Risk assessment of NSAID-induced gastrointestinal toxicity in ambulatory care patients.
OBJECTIVE
The risk of gastrointestinal (GI) toxicity associated with the use of a traditional nonsteroidal antiinflammatory drug (NSAID) versus a cyclooxygenase-2 (COX-2) inhibitor was compared among patients in a managed care organization.


METHODS
Patients over 18 years old who received a prescription for ibuprofen, naproxen, celecoxib, or rofecoxib between March 2001 and June 2001 were included in this study. All subjects were followed for 12 months for GI complications, medication use, and changes in physical conditions from baseline. A simplified risk-scoring scale was used to measure patients' risk of GI complications.


RESULTS
A total of 172 patients were randomly selected: 86 receiving traditional NSAIDs and 86 receiving COX-2 inhibitors. Patients receiving COX-2 inhibitors were older and more likely to be receiving treatment for osteoarthritis (OA) or rheumatoid arthritis (RA), while patients taking traditional NSAIDs were more likely to be receiving treatment for acute pain. The average risk scores for patients receiving traditional NSAIDs and COX-2 inhibitors were 0.23% and 0.36%, respectively (p = 0.11). When stratified by indication, there was a significant difference in the risk score for acute pain (p = 0.02) but not for OA, RA, or chronic pain. No GI adverse effects occurred in either group.


CONCLUSIONS
Among patients in a managed care organization who were taking NSAIDs, most were at low risk for an NSAID-related GI adverse effect. The risk of GI adverse effects did not differ significantly between patients treated with a traditional NSAID and those treated with a COX-2 inhibitor.
University of Michigan Health System, UH B2D301 Box 0008, 1500 East Medical Center Drive, Ann Arbor, MI 48109-0008, USA. gsweet@umich.edu
Burgunda V
BV
Sweet
Kevin A
KA
Townsend
Christine Y
CY
Tsai
D000328:Adult; D000553:Ambulatory Care; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects*; D016861:Cyclooxygenase Inhibitors / Q000009:adverse effects*; D005260:Female; D006471:Gastrointestinal Hemorrhage / Q000139:chemically induced*; D006801:Humans; D016015:Logistic Models; D008297:Male; D008329:Managed Care Programs; D008875:Middle Aged; D012189:Retrospective Studies; D012307:Risk Factors
D000894:Anti-Inflammatory Agents, Non-Steroidal; D016861:Cyclooxygenase Inhibitors