Safety profile of topical diclofenac: a meta-analysis of blinded, randomized, controlled trials in musculoskeletal conditions

Taylor, R.S. , Fotopoulos, G. and Maibach, H. (2011) Safety profile of topical diclofenac: a meta-analysis of blinded, randomized, controlled trials in musculoskeletal conditions. Current Medical Research and Opinion, 27(3), pp. 605-622. (doi: 10.1185/03007995.2010.550606) (PMID:21231861)

Abstract

Background: Topical non-steroidal anti-inflammatory drugs (NSAIDs) are clinically proven for the management of musculoskeletal conditions. It is important that prescribers and patients are aware of the safety profile of topical NSAIDs. Objectives: To evaluate the risk of adverse events (AEs) associated with topical diclofenac for the treatment of acute and chronic musculoskeletal conditions. Design: Systematic review and meta-analysis of blinded, randomized, placebo-, vehicle- or active-controlled trials. Results: The risk of any type of AE experienced with topical diclofenac was slightly higher compared with placebo/vehicle (RR 1.11), but was more than 50% lower than the risk observed with active topical comparators (RR 0.53). Absolute risk values indicated differences in the risk of AEs depending on the diclofenac formulation used; in particular, lower rates of local skin reactions were observed with diclofenac patches (e.g. 2.5% in placebo/vehicle-controlled studies) and gels (4.2%) compared with diclofenac solutions containing dimethylsulfoxide (34.2%). Dry skin/crusting and rash were the most common local skin reactions reported (9.0% and 3.0% of patients, respectively, in placebo/vehicle-controlled studies), which were usually mild-to-moderate and self-resolving. The discontinuation rate due to local skin reactions with topical diclofenac (1.9%) was low and comparable with non-active comparators (0.7%), and the tolerability of topical diclofenac treatment was rated as ‘good’ to ‘excellent’ by >90% physicians and patients. Conclusions: Topical diclofenac appears to be generally well tolerated for cutaneous use in acute and chronic musculoskeletal conditions.

• Item Type: Articles
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Taylor, Professor Rod
• Authors: Taylor, R.S., Fotopoulos, G., and Maibach, H.
• College/School: College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > MRC/CSO SPHSU
• Journal Name: Current Medical Research and Opinion
• Publisher: Informa Healthcare
• ISSN: 0300-7995
• ISSN (Online): 1473-4877
• Published Online: 14 January 2011