Gastroprotection by coxibs: What do the Celecoxib Long-Term Arthritis Safety Study and the Vioxx Gastrointestinal Outcomes Research Trial tell us?

Rheumatic Disease Clinics of North America

Volumn 29, Issue 4, 2003, Pages 769-788

  Oviedo, Jaime A ^a   Wolfe, Michael ^a  

^a BOSTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; CELECOXIB; CYCLOOXYGENASE 2 INHIBITOR; DICLOFENAC; ETODOLAC; ETORICOXIB; IBUPROFEN; INDOMETACIN; LUMIRACOXIB; MELOXICAM; MISOPROSTOL; NABUMETONE; NAPROXEN; NONSTEROID ANTIINFLAMMATORY AGENT; OMEPRAZOLE; PARECOXIB; PLACEBO; PROTON PUMP INHIBITOR; RANITIDINE; ROFECOXIB; VALDECOXIB; WARFARIN;

ARTHRITIS; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG TOLERABILITY; DUODENUM ULCER; DYSPEPSIA; GASTRODUODENAL ULCER; GASTROINTESTINAL DISEASE; GASTROINTESTINAL HEMORRHAGE; HUMAN; MAJOR CLINICAL STUDY; META ANALYSIS; OSTEOARTHRITIS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REVIEW; RHEUMATOID ARTHRITIS; STOMACH ULCER; ULCER;

EID: 0142094513     PISSN: 0889857X     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0889-857X(03)00059-0     Document Type: Review

References (57)

1. Wolfe MM, Lichtenstein DR, Singh G. Gastrointestinal toxicity of nonsteroidal antiinflammatory drugs. N Engl J Med 1999;340(24):1888-99.
2. Larkai EN, Smith JL, Lidsky MD, Graham DY. Gastroduodenal mucosa and dyspeptic symptoms in arthritic patients during chronic nonsteroidal anti-inflammatory drug use. Am J Gastroenterol 1987;82(11):1153-8.
3. Singh G, Ramey DR, Morfeld D, Shi H, Hatoum HT, Fries JF. Gastrointestinal tract complications of nonsteroidal anti-inflammatory drug treatment in rheumatoid arthritis. A prospective observational cohort study. Arch Intern Med 1996;156(14):1530-6.
4. Straus WL, Ofman JJ, MacLean C, Morton S, Berger ML, Roth EA, et al. Do NSAIDs cause dyspepsia? A meta-analysis evaluating alternative dyspepsia definitions. Am J Gastroenterol 2002; 97(8):1951-8.
5. Singh G, Triadafilopoulos G. Epidemiology of NSAID induced gastrointestinal complications. J Rheumatol 1999;26(Suppl 56):18-24.
6. 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(10): 787-96.
7. Piper JM, Ray WA, Daugherty JR, Griffin MR. Corticosteroid use and peptic ulcer disease: role of nonsteroidal anti-inflammatory drugs. Ann Intern Med 1991; 114(9):735-40.
8. Silverstein FE, Graham DY, Senior JR, Davies HW, Struthers BJ, Bitttman RM, et al. Misoprostol reduces serious gastrointestinal complications in patients with rheumatoid arthritis receiving nonsteroidal anti-inflammatory drugs. A randomized, double-blind, placebo-controlled trial. Ann Intern Med 1995;123(4):241-9.
9. Wallace JL. Nonsteroidal anti-inflammatory drugs and gastroenteropathy: the second hundred years. Gastroenterology 1997;112(3):1000-16.
10. IMS Health. Global information solutions for the pharmaceutical and healthcare industries. Potential of the COX-2 inhibitor market. March 30, 2000. Available at: http://www.ims.global. com/insight/news_story_000330a.htm. Accessed February 24, 2003.
11. Singh G, Ramey DR, Terry R, Khraishi M, Triadafilopoulos G. NSAID-related effects on the GI tract: an ever-widening spectrum. Arthritis Rheum 1997;40(Suppl):s 93.
12. Carson JL, Strom BL, Morse ML, West SL, Soper KA, Stolley PD, et al. The relative gastrointestinal toxicity of the nonsteroidal anti-inflammatory drugs. Arch Intern Med 1987;147(6):1054-9.
13. Wolfe MM, Sachs G. Acid suppression: optimizing therapy for gastroduodenal ulcer healing, gastroesophageal reflux disease, and stress-related erosive syndrome. Gastroenterology 2000; 118(2 Suppl 1):S9-31.
14. Schoen RT, Vender RJ. Mechanisms of nonsteroidal anti-inflammatory drug-induced gastric damage. Am J Med 1989;86(4):449-58.
15. Shultz PJ, Raij L. Endogenously synthesized nitric oxide prevents endotoxin-induced glomerular thrombosis. J Clin Invest 1992;90(5):1718-25.
16. Crofford LJ. COX-1 and COX-2 tissue expression: implications and predictions. J Rheumatol 1997;24(Suppl 49):15-9.
17. Masferrer JL, Seibert K, Zweifel B, Needleman P. Endogenous glucocorticoids regulate an inducible cyclooxygenase enzyme. Proc Natl Acad Sci USA 1992;89(9):3917-21.
18. Oviedo JA, Wolfe MM. Clinical potential of cyclo-oxygenase-2 inhibitors. BioDrugs 2001; 15(9):563-72.
19. Needleman P, Isakson PC. The discovery and function of COX-2. J Rheumatol 1997; 24(Suppl 49):6-8.
20. Beejay LI, Wolfe MM. Cyclooxygenase 2 selective inhibitors: panacea or flash in the pan? Gastroenterology 1999;117(4):1002-5.
21. Griffin MR, Ray WA, Schaffner W. Nonsteroidal anti-inflammatory drug use and death from peptic ulcer in elderly persons. Ann Intern Med 1988; 109(5):359-63.
22. Hansen JM, Hallas J, Lauritsen JM, Bytzer P, et al. Non-steroidal anti-inflammatory drugs and ulcer complications: a risk factor analysis for clinical decision-making. Scand J Gastroenterol 1996;31(2):126-30.
23. Laine L. Approaches to nonsteroidal anti-inflammatory drug use in the high-risk patient. Gastroenterology 2001;120(3):594-606.
24. Bjorkman DJ. Nonsteroidal anti-inflammatory drug-induced gastrointestinal injury. Am J Med 1996;101(1A):25S-32S.
25. Bombardier C, Laine L, Reicin A, Shapiro D, Burgos-Vargas R, Davis B, et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. VIGOR Study Group. N Engl J Med 2000;343(21):1520-30.
26. Laine L, Bombardier C, Hawkey CJ, Davis B, Shapiro D, Brett C, et al. Stratifying the risk of NSAID-related upper gastrointestinal clinical events: results of a double-blind outcomes study in patients with rheumatoid arthritis. Gastroenterology 2002;123(4):1006-12.
27. Wallace JL. Distribution and expression of cyclooxygenase (COX) isoenzymes, their physiological roles, and the categorization of nonsteroidal anti-inflammatory drugs (NSAIDs). Am J Med 1999;107(6A):11S-6S [discussion 16S-7S].
28. Cryer B. Second-generation cyclooxygenase-2-specific inhibitors. Clinical Perspectives in Gastroenterology 2002;5(2):122-8.
29. Harris SI, Kuss M, Hubbard RC, Goldstein JL. Upper gastrointestinal safety evaluation of parecoxib sodium, a new parenteral cyclooxygenase-2-specific inhibitor, compared with ketorolac, naproxen, and placebo. Clin Ther 2001;23(9):1422-8.
30. Feldman M, McMahon AT. Do cyclooxygenase-2 inhibitors provide benefits similar to those of traditional nonsteroidal anti-inflammatory drugs, with less gastrointestinal toxicity? Ann Intern Med 2000;132(2):134-43.
31. Langman MJ, Jensen DM, Watson DJ, Harper SE, Zhao PL, Quan H, et al. Adverse upper gastrointestinal effects of rofecoxib compared with NSAIDs. JAMA 1999;282(20):1929-33.
32. Simon LS, Weaver AL, Graham DY, Kivitz AJ, Lipsky PE, Hubbard RC, et al. Anti-inflammatory and upper gastrointestinal effects of celecoxib in rheumatoid arthritis: a randomized controlled trial. JAMA 1999;282(20):1921-8.
33. Silverstein FE, Faich G, Goldstein JL, Simon LS, Pincus T, Whelton A, 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. JAMA 2000;284(10):1247-55.
34. Goldstein JL, Silverstein FE, Agrawal NM, Hubbard RC, Kaiser J, Maurath CJ, et al. Reduced risk of upper gastrointestinal ulcer complications with celecoxib, a novel COX-2 inhibitor. Am J Gastroenterol 2000;95(7):1681-90.
35. MMWR. Physician advice and individual behaviors about cardiovascular disease risk reduction-seven states and Puerto Rico, 1997. MMWR Morb Mortal Wkly Rep 1999;48(4): 74-7.
36. Lee M, Cryer B, Feldman M. Dose effects of aspirin on gastric prostaglandins and stomach mucosal injury. Ann Intern Med 1994;120(3):184-9.
37. Weil J, Colin-Jones D, Langman M, Lawson D, Logan R, Murphy M, et al. Prophylactic aspirin and risk of peptic ulcer bleeding. BMJ 1995; 310(6983):827-30.
38. Laine L, Harper S, Simon T, Bath R, Johanson J, Schwartz H, et al. A randomized trial comparing the effect of rofecoxib, a cyclooxygenase 2-specific inhibitor, with that of ibuprofen on the gastroduodenal mucosa of patients with osteoarthritis. Rofecoxib Osteoarthritis Endoscopy Study Group. Gastroenterology 1999;117(4):776-83.
39. Hawkey C, Laine L, Simon T, Beaulieu A, Maldonado-Cocco J, Acevedo E, et al. Comparison of the effect of rofecoxib (a cyclooxygenase 2 inhibitor), ibuprofen, and placebo on the gastroduodenal mucosa patients with osteoarthritis: a randomized, double-blind, placebo-controlled trial. The Rofecoxib Osteoarthritis Endoscopy Multinational Study Group. Arthritis Rheum 2000;43(2): 370-7.
40. McAdam BF, Catella-Lawson F, Mardini IA, Kapoor S, Lawson JA, FitzGerald GA. Systemic biosynthesis of prostacyclin by cyclooxygenase (COX)-2: the human pharmacology of a selective inhibitor of COX-2. Proc Natl Acad Sci USA 1999;96(1):272-7.
41. Rofecoxib Drug information. Whitehouse Station (NJ): Merck & Co; 2000.
42. Mukherjee D, Nissen SE, Topol EJ. Risk of cardiovascular events associated with selective COX-2 inhibitors. JAMA 2001;286(8):954-9.
43. Patrono C. Aspirin as an antiplatelet drug. N Engl J Med 1994;330(18):1287-94.
44. Baigent C, Patrono C. Selective cyclooxygenase 2 inhibitors, aspirin, and cardiovascular disease: a reappraisal. Arthritis Rheum 2003;48(1):12-20.
45. Antithrombotic Trialist's Collaboration. Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. BMJ 2002;324(7329):71-86.
46. Solomon DH, Glynn RJ, Levin R, Avorn J. Nonsteroidal anti-inflammatory drug use and acute myocardial infarction. Arch Intern Med 2002;162(10):1099-104.
47. Watson DJ, Rhodes T, Cai B, Guess HA. Lower risk of thromboembolic cardiovascular events with naproxen among patients with rheumatoid arthritis. Arch Intern Med 2002;162(10):1105-10.
48. Rahme E, Pilote L, LeLorier J. Association between naproxen use and protection against acute myocardial infarction. Arch Intern Med 2002;162(10):1111-5.
49. Konstam MA, Weir MR, Reicin A, Shapiro D, Sperling RS, Barr E, et al. Cardiovascular thrombotic events in controlled, clinical trials of rofecoxib. Circulation 2001;104(19):2280-8.
50. Dalen JE. Selective COX-2 inhibitors, NSAIDs, aspirin, and myocardial infarction. Arch Intern Med 2002; 162(10):1091-2.
51. Agrawal NM, Campbell DR, Safdi MA, Lukasik NL, Huang B, Haber MM. Superiority of lansoprazole vs ranitidine in healing nonsteroidal anti-inflammatory drug-associated gastric ulcers: results of a double-blind, randomized, multicenter study. NSAID-Associated Gastric Ulcer Study Group. Arch Intern Med 2000;160(10):1455-61.
52. Walan A, Bader JP, Classen M, Lamers CB, Piper DW, Rutgersson K, et al. Effect of omeprazole and ranitidine on ulcer healing and relapse rates in patients with benign gastric ulcer. N Engl J Med 1989;320(2):69-75.
53. Oddsson E, Gudjonsson H, Thjodleifsson B. Comparison between ranitidine and omeprazole for protection against gastroduodenal damage caused by naproxen. Scand J Gastroenterol 1992; 27(12):1045-8.
54. Scheiman JM, Behler EM, Loeffler KM, Elta GH. Omeprazole ameliorates aspirin-induced gastroduodenal injury. Dig Dis Sci 1994;39(1):97-103.
55. Yeomans ND, Tulassay Z, Juhasz L, Racz I, Howard JM, Van Rensburg CJ, et al. A comparison of omeprazole with ranitidine for ulcers associated with nonsteroidal antiinflammatory drugs. Acid Suppression Trial: Ranitidine versus Omeprazole for NSAID-associated Ulcer Treatment (ASTRONAUT) Study Group. N Engl J Med 1998;338(11):719-26.
56. Hawkey CJ, Karrasch JA, Szczepanski L, Walker DG, Barkun A, Swannell AJ, et al. Omeprazole compared with misoprostol for ulcers associated with nonsteroidal antiinflammatory drugs. Omeprazole versus Misoprostol for NSAID-induced Ulcer Management (OMNIUM) Study Group. N Engl J Med 1998;338(11):727-34.
57. Chan FK, Hung LCT, Suen BY, Wu JCY, Lee KC, Leung VKS, et al. Celecoxib versus diclofenac and omeprazole in reducing the risk of recurrent ulcer bleeding in patients with arthritis. N Engl J Med 2002;347(26):2104-10.