Comparison of the Efficacy and Safety of Ketoprofen Plaster and Diclofenac Plaster for Osteoarthritis-Related Knee Pain: A Multicenter, Randomized, Active-Controlled, Open-Label, Parallel-Group, Phase III Clinical Trial

Abstract

Purpose: To compare the efficacy and safety of ketoprofen plasters and diclofenac plasters after 3 weeks of administration in patients with osteoarthritisrelated knee pain.Methods: This multicenter, randomized, activecontrolled, open-label, parallel-group, noninferiority phase III study randomized 236 adults with osteoarthritis-related knee pain for 3 weeks with ketoprofen plaster 30 mg twice daily (n = 118) or diclofenac plaster 15 mg once daily (n = 118). The primary efficacy end point was the mean change from baseline to week 3 in the mean knee pain intensity score during walking, as measured by a 100-mm visual analog scale with a predefined noninferiority margin of 10.0 mm. Secondary end points included changes in knee pain intensity score during walking (weeks 1 and 2) and at rest (weeks 1, 2, and 3), Knee Injury and Osteoarthritis Outcome Score, Patient Global Impression of Improvement scale assessments, and frequency of rescue medication use after 2 and 3 weeks of treatment.Findings: A total of 223 patients (115 in the ketoprofen group and 108 in the diclofenac group) were included in the per-protocol analysis. After 3 weeks of treatment, the least squares mean change from baseline in knee pain intensity scores during walking was −35.9 (95% CI, −39.7 to −32.2) in the ketoprofen

Multidisciplinary Guidelines for the Rational Use of Topical Non-Steroidal Anti-Inflammatory Drugs for Musculoskeletal Pain (2022)

“…A 2016 Cochrane systematic review on topical NSAIDs for chronic musculoskeletal pain was included [ 16 ]. This review was updated with an additional 42 studies: 14 compared to placebo [ 70 , 71 , 72 , 73 , 74 , 75 , 76 , 77 , 78 , 79 , 80 , 81 , 82 , 83 ], four compared to oral NSAIDs [ 84 , 85 , 86 , 87 ], five compared to topical NSAIDs [ 88 , 89 , 90 , 91 , 92 ], and 19 compared to other topical drugs [ 93 , 94 , 95 , 96 , 97 , 98 , 99 , 100 , 101 , 102 , 103 , 104 , 105 , 106 , 107 , 108 , 109 , 110 , 111 ].…”