Incidence of Thrombotic Cardiovascular Events in Patients Taking Celecoxib Compared with Those Taking Rofecoxib
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Background: Rofecoxib was withdrawn from the market worldwide because of concerns relating to cardiovascular safety.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.
- Singh D. Merck withdraws arthritis drug worldwide. BMJ 2004; 329: 816 CrossRef
- Bresalier RS, Sandler RS, Quan H, et al. Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial. N Engl J Med 2005; 352: 1092–102 CrossRef
- Solomon SD, McMurray JJV, Pfeffer MA, et al. Cardiovascular risk associated with celecoxib in a clinical trial for colorectal adenoma prevention. N Engl J Med 2005; 352: 1071–80 CrossRef
- Ketelbey B (Pfizer NZ Ltd). Letter to New Zealand doctors. 2004 Dec 23
- World Health Organisation. Information exchange system: cyclooxygenase-2 (COX-2) inhibitor medicines. 2005 Feb 28. QSM/MC/IEA.111
- Coulter DM. The New Zealand intensive medicines monitoring programme in pro-active safety surveillance. Pharmacoepidemiol Drug Saf 2000; 9: 273–80 CrossRef
- White WB, Faich G, Borer JS, et al. Cardiovascular thrombotic events in arthritis trials of the cyclo-oxygenase-2 inhibitor celecoxib. Am J Cardiol 2003; 92: 411–8 CrossRef
- Bombardier C, Laine L, Reicin A, et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. N Engl J Med 2000; 343: 1520–8 CrossRef
- Solomon DH, Schneeweiss S, Glynn RJ, et al. Relationship between selective cyclooxygenase-2 inhibitors and acute myocardial infarction in older adults. Circulation 2004; 109: 2068–73 CrossRef
- Clark DWJ, Layton D, Shakir SAW. Do some inhibitors of COX-2 increase the risk of thromboembolic events? Linking pharmacology with pharmacoepidemiology. Drug Saf 2004; 27(7): 427–56 CrossRef
- Drazen JM. COX II inhibitors: a lesson in unexpected problems [online]. Available from URL: http://www.nejm.org [Accessed 2005 Feb 15]
- Ray WA, Stein CM, Hall K, et al. Non-steroidal anti-inflammatory drugs and risk of serious coronary heart disease: an observational cohort study. Lancet 2002; 359: 118–23 CrossRef
- Mamdani M, Rochon P, Juurlink DN, et al. Effect of selective cyclo-oxygenase-2 inhibitors and naproxen on the short term risk of acute myocardial infarction in the elderly. Arch Intern Med 2003; 163(4): 481–6 CrossRef
- Kimmel SE, Berlin JA, Reilly M, et al. Patients exposed to rofecoxib and celecoxib have different odds of nonfatal myocardial infarction. Ann Intern Med 2005; 142: 157–64
- Graham DJ, Campen D, Hui R, et al. Risk of acute myocardial infarction and sudden cardiac death in patients treated with cyclo-oxygenase 2 selective and non-selective non-steroidal anti-inflammatory drugs: nested case-control study [online]. Available from URL: http://image.thelancet.com [Accessed 2005 Jan 25]
- Topol EJ. Arthritis medicines and cardiovascular events: “house of coxibs”. JAMA 2005; 293(3): 366–8 CrossRef
- Incidence of Thrombotic Cardiovascular Events in Patients Taking Celecoxib Compared with Those Taking Rofecoxib
Volume 28, Issue 5 , pp 435-442
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- Author Affiliations
- 1. Intensive Medicines Monitoring Programme, Department of Preventive and Social Medicine, University of Otago, Box 913, Dunedin, New Zealand
- 2. Department of Preventive and Social Medicine, University of Otago, Dunedin, New Zealand
- 3. European Medicines Evaluation Agency, Westferry Circus, Canary Wharf, London, UK