Clinical Study Data: Product Safety

Voltaren provides safe, effective arthritis relief

Voltaren is a clinically proven safe option when used according to the label for a wide range of patients. Learn more about the latest safety research below.

OA Prevalence Continues to Grow

According to the Centers of Disease Control and Prevention (CDC), OA affects over 32.5 million US adults.1 This number is expected to grow as the population continues to age. This makes it critical that patients are treated with safe and effective solutions.

Study Summary: Long-term tolerability of topical diclofenac sodium 1% gel for OA in patients with comorbidities
Study objective & methodology

A multicenter, open-label, post hoc analysis was conducted to determine the long-term (12 months) tolerability of diclofenac sodium gel 1% (DSG) in elderly knee OA patients with an elevated risk of gastrointestinal, cardiovascular, and renal adverse events.

Results:

For both patient groups <65 years and ≥ 65 years, 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.

Long-term treatment (12 months) with DSG is safe in-patient subpopulations with an elevated risk of NSAID-related adverse events.

Download our study summary to learn more about how Voltaren can be safely administered in elderly patients with knee OA and patients with comorbid conditions that predispose them to NSAID-related adverse events.

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Study Summary: Systemic exposure of topical vs. oral diclofenac sodium in healthy volunteers
Study objective & methodology

A seven-week, single-center, randomized, open-label, multiple-dose, 3-way crossover study conducted in healthy volunteers ≥ 50 years (n=40) to compare the systemic bioavailability and pharmacodynamics of topical diclofenac sodium gel 1% (DSG) vs. oral diclofenac sodium 50-mg tablets.

Results:

Systemic exposure and maximum plasma concentrations of diclofenac were significantly lower with DSG than with oral diclofenac sodium tablets (DS Tab)

Platelet aggregation and COX-1 were minimally inhibited by DSG when compared with DS Tab which ensures low risk of cardiovascular health related AEs

Topical diclofenac, with a more favorable safety profile, represents a useful alternative to oral diclofenac therapy in pain management

Download our study summary to learn more about how diclofenac sodium gel 1% showed significantly lower systemic exposure and fluctuation in plasma levels compared with oral diclofenac sodium for osteoarthritis.

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