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Safety and efficacy of topical diclofenac sodium 1% gel in knee osteoarthritis: a randomized controlled trial.
Phys Sportsmed. 2010 Jun; 38(2):19-28.PS

Abstract

BACKGROUND

Topical nonsteroidal anti-inflammatory drugs (NSAIDs) may provide an alternative to oral NSAIDs to relieve pain from osteoarthritis (OA), reducing systemic exposure. This 12-week, randomized, double-blind, parallel-group, multicenter trial examined the efficacy and safety of topical diclofenac sodium 1% gel (DSG) for symptomatic knee OA.

METHODS

Eligible patients were aged >/= 35 years with symptomatic Kellgren-Lawrence grade (KLG) 1 to 3 OA in 1 or both knees for >/= 6 months. Patients meeting entry criteria applied DSG 4 g or vehicle 4 times daily to the symptomatic knee(s). Primary endpoints were Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and physical function subscales and global rating of benefit at week 12. Pain on movement at week 4 was an additional primary endpoint for European regulatory purposes. Secondary endpoints included primary outcomes at weeks 1, 4, and 8; WOMAC stiffness subscale; spontaneous pain; global rating of disease; and global evaluation of treatment. Subanalyses were performed according to KLG, the number of knees treated, and age.

RESULTS

Four hundred twenty patients were randomly assigned to DSG (n = 208) or vehicle (n = 212). At week 12, DSG provided significantly greater reductions in WOMAC pain (52.6% vs 43.1%; P = 0.008) and physical function (49.7% vs 39.4%; P = 0.004) versus vehicle and provided significant improvements in most secondary endpoints. Treatment-related adverse events (AEs) were infrequent (DSG, 7.7%; vehicle, 4.2%), with application site dermatitis being the most common AE (DSG, 4.8%; vehicle, 0%). No treatment-related gastrointestinal or serious AEs occurred with DSG.

CONCLUSION

Topical DSG treatment provided effective pain relief and functional improvement of OA in 1 or both knees and was well tolerated, irrespective of disease severity or patient age.

Authors+Show Affiliations

The Center for Rheumatology and Bone Research, Wheaton, MD. hsbbaraf@mac.com.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20631460

Citation

Baraf, Herbert S B., et al. "Safety and Efficacy of Topical Diclofenac Sodium 1% Gel in Knee Osteoarthritis: a Randomized Controlled Trial." The Physician and Sportsmedicine, vol. 38, no. 2, 2010, pp. 19-28.
Baraf HS, Gold MS, Clark MB, et al. Safety and efficacy of topical diclofenac sodium 1% gel in knee osteoarthritis: a randomized controlled trial. Phys Sportsmed. 2010;38(2):19-28.
Baraf, H. S., Gold, M. S., Clark, M. B., & Altman, R. D. (2010). Safety and efficacy of topical diclofenac sodium 1% gel in knee osteoarthritis: a randomized controlled trial. The Physician and Sportsmedicine, 38(2), 19-28. https://doi.org/10.3810/psm.2010.06.1779
Baraf HS, et al. Safety and Efficacy of Topical Diclofenac Sodium 1% Gel in Knee Osteoarthritis: a Randomized Controlled Trial. Phys Sportsmed. 2010;38(2):19-28. PubMed PMID: 20631460.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and efficacy of topical diclofenac sodium 1% gel in knee osteoarthritis: a randomized controlled trial. AU - Baraf,Herbert S B, AU - Gold,Morris S, AU - Clark,Michael B, AU - Altman,Roy D, PY - 2010/7/16/entrez PY - 2010/7/16/pubmed PY - 2016/4/23/medline SP - 19 EP - 28 JF - The Physician and sportsmedicine JO - Phys Sportsmed VL - 38 IS - 2 N2 - BACKGROUND: Topical nonsteroidal anti-inflammatory drugs (NSAIDs) may provide an alternative to oral NSAIDs to relieve pain from osteoarthritis (OA), reducing systemic exposure. This 12-week, randomized, double-blind, parallel-group, multicenter trial examined the efficacy and safety of topical diclofenac sodium 1% gel (DSG) for symptomatic knee OA. METHODS: Eligible patients were aged >/= 35 years with symptomatic Kellgren-Lawrence grade (KLG) 1 to 3 OA in 1 or both knees for >/= 6 months. Patients meeting entry criteria applied DSG 4 g or vehicle 4 times daily to the symptomatic knee(s). Primary endpoints were Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and physical function subscales and global rating of benefit at week 12. Pain on movement at week 4 was an additional primary endpoint for European regulatory purposes. Secondary endpoints included primary outcomes at weeks 1, 4, and 8; WOMAC stiffness subscale; spontaneous pain; global rating of disease; and global evaluation of treatment. Subanalyses were performed according to KLG, the number of knees treated, and age. RESULTS: Four hundred twenty patients were randomly assigned to DSG (n = 208) or vehicle (n = 212). At week 12, DSG provided significantly greater reductions in WOMAC pain (52.6% vs 43.1%; P = 0.008) and physical function (49.7% vs 39.4%; P = 0.004) versus vehicle and provided significant improvements in most secondary endpoints. Treatment-related adverse events (AEs) were infrequent (DSG, 7.7%; vehicle, 4.2%), with application site dermatitis being the most common AE (DSG, 4.8%; vehicle, 0%). No treatment-related gastrointestinal or serious AEs occurred with DSG. CONCLUSION: Topical DSG treatment provided effective pain relief and functional improvement of OA in 1 or both knees and was well tolerated, irrespective of disease severity or patient age. SN - 2326-3660 UR - https://www.unboundmedicine.com/medline/citation/20631460/Safety_and_efficacy_of_topical_diclofenac_sodium_1_gel_in_knee_osteoarthritis:_a_randomized_controlled_trial_ DB - PRIME DP - Unbound Medicine ER -