Changes in the characteristics of patients prescribed selective cyclooxygenase 2 inhibitors after the 2004 withdrawal of rofecoxib.
OBJECTIVE
To evaluate the impact of rofecoxib withdrawal on the characteristics of patients prescribed selective cyclooxygenase 2 (COX-2) inhibitors.


METHODS
The General Practice Research Database was used to identify patients age > or =18 years who were prescribed a selective COX-2 inhibitor. Various patient characteristics were noted at the start of therapy: age, sex, nonsteroidal antiinflammatory drug-related risk factors for upper gastrointestinal (GI) events, and the Framingham risk score for cardiovascular disease. Logistic regression was used to compare patients using selective COX-2 inhibitors before and after September 2004.


RESULTS
The study population included 171,645 patients receiving selective COX-2 inhibitors. The number of users substantially increased over time until September 2004 and sharply declined thereafter. Approximately 80% stopped selective COX-2 inhibitor therapy within 6 months. Patients receiving selective COX-2 inhibitors after September 2004 were younger and included more men compared with those receiving therapy before September 2004. There was no change before and after September 2004 in the proportion of patients with GI risk factors or high Framingham risk scores, after adjustment for age and sex. A correlation was found between presence of GI risk factors and high Framingham risk scores. Only 20% of patients receiving selective COX-2 inhibitors had GI risk factors but low Framingham risk score, which did not change after September 2004.


CONCLUSIONS
There was no channeling in the usage of selective COX-2 inhibitors toward patients with a high risk of GI and low risk of cardiovascular disease following the withdrawal of rofecoxib.
Setakis
E
E
General Practice Research Database, Medicines and Healthcare products Regulatory Agency, 1 Nine Elms Lane, London, UK.
Leufkens
H G M
HG
van Staa
T P
TP
D000293:Adolescent; D000328:Adult; D000368:Aged; D002318:Cardiovascular Diseases / Q000453:epidemiology; D052246:Cyclooxygenase 2 Inhibitors / Q000627:therapeutic use*; D016208:Databases, Factual / Q000706:statistics & numerical data; D011307:Drug Prescriptions / Q000706:statistics & numerical data; D017723:Drug Utilization Review / Q000706:statistics & numerical data*; D005260:Female; D005767:Gastrointestinal Diseases / Q000453:epidemiology; D006801:Humans; D015994:Incidence; D007783:Lactones; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D012216:Rheumatic Diseases / Q000188:drug therapy* / Q000453:epidemiology*; D012307:Risk Factors; D013450:Sulfones; D006113:United Kingdom / Q000453:epidemiology
D052246:Cyclooxygenase 2 Inhibitors; D007783:Lactones; D013450:Sulfones; C116926:rofecoxib