Study Summary: Efficacy of diclofenac sodium gel 1% in patients with hand OA
Background
- Radiographic hand OA is prevalent in 55% while symptomatic hand OA is prevalent in around 7 to 26% of the elderly population
- Nonsteroidal anti-inflammatory drugs (NSAIDs) can reduce pain and improve function in hand OA. However, nonselective NSAIDs carry dose-related gastrointestinal (GI) risks, cardiovascular and renal adverse effects
- Topical NSAIDs provide effective analgesia but minimize systemic exposure, potentially reducing risk of adverse events. ACR guidelines conditionally recommended the use of topical NSAIDs in patients with hand OA
Study Objective and Methodology
- Multicenter, 8-week, randomized, double-blind, placebo-controlled study
- To assess the efficacy and safety of topical diclofenac sodium 1% gel (DSG) in patients with symptomatic hand aged ≥ 40 years
Results
- Topical diclofenac sodium gel was generally well tolerated and effective in primary hand OA
- Improvements in the DSG group (16%–25%) were 47% to 125% greater than the vehicle group at Weeks 1 through 6, and 21% greater at Week 8
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