PMID- 21231861 OWN - NLM STAT- MEDLINE DCOM- 20110614 LR - 20191210 IS - 1473-4877 (Electronic) IS - 0300-7995 (Linking) VI - 27 IP - 3 DP - 2011 Mar TI - Safety profile of topical diclofenac: a meta-analysis of blinded, randomized, controlled trials in musculoskeletal conditions. PG - 605-22 LID - 10.1185/03007995.2010.550606 [doi] AB - 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. FAU - Taylor, R S AU - Taylor RS AD - Peninsula College of Medicine & Dentistry, Universities of Exeter & Plymouth, Exeter, UK. rod.taylor@pms.ac.uk FAU - Fotopoulos, G AU - Fotopoulos G FAU - Maibach, H AU - Maibach H LA - eng PT - Evaluation Study PT - Journal Article PT - Meta-Analysis PT - Review PT - Systematic Review DEP - 20110113 PL - England TA - Curr Med Res Opin JT - Current medical research and opinion JID - 0351014 RN - 0 (Anti-Inflammatory Agents, Non-Steroidal) RN - 0 (Placebos) RN - 144O8QL0L1 (Diclofenac) SB - IM MH - Administration, Topical MH - Algorithms MH - Anti-Inflammatory Agents, Non-Steroidal/administration & dosage/adverse effects MH - Diclofenac/*administration & dosage/*adverse effects MH - Double-Blind Method MH - Drug-Related Side Effects and Adverse Reactions/*epidemiology MH - Humans MH - Musculoskeletal Diseases/*drug therapy/*epidemiology MH - Placebos MH - Randomized Controlled Trials as Topic/*statistics & numerical data MH - Single-Blind Method EDAT- 2011/01/15 06:00 MHDA- 2011/06/15 06:00 CRDT- 2011/01/15 06:00 PHST- 2011/01/15 06:00 [entrez] PHST- 2011/01/15 06:00 [pubmed] PHST- 2011/06/15 06:00 [medline] AID - 10.1185/03007995.2010.550606 [doi] PST - ppublish SO - Curr Med Res Opin. 2011 Mar;27(3):605-22. doi: 10.1185/03007995.2010.550606. Epub 2011 Jan 13.