John H Peniston, 1 Morris S Gold, 2 Matthew S Wieman, 3 Lawrence K Alwine 4
1 Feasterville Family Health Care Center, Feasterville, PA, 2 Clinical Research and Biostatistics, Novartis Consumer Health Inc, Parsippany, NJ, 3 Medical Affairs, Endo Pharmaceuticals Inc, Chadds Ford, PA, 4 Downingtown Family Medicine, Downingtown, PA, USA
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 (%) and ≥65 years (%) experienced any adverse event at similar rates. The percentage of patients who experienced any adverse event was similar between patients with and without hypertension (% versus %, respectively), type 2 diabetes mellitus (% versus %), or cerebrovascular or cardiovascular disease (% versus %). Among the 15 patients with all three comorbidities, the percentage of patients with any adverse event (%) was less than that of patients who did not have all three comorbidities (%).
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.
Keywords: diclofenac, nonsteroidal anti-inflammatory drugs, osteoarthritis, topical analgesic
Results The number of AKs on the face and ears per participant was not different between the fluorouracil and control groups at randomization ( vs , P > .10). After randomization, the fluorouracil group had fewer AKs compared with the control group at 6 months ( vs , P < .001) and for the overall study duration ( P < .001). The fluorouracil group also had higher complete AK clearance rates (38% vs 17% at 6 months) and fewer spot treatments at 6-month intervals, at study visits, and in between study visits during the trial ( P < .01 for all). The fluorouracil group took longer to require the first spot AK treatment ( months) compared with the control group ( months) (hazard ratio, ; 95% CI, -). The number of hypertrophic AKs was not different between the 2 groups overall ( P = .60), although there were fewer hypertrophic AKs in the fluorouracil group at 6 months ( vs ) ( P = .05).
No. with Atopic Dermatitis
No. with Psoriasis vulgaris
Mean age (years)
43 (range 22-57)
Mean duration of treatment with Group III or IV topical steroids (years)
16 (range 6-25)
Localization of skin atrophy:
Clinical evaluation of severity of symptoms and signs of skin atrophy at baseline and at end of treatment.
Clinical parameters Mean severity at baseline Mean severity at end of treatment Decreased thickness of skin (range 2-3) Laxity (range 2-3) Purpura/Echymoses (range 1-3) Dryness Teleangiectasia (range 2-3) (range 1-2) Table 3.
Mean epidermal and dermal thickness, skin elasticity, erythemal and moisture indexes at baseline and after 8 months of treatment with Vivida of 40 patients with corticosteroid induced skin atrophy. Parameters Baseline 8 months Epidermal thickness (mm) (-) (-) Dermal thickness (mm) (-) (-) Elasticity Index 44 (39-53) 74 (65-78) Erythemal Index (-) (-) Moisture Index (11-37) (75-97)