Safety and Efficacy of Topical Diclofenac Sodium 1% Gel in Seniors and Younger Patients with Hand Osteoarthritis

San Antonio, TX—Roy D. Altman, MD, University of California-Los Angeles, and colleagues examined the safety and efficacy of diclofenac sodium 1% gel (DSG) in patients age < 65 and ≥ 65 years with hand osteoarthritis (OA). Results, presented at the annual AAPM meeting, revealed that DSG was effective and generally well tolerated for hand OA, regardless of patient age. Three hundred eighty-five adults with radiographically verified hand OA were randomized to double-blind treatment with DSG (n=198) or placebo (n=187), 2 g to each hand 4 times daily for 8 weeks. OA pain intensity (100-mm visual analog scale), Australian/Canadian Osteoarthritis Hand Index (AUSCAN) score, and global rating of disease (GRD) at 4 and 6 weeks were the primary outcomes. Efficacy outcomes were compared by patient age (< 65 yr vs ≥ 65 yr) using analysis of variance (ANOVA). Researchers recorded all adverse events (AEs). Participants randomized to DSG experienced improvements relative to baseline at weeks 4 and 6, in OA pain intensity (42%, 46%), total AUSCAN score (35%, 38%), and GRD (36%, 40%). These improvements were significantly superior to those experienced by patients randomized to placebo for OA pain intensity and total AUSCAN score (P ≤ 0.02) at weeks 4 and 6, but for GRD only at week 6 (P = 0.02). Efficacy differences (DSG vs placebo) between patients age < 65 years (DSG, n=109; placebo n=100) versus ≥ 65 years (DSG, n=89; placebo n=87) were not statistically significant. Application-site reactions were more common with DSG versus placebo for patients age < 65 years (4% vs 1%) and ≥ 65 years (5% vs 3%). Researchers reported that no gastrointestinal bleeding or serious treatment-related AEs occurred. Funding was provided by Endo Pharmaceuticals Inc.