Age analysis of long-term safety of diclofenac sodium 1% gel for patients with osteoarthritis of the knee

Abstract

This study evaluated the safety of topical diclofenac sodium 1% gel (DSG) in an open-label extension of 2 double-blind, randomized, 3-month trials of DSG in patients ≥35 years with a ≥6-month history of symptomatic Kellgren-Lawrence grade 1–3 knee OA. Patients applied 4 g DSG to 1 or both knees 4 times daily for 9 (continuing patients) or 12 (new patients) months; use of rescue acetaminophen (≤4 g/d) was allowed. AEs were monitored throughout the study and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain, stiffness, and physical function subscales were assessed at baseline and 3, 6, 9, and 12 months.