Characterizing new users of NSAIDs before and after rofecoxib withdrawal

• Published in: British journal of clinical pharmacology Vol. 63; no. 4; pp. 494 - 497
• Main Authors: Usher, Cara, Bennett, Kathleen, Teeling, Mary, Feely, John
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01.04.2007; Blackwell Science
• Subjects: Aged; Anti-Inflammatory Agents, Non-Steroidal - therapeutic use; Atherosclerosis (general aspects, experimental research); Biological and medical sciences; Blood and lymphatic vessels; Cardiology. Vascular system; Cardiovascular Diseases - diagnosis; cardiovascular risk; Case-Control Studies; COX‐2 inhibitors; Cyclooxygenase 2 Inhibitors - adverse effects; Cyclooxygenase 2 Inhibitors - supply & distribution; Drug Approval; Female; general practice; Humans; Lactones - adverse effects; Lactones - supply & distribution; Male; Medical sciences; nonselective NSAIDs; Pharmacology. Drug treatments; prescribing database; Risk Factors; Short Reports; Sulfones - adverse effects; Sulfones - supply & distribution; Time Factors; Human; Prostaglandin-endoperoxide synthase; COX-2 inhibitors; Rofecoxib; User; Enzyme; Enzyme inhibitor; Cardiovascular disease; Cyclooxygenase 2 inhibitor; Vascular disease; Non steroidal antiinflammatory agent; Medical prescription; general practice; Atherosclerosis; Cardiovascular risk; Database; nonselective NSAIDs; Oxidoreductases; prescribing database
• ISSN: 0306-5251; 1365-2125
• DOI: 10.1111/j.1365-2125.2006.02784.x

What is already known about this subject • Public concern regarding the cardiovascular safety of the COX‐2 inhibitors began with the withdrawal of rofecoxib from the market in September 2004. • Since then, a myriad of evidence has pointed towards an adverse cardiovascular effect of other COX‐2 inhibitors in persons with cardiovascular risk. • This study examines the impact of the clinical trial publicity and drug regulatory advice on nonsteroidal anti‐inflammatory drug (NSAID) prescribing in patients in general practice with known cardiovascular risk both before and after the rofecoxib withdrawal. What this study adds • Results from this study indicate that the profile of new users of NSAIDs and COX‐2 inhibitors did not change despite new information becoming available. • This may highlight the uncertainty experienced by prescribers of treatment alternatives available and the lack of unbiased information at this time for at‐risk groups. Aims To characterize patients initiated on nonsteroidal anti‐inflammatory drugs (NSAIDs), pre and postrofecoxib withdrawal, by age, gender and concomitant cardiovascular (CV) therapy. Methods A national primary care prescription database was used to identify patients who initiated NSAID therapy pre and postrofecoxib withdrawal. Patients receiving CV therapy were identified in the same periods also. Adjusted odds ratios (OR) and 95% confidence intervals are presented. Results Female patients [OR = 1.15 (1.11, 1.19)], those over 65 years [OR = 2.76 (2.65, 2.86)] and those at CV risk [OR = 1.72 (1.67, 1.79)] were more likely to start on celecoxib (over a nonselective NSAID) than male patients, those under 65 years and those not at CV risk. Similar results were found for rofecoxib and nimesulide. Postwithdrawal analysis showed results comparable to the prewithdrawal period. Conclusion The results highlight a possible uncertainty experienced by prescribers of treatment alternatives available and a lack of unbiased information at this time for at‐risk groups.