It bites the heart or does it not?

Danda, Debashish

doi:10.1111/1756-185x.12064

Cited by 1 publication

(1 citation statement)

References 7 publications

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“…The current findings showed that LOX-T was effective in 81.3% of patients compared with 72.7% of those in the LOX-O group. These results are in line with findings from double-blind trials, which assessed the overall improvement in clinical symptoms of once-daily LOX 100 mg hydrogel patches versus oral LOX 60 mg three times daily in patients with knee osteoarthritis, myalgia, or trauma-induced swelling and pain [12, 14, 18–21]. Most patients in both treatment groups (60–98%) had > 50% of overall improvement in clinical symptoms.…”

Section: Discussionsupporting

confidence: 85%

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

Zhao

Chen

et al. 2019

Clin Drug Investig

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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).

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Section: Discussionsupporting

confidence: 85%