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

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).

Healthcare and Scientific Treatment of Knee Osteoarthritis

“…Topical Treatment. Zhao et al [36] found that oral loxoprofen sodium (LOX-O) was found to be comparable to loxoprofen sodium hydrogel transdermal patch (LOX-T), indicating promising topical use of nonsteroid anti-inflammatory drugs (NSAIDS). Coskun Benlidayi et al [37] found that both ibuprofen gels and creams had significant clinical efficacy.…”

<p>Loxoprofen Sodium Alleviates Oxidative Stress and Apoptosis Induced by Angiotensin II in Human Umbilical Vein Endothelial Cells (HUVECs)</p>

“…Loxoprofen sodium is the first non-steroidal antiinflammatory drug (NSAID), which belongs to the propionic acid group which includes commonly used drugs ibuprofen and naproxen. 13,14 The main therapeutic mechanism of loxoprofen sodium is its inhibition on the synthesis of prostaglandin, and its analgesic effect is approximately 10-20 fold of several other NSAIDs such as indomethacin, ketoprofen, or naproxen. 15 Recognized as a promising analgesic, antiinflammatory and antipyretic effects have been observed on the clinical trials on loxoprofen sodium.…”

Development of omega-3 loxoprofen-loaded nanoemulsion to limit the side effect associated with NSAIDs in treatment of tooth pain

“…Omega-3 fatty acids are long-chain polyunsaturated fatty acids composed of a mixture of α-linolenic (ALA, 18:3 n-3), eicosapentaenoic (EPA, 20:5 n-3), and docosahexaenoic (DHA, 22:6 n-3) acids. Vegetable oils, such as olive and flaxseed oil, are rich in ALA while, marine oils are major sources of EPA and DHA (Zhao et al., 2019 ). Since the human body is unable to synthesize omega-3 fatty acids, which are important to our diet, they must be supplied from external sources (Lavie et al., 2009 ).…”