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Tolerability of topical diclofenac sodium 1% gel for osteoarthritis in seniors and patients with comorbidities.
Am J Geriatr Pharmacother. 2012 Feb; 10(1):47-60.AJ

Abstract

BACKGROUND

Nonsteroidal anti-inflammatory drugs (NSAIDs) are associated with a dose-related risk of cardiovascular, renal, and gastrointestinal adverse events (AEs). Topical NSAIDs produce lower systemic NSAID exposure compared with oral NSAIDs, offering potential benefits.

OBJECTIVE

To evaluate the safety of topical diclofenac sodium 1% gel (DSG) for knee and hand osteoarthritis (OA) in older and younger patients and in patients with versus without comorbid hypertension, type 2 diabetes, or cerebrovascular or cardiovascular disease.

METHODS

Post hoc analysis of pooled data from 5 randomized, double-blind, placebo-controlled trials involving 1426 patients (aged ≥35 years) with mild to moderate OA of the knee and 783 patients (aged ≥40 years) with mild to moderate OA of the hand. Patients applied 4 g of DSG or vehicle to affected knees QID for 12 weeks or 2 g of DSG or vehicle to affected hands QID for 8 weeks.

RESULTS

In patients with knee OA, the percentage with ≥1 adverse event was similar in patients aged <65 years (56.6%) versus ≥65 years (55.8%) and was similar in patients with versus without comorbid hypertension (53.4% vs 59.0%, respectively), type 2 diabetes mellitus (50.0% vs 57.2%), or cerebrovascular or cardiovascular disease (53.8% vs 56.5%). In patients with hand OA, the percentage with ≥1 AE was similar in patients aged ≥65 years (42.7%) versus <65 years (39.1%) and was similar in patients with versus without hypertension (39.6% vs 41.7%, respectively), lower in patients with versus without type 2 diabetes mellitus (28.0% vs 41.6%), and higher in patients with versus without cerebrovascular or cardiovascular disease (48.5% vs 39.2%). Gastrointestinal, cardiovascular, and renal AEs were rare and did not differ according to age or comorbidity. Application site reactions were the primary cause for the greater frequency of AEs with DSG versus vehicle.

CONCLUSION

The similar and low rates of AEs in DSG-treated patients aged ≥65 years and <65 years and in those with and without comorbid hypertension, type 2 diabetes, or cerebrovascular or cardiovascular disease suggest that DSG treatment is generally well tolerated.

Authors+Show Affiliations

Center for Rheumatology and Bone Research, a division of Arthritis and Rheumatism Associates, PC, Wheaton, Maryland, USA.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Evaluation Study
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22264852

Citation

Baraf, Herbert S B., et al. "Tolerability of Topical Diclofenac Sodium 1% Gel for Osteoarthritis in Seniors and Patients With Comorbidities." The American Journal of Geriatric Pharmacotherapy, vol. 10, no. 1, 2012, pp. 47-60.
Baraf HS, Gold MS, Petruschke RA, et al. Tolerability of topical diclofenac sodium 1% gel for osteoarthritis in seniors and patients with comorbidities. Am J Geriatr Pharmacother. 2012;10(1):47-60.
Baraf, H. S., Gold, M. S., Petruschke, R. A., & Wieman, M. S. (2012). Tolerability of topical diclofenac sodium 1% gel for osteoarthritis in seniors and patients with comorbidities. The American Journal of Geriatric Pharmacotherapy, 10(1), 47-60. https://doi.org/10.1016/j.amjopharm.2011.12.002
Baraf HS, et al. Tolerability of Topical Diclofenac Sodium 1% Gel for Osteoarthritis in Seniors and Patients With Comorbidities. Am J Geriatr Pharmacother. 2012;10(1):47-60. PubMed PMID: 22264852.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Tolerability of topical diclofenac sodium 1% gel for osteoarthritis in seniors and patients with comorbidities. AU - Baraf,Herbert S B, AU - Gold,Morris S, AU - Petruschke,Richard A, AU - Wieman,Matthew S, Y1 - 2012/01/20/ PY - 2011/12/12/accepted PY - 2012/1/24/entrez PY - 2012/1/24/pubmed PY - 2012/12/10/medline SP - 47 EP - 60 JF - The American journal of geriatric pharmacotherapy JO - Am J Geriatr Pharmacother VL - 10 IS - 1 N2 - BACKGROUND: Nonsteroidal anti-inflammatory drugs (NSAIDs) are associated with a dose-related risk of cardiovascular, renal, and gastrointestinal adverse events (AEs). Topical NSAIDs produce lower systemic NSAID exposure compared with oral NSAIDs, offering potential benefits. OBJECTIVE: To evaluate the safety of topical diclofenac sodium 1% gel (DSG) for knee and hand osteoarthritis (OA) in older and younger patients and in patients with versus without comorbid hypertension, type 2 diabetes, or cerebrovascular or cardiovascular disease. METHODS: Post hoc analysis of pooled data from 5 randomized, double-blind, placebo-controlled trials involving 1426 patients (aged ≥35 years) with mild to moderate OA of the knee and 783 patients (aged ≥40 years) with mild to moderate OA of the hand. Patients applied 4 g of DSG or vehicle to affected knees QID for 12 weeks or 2 g of DSG or vehicle to affected hands QID for 8 weeks. RESULTS: In patients with knee OA, the percentage with ≥1 adverse event was similar in patients aged <65 years (56.6%) versus ≥65 years (55.8%) and was similar in patients with versus without comorbid hypertension (53.4% vs 59.0%, respectively), type 2 diabetes mellitus (50.0% vs 57.2%), or cerebrovascular or cardiovascular disease (53.8% vs 56.5%). In patients with hand OA, the percentage with ≥1 AE was similar in patients aged ≥65 years (42.7%) versus <65 years (39.1%) and was similar in patients with versus without hypertension (39.6% vs 41.7%, respectively), lower in patients with versus without type 2 diabetes mellitus (28.0% vs 41.6%), and higher in patients with versus without cerebrovascular or cardiovascular disease (48.5% vs 39.2%). Gastrointestinal, cardiovascular, and renal AEs were rare and did not differ according to age or comorbidity. Application site reactions were the primary cause for the greater frequency of AEs with DSG versus vehicle. CONCLUSION: The similar and low rates of AEs in DSG-treated patients aged ≥65 years and <65 years and in those with and without comorbid hypertension, type 2 diabetes, or cerebrovascular or cardiovascular disease suggest that DSG treatment is generally well tolerated. SN - 1876-7761 UR - https://www.unboundmedicine.com/medline/citation/22264852/Tolerability_of_topical_diclofenac_sodium_1_gel_for_osteoarthritis_in_seniors_and_patients_with_comorbidities_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1543-5946(11)00209-1 DB - PRIME DP - Unbound Medicine ER -