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Long-term tolerability of topical diclofenac sodium 1% gel for osteoarthritis in seniors and patients with comorbidities.
Clin Interv Aging. 2012; 7:517-23.CI

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.

Authors+Show Affiliations

Feasterville Family Health Care Center, Feasterville, PA 19053, USA. jhpdo@aol.comNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23204844

Citation

Peniston, John H., et al. "Long-term Tolerability of Topical Diclofenac Sodium 1% Gel for Osteoarthritis in Seniors and Patients With Comorbidities." Clinical Interventions in Aging, vol. 7, 2012, pp. 517-23.
Peniston JH, Gold MS, Wieman MS, et al. Long-term tolerability of topical diclofenac sodium 1% gel for osteoarthritis in seniors and patients with comorbidities. Clin Interv Aging. 2012;7:517-23.
Peniston, J. H., Gold, M. S., Wieman, M. S., & Alwine, L. K. (2012). Long-term tolerability of topical diclofenac sodium 1% gel for osteoarthritis in seniors and patients with comorbidities. Clinical Interventions in Aging, 7, 517-23. https://doi.org/10.2147/CIA.S35416
Peniston JH, et al. Long-term Tolerability of Topical Diclofenac Sodium 1% Gel for Osteoarthritis in Seniors and Patients With Comorbidities. Clin Interv Aging. 2012;7:517-23. PubMed PMID: 23204844.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Long-term tolerability of topical diclofenac sodium 1% gel for osteoarthritis in seniors and patients with comorbidities. AU - Peniston,John H, AU - Gold,Morris S, AU - Wieman,Matthew S, AU - Alwine,Lawrence K, Y1 - 2012/11/20/ PY - 2012/12/4/entrez PY - 2012/12/4/pubmed PY - 2013/5/17/medline KW - diclofenac KW - nonsteroidal anti-inflammatory drugs KW - osteoarthritis KW - topical analgesic SP - 517 EP - 23 JF - Clinical interventions in aging JO - Clin Interv Aging VL - 7 N2 - 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. SN - 1178-1998 UR - https://www.unboundmedicine.com/medline/citation/23204844/Long_term_tolerability_of_topical_diclofenac_sodium_1_gel_for_osteoarthritis_in_seniors_and_patients_with_comorbidities_ L2 - https://dx.doi.org/10.2147/CIA.S35416 DB - PRIME DP - Unbound Medicine ER -