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Topical Ketoprofen Patch in the Treatment of Tendinitis: A Randomized, Double Blind, Placebo Controlled Study
BERNARD MAZIÈRES, STÉPHANIE ROUANET, YANNICK GUILLON, CLAUDIA SCARSI, and VALENTINA REINER
ABSTRACT. Methods. A multicenter, 14 day, randomized, double blind placebo controlled trial of a once-a-day ketoprofen 100 mg patch in symptomatic tendinitis of recent onset, not requiring orthopedic or surgical treatment. Pain on daily activities scored on a 100 mm visual analog scale was the primary efficacy criterion. Other criteria were spontaneous pain at rest, pain on full passive motion, pain relief, and pain intensity assessed twice daily by the patient (calculation of total pain relief and summed time-weighted pain intensity difference). Statistical analysis was performed on the differences between the 2 groups in the intention-to-treat population. Results. One hundred seventy-two patients were included. Good compliance was obtained in 98% of patients. Twenty-six patients (15%) discontinued the study mainly because of adverse events, inefficacy, or cure. Decrease in pain after one week of treatment (primary criterion) was –38.4 ± 25.6 mm (56%) and –25.8 ± 24.5 mm (37%) in the ketoprofen and placebo groups, respectively (p = 0.0013). The differences of the secondary criteria during the trial between the 2 groups were significant more often than not. Tolerance was considered satisfactory in both groups, most adverse events reported being local reactions: 47 versus 44 were possibly or probably related to treatment in the ketoprofen and placebo groups, respectively. These local skin reactions resolved spontaneously and rarely led to premature termination of treatment. Conclusion. This trial suggested that a 3–14 day course of treatment by ketoprofen patch is useful in nonarticular rheumatisms, the duration of treatment depending on the results obtained. The safety profile revealed no unexpected adverse events. (J Rheumatol 2005;32:1563-70) Key Indexing Terms:
TENDINITIS
From the Department of Rheumatology, Rangueil University Hospital, Toulouse; CRO Therapharm Researches, Boulogne-Billancourt, France; and Applied Pharma Research SA, Balerna, Switzerland. B. Mazières, MD, Professor of Rheumatology, Department of Rheumatology, Rangueil University Hospital; S. Rouanet, PhD, Statistician; Y. Guillon, MD, CRO Therapharm Researches; C. Scarsi, PharM; V. Reiner, PharB, Applied Pharma Research SA. Address reprint requests to Prof. Bernard Mazières, Department of Rheumatology, Rangueil University Hospital, 1 avenue Jean-Poulhes, 31059 Toulouse Cedex 9, France. E-mail: mazieres@cict.fr Accepted for publication March 17, 2005. |