Incidence of Thrombotic Cardiovascular Events in Patients Taking Celecoxib Compared with Those Taking Rofecoxib Interim Results from the New Zealand Intensive Medicines Monitoring Programme

• Published in: Drug safety Vol. 28; no. 5; pp. 435 - 442
• Main Authors: Harrison-Woolrych, Mira, Herbison, Peter, McLean, Rachael, Ashton, Janelle, Slattery, Jim
• Format: Journal Article
• Language: English
• Published: Auckland Adis international 01.01.2005; Wolters Kluwer Health, Inc
• Subjects: Aged; Anti-Inflammatory Agents, Non-Steroidal - administration & dosage; Anti-Inflammatory Agents, Non-Steroidal - adverse effects; Biological and medical sciences; Cardiovascular Diseases - chemically induced; Celecoxib; Cohort Studies; Drug toxicity and drugs side effects treatment; Female; Humans; Intracranial Thrombosis - chemically induced; Lactones - administration & dosage; Lactones - adverse effects; Male; Medical sciences; Middle Aged; New Zealand; Pharmacology. Drug treatments; Product Surveillance, Postmarketing - methods; Pyrazoles - administration & dosage; Pyrazoles - adverse effects; Sulfonamides - administration & dosage; Sulfonamides - adverse effects; Sulfones - administration & dosage; Sulfones - adverse effects; Surveys and Questionnaires; Toxicity: cardiovascular system; New Zealand; Oceania; Human; Prostaglandin-endoperoxide synthase; Rofecoxib; Enzyme; Toxicity; Enzyme inhibitor; Cardiovascular disease; Cyclooxygenase 2 inhibitor; Celecoxib; Thrombosis; Incidence; Vascular disease; Non steroidal antiinflammatory agent; Oxidoreductases; Circulatory system; Comparative study
• ISSN: 0114-5916
• DOI: 10.2165/00002018-200528050-00006

Rofecoxib was withdrawn from the market worldwide because of concerns relating to cardiovascular safety.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. 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. New Zealand patients with at least one prescription for either rofecoxib or celecoxib between 1 December 2000 and 30 November 2001. 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. 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. 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.