| Title | Efficacy and Safety of Loxoprofen Hydrogel TransdermalPatch Versus Loxoprofen Tablet in Chinese Patients with Myalgia: A Double-Blind, Double-Dummy, Parallel-Group, Randomized, Controlled, Non-Inferiority Trial |
| Authors | Zhao, Dongbao Chen, Zhiwei Hu, Shaoxian Lin, Jianhao Shao, Zengwu Wang, Guochun Xiao, Weiguo Zheng, Yi Zhang, Zhiyi Shi, Yeqing Li, Zhanguo |
| Affiliation | Changhai Hosp Shanghai, Dept Rheumatol, Shanghai, Peoples R China Soochow Univ, Affiliated Hosp 1, Dept Rheumatol, Suzhou, Peoples R China Huazhong Univ Sci & Technol, Tongji Med Coll, Tongji Hosp, Dept Rheumatol, Wuhan, Hubei, Peoples R China Peking Univ, Peoples Hosp, Dept Orthopaed, Beijing, Peoples R China Huazhong Univ Sci & Technol, Tongji Med Coll, Union Hosp, Dept Orthopaed, Wuhan, Hubei, Peoples R China China Japan Friendship Hosp, Dept Rheumatol, Beijing, Peoples R China China Med Univ, Hosp 1, Dept Rheumatol, Shenyang, Liaoning, Peoples R China Capital Med Univ, Beijing Chao Yang Hosp, Dept Rheumatol, Beijing, Peoples R China Harbin Med Univ, Affiliated Hosp 1, Dept Rheumatol, Harbin, Heilongjiang, Peoples R China Peking Univ, Peoples Hosp, Dept Rheumatol & Immunol, 11 Xizhimen South St, Beijing, Peoples R China |
| Issue Date | 2019 |
| Publisher | CLINICAL DRUG INVESTIGATION |
| Abstract | Background and ObjectiveLoxoprofen (LOX) is a nonsteroidal anti-inflammatory drug (NSAID). Although oral administration of LOX has been widely prescribed, clinical guidelines for osteoarthritis generally recommend topical rather than oral NSAIDs in specific patients. However, there is limited information on the effects of loxoprofen sodium oral (LOX-O) versus loxoprofensodium hydrogel transdermal patch (LOX-T) in myalgia patients. Hence, this non-inferiority study was designed to compare the efficacy and safety of LOX-O versus LOX-T in Chinese patients with myalgia.MethodsIn this double-blind, double-dummy, parallel-group, randomized controlled trial, 182 Chinese patients were enrolled and randomized equally to either LOX-T or LOX-O treatment for 2weeks. Patients in the LOX-T group applied one sheet of the active LOX-T once a day on the affected site and took one placebo tablet three times a day immediately after meals, whereas patients in the LOX-O group applied one sheet of the placebo patch once a day and took one active LOX-O three times a day. Primary endpoint was the proportion of patients with 50% overall improvement or higher at the final visit. The cutoff value of a non-inferiority difference was set as -10%.ResultsIn the full analysis set, the primary endpoint of final efficacy rate was 81.3% (n=91) in the LOX-T group and 72.2% (n=88) in the LOX-O group. The difference between the two groups was 9.1% [95% confidence interval (CI) -3.1 to 21.3%], which showed that LOX-T was non-inferior compared with LOX-O. No serious adverse events occurred in either group.ConclusionsThis trial showed the non-inferiority of LOX-T compared with LOX-O in efficacy and safety in Chinese patients with myalgia. Also, the characteristic features of topical LOX-T, such as better compliance and lower risk-benefit ratio, make it more favorable for clinical practice.Trial RegistrationThe study was registered in the isrctn.com registry (ISRCTN trial ID: ISRCTN16227145). |
| URI | http://hdl.handle.net/20.500.11897/549502 |
| ISSN | 1173-2563 |
| DOI | 10.1007/s40261-019-00756-x |
| Indexed | SCI(E) |
| Appears in Collections: | 人民医院 |
