Safety and Efficacy of Topical Diclofenac Sodium 1% Gel in Knee Osteoarthritis: A Randomized Controlled Trial As Published In The June 2010 Edition Of The Physician And Sportsmedicine

Consumer survey data indicate that most Americans with osteoarthritis (OA) either do not seek treatment or use over-the-counter remedies, including topical rubefacients, acetaminophen, and oral nonsteroidal anti-inflammatory drugs (NSAIDs). However, NSAIDs carry risks of gastrointestinal, cardiovascular, and renal adverse events (AEs). Topical NSAIDs may provide an alternative to oral NSAIDs to relieve pain from OA, reducing systemic exposure.

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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