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Celecoxib Effectively Treats Patients with Acute Shoulder Tendinitis/Bursitis
MICHELLE PETRI, STEPHEN L. HUFMAN, GREGORY WASER, HARRY CUI, MICHAEL C. SNABES, and KENNETH M. VERBURG
ABSTRACT. Methods. In this double blind, placebo controlled, parallel group study, patients with acute onset shoulder tendinitis and/or subacromial bursitis were randomized to receive one of: celecoxib 400 mg followed by 200 mg bid, naproxen 500 mg bid, or placebo bid for 14 days. The primary measure of efficacy was the mean reduction in Maximum Pain Intensity at Rest, measured using a 100 mm visual analog scale, from baseline to Days 7 and 14. Results. Of the 306 patients randomized to treatment, 254 completed the study. On Day 7, the mean reduction from baseline in Maximum Pain Intensity at Rest was significantly greater in the celecoxib group compared with the placebo group (–27.7 ± 2.75 mm vs –18.4 ± 2.63 mm, respectively; p < 0.05). Similarly, on Day 14, the mean reduction from baseline in Maximum Pain Intensity at Rest was greater in the celecoxib group compared with placebo (–35.0 ± 3.06 mm vs –25.0 ± 3.05 mm; p < 0.05). The mean reduction from baseline in Maximum Pain Intensity at Rest was also greater in the naproxen group compared with the placebo group at Day 7 (–26.4 ± 2.70 mm vs –18.4 ± 2.63 mm; p < 0.05), but not on Day 14. Secondary measures of efficacy also showed treatment with celecoxib to be significantly better than placebo treatment and similar to treatment with naproxen. In addition, celecoxib was well tolerated in these patients. Conclusion. Celecoxib showed comparable efficacy to naproxen in relieving the pain of patients with acute shoulder tendinitis and/or subacromial bursitis. (J Rheumatol 2004;31:1614-20) Key Indexing Terms:
SHOULDER TENDINITIS
From the Department of Medicine–Rheumatology, The Johns Hopkins University, Baltimore, Maryland; Clinical Research Department, Wenatchee Valley Medical Center, Wenatchee, Washington; Clinical Studies, Comprehensive NeuroScience Inc., Melbourne, Florida; Research and Development, Pharmacia Corporation, Skokie, Illinois; and Pfizer Global Research and Development, Ann Arbor, Michigan, USA. Sponsored by Pfizer Inc. and Pharmacia Corporation. M. Petri, MD, MPH, Department of Medicine–Rheumatology, The Johns Hopkins University; S.L. Hufman, MD, Clinical Research Department, Wenatchee Valley Medical Center; G. Waser, MD, Clinical Studies, Comprehensive NeuroScience Inc.; H. Cui, PhD(c); M.C. Snabes, MD, PhD, Research and Development, Pharmacia Corporation; K.M. Verburg, PhD, Pfizer Global Research and Development. Address reprint requests to Dr. M. Petri, Department of Medicine–Rheumatology, The Johns Hopkins University, 601 North Caroline Street, Baltimore, MD 21287. E-mail: mpetri@mail.jhmi.edu Submitted August 7, 2003; revision accepted February 18, 2004. |