Diclofenac sodium gel in patients with primary hand osteoarthritis: A randomized, double-blind, placebo-controlled trial

Roy D Altman, Renée Liliane Dreiser, Chester L. Fisher, Walter F. Chase, Donatus S. Dreher, Josef Zacher

Research output: Contribution to journalArticle

81 Citations (Scopus)

Abstract

Objective. To measure the efficacy and safety of diclofenac sodium gel in patients with primary hand osteoarthritis (OA). Methods. In a randomized, double-blind, placebo-controlled trial, men and women aged ≥ 40 years diagnosed with primary OA in the dominant hand were randomly assigned to self-apply topical 1% diclofenac sodium gel (Voltaren® Gel) (n = 198) or vehicle (n = 187) to both hands 4 times daily for 8 weeks. Primary outcome measures included OA pain intensity (100-mm visual analog scale), total Australian/Canadian Osteoarthritis Hand Index (AUSCAN) score, and global rating of disease activity at 4 and 6 weeks. Secondary outcomes included onset of efficacy inWeeks 1 and 2, durability of efficacy at 8 weeks, measures of disease activity in the dominant hand, pain intensity in the nondominant hand, AUSCAN subindices, end of study rating of efficacy, and Osteoarthritis Research Society International response criteria. Results. Diclofenac sodium gel decreased pain intensity scores by 42%-45%, total AUSCAN scores by 35%-40%, and global rating of disease by 36%-40%. Significant differences favoring diclofenac sodium gel over vehicle were observed at Week 4 for pain intensity and AUSCAN, with a trend for global rating of disease activity. At Week 6, diclofenac sodium gel treatment significantly improved each primary outcome measure compared with vehicle. Secondary outcomes generally supported the primary outcomes. The most common treatment-related adverse event (AE) was application-site paresthesia. Most AE were mild. No cardiac events, gastrointestinal bleeding, or ulcers were reported. Conclusion. Topical diclofenac sodium gel was generally well tolerated and effective in primary hand OA. (NCT ID: NCT00171665). The Journal of Rheumatology

Original languageEnglish (US)
Pages (from-to)1991-1999
Number of pages9
JournalJournal of Rheumatology
Volume36
Issue number9
DOIs
StatePublished - Sep 2009
Externally publishedYes

Fingerprint

Diclofenac
Osteoarthritis
Hand
Gels
Placebos
Pain
Outcome Assessment (Health Care)
Paresthesia
Rheumatology
Visual Analog Scale
Ulcer
Hemorrhage
Safety
Therapeutics

Keywords

  • Diclofenac sodium
  • Nonsteroidal antiinflammatory agents
  • Osteoarthritis
  • Pain
  • Topical administration

ASJC Scopus subject areas

  • Rheumatology
  • Immunology
  • Immunology and Allergy

Cite this

Diclofenac sodium gel in patients with primary hand osteoarthritis : A randomized, double-blind, placebo-controlled trial. / Altman, Roy D; Dreiser, Renée Liliane; Fisher, Chester L.; Chase, Walter F.; Dreher, Donatus S.; Zacher, Josef.

In: Journal of Rheumatology, Vol. 36, No. 9, 09.2009, p. 1991-1999.

Research output: Contribution to journalArticle

Altman, Roy D ; Dreiser, Renée Liliane ; Fisher, Chester L. ; Chase, Walter F. ; Dreher, Donatus S. ; Zacher, Josef. / Diclofenac sodium gel in patients with primary hand osteoarthritis : A randomized, double-blind, placebo-controlled trial. In: Journal of Rheumatology. 2009 ; Vol. 36, No. 9. pp. 1991-1999.
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abstract = "Objective. To measure the efficacy and safety of diclofenac sodium gel in patients with primary hand osteoarthritis (OA). Methods. In a randomized, double-blind, placebo-controlled trial, men and women aged ≥ 40 years diagnosed with primary OA in the dominant hand were randomly assigned to self-apply topical 1{\%} diclofenac sodium gel (Voltaren{\circledR} Gel) (n = 198) or vehicle (n = 187) to both hands 4 times daily for 8 weeks. Primary outcome measures included OA pain intensity (100-mm visual analog scale), total Australian/Canadian Osteoarthritis Hand Index (AUSCAN) score, and global rating of disease activity at 4 and 6 weeks. Secondary outcomes included onset of efficacy inWeeks 1 and 2, durability of efficacy at 8 weeks, measures of disease activity in the dominant hand, pain intensity in the nondominant hand, AUSCAN subindices, end of study rating of efficacy, and Osteoarthritis Research Society International response criteria. Results. Diclofenac sodium gel decreased pain intensity scores by 42{\%}-45{\%}, total AUSCAN scores by 35{\%}-40{\%}, and global rating of disease by 36{\%}-40{\%}. Significant differences favoring diclofenac sodium gel over vehicle were observed at Week 4 for pain intensity and AUSCAN, with a trend for global rating of disease activity. At Week 6, diclofenac sodium gel treatment significantly improved each primary outcome measure compared with vehicle. Secondary outcomes generally supported the primary outcomes. The most common treatment-related adverse event (AE) was application-site paresthesia. Most AE were mild. No cardiac events, gastrointestinal bleeding, or ulcers were reported. Conclusion. Topical diclofenac sodium gel was generally well tolerated and effective in primary hand OA. (NCT ID: NCT00171665). The Journal of Rheumatology",
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AB - Objective. To measure the efficacy and safety of diclofenac sodium gel in patients with primary hand osteoarthritis (OA). Methods. In a randomized, double-blind, placebo-controlled trial, men and women aged ≥ 40 years diagnosed with primary OA in the dominant hand were randomly assigned to self-apply topical 1% diclofenac sodium gel (Voltaren® Gel) (n = 198) or vehicle (n = 187) to both hands 4 times daily for 8 weeks. Primary outcome measures included OA pain intensity (100-mm visual analog scale), total Australian/Canadian Osteoarthritis Hand Index (AUSCAN) score, and global rating of disease activity at 4 and 6 weeks. Secondary outcomes included onset of efficacy inWeeks 1 and 2, durability of efficacy at 8 weeks, measures of disease activity in the dominant hand, pain intensity in the nondominant hand, AUSCAN subindices, end of study rating of efficacy, and Osteoarthritis Research Society International response criteria. Results. Diclofenac sodium gel decreased pain intensity scores by 42%-45%, total AUSCAN scores by 35%-40%, and global rating of disease by 36%-40%. Significant differences favoring diclofenac sodium gel over vehicle were observed at Week 4 for pain intensity and AUSCAN, with a trend for global rating of disease activity. At Week 6, diclofenac sodium gel treatment significantly improved each primary outcome measure compared with vehicle. Secondary outcomes generally supported the primary outcomes. The most common treatment-related adverse event (AE) was application-site paresthesia. Most AE were mild. No cardiac events, gastrointestinal bleeding, or ulcers were reported. Conclusion. Topical diclofenac sodium gel was generally well tolerated and effective in primary hand OA. (NCT ID: NCT00171665). The Journal of Rheumatology

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