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. 2005 Oct;20(10):879-83.
doi: 10.1111/j.1525-1497.2005.0173.x.

Prescriptions for chronic high-dose cyclooxygenase-2 inhibitors are often inappropriate and potentially dangerous

Christianne L Roumie  1 , Patrick G Arbogast, Edward F Mitchel Jr, Marie R Griffin
Affiliations

Prescriptions for chronic high-dose cyclooxygenase-2 inhibitors are often inappropriate and potentially dangerous

Christianne L Roumie et al. J Gen Intern Med. 2005 Oct.

Abstract

Objective: To describe the use of coxibs outside of licensed indications and recommended dosing ranges including rofecoxib 50 mg, valdecoxib 20 to 40 mg, and celecoxib 400 mg.

Design: Cross-sectional study of coxib utilization in 2002 and 2003 and retrospective cohort analysis of new users.

Participants: Patients with known age and sex enrolled in Tennessee's Medicaid program.

Measurements: The prevalence of coxib use by dose and duration, and the proportion of persons initially prescribed a high-dose coxib and indications for such use.

Results: The estimated daily prevalence of nonaspirin prescription nonsteroidal anti-inflammatory drugs (NSAIDs) was 8.7% in 2002 to 2003 (45.7% coxibs). NSAID use peaked at age 65 to 74 with a prevalence of 19.8% (56.3% coxibs). Doses above the recommended daily dose for osteoarthritis accounted for 33.2% (95% confidence intervals [CIs] 32.4%, 33.9%) of celecoxib use, 14.9% (95% CI 14.4%, 15.5%) of rofecoxib use, and 52.2% (95% CI 50.6%, 53.8%) of valdecoxib use. Most of these prescriptions were for a month's supply. For new coxib users, 13.5% were given a month's supply for the highest dose category, and 28% refilled their prescriptions within 7 days of the end of the original prescription. Of these new chronic high-dose users, 17.2% had ischemic heart disease and 7.1% had heart failure.

Conclusions: A substantial portion of coxib prescriptions were for a month's supply at doses above those recommended for most chronic indications. New users were also prescribed high doses despite evidence for cardiovascular comorbidity. These prescribing patterns at doses outside licensed indications are both inappropriate and potentially dangerous.

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References

    1. Cardiovascular Safety Review Rofecoxib. Available at http://www.fda.gov/ohrms/dockets/ac/01/briefing/3677b2_06_cardio.pdf Accessed July 26, 2004.
    1. Merck. Press Release: Merck Announces Voluntary WorldWide Withdrawal of Vioxx. Merck and Co. Available at http://www.merck.com/ Accessed September 30, 2004.
    1. Solomon DH, Schneeweiss S, Glynn RJ, et al. Relationship between selective cyclooxygenase-2 inhibitors and acute myocardial infarction in older adults. Circulation. 2004;109:2068–73. - PubMed
    1. Ray WA, Stein CM, Daugherty JR, Hall K, Arbogast PG, Griffin MR. COX-2 selective non-steroidal anti-inflammatory drugs and risk of serious coronary heart disease. Lancet. 2002;360:1071–3. - PubMed
    1. Ray WA, MacDonald TM, Solomon DH, Graham DJ, Avorn J. COX-2 selective non-steroidal anti-inflammatory drugs and cardiovascular disease. Pharmacoepidemiol Drug Safety. 2003;12:67–70. - PubMed

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