In order to evaluate the incidence and relative risk of inpatient upper gastrointestinal bleeding (UGIB) from naproxen sodium vs. ibuprofen when used overthe-counter (OTC), a case-cohort study was performed. Using the Medicaid claims databases in Ohio from January 1986 through February 1993 and in Michigan from April 1983 through July 1993, 101,318 patients who were dispensed naproxen sodium were compared to a control group of 277,601 patients dispensed ibuprofen. Only short term and low dose prescription use of the drugs were investigated, to simulate their OTC use. All 59 cases with UGIB that developed within 14 days after the first prescription for the study drugs were compared to a subcohort made up of a 10% random sample of subjects selected from the combined drug cohorts. The incidence of UGIB occurring within 14 days after the first prescription in the naproxen cohort was 26/101,318 (0.026% (95% CI: 0.017-0.038%)) compared to 33/277,601 (0.012% (95% CI: 0.008-0.017%)) in the ibuprofen cohort. Overall, use of naproxen sodium vs. ibuprofen was associated widi an adjusted relative risk (RR) (95% CI) of 2.0 ( 1.1-3.8). The crude RR (95% CI) for those receiving low dose therapy among persons with multiple prescriptions was 4.1 (1.2-13.8). Use of naproxen sodium is associated with a higher risk of UGIB than use of ibuprofen. Given the low incidence, there is relatively little additional risk posed. However, potential users should be aware of the risk associated with the use of both of these drugs.
|Original language||English (US)|
|Journal||Journal of Investigative Medicine|
|State||Published - Jan 1 1996|
All Science Journal Classification (ASJC) codes
- Biochemistry, Genetics and Molecular Biology(all)