In a 12-week, randomized, double-blind, parallel-group, multicenter trial, investigators examined the efficacy and safety of topical diclofenac sodium 1% gel (DSG) for treating symptomatic knee OA. Diclofenac sodium 1% gel is currently indicated for OA pain localized to a few superficial joints, such as the knees and hands.
In the trial, 420 patients (aged = 35 years with symptomatic Kellgren-Lawrence grade [KLG] 1 to 3 OA in 1 or both knees for = 6 months) were randomly assigned to DSG (n = 208) or vehicle (n = 212). Patients who met entry level criteria applied DSG 4 g or vehicle 4 times daily to the symptomatic knee(s). At week 12, DSG provided significantly greater reductions in Western Ontario and McMaster Universities Arthritis Index pain (52.6% vs 43.1%; P = 0.008) and physical function (49.7% vs 39.4%; P = 0.004) versus vehicle and provided significant improvements in most secondary endpoints. Treatment-related AEs were infrequent (DSG, 7.7%; vehicle, 4.2%), with application site dermatitis being the most common AE (DSG, 4.8%; vehicle, 0%). No treatment-related gastrointestinal or serious AEs occurred with DSG. Investigators concluded that topical DSG treatment provided effective pain relief and functional improvement of OA in 1 or both knees and was well tolerated, irrespective of disease severity or patient age.
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