Gastrointestinal Tolerability of Diclofenac Epolamine Topical Patch 1.3%: A Pooled Analysis of 14 Clinical Studies

Abstract

Objective: The purpose of this investigation was to evaluate the gastrointestinal (GI) tolerability profile of diclofenac epolamine topical patch 1.3% (DETP) during short-term treatment in patients with mild-to-moderate pain. Design: Fourteen clinical trials of DETP were examined; 10 placebo-controlled studies were further integrated for analyses. All adverse event (AE) data were coded to the Medical Dictionary for Regulatory Activities. Outcome Measures: Frequency of GI AEs was summarized by treatment, preferred term, sex, and age group. Results: The percentage of patients reporting GI AEs were similar between patients treated with the DETP and placebo, with only 3 of the 10 placebo-controlled trials reporting events in > 2% of patients; there was no significant difference between DETP and placebo for any preferred GI term. The most common GI AE reported for both treatment groups was nausea (1.5% DETP, 1.1% placebo). There was no significant difference between treatment groups and sex in the number of reported events and no noted difference between age groups. Conclusion: This study provides evidence that DETP is a topical nonsteroidal anti-inflammatory drug that is a well-tolerated treatment option, demonstrating a low incidence of GI AEs across 14 clinical trials, making it a possible alternative to short-term oral NSAIDs, which are commonly associated with GI complications.