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Cyclooxygenase-2 Specific Inhibitors and Upper Gastrointestinal Tolerability in Patients with Osteoarthritis Receiving Concomitant Low Dose Aspirin: Pooled Analysis of 2 Trials
JAY L. GOLDSTEIN, ALFONSO E. BELLO, WILLIAM SPALDING, SANDY SUH, and JOHN G. FORT
ABSTRACT. Methods. Two independently conducted, multicenter, double blind, randomized controlled trials designed to evaluate GI tolerability, in addition to cardiorenal study endpoints, in patients randomized to celecoxib 200 mg once daily (qd; n = 960) or rofecoxib 25 mg qd (n = 942) were analyzed. GI tolerability was assessed using investigator-reported GI symptoms, prespecified as abdominal pain, dyspepsia, and nausea. The pooled incidences of the 3 reported GI symptoms, regardless of severity (mild and moderate to severe), and the incidences of mild or moderate to severe GI symptoms individually were evaluated. Results. In the pooled population, the incidence of the 3 GI symptoms, regardless of severity, was not significantly different for patients receiving celecoxib or rofecoxib. In contrast, the aggregate incidence of moderate to severe GI symptoms for patients receiving rofecoxib (5.2%) was significantly greater than for those receiving celecoxib (3.2%; p < 0.05). Notably, the significant difference between the 2 arms was more pronounced in the population of patients receiving concomitant low dose ASA (rofecoxib 9.7% vs celecoxib 1.5%; p < 0.001). The incidence of moderate to severe GI symptoms was similar with rofecoxib (3.3%) and celecoxib (3.9%; p = 0.564) treatment in patients who did not receive low dose ASA. Conclusion. While the GI tolerability was similar in the 2 arms of the entire pooled population, celecoxib 200 mg qd was associated with a significantly lower incidence of moderate to severe GI symptoms than rofecoxib 25 mg qd in patients receiving concomitant low dose ASA. (J Rheumatol 2005;32:111-7) Key Indexing Terms:
GASTROINTESTINAL
From the Section of Digestive and Liver Diseases and Section of Rheumatology, Department of Medicine, University of Illinois at Chicago, Chicago, Illinois; Illinois Bone and Joint Institute, Chicago, Illinois; and Pfizer Inc., Peapack, New Jersey, USA. Sponsored by Pfizer Inc., Peapack, New Jersey, USA. Dr. Goldstein is a consultant to Pfizer Inc. and has received travel expenses, research grants, and speaker honoraria. Drs. Bello and Fort and Ms Suh are former employees of Pfizer Inc. and/or Pharmacia Corporation. Mr. Spalding is currently an employee of Pfizer Inc. J.L. Goldstein, MD, Section of Digestive and Liver Diseases; A.E. Bello, MD, Section of Digestive and Liver Diseases and Section of Rheumatology and Illinois Bone and Joint Institute; W. Spalding, MS; S. Suh, PharmD; J.G. Fort, MD, Pfizer Inc. Address reprint requests to Dr. J.L. Goldstein, Department of Medicine, University of Illinois at Chicago, 840 South Wood (M/C 787), Room 1020 CSB, Chicago, IL 60612-7323. E-mail: jlgoldst@uic.edu Submitted August 19, 2003; revision accepted August 16, 2004. |