Prescription channeling of COX-2 inhibitors and traditional nonselective nonsteroidal anti-inflammatory drugs: a population-based case–control study

Arthritis Research & Therapy

Sean Zhao⁴  Sylvie Perreault²  Nicholas Moore⁵  Jean-François Boivin¹  Thierry Ducruet³  Yola Moride⁵ 

[1]Joint Department of Epidemiology and Biostatistics, and Occupational Health, McGill University, Montreal, Canada

[2]Faculty of Pharmacy, Université de Montréal, Montreal, Canada

[3]Centre for Clinical Epidemiology and Community Studies, SMBD Jewish General Hospital, Montreal, Canada

[4]Department of Pharmacoepidemiology, Pharmacia Corporation, Paepack, New Jersey, USA

[5]Department of Pharmacology, Université Victor Segalen, Bordeaux, France

关键词: prescription channeling;    pharmacoepidemiology;    nonsteroidal anti-inflammatory drugs;    COX-2 inhibitors;    administrative health care databases;   

Others  :  1101110
DOI  :  10.1186/ar1488

 received in 2004-07-08, accepted in 2004-12-01,  发布年份 2005

【 摘 要 】

This pharmacoepidemiologic study was conducted to determine whether risk factors for upper gastrointestinal bleeding influenced the prescription of cyclo-oxygenase (COX)-2 inhibitors and traditional nonselective nonsteroidal anti-inflammatory drugs (NSAIDs) at the time when COX-2 inhibitors were first included in the formulary of reimbursed medications. A population-based case–control study was conducted in which the prevalence of risk factors and the medical histories of patients prescribed COX-2 inhibitors and traditional nonselective NSAIDs were compared. The study population consisted of a random sample of members of the Quebec drug plan (age 18 years or older) who received at least one dispensation of celecoxib (n = 42,422; cases), rofecoxib (n = 25,674; cases), or traditional nonselective NSAIDs (n = 12,418; controls) during the year 2000. All study data were obtained from the Quebec health care databases. Adjusting for income level, Chronic Disease Score, prior use of low-dose acetylsalicylic acid, acetaminophen, antidepressants, benzodiazepines, prescriber specialty, and time period, the following factors were significantly associated with the prescription of COX-2 inhibitors: age 75 years or older (odds ratio [OR] 4.22, 95% confidence interval [CI] 3.95–4.51), age 55–74 years (OR 3.23, 95% CI 3.06–3.40), female sex (OR 1.52, 95% CI 1.45–1.58), prior diagnosis of gastropathy (OR 1.21, 95% CI 1.08–1.36) and prior dispensation of gastroprotective agents (OR 1.57, 95% CI 1.47–1.67). Patients who received a traditional nonselective NSAID recently were more likely to switch to a coxib, especially first-time users (OR 2.17, 95% CI 1.93–2.43). Associations were significantly greater for celecoxib than rofecoxib for age, chronic NSAID use, and last NSAID use between 1 and 3 months before the index date. At the time of introduction of COX-2 inhibitors into the formulary, prescription channeling could confound risk comparisons across products.

【 授权许可】

   
2005 Moride et al., licensee BioMed Central Ltd.

【 参考文献 】

• [1]Simon LS, Weaver AL, Graham DY, Kivitz AJ, Lipsky PE, Hubbard RC, Isakson PC, Verburg KM, Yu SS, Zhao WW, et al.: Anti-inflammatory and upper gastrointestinal effects of celecoxib in rheumatoid arthritis: A randomized controlled trial. JAMA 1999, 282:1921-1928.
• [2]Emery P, Zeidler H, Kvien TK, Guslandi M, Naudin R, Stead H, Verburg KM, Isakson PC, Hubbard RC, Geis GS: Celecoxib versus diclofenac in long-term management of rheumatoid arthritis: randomised double-blind comparison. Lancet 1999, 354:2106-2111.
• [3]Silverstein FE, Faich G, Goldstein JL, Simon LS, Pincus T, Whelton A, Makuch R, Eisen G, Agrawal NM, Stenson WF, et al.: Gastrointestinal toxicity with celecoxib vs. nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: the CLASS study: a randomized controlled trial. JAMA 2000, 284:1247-1255.
• [4]Geba GP, Weaver AL, Polis AB, Dixon ME, Schnitzer TJ, Vioxx, Acetaminophen, Celecoxib Trial (VACT) Group: Efficacy of rofecoxib, celecoxib, and acetaminophen in osteoarthritis of the knee. JAMA 2002, 287:64-71.
• [5]Day R, Morrison B, Luza A, Castaneda O, Strusberg A, Nahir M, Helgetveit KB, Kress B, Daniels B, Bolognese J, et al.: Randomized trial of the efficacy and tolerability of the COX-2 inhibitor rofecoxib vs ibuprofen in patients with osteoarthritis. Arch Intern Med 2000, 160:1781-1787.
• [6]Bombardier C, Laine L, Reicin A, Shapiro D, Burgos-Vargas R, Davis B, Day R, Ferraz MB, Hawkey CJ, Hochberg MC, et al.: Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. N Engl J Med 2000, 343:1520-1528.
• [7]Langman MJ, Jensen DM, Watson DJ, Harper SE, Zhao PL, Quan H, Bolognese JA, Simon TJ: Adverse upper gastrointestinal effects of rofecoxib compared with NSAIDs. JAMA 1999, 282:1929-1933.
• [8]Watson DJ, Harper SE, Zhao PL, Quan H, Bolognese JA, Simon TJ: Gastrointestinal tolerability of the selective cyclooxygenase-2 (COX-2) inhibitor rofecoxib compared with nonselective COX-1 and COX-2 inhibitors in osteoarthritis. Arch Intern Med 2000, 160:2998-3003.
• [9]Health Canada: Celecoxib: one year later. Adverse Effects Newslett 2000, 10:2-5.
• [10]Jüni P, Rutjes AWS, Dieppe PA: Are selective COX-2 inhibitors superior to traditional non-steroidal anti-inflammatory drugs? BMJ 2002, 324:1287-1288.
• [11]Skelly MM, Hawkey CJ: Potential alternatives to COX-2 inhibitors [editorial]. BMJ 2002, 324:1289-1290.
• [12]Pathak A, Boveda S, Defaye P, Mansourati J, Mallaret M, Thebault L, Galinier M, Blanc JJ, Montastruc JL: Celecoxib-associated torsade de pointes [letter]. Ann Pharmacother 2002, 36:1290-1291.
• [13]Mukherjee D, Nissen SE, Topol EJ: Risk of cardiovascular events associated with selective COX-2 inhibitors. JAMA 2001, 286:954-959.
• [14]Lichtenstein RD, Wolfe MM: COX-2 selective NSAIDs: new and Improved? JAMA 2000, 284:1297-1299.
• [15]The University of British Columbia Department of Pharmacology & Therapeutics: Therapeutics initiative evidence based drug therapy. COX-2 inhibitors update: do journal publications tell the full story? Ther Lett 2002., 43
• [16]Peterson LW, Cryer B: COX-1 sparing NSAID: is the enthusiasm justified? JAMA 1999, 282:1961-1963.
• [17]Jones R: Efficacy and safety of COX-2 inhibitors. New data are encouraging but the risk:benefit ratio remains unclear. BMJ 2002, 325:607-608.
• [18]Griffin MR, Piper JM, Daugherty JR, Snowden M, Ray WA: Nonsteroidal antiinflammatory drug use and increased risk for peptic ucler disease in elderly persons. Ann Intern Med 1991, 114:257-263.
• [19]Moride Y, Abenhaim L: The depletion of susceptibles effect in non-experimental pharmacoepidemiologic research. J Clin Epidemiol 1994, 47:731-737.
• [20]Donabedian A: Aspects of Medical Care Administration. Cambridge, MA: Harvard University Press; 1973.
• [21]Von Korff M, Wagner E, Saunders K: A chronic disease score from automated pharmacy data. J Clin Epidemiol 1992, 45:197-203.
• [22]Tamblyn R, Lavoie G, Petrella L, Monette J: The use of prescription claims databases in pharmacoepidemiological research: the accuracy and comprehensiveness of the prescription claims database in Quebec. J Clin Epidemiol 1995, 48:999-1009.
• [23]MacDonald T, Pettitt DA, Goldstein JL, Burke TA, Zhao SZ, Morant SV: The risks of upper gastrointestinal haemorrhage in users of meloxicam, cyclooxygenase-2 (COX-2) specific inhibitors and other nonsteroidal anti-inflammatory drugs (NSAIDs) [abstract]. Pharmacoepidemiol Drug Safety 2002, S12.
• [24]Solomon DH, Levin R, Avorn J: GI risk factors in patients prescribed COX-2 agents and NSAIDs [abstract]. Pharmacoepidemiol Drug Safety 2002, S149.