, Z. Y., Xiao, W. G., Zhang, W., & Li, Z. G. (2016). Efficacy and safety of loxoprofen hydrogel patch versus loxoprofen tablet in patients with knee osteoarthritis: a randomized controlled non-inferiority trial. Clinical Rheumatology, 35(1), 165-173. https://doi.org/10.1007/s10067-014-2701-4

• Journal Article Type: Article
• Acceptance Date: May 25, 2014
• Online Publication Date: Jun 14, 2014
• Publication Date: Jan 1, 2016
• Deposit Date: Nov 26, 2019
• Journal: Clinical Rheumatology
• Print ISSN: 0770-3198
• Electronic ISSN: 1434-9949
• Publisher: Springer Verlag
• Peer Reviewed: Peer Reviewed
• Volume: 35
• Issue: 1
• Pages: 165-173
• DOI: https://doi.org/10.1007/s10067-014-2701-4
• Keywords: Rheumatology; General Medicine
• Public URL: https://nottingham-repository.worktribe.com/output/3086465