GASTROINTESTINAL-TRACT BLEEDING ASSOCIATED WITH NAPROXEN SODIUM VS IBUPROFEN

Background: The risk of gastrointestinal tract bleeding requiring hosp italization associated with naproxen sodium was compared with that wit h ibuprofen, using a prescription database to approximate over-the-cou nter dosing. Objective: To evaluate the safety of naproxen sodium. Met hods: A claims database containing Ohio Medicaid data from January 198 6 through February 1993 and Michigan Medicaid data from April 1983 thr ough July 1993 was used to compare 101 318 patients dispensed naproxen sodium with 277 601 patients dispensed ibuprofen. Using a case-cohort design, all 59 patients from the full cohort who had been hospitalize d with upper gastrointestinal tract bleeding (UGIB) that developed wit hin 14 days after the first prescription for the study drugs were comp ared with a subcohort made up of a 10% random sample of subjects selec ted from the combined drug cohorts. Results: The incidence of UGIB occ urring within 14 days after the first prescription in the naproxen sod ium cohort was 26 (0.026%) of 101 318 (95% confidence interval [CI], 0 .017%-0.038%), compared with 33 (0.012%) of 277 601 patients (95% Cl,0 .008%-0.017%) in the ibuprofen cohort. Overall, the use of naproxen so dium vs ibuprofen was associated with an adjusted relative risk of 2.0 (95% CI, 1.1-3.8). Among people with multiple prescriptions, the crud e relative risk for those receiving therapy in a dose typical of over- the-counter use was 4.1 (95% CI, 1.2-13.8). Conclusions: The overall i ncidence of UGIB is low with both drugs. There is little additional ab solute risk posed by the use of low-dose naproxen sodium, compared wit h low-dose ibuprofen, despite an increased relative risk. However, giv en the widespread use of these drugs, a substantial number of addition al cases of UGIB could result from use of naproxen sodium. This increa sed risk should be considered, especially for patients whose baseline risk of UGIB is elevated.