Photo Credit: AI

The following is a summary of “Evaluating the Real-World Use of Topical Diclofenac Sodium Gel 1% Using US Longitudinal Electronic Health Records Database: A study supporting OTC switch,” published in the April 2025 issue of Pain and Therapy by Sicignano et al. 

Musculoskeletal conditions were a major health challenge and the second leading cause of disability worldwide, while long-term safety data on diclofenac sodium topical gel 1% (DSG1%) in real-world settings remained limited.  

Researchers conducted a retrospective study to profile users and prescribers of DSG1%, evaluating its safety and tolerability over 8.5 years, with an average follow-up of nearly 1 year, particularly in individuals with risk factors and comorbidities using concomitant medications with topical nonsteroidal anti-inflammatory drugs (NSAIDs).  

They utilized the US Department of Defense (DoD) electronic health records (EHR) database, which included 5,21,593 individuals with at least 1 prescription for DSG1% for indicated or non-indicated conditions, with a mean (standard deviation; SD) follow-up of 348.4 (562.4) days. The primary outcome measure evaluated the incidence of predefined events of interest (EOIs), including gastrointestinal, hepatic, and renal diseases, cardiovascular events, hypertension, skin reactions, misuse, abuse, and death (all-cause mortality).  

The results showed that the average age of individuals was 56.7 years (SD = 18.1), with 60.4% being women. Throughout the study period, 74.2% did not experience adverse EOIs after starting DSG1%. Among the 25.8% who developed EOIs, the mean time to the first event was 244.0 days (SD = 368.6). The frequency of EOIs increased with age, and individuals with rheumatoid arthritis, systemic lupus erythematosus, or diabetes had a higher incidence of cardiovascular EOIs.  

Investigators concluded that DSG displayed a favorable safety profile, even in older, high-risk patients with comorbidities and concomitant medications, with a low incidence of predefined events of interest over a significant period, confirming the long-term tolerability of topical DSG1% for musculoskeletal disorders. 

Source: link.springer.com/article/10.1007/s40122-025-00723-9