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Clin Drug Investig. 2019 Apr;39(4):369-377. doi: 10.1007/s40261-019-00756-x.

Efficacy and Safety of Loxoprofen Hydrogel Transdermal Patch Versus Loxoprofen Tablet in Chinese Patients with Myalgia: A Double-Blind, Double-Dummy, Parallel-Group, Randomized, Controlled, Non-Inferiority Trial.

Author information

1
Department of Rheumatology, Changhai Hospital of Shanghai, Shanghai, China.
2
Department of Rheumatology, The First Affiliated Hospital of Soochow University, Suzhou, China.
3
Department of Rheumatology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
4
Department of Orthopaedics, Peking University People's Hospital, Beijing, China.
5
Department of Orthopaedics, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
6
Department of Rheumatology, China-Japan Friendship Hospital, Beijing, China.
7
Department of Rheumatology, The First Hospital of China Medical University, Shenyang, China.
8
Department of Rheumatology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.
9
Department of Rheumatology, The First Affiliated Hospital of Harbin Medical University, Harbin, China.
10
Department of Rheumatology and Immunology, Peking University People's Hospital, No. 11 Xizhimen South Street, Xicheng District, Beijing, People's Republic of China. lzg20140310@sina.com.

Abstract

BACKGROUND AND OBJECTIVE:

Loxoprofen (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 loxoprofen sodium 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.

METHODS:

In 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 2 weeks. 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%.

RESULTS:

In 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.

CONCLUSIONS:

This 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 REGISTRATION:

The study was registered in the isrctn.com registry (ISRCTN trial ID: ISRCTN16227145).

PMID:
30725315
PMCID:
PMC6443607
DOI:
10.1007/s40261-019-00756-x
[Indexed for MEDLINE]
Free PMC Article

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