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

Interim Results from the New Zealand Intensive Medicines Monitoring Programme

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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Background: Rofecoxib was withdrawn from the market worldwide because of concerns relating to cardiovascular safety.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.

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Notes

  1. The use of trade names is for product identification purposes only and does not imply endorsement.

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Acknowledgements

Funding statement: the IMMP receives the majority of its funding from the New Zealand Ministry of Health and the work presented in this report has largely been funded by this source. General donations towards the work of the IMMP are also received from some pharmaceutical companies. However, these donations are unconditional and the companies have no role in the analysis or interpretation of IMMP data and are not involved in the decision to publish results.

Conflict of interests statement: the authors declare that they have no competing interests that might affect this report.

We would like to acknowledge David Coulter, who as former Director of the IMMP initiated the IMMP monitoring of the cyclo-oxygenase (COX)-2 inhibitors and performed all of the initial clinical coding of events for this study. The data processors of the IMMP contributed a huge effort in entering all of the data analysed in this report. We thank them for their commitment to the programme, especially during a time when its future was under threat. We also thank Ruth Savage for her help and rheumatology expertise in assessing the indications for use of COX-2 inhibitors and David Clark for his advice. In addition, we are most grateful to Lianne Parkin and Charlotte Paul for their advice regarding design for this study and for reviewing the manuscript.

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Authors and Affiliations

  1. Intensive Medicines Monitoring Programme, Department of Preventive and Social Medicine, University of Otago, Box 913, Dunedin, New Zealand

    Mira Harrison-Woolrych, Rachael McLean & Janelle Ashton

  2. Department of Preventive and Social Medicine, University of Otago, Dunedin, New Zealand

    Peter Herbison

  3. European Medicines Evaluation Agency, Westferry Circus, Canary Wharf, London, UK

    Jim Slattery

Authors
  1. Mira Harrison-Woolrych
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  2. Peter Herbison
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  3. Rachael McLean
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  4. Janelle Ashton
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  5. Jim Slattery
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Correspondence to Mira Harrison-Woolrych.

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Harrison-Woolrych, M., Herbison, P., McLean, R. et al. Incidence of Thrombotic Cardiovascular Events in Patients Taking Celecoxib Compared with Those Taking Rofecoxib. Drug-Safety 28, 435–442 (2005). https://doi.org/10.2165/00002018-200528050-00006

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  • DOI: https://doi.org/10.2165/00002018-200528050-00006

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