Incidence of thrombotic cardiovascular events in patients taking celecoxib compared with those taking rofecoxib: interim results from the New Zealand Intensive Medicines Monitoring Programme.
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Rofecoxib was withdrawn from the market worldwide because of concerns relating to cardiovascular safety.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.


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


METHODS
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.


CONCLUSIONS
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.
Harrison-Woolrych
Mira
M
Intensive Medicines Monitoring Programme, Department of Preventive and Social Medicine, University of Otago, Dunedin, New Zealand. mira.harrison-woolrych@stonebow.otago.ac.nz
Herbison
Peter
P
McLean
Rachael
R
Ashton
Janelle
J
Slattery
Jim
J
D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects*; D002318:Cardiovascular Diseases / Q000139:chemically induced*; D000068579:Celecoxib; D015331:Cohort Studies; D005260:Female; D006801:Humans; D020767:Intracranial Thrombosis / Q000139:chemically induced*; D007783:Lactones / Q000008:administration & dosage / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D009520:New Zealand; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D011720:Pyrazoles / Q000008:administration & dosage / Q000009:adverse effects*; D013449:Sulfonamides / Q000008:administration & dosage / Q000009:adverse effects*; D013450:Sulfones / Q000008:administration & dosage / Q000009:adverse effects*; D011795:Surveys and Questionnaires
D000894:Anti-Inflammatory Agents, Non-Steroidal; D007783:Lactones; D011720:Pyrazoles; D013449:Sulfonamides; D013450:Sulfones; C116926:rofecoxib; D000068579:Celecoxib