Topical nonsteroidal anti-inflammatory drugs for the treatment of pain due to soft tissue injury: diclofenac epolamine topical patch

Abstract

The objective of this article is to review published clinical data on diclofenac epolamine topical patch 1.3% (DETP) in the treatment of acute soft tissue injuries, such as strains, sprains, and contusions. Review of published literature on topical nonsteroidal anti-inflammatory drugs (NSAIDs), diclofenac, and DETP in patients with acute soft tissue injuries was included. Relevant literature was identified on MEDLINE using the search terms topical NSAIDs, diclofenac, diclofenac epolamine, acute pain, sports injury, soft tissue injury, strain, sprain, and contusion, and from citations in retrieved articles covering the years 1978-2008. Review of published, randomized clinical trials and meta-analyses shows that topical NSAIDs are significantly more effective than placebo in relieving acute pain; the pooled average relative benefit was 1.7 (95% confidence interval, 1.5-1.9). In a limited number of comparisons, topical and oral NSAIDs provided comparable pain relief, but the use of topical agents produced lower plasma drug concentrations and fewer systemic adverse events (AEs). The physical-chemical properties of diclofenac epolamine make it well suited for topical use. In patients with acute soft tissue injuries treated with DETP, clinical data report an analgesic benefit within hours of the first application, and significant pain relief relative to placebo within 3 days. Moreover, DETP displayed tolerability comparable with placebo; the most common AEs were pruritus and other application site reactions. Review of published literature suggests that DETP is generally safe and well tolerated, clinically efficacious, and a rational treatment option for patients experiencing acute pain associated with strains, sprains, and contusions, and other localized painful conditions.

Keywords: contusions; diclofenac epolamine; soft tissue injury; sprains; strains; topical analgesics.

Figure 1

Success rates with topical nonsteroidal anti-inflammatory drugs (NSAIDs) vs topical placebo in the treatment of acute (open circles) and chronic (filled squares) painful conditions. Outcomes were assessed after 7 days in acute conditions and 14 days in chronic conditions. Copyright © 1998, BMJ Publishing Group Ltd. Reproduced with permission from Moore RA, Tramer MR, Carroll D, Wiffen PJ, McQuay HJ. Quantitative systematic review of topically applied non-steroidal anti-inflammatory drugs, BMJ. 1998;316:333–338.

Figure 2

Comparison of diclofenac epolamine topical patch (DETP) and placebo in reducing pain on movement in patient with acute ankle sprains. Pain was measured on a 100-mm visual analog scale (VAS) at baseline (day 0) and on days 1, 3, and 7 of twice-daily treatment. Copyright © 2003, Elsevier Masson SAS Editeur, all rights reserved. Adapted with permission from Joussellin E. Flector Tissugel^® in the treatment of painful ankle sprain. J Traumatol Sport. 2003;20:1S5–1S9.