ArticlePain and therapy2025
Evaluating the Real-World Use of Topical Diclofenac Sodium Gel 1% Using US Longitudinal Electronic Health Records Database: A study supporting OTC switch.
Article in Pain and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Who cites it
1 citing paper in PubMed, 1 synthesis or guideline pooled it.
- Renal Safety of Topical Diclofenac in Adults with Increased Renal Risk: A Systematic Review.Medicina (Kaunas, Lithuania) · 2026Pooled it
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PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionMusculoskeletal conditions are a significant health challenge and second leading cause of disability worldwide. Diclofenac sodium topical gel 1% (DSG1%) provides effective relief of arthritis pain. While clinical studies show that DSG1% is safe and well-tolerated, long-term safety and tolerability in real-world settings are limited. This study aimed to profile users and prescribers of DSG1% and to evaluate its safety and tolerability over a screening period of 8.5 years with an average follow-up of nearly 1 year. The focus was on patients with risk factors and comorbidities, especially those taking concomitant medication in addition to topical nonsteroidal anti-inflammatory drugs (NSAIDs).
methodsThis retrospective, longitudinal cohort study used the US Department of Defense (DoD) electronic health records (EHR) database. The database included 521,593 individuals with ≥ 1 prescription for DSG1% for either indicated or non-indicated conditions with mean (standard deviation; SD) follow-up of 348.4 (562.4) days. The primary outcome measure assessed the incidence of predefined events of interest (EOIs), including gastrointestinal, hepatic, renal diseases, cardiovascular events, hypertension, skin reaction, misuse, abuse, and death (all-cause mortality).
resultsThe average age of subjects was 56.7 years (SD = 18.1), with women comprising 60.4% of population. During study-period, 74.2% of subjects experienced no adverse EOIs after initiating treatment with DSG1%. Among the remaining 25.8%, average time to first EOI was 244.0 (SD = 368.6) days. Notably, the frequency of reported EOIs increased with age. Additionally, subjects with conditions such as rheumatoid arthritis, systemic lupus erythematosus, or diabetes had a higher incidence of cardiovascular EOIs.
conclusionsThe study results indicate that DSG demonstrated a favorable safety profile, particularly for patients with comorbidities and high-risk factors and when used with other medications. Despite an older population and high baseline risk factors (93%), only 26% DSG1% users experienced a predefined EOI, observed on average 244.0 (368.6) days from index date. These findings confirm the long-term tolerability of topical DSG1% for musculoskeletal disorders.
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