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Diclofenac Sodium 1% Gel Appears Safe, Effective for Knee Osteoarthritis: Presented at APS By Kristina Rebelo SAN DIEGO -- May 14, 2009 -- Topically applied diclofenac sodium 1% gel (DSG) can provide safe and effective relief of mild to moderate osteoarthritis (OA) of the knee in patients who have previously suffered adverse events with oral nonsteroidal anti-inflammatory drugs (NSAIDS) or for those who want to avoid cardiovascular, renal, or gastrointestinal adverse events, according to a study presented here at the 28th Annual Scientific Meeting of the American Pain Society (APS). "We evaluated the safety and efficacy of DSG in patients with symptomatic OA in one or both knees," said Roy D. Altman, MD, Division of Rheumatology and Immunology, University of California, Los Angeles, Los Angeles, California, in a presentation on May 7. A 12-week, randomised, double-blind, parallel-group, vehicle-controlled trial was conducted at 65 centres around the United States from November 2006 to June 2007. The study population comprised 420 ambulatory men and women aged 35 years and older with mild to moderate symptomatic OA radiographically confirmed by American College of Rheumatology criteria. After a 7-day analgesic washout period, patients were randomly assigned to receive DSG (n = 208) or its identical vehicle (n = 212) without the bioactive ingredient of diclofenac sodium. Patients returned at baseline (after the 7-day washout period) and again at weeks 1, 3, 8, and 12. Primary efficacy outcomes were assessed in the intent-to-treat population for the target (symptomatic) knee at week 12. Primary outcomes were measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and physical function subscales and Global Rating of Benefit (GRB). DSG was associated with significantly greater reductions than with vehicle alone in WOMAC pain (52.6% vs 43.1%; P = .008) and physical function (49.7% vs 39.4%; P = .004) relative to baseline. DSG-treated patients showed a nonsignificant trend toward greater GRB (P = .09). The study reported significant improvement with DSG versus vehicle in both WOMAC measures beginning at week 1. In patients whose contralateral knee was also treated (n = 277), improvement in WOMAC scores at week 12 were numerically but not significantly greater with DSG than with vehicle alone. However, contralateral knees had milder pain at baseline, making significant treatment effects less likely. Application-site dermatitis was the only adverse event that was reported by more than 1 patient (n = 7 [3.4%] in the DSG group). Gastrointestinal adverse events occurred minimally (5.3% in DSG group and 4.2% in vehicle group). Topical DSG applied to one or both knees reduced symptoms to a significantly greater extent than vehicle alone in this study, suggesting that DSG gives safe and effective relief of mild to moderate OA with low systemic NSAID exposure. Funding for this study was supported by Novartis Consumer Healthcare. [Presentation title: Safety and Efficacy of Diclofenac Sodium 1% Gel in Unilateral and Bilateral Osteoarthritis of the Knee: A Randomized, Double-Blind, Placebo-Controlled Trial. Abstract 302] E-mail this page to a friend or colleague! To print, use this version