Authors' objectives:

The purpose of this report is to: 1. Examine clinically relevant outcomes associated with COX-2 inhibitors relative to nonselective nonsteroidal anti-inflammatory drugs (NSAIDs) among an elderly population. 2. Examine changes in population costs to the health care system and clinical outcome rates following the introduction of the COX-2 inhibitors on to the Ontario Drug Benefit formulary. 3. Examine basic adherence rates associated with COX-2 inhibitors and nonselective NSAIDs among an elderly population.

Authors' recommendations: The findings of this evaluation suggest potentially reduced risks of hospitalization for UGIH among users of celecoxib and rofecoxib relative to nonselective NSAID users and an increased risk of hospitalization for CHF among users of rofecoxib and nonselective NSAIDs, but not celecoxib. All NSAIDs, however, appear to be associated with clinically meaningful elevations in blood pressure requiring medical management. Given the significant increase in the number of patients dispensed NSAIDs following the introduction of the COX-2 inhibitors, a population-based increase in the rate of hospitalization for upper gastrointestinal hemorrhage (UGIH) followed, translating to over 650 additional admissions for UGIH that otherwise may not have occurred. This observation, along with other data presented in this report, raises concerns about the rapid adoption of COX-2 inhibitors, appropriateness of utilization, extent of compliance with the approved conditions for use, and the nature of the policy. For example, meloxicam is approved as a General Benefit product despite the lack of high-quality evidence examining clinically meaningful gastrointestinal outcomes, whereas celecoxib and rofecoxib are approved as Limited Use products with imposed conditions for use. Unpublished observational data from ICES suggest that the risk for hospitalization for UGIHH among meloxicam users is no different from nonselective NSAIDs and meloxicam has become the most widely dispensed COX-2 inhibitor on the Ontario Drug Benefit (ODB). Beyond this issue, and perhaps more important, is the general nature of utilization of these drugs, for which information is lacking. While costs must be balanced with clinical outcomes, this report suggests a re-evaluation of the utilization and outcomes associated with this group of drugs.

Authors' methods: Cohort study

Project Status: Completed

URL for project: http://www.ices.on.ca/file/COX2_Report_June%2030-05_2.pdf

Year Published: 2005

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Canada

Organisation Name: Institute for Clinical Evaluative Sciences

Contact Address: Institute for Clinical Evaluative Sciences, 2075 Bayview Avenue, G-Wing, Toronto ON, Canada, M5N 3M5. Tel: 416-480-4055; Fax: 416-480-6048

Contact Name: info@ices.on.ca

Contact Email: info@ices.on.ca

Copyright: Institute for Clinical Evaluative Sciences (ICES)