title: Risk of gastrointestinal events in patients with rheumatoid arthritis after withdrawal of rofecoxib.
abstract: OBJECTIVE
  To examine the incidence of gastrointestinal (GI) events in patients with rheumatoid arthritis (RA) after the removal of rofecoxib from the market.
  
  
  METHODS
  Residents of British Columbia with a diagnosis of RA who were chronic users of cyclooxygenase 2 (COX-2) inhibitors or nonselective nonsteroidal antiinflammatory drugs (nsNSAID) as of September 30, 2004, were included. We studied the risk of GI events using incidence rates and adjusted HR from Cox proportional hazards regression using time-dependent covariates.
  
  
  RESULTS
  The cohort comprised 4266 patients with a mean age of 60 years and over 72% women, of which 2034 (48%) were classified as COX-2 inhibitor users and 2232 (52%) as chronic nsNSAID users as of September 30, 2004. The 2 groups were well balanced on baseline covariates except for comorbid conditions. In the year following rofecoxib withdrawal, 174 patients (5.5%) experienced 1 or more GI events, defined as a GI-related physician visit or hospitalization. There was no statistically significant increase in the risk of a GI event between those classified as a COX-2 inhibitor or nsNSAID user at the time of withdrawal (HR 1.03, 95% CI 0.69-1.54). Considering the drug exposure at the time of the event, there was no increased risk of GI events associated with the use of either COX-2 inhibitors or nsNSAID, or with the use of oral corticosteroids, low-dose aspirin, or clopidogrel, after adjustment for potential confounders.
  
  
  CONCLUSIONS
  In this cohort, withdrawal of rofecoxib did not result in a significant increase in GI events among patients with RA.
authors.affiliation: Faculty of Pharmaceutical Sciences, University of British Columbia (UBC), Vancouver, Canada.
authors.forename: Carlo A
authors.initials: CA
authors.lastname: Marra
authors.forename: Larry D
authors.initials: LD
authors.lastname: Lynd
authors.forename: Lindsey
authors.initials: L
authors.lastname: Colley
authors.forename: Stephanie S
authors.initials: SS
authors.lastname: Harvard
authors.forename: Diane
authors.initials: D
authors.lastname: Lacaille
authors.forename: Erin
authors.initials: E
authors.lastname: Schwenger
authors.forename: Aslam H
authors.initials: AH
authors.lastname: Anis
authors.forename: John M
authors.initials: JM
authors.lastname: Esdaile
mesh_terms: D000368:Aged; D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000453:epidemiology*; D001955:British Columbia / Q000453:epidemiology; D015331:Cohort Studies; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced* / Q000453:epidemiology*; D006801:Humans; D007783:Lactones / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D012307:Risk Factors; D013450:Sulfones / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D007783:Lactones; D013450:Sulfones; C116926:rofecoxib