Safety and efficacy of topical diclofenac sodium 1% gel in knee osteoarthritis: A randomized controlled trial

H. S B Baraf, Morris S. Gold, Michael B. Clark, Roy D Altman

Research output: Contribution to journalArticle

29 Citations (Scopus)

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 a 35 years with symptomatic Kellgren-Lawrence grade (KLG) 1 to 3 OA in 1 or both knees for a ≥ 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.

Original languageEnglish (US)
Pages (from-to)19-28
Number of pages10
JournalPhysician and Sportsmedicine
Volume38
Issue number2
DOIs
StatePublished - Jun 2010
Externally publishedYes

Fingerprint

Knee Osteoarthritis
Diclofenac
Randomized Controlled Trials
Gels
Safety
Pain
Osteoarthritis
Knee
Anti-Inflammatory Agents
Ontario
Dermatitis
Therapeutics
Pharmaceutical Preparations
Multicenter Studies

Keywords

  • Diclofenac sodium
  • Nonsteroidal anti-inflammatory drug
  • Osteoarthritis
  • Topical administration

ASJC Scopus subject areas

  • Orthopedics and Sports Medicine
  • Physical Therapy, Sports Therapy and Rehabilitation

Cite this

Safety and efficacy of topical diclofenac sodium 1% gel in knee osteoarthritis : A randomized controlled trial. / Baraf, H. S B; Gold, Morris S.; Clark, Michael B.; Altman, Roy D.

In: Physician and Sportsmedicine, Vol. 38, No. 2, 06.2010, p. 19-28.

Research output: Contribution to journalArticle

Baraf, H. S B ; Gold, Morris S. ; Clark, Michael B. ; Altman, Roy D. / Safety and efficacy of topical diclofenac sodium 1% gel in knee osteoarthritis : A randomized controlled trial. In: Physician and Sportsmedicine. 2010 ; Vol. 38, No. 2. pp. 19-28.
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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 a 35 years with symptomatic Kellgren-Lawrence grade (KLG) 1 to 3 OA in 1 or both knees for a ≥ 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.",
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