Withdrawal of COX-2 selective inhibitors rofecoxib and valdecoxib: impact on NSAID and gastroprotective drug prescribing and utilization

References

• Roth SH, Bennett RW. Nonsteroidal anti-inflammatory drug gastropathy. Recognition and response. Arch Intern Med 1987;147:2093–100
   PubMedGoogle Scholar
• Clinard F, Sgro C, Bardou M, et al. Non-steroidal anti-inflammatory drug prescribing patterns in general practice: comparison of a general practitioner-based survey and a pharmacy-based survey in France. Pharmacoepidemiol Drug Saf 2001;10:329–38
   PubMed Web of Science ®Google Scholar
• Dubois RW, Melmed GY, Henning JM, et al. Guidelines for the appropriate use of non-steroidal anti-inflammatory drugs, cyclooxygenase-2-specific inhibitors and proton pump inhibitors in patients requiring chronic anti-inflammatory therapy. Aliment Pharmacol Ther 2004;19:197–208
   PubMed Web of Science ®Google Scholar
• Gabriel SE, Jaakkimainen L, Bombardier C. Risk for serious gastrointestinal complications related to use of nonsteroidal anti-inflammatory drugs. A meta-analysis. Ann Intern Med 1991;115:787–96
   Google Scholar
• Hernandez-Diaz S, Rodriguez LA. Association between nonsteroidal anti-inflammatory drugs and upper gastrointestinal tract bleeding/perforation: an overview of epidemiologic studies published in the 1990s. Arch Intern Med 2000;160: 2093–9
   Google Scholar
• Garcia-Rodriguez LA, Jick H. Risk of upper gastrointestinal bleeding and perforation associated with individual nonsteroidal anti-inflammatory drugs. Lancet 1994;343:769–72
   Google Scholar
• Smalley WE, Ray WA, Daugherty JR, et al. Nonsteroidal anti-inflammatory drugs and the incidence of hospitalizations for peptic ulcer disease in elderly persons. Am J Epidemiol 1995;141:539–45
   PubMed Web of Science ®Google Scholar
• Ofman JJ, MacLean CH, Straus WL, et al. A meta-analysis of severe upper gastrointestinal complications of nonsteroidal anti-inflammatory drugs. J Rheumatol 2002;29:804–12
   PubMed Web of Science ®Google Scholar
• Smalley WE, Griffin MR, Fought RL, et al. Excess costs from gastrointestinal disease associated with nonsteroidal anti-inflammatory drugs. J Gen Intern Med 1996;11:461–9
   PubMed Web of Science ®Google Scholar
• Rahme E, Joseph L, Kong SX, et al. Gastrointestinal health care resource use and costs associated with nonsteroidal anti-inflammatory drugs versus acetaminophen: retrospective cohort study of an elderly population. Arthritis Rheum 2000;43:917–24
   PubMed Web of Science ®Google Scholar
• Herings RM, Klungel OH. An epidemiological approach to assess the economic burden of NSAID-induced gastrointestinal events in the Netherlands. Pharmacoeconomics 2001;19:655–65
   PubMed Web of Science ®Google Scholar
• Bombardier C, Laine L, Reicin A, et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. New Engl J Med 2000;343:1520–8
   PubMed Web of Science ®Google Scholar
• Silverstein FE, Faich G, Goldstein JL, et al. Gastrointestinal toxicity with celecoxib vs nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: the CLASS Study: a randomized controlled trial. Celecoxib Long-term Arthritis Safety Study. J Am Med Assoc 2000;282:1247–55
   Google Scholar
• Goldstein JL, Silverstein FE, Agrawal NM, et al. Reduced risk of upper gastrointestinal ulcer complications with celecoxib, a novel COX-2 inhibitor. Am J Gastroenterol 2000;95:1681–90
   PubMed Web of Science ®Google Scholar
• Goldstein JL, Zhao SZ, Burke TA, et al. Incidence of outpatient physician claims for upper gastrointestinal symptoms among new users of celecoxib, ibuprofen, and naproxen in an insured population in the United States. Am J Gastroenterol 2003;98:2627–34
   PubMed Web of Science ®Google Scholar
• Mukherjee D, Nissen SE, Topol EJ. Risk of cardiovascular events associated with selective COX-2 inhibitors. J Am Med Assoc 2001;286: 954–9
   Google Scholar
• Mukherjee D. Selective cyclooxygenase-2 (COX-2) inhibitors and potential risk of cardiovascular events. Biochem Pharmacol 2002;63:817–21
   PubMed Web of Science ®Google Scholar
• FDA News. April 7, 2005. Available at http://www.fda.gov/bbs/topics/news/2004/NEW01122.html [last accessed March 30, 2007]
   Google Scholar
• FDA Press Release. September 30, 2004. Available at http://www.fda.gov/bbs/topics/news/2005/NEW01171.html [last accessed March 30, 2007]
   Google Scholar
• Watson DJ, Rhodes T, Cai B, et al. Lower risk of thromboembolic cardiovascular events with naproxen among patients with rheumatoid arthritis. Arch Intern Med 2002;162:1105–10
   PubMed Web of Science ®Google Scholar
• Mamdani M, Rochon P, Juurlink DN, et al. Effect of selective cyclooxygenase 2 inhibitors and naproxen on short-term risk of acute myocardial infarction in the elderly. Arch Intern Med 2003;163:481–6
   PubMed Web of Science ®Google Scholar
• Kimmel SE, Berlin JA, Reilly M, et al. The effects of nonselective non-aspirin non-steroidal anti inflammatory medications on the risk of nonfatal myocardial infarction and their interaction with aspirin. J Am Coll Cardiol 2004;43:985–90
   PubMed Web of Science ®Google Scholar
• 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 Web of Science ®Google Scholar
• Bannwarth B. Do selective cyclo-oxygenase-2 inhibitors have a future? Drug Safety 2005;28:183–9
   PubMed Web of Science ®Google Scholar
• Johnsen SP, Larsson H, Tarone RE, et al. Risk of hospitalization for myocardial infarction among users of rofecoxib, celecoxib, and other NSAIDs: a population-based case-control study. Arch Intern Med 2005;165:978–84
   PubMed Web of Science ®Google Scholar
• Kimmel SE, Berlin JA, Reilly M, et al. Patients exposed to rofecoxib and celecoxib have different odds of nonfatal myocardial infarction. Ann Intern Med 2005;142:157–64
   PubMed Web of Science ®Google Scholar
• Mamdani M, Juurlink DN, Lee DS, et al. Cyclo-oxygenase-2 inhibitors versus non-selective non-steroidal anti-inflammatory drugs and congestive heart failure outcomes in elderly patients: a population-based cohort study. Lancet 2004;363:1751–6
   PubMed Web of Science ®Google Scholar
• FDA Statement on Naproxen. Rockville, MD: US Food and Drug Administration. December 20, 2004. Available at http://www.fda.gov/bbs/topics/news/2004/new01148.html [last accessed August 23, 2006]
   Google Scholar
• Graham DJ, Campen D, Hui R, et al. Risk of acute myocardial and sudden cardiac death in patients treated with cyclo-oxygen-ase 2 selective and nonselective non-steroidal anti-inflammatory drugs: nested case-control study. Lancet 2005;365:475–81
   PubMed Web of Science ®Google Scholar
• Couzin J. FDA panel urges caution on many anti-inflammatory drugs. Science 2005;307:1183–4
   PubMed Web of Science ®Google Scholar
• Reicin A, Shapiro D, Sperling RS, et al. Comparison of cardiovascular thrombotic events in patients with osteoarthritis treated with rofecoxib versus nonselective nonsteroidal anti-inflammatory drugs (ibuprofen, diclofenac, and nabumetone). Am J Cardiol 2002;89:204–9
   PubMed Web of Science ®Google Scholar
• Farkouh ME, Kirshner H, Harrington RA, et al. Comparison of lumiracoxib with naproxen and ibuprofen in the Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET), cardiovascular outcomes: randomised controlled trial. Lancet 2004;364:675–84
   PubMed Web of Science ®Google Scholar
• Cannon CP, Curtis SP, FitzGerald GA, et al. Cardiovascular outcomes with etoricoxib and diclofenac in patients with osteoarthritis and rheumatoid arthritis in the Multinational Etoricoxib and Diclofenac Arthritis Long-term (MEDAL) programme: a randomised comparison. Lancet 2006;368:1771–81
   PubMed Web of Science ®Google Scholar
• Page J, Henry D. Consumption of NSAIDs and the development of congestive heart failure in elderly patients: an underrecognized public health problem. Arch Intern Med 2000;160:777–84
   PubMed Web of Science ®Google Scholar
• Ray WA, Stein CM, Hall K, et al. Non-steroidal anti-inflammatory drugs and risk of serious coronary heart disease: an observational cohort study. Lancet 2002;359:118–23
   PubMed Web of Science ®Google Scholar
• Health Insurance Portability and Accountability Act [HIPAA Web site]. Available at http://www.hipaa.org/ [last accessed March 30, 2007]
   Google Scholar
• Wagner AK, Soumerai SB, Zhang F, et al. Segmented regression analysis of interrupted time series studies in medication use research. J Clin Pharm Ther 2002;27:299–309
   PubMed Web of Science ®Google Scholar
• Schneeweiss S, Malcolm M, Dormuth CR, et al. A therapeutic substitution policy for proton pump inhibitors: clinical and economic consequences. Clin Pharmacol Ther 2006;79:379–88
   PubMed Web of Science ®Google Scholar
• Wolfe MM, Lichtenstein DR, Singh G. Gastrointestinal toxicity of nonsteroidal antiinflammatory drugs. New Engl J Med 1999;340:1888–99
   PubMed Web of Science ®Google Scholar
• Chey WD, Lukasik N, Huang B, et al. Lansoprazole effectively reduces the risk of GI symptom occurrence in ulcer free patients who continue chronic NSAID use. Am J Gastroenterol 2003;98:S296
   PubMedGoogle Scholar
• Goldstein JL, Johanson JF, Suchower LJ, et al. Healing of gastric ulcers with esomeprazole versus ranitidine in patients who continued to receive NSAID therapy: a randomized trial. Am J Gastroenterol 2005;100:2650–7
   PubMed Web of Science ®Google Scholar
• Girvin B, Rafferty T, Stevenson MR, et al. Uptake of COX-2 selected inhibitors and influence on NSAID prescribing in Northern Ireland. Pharmacoepidemiol Drug Saf 2004;13:153–7
   PubMed Web of Science ®Google Scholar
• Teeling M, Bennett K, Feely J. Have COX-2 inhibitors influenced the co-prescription of anti-ulcer drugs with NSAIDs? Br J Clin Pharmacol 2003;57: 337–43
   Google Scholar
• Cox ER, Motheral B, Frisse M, et al. Prescribing COX-2s for patients new to cyclo-oxygenase inhibition therapy. Am J Manag Care 2003;9:735–42
   PubMed Web of Science ®Google Scholar
• Dai C, Stafford RS, Alexander GC. National trends in cyclooxygenase-2 inhibitor use since market release: nonselective diffusion of a selectively cost-effective innovation. Arch Intern Med 2005;165: 171–7
   Google Scholar
• Dubois RW, Melmed GY, Henning JM, et al. Guidelines for the appropriate use of non-steroidal anti-inflammatory drugs, cyclooxygenase-2-specific inhibitors and proton pump inhibitors in patients requiring chronic anti-inflammatory therapy. Aliment Pharmacol Ther 2004;19:197–208
   PubMed Web of Science ®Google Scholar
• Lanas A. The appropriate use of proton-pump inhibitor co-therapy with non-steroidal anti-inflammatory drugs and cyclooxygenase-2 selective inhibitors. Aliment Pharmacol Ther 2005;21(Suppl 1):2–4
   PubMedGoogle Scholar
• Chan FKL. Non-steroidal anti-inflammatory drugs and proton-pump inhibitors vs. cyclo-oxygenase-2 selective inhibitors in reducing the risk of recurrent ulcer bleeding in patients with arthritis. Aliment Pharmacol Ther 2005;21(Suppl 1):5–6
   Google Scholar
• Harris BN, West DS, Johnson J, et al. Effects on the cost and utilization of proton pump inhibitors from adding over-the counter omeprazole to drug benefit coverage in a state employee health plan. J Manag Care Pharm 2004;10:449–55
   PubMedGoogle Scholar