Drug Safety

, Volume 28, Issue 5, pp 435–442

Incidence of Thrombotic Cardiovascular Events in Patients Taking Celecoxib Compared with Those Taking Rofecoxib

Interim Results from the New Zealand Intensive Medicines Monitoring Programme
  • Mira Harrison-Woolrych
  • Peter Herbison
  • Rachael McLean
  • Janelle Ashton
  • Jim Slattery
Original Research Article

DOI: 10.2165/00002018-200528050-00006

Cite this article as:
Harrison-Woolrych, M., Herbison, P., McLean, R. et al. Drug-Safety (2005) 28: 435. doi:10.2165/00002018-200528050-00006

Abstract

Background: Rofecoxib was withdrawn from the market worldwide because of concerns relating to cardiovascular safety. There is conflicting evidence as to whether celecoxib, the most popular alternative to rofecoxib, carries the same cardiovascular risks. This study’s aim was to compare the incidence of thrombotic cardiovascular events in patients taking celecoxib with patients taking rofecoxib.

Methods: Prescription event monitoring methodology was used in this prospective, longitudinal, observational cohort study, in which cohorts of patients were established from prescription data and thrombotic cardiovascular events were identified from follow-up questionnaires to patients’ doctors and other sources.

Subjects: New Zealand patients with at least one prescription for either rofecoxib or celecoxib between 1 December 2000 and 30 November 2001.

Analysis: For this interim analysis the total cohorts were separated into three groups at different stages of follow-up: complete, incomplete and no follow-up. Cox’s proportional hazards models were applied to calculate hazard ratios for celecoxib compared with rofecoxib.

Results: The total cohorts included 26 403 patients receiving rofecoxib and 32 446 patients receiving celecoxib. 4882 (18%) rofecoxib and 6267 (19%) celecoxib patients had been completely followed up. In this group the unadjusted hazard ratio for celecoxib compared with rofecoxib was 1.07 (95% CI 0.59, 1.93). After adjustment for age this hazard ratio was 0.94 (95% CI 0.51, 1.70). Further adjustment for sex, ‘as required’ use, indication for use, concomitant NSAID use and pre-existing cardiovascular disease resulted in only minor changes to the hazard ratio.

Conclusion: This interim analysis of the Intensive Medicines Monitoring Programme data suggests that in ‘real-life’ postmarketing use in New Zealand there is no significant difference in the risk of cardiovascular thrombotic events in patients taking celecoxib compared with those taking rofecoxib.

Copyright information

© Adis Data Information BV 2005

Authors and Affiliations

  • Mira Harrison-Woolrych
    • 1
  • Peter Herbison
    • 2
  • Rachael McLean
    • 1
  • Janelle Ashton
    • 1
  • Jim Slattery
    • 3
  1. 1.Intensive Medicines Monitoring Programme, Department of Preventive and Social MedicineUniversity of OtagoDunedinNew Zealand
  2. 2.Department of Preventive and Social MedicineUniversity of OtagoDunedinNew Zealand
  3. 3.European Medicines Evaluation Agency, Westferry Circus, Canary WharfUK