Voltaren: Long-Term Tolerability of Topical Diclofenac Sodium Gel for Knee Osteoarthritis in Elderly and Comorbid Patients

Background

• Knee Osteoarthritis (OA) is common in individuals aged ≥ 65 years, who are at higher risk for adverse events. Therapy must balance pain relief with potential side effects.
• Oral NSAIDs effectively relieve OA pain but pose gastrointestinal, cardiovascular, and renal risks, especially in the elderly and those with conditions like hypertension, type 2 diabetes, and cardiovascular disease.
• Topical NSAIDs, such as diclofenac sodium 1% gel (DSG), offer similar efficacy with fewer adverse events compared to oral NSAIDs. Studies show DSG is well-tolerated in patients with hand or knee OA at high risk for adverse events.
• OARSI guidelines recommend topical NSAIDs like 1% DSG as the first-line therapy for OA due to their equivalent efficacy and lower adverse event frequency compared to oral NSAIDs.

Study Objective and Methodology

A multicenter, open-label, post hoc analysis was conducted to determine the long-term (12 months) tolerability of DSG in elderly knee OA patients with an elevated risk of gastrointestinal, cardiovascular, and renal adverse events.

Results

Stratification by age, < 65 years and ≥ 65 years: For both groups, the percentage of patients who had any adverse event was similar. Patients aged <65 years were more likely to experience gastrointestinal (GI) adverse events and less likely to experience application site dermatitis (ASD), in comparison to patients aged ≥ 65 years.

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