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| |  Topical Diclofenac Effective for Elderly and Younger Patients With Hand Osteoarthritis: Presented at AAPM By Jennifer Reising SAN ANTONIO, Tex -- February 5, 2010 -- Topical diclofenac sodium 1% gel significantly improves pain, function, and disease status in patients of all ages with hand osteoarthritis (OA), according to findings presented here at the 26th annual meeting of the American Academy of Pain Medicine (AAPM). “Reducing the risk of NSAID [non-steroidal anti-inflammatory drug] adverse events is important for hand osteoarthritis patients of all ages,” said Roy D. Altman, MD, The David Geffen School of Medicine, University of California, Los Angeles, California, on February 3. “Older patients may have comorbidities and multiple medications, presenting increased toxicity and drug interaction risks; younger patients may require NSAID therapy over many years, presenting a prolonged exposure to risk.” Dr. Altman and colleagues conducted a post-hoc analysis of an 8-week, multicentre, prospective, randomised, double-blind, parallel-group trial evaluating the efficacy and safety of the NSAID diclofenac in 385 patients with mild to moderate OA in the dominant hand. Patients were stratified by age (<65 and >=65 years) and randomised to placebo (n = 187) or diclofenac (n = 198) 2 g to each hand 4 times daily. Primary outcomes -- OA pain intensity (100-mm Visual Analog Scale [VAS]), Australian/Canadian Osteoarthritis Hand Index (AUSCAN) score, and global rating of disease (GRD) -- were measured at 4 and 6 weeks and were compared by patient age (<65 vs >= 65 years). Patients receiving diclofenac showed improvements at weeks 4 and 6 in OA pain intensity (42% and 46%, respectively), total AUSCAN score (35% and 38%), and GRD (36% and 40%). These improvements were significantly superior to receiving placebo for OA pain intensity and total AUSCAN score (P <= .02) at weeks 4 and 6, but for GRD only at week 6 (P = .02). There were no significant differences in efficacy between the younger patient group and the elderly patient group. Adverse events (AE) in patients receiving diclofenac were similar across both age groups. Application site reactions were the most common AE and were more frequent in the diclofenac group compared with the placebo group for patients aged <65 years (4% vs 1%) and >= 65 years (5% vs 3%). No serious treatment-related AEs or incidences of gastrointestinal bleeding were reported. Funding for this study was provided by Novartis Consumer Health Inc. and Endo Pharmaceuticals Inc. [Presentation title: Safety and Efficacy of Topical Diclofenac Sodium 1% Gel in Seniors and Younger Patients with Hand Osteoarthritis. Abstract 100]
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