Article: Characterizing new users of NSAIDs before and after rofecoxib withdrawal

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. Post-withdrawal analysis showed results comparable to the pre-withdrawal 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.

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References

1.

Bjorkman D . Current status of nonsteroidal anti-inflammatory drug (NSAID) use in the United States: risk factors and frequency of complications. Am J Med. 2000; 107(6A):3S-8S; discussion 8S-10S. DOI: 10.1016/s0002-9343(99)00362-9. View

2.

Gray J, Majeed A, Kerry S, Rowlands G . Identifying patients with ischaemic heart disease in general practice: cross sectional study of paper and computerised medical records. BMJ. 2000; 321(7260):548-50. PMC: 27471. DOI: 10.1136/bmj.321.7260.548. View

3.

Bombardier C, Laine L, Reicin A, Shapiro D, Burgos-Vargas R, Davis B . Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. VIGOR Study Group. N Engl J Med. 2000; 343(21):1520-8, 2 p following 1528. DOI: 10.1056/NEJM200011233432103. View

4.

Shah A, Thjodleifsson B, Murray F, Kay E, Barry M, Sigthorsson G . Selective inhibition of COX-2 in humans is associated with less gastrointestinal injury: a comparison of nimesulide and naproxen. Gut. 2001; 48(3):339-46. PMC: 1760142. DOI: 10.1136/gut.48.3.339. View

5.

Roumie C, Arbogast P, Mitchel Jr E, Griffin M . Prescriptions for chronic high-dose cyclooxygenase-2 inhibitors are often inappropriate and potentially dangerous. J Gen Intern Med. 2005; 20(10):879-83. PMC: 1490217. DOI: 10.1111/j.1525-1497.2005.0173.x. View

Characterizing New Users of NSAIDs Before and After Rofecoxib Withdrawal