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Diclofenac Sodium Gel Effective and Safe in Elderly Patients With Osteoarthritis: Presented at AGS
Diclofenac sodium gel offers elderly osteoarthritis patients an effective and well-tolerated treatment option, according to research presented here at the 2008 Annual Scientific Meeting of the American Geriatrics Society (AGS).
This randomised, double-blind, vehicle-controlled, parallel-group, phase 3 study was conducted in patients with knee osteoarthritis diagnosed clinically using American College of Rheumatology (ACR) criteria and x-ray evidence (Kellgren-Lawrence grades 1 to 3).
All patients on trial had pain only in the target knee, requiring treatment with nonsteroidal anti-inflammatory drugs or acetaminophen, explained lead author F. Michael Gloth, MD, President, Victory Springs Senior Health Associates, and Associate Professor of Medicine, Division of Geriatric Medicine and Gerontology, Johns Hopkins University School of Medicine, Baltimore, Maryland.
The study compared the efficacy of topical diclofenac sodium gel 1% (DSG) versus vehicle in this patient population. The 12-week trial was conducted in 64 centres across the United States.
Dr. Gloth and his collaborator reported their findings in a poster presentation on May 1.
A total of 492 patients were randomised to DSG or vehicle, with 4 g applied to the target knee 4 times daily.
A total of 338 patients were younger than 65 years of age; 173 of these patients were randomised to DSG and 165 to the vehicle. Among the 154 patients who were aged 65 years or older, 81 were randomised to DSG and 73 to vehicle. However, the study was not powered to show differences in efficacy between age groups, noted Dr. Gloth.
Primary endpoints, which were measured at week 12, were the Western Ontario McMaster Osteoarthritis Index (WOMAC) pain score (range, 0-20), WOMAC physical function score (range, 0-68), and Global Rating of Disease.
A modified subpopulation was used for the efficacy analysis. Patients with pain on movement in the target knee that declined in the time interval between the screening and baseline visits were excluded from the efficacy analysis, in addition to patients presenting with at least mild pain in the contralateral knee at baseline.
The study consisted of a screening period (days -14 to -7), followed by a 7-day washout period and a 12-week treatment period with evaluations at baseline and at weeks 1, 4, and 8, explained Dr. Gloth.
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