Author(s): Peniston JH, Gold MS, Wieman MS, Alwine LK
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Abstract BACKGROUND: Adverse events associated with nonsteroidal anti-inflammatory drugs (NSAIDs) used to treat knee and hand osteoarthritis may be more frequent in certain patient populations. Topical NSAIDs, such as diclofenac sodium 1\% gel (DSG), have equivalent efficacy and fewer adverse events compared with oral NSAIDs. This post hoc analysis assessed the long-term tolerability of DSG in elderly patients and patients with an elevated risk of gastrointestinal, cardiovascular, and renal adverse events. METHODS: Patients ≥ 35 years of age with knee osteoarthritis applied DSG (4 g) to one or both knees for 12 weeks during either of two primary studies and for 9 months during a long-term extension study. Other patients entered the long-term extension study directly and applied DSG for 12 months. Safety was assessed by reported adverse events. Subpopulations were defined based on age, or the comorbidities of hypertension, type 2 diabetes mellitus, and cerebrovascular or cardiovascular disease. RESULTS: The safety population consisted of 947 patients who received at least one dose of DSG during the primary or extension study. Patients aged < 65 years (68.2\%) and ≥65 years (67.2\%) experienced any adverse event at similar rates. The percentage of patients who experienced any adverse event was similar between patients with and without hypertension (65.5\% versus 69.7\%, respectively), type 2 diabetes mellitus (64.0\% versus 68.2\%), or cerebrovascular or cardiovascular disease (61.9\% versus 68.5\%). Among the 15 patients with all three comorbidities, the percentage of patients with any adverse event (53.3\%) was less than that of patients who did not have all three comorbidities (68.0\%). CONCLUSION: These results suggest that long-term DSG treatment is safe in patient subpopulations with an elevated risk of NSAID-related adverse events, such as the elderly and those with the comorbidities of hypertension, type 2 diabetes mellitus, and cerebrovascular or cardiovascular disease.
This article was published in Clin Interv Aging
and referenced in Emergency Medicine: Open Access