Pooled analysis of clinical trial data evaluating the safety and effectiveness of diclofenac epolamine topical patch 1.3% for the treatment of acute ankle sprain

Abstract

This pooled analysis assessed the efficacy and safety of the diclofenac epolamine topical patch 1.3% (DETP) for the treatment of acute mild-to-moderate ankle sprain. Data from 2 randomized, double-blind, placebo-controlled studies enrolling 274 male and female patients aged 18 to 65 years with acute ankle sprain were pooled and evaluated. The primary end point was pain reduction on movement assessed using a 100 mm visual analog scale (VAS). Safety and tolerability were also assessed. Beginning approximately 3 hours after initial treatment, DETP-treated patients experienced statistically significant and sustained lower mean VAS scores in pain intensity on movement (mean ± SD, 54.1 ± 20.0 mm versus 60.3 ± 16.8 mm) compared with placebo-treated patients, representing a 20% versus 13% reduction in VA S pain scores from baseline (P = 0.012). This statistically significant difference in mean VAS score was maintained through day 7 (9.4 ± 14.4 mm versus 18.4 ± 18.2 mm, P < 0.0001). The DETP and placebo patches were well tolerated. These results further confirm the efficacy and safety of DETP for the treatment of acute pain from ankle sprains.

Keywords: acute pain; clinical trial; double-blind; safety; soft tissue injury; visual analog scale.

Figure 1

Patient disposition flow chart showing the total number of patients randomized to each study (by treatment group), as well as the number of individuals that completed each study (by treatment group). Abbreviation: DEPT, diclofenac epolamine topical patch.

Figure 2

Percent (%) reduction of post-treatment scores for pain on movement (visual analog scale; VAS) in patients treated with diclofenac epolamine topical patch (DETP) and placebo. Pain reduction was statistically significantly different between treatment groups, favoring DETP treatment, starting 3 hours after initial patch application and continuing through the end of the study (day 7). The asterisk denotes statistical significance (P ≤ 0.05).

Figure 3

Global efficacy assessments for each treatment group judged by both patients and investigators at day 7 for Study 1 A) and Study 2 B). This assessment revealed that, for both studies, the diclofenac epolamine topical patch (DETP) treatment was superior to placebo treatment at day 7; day 3 analyses demonstrated comparable results (not shown).

Figure 4

Overall tolerability of diclofenac epolamine topical patch (DETP) or placebo for each treatment group, assessed by patients and investigators at day 7 for Study 1 A) and Study 2 B). The majority of patients in both treatment groups judged the patch tolerability as excellent. No significant differences were found between DETP- and placebo-treated patients at day 7; results from day 3 tolerability assessments were comparable (not shown).