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.

• 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