title: Efficacy and safety of loxoprofen hydrogel patch versus loxoprofen tablet in patients with knee osteoarthritis: a randomized controlled non-inferiority trial.
abstract: 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.
authors.affiliation: Department of Rheumatology and Immunology, Peking University People's Hospital, Beijing, 100044, China. murongster@gmail.com.
authors.forename: Rong
authors.initials: R
authors.lastname: Mu
authors.affiliation: Department of Rheumatology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. baochunde_1678@126.com.
authors.forename: Chun-de
authors.initials: CD
authors.lastname: Bao
authors.affiliation: Department of Rheumatology, The First Affiliated Hospital of Soochow University, Suzhou, China. czw0512@126.com.
authors.forename: Zhi-wei
authors.initials: ZW
authors.lastname: Chen
authors.affiliation: Department of Rheumatology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China. zzyy90@sina.com.
authors.forename: Yi
authors.initials: Y
authors.lastname: Zheng
authors.affiliation: Department of Rheumatology, China-Japan Friendship Hospital, Beijing, China. guochunwang@hotmail.com.
authors.forename: Guo-chun
authors.initials: GC
authors.lastname: Wang
authors.affiliation: Department of Rheumatology, Changhai Hospital of Shanghai, Shanghai, China. dongbaozhao@163.com.
authors.forename: Dong-bao
authors.initials: DB
authors.lastname: Zhao
authors.affiliation: Department of Rheumatology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. sxianhu@139.com.
authors.forename: Shao-xian
authors.initials: SX
authors.lastname: Hu
authors.affiliation: Department of Orthopaedics, Beijing Jishuitan Hospital, Beijing, China. liyujunmd@aliyun.com.
authors.forename: Yu-jun
authors.initials: YJ
authors.lastname: Li
authors.affiliation: Department of Orthopaedics, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. szwjj@medmail.com.cn.
authors.forename: Zeng-wu
authors.initials: ZW
authors.lastname: Shao
authors.affiliation: Department of Rheumatology, The First Affiliated Hospital of Harbin Medical University, Harbin, China. zhangzhiyi@medmail.com.cn.
authors.forename: Zhi-yi
authors.initials: ZY
authors.lastname: Zhang
authors.affiliation: Department of Rheumatology, The First Hospital of China Medical University, Shenyang, China. xonet5670@163.com.
authors.forename: Wei-guo
authors.initials: WG
authors.lastname: Xiao
authors.affiliation: Academic Rheumatology, University of Nottingham, Nottingham, NG5 1PB, UK. weiya.zhang@nottingham.ac.uk.
authors.forename: Weiya
authors.initials: W
authors.lastname: Zhang
authors.affiliation: Department of Rheumatology and Immunology, Peking University People's Hospital, Beijing, 100044, China. lzg20140310@163.com.
authors.forename: Zhan-guo
authors.initials: ZG
authors.lastname: Li
mesh_terms: D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects; D002681:China; D015897:Comorbidity; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D020136:Hydrogel, Polyethylene Glycol Dimethacrylate / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000188:drug therapy*; D010147:Pain Measurement; D010666:Phenylpropionates / Q000008:administration & dosage* / Q000009:adverse effects; D013607:Tablets / Q000009:adverse effects; D057968:Transdermal Patch / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D010666:Phenylpropionates; D013607:Tablets; D020136:Hydrogel, Polyethylene Glycol Dimethacrylate; C040656:loxoprofen
keywords: Hydrogel patch; Knee osteoarthritis; Loxoprofen sodium; Topical application