Long-term tolerability of topical diclofenac sodium 1% gel for osteoarthritis in seniors and patients with comorbidities

• Published in: Clinical interventions in aging 2012-01, Vol.7, p.517-523
• Main Authors: Peniston, John H, Gold, Morris S, Wieman, Matthew S, Alwine, Lawrence K
• Format: Article
• Language: English
• Subjects: Administration, Cutaneous; Adult; Age Factors; Aged; Analysis; Anti-Inflammatory Agents, Non-Steroidal - administration & dosage; Anti-Inflammatory Agents, Non-Steroidal - adverse effects; Anti-Inflammatory Agents, Non-Steroidal - therapeutic use; Arthritis; Cardiovascular disease; Cardiovascular Diseases - epidemiology; Care and treatment; Cholesterol; Comorbidity; Complications and side effects; Diabetes; Diabetes Mellitus, Type 2 - epidemiology; Diclofenac; Diclofenac - administration & dosage; Diclofenac - adverse effects; Diclofenac - therapeutic use; Female; Gels; Health risk assessment; Humans; Hypertension; Hypertension - epidemiology; Male; Middle Aged; Nonsteroidal anti-inflammatory drugs; Older people; Original Research; Osteoarthritis; Osteoarthritis - drug therapy; Osteoarthritis - epidemiology; Patients; topical analgesic; topical analgesics
• ISSN: 1178-1998; 1176-9092; 1178-1998
• DOI: 10.2147/CIA.S35416

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. 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. 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%). 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.