Nonsteroidal antiinflammatory drugs (NSAIDs) cause both minor and severe gastrointestinal (GI) side effects. Significant amounts of healthcare resources are used to prevent/manage these side effects. Arthrotec is a combination of an NSAID (diclofenac) and a gastroprotective agent (GPA, misoprostol) that is thought to decrease NSAID-induced side-effects. OBJECTIVE: To investigate whether there is a reduction in GPA use, diagnostic tests, and hospitalizations attributed to Arthrotec versus other NSAIDs among an elderly population. METHODS: We analyzed a 10% random sample (n=73,850 patients) of the "Régie de l'assurance-maladie du Québec" (RAMQ) database collected between January 1993 and December 1997. Patients were eligible for the study if they were free of NSAIDs, GPAs and upper gastrointestinal diagnostic tests during the year preceding the index-date (the date of first NSAID dispensation during the study period). The patients were followed up for 2 years. RESULTS: 9,618 patients were included in the study, 1,153 of them were started on Arthrotec and 8,465 on any other NSAID. Comorbidity markers were not significantly different in the two groups. Of the Arthrotec patients 17(1.5%) were hospitalized for GI related problems compared to 144(1.7%) of the other group; 3 (0.3%) of the hospitalized Arthrotec patients died during the hospitalization compared to 15(0.2%) of the other group; 292(25.3%) Arthrotec patients used GPAs compared to 2,117(25.0%) of the other group ; 131(11.4%) Arthrotec patients had GI diagnostic tests compared to 808(9.5%) of the other group. All these outcomes were not statistically different. The cost of the GI related events was $172/patient-year in the Arthrotec group compared to $103/patient-year in the other group.CONCLUSIONS: Our data showed no significant difference in GI related events attributable to Arthrotec compared to other NSAIDs. Moreover, the cost of managing these events tends to be higher in the Arthrotec group.