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Penetration of topical diclofenac sodium 4 % spray gel into the synovial tissue and synovial fluid of the knee : a randomised clinical trial
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Efe, Turgay, Sagnak, Ercan, Roessler, Philip P., Getgood, A., Patzer, Thilo, Fuchs-Winkelmann, Susanne, Peterlein, Christian D. and Schofer, Markus D. (2014) Penetration of topical diclofenac sodium 4 % spray gel into the synovial tissue and synovial fluid of the knee : a randomised clinical trial. Knee Surgery, Sports Traumatology, Arthroscopy, Volume 22 (Number 2). pp. 345-350. doi:10.1007/s00167-013-2408-0 ISSN 0942-2056.
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Official URL: http://dx.doi.org/10.1007/s00167-013-2408-0
Abstract
PURPOSE:
The present study was designed to evaluate the penetration of diclofenac sodium 4 % spray gel in synovial tissue, synovial fluid and blood plasma after topical application in subjects with joint effusions and planned total knee arthroplasty (TKA) due to osteoarthritis.
METHODS:
A total of 39 patients were randomised to two- or three-times daily application of diclofenac sodium 4 % spray gel to knees requiring surgery over a treatment period of 3 days. Within 8 h after the last application, TKA was conducted, and the diclofenac concentrations in synovial tissue, synovial fluid and blood plasma were measured by liquid chromatography.
RESULTS:
The median diclofenac concentration was approximately 10-20-fold higher in synovial tissue (36.2 and 42.8 ng/g) than in synovial fluid (2.6 and 2.8 ng/mL) or plasma (3.9 and 4.1 ng/mL) in both treatment groups. Dose proportionality for any compartment or treatment groups could not be detected. Treatment-related adverse events were noted in two cases and limited to skin reactions.
CONCLUSION:
Diclofenac sodium 4 % spray gel was found to penetrate the skin locally in substantial amounts and thus reach the desired target tissue. Concentrations were not dose-dependent, and application was well tolerated by 97.4 % of patients. Topical application of diclofenac should be considered a valuable alternative to systemic NSAID therapy in the initial treatment of osteoarthritis.
Item Type: | Journal Article | ||||||||||
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Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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Journal or Publication Title: | Knee Surgery, Sports Traumatology, Arthroscopy | ||||||||||
Publisher: | Springer | ||||||||||
ISSN: | 0942-2056 | ||||||||||
Official Date: | 1 February 2014 | ||||||||||
Dates: |
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Volume: | Volume 22 | ||||||||||
Number: | Number 2 | ||||||||||
Page Range: | pp. 345-350 | ||||||||||
DOI: | 10.1007/s00167-013-2408-0 | ||||||||||
Status: | Peer Reviewed | ||||||||||
Publication Status: | Published | ||||||||||
Access rights to Published version: | Restricted or Subscription Access |
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