Reduced incidence of gastroduodenal ulcers associated with lumiracoxib compared with ibuprofen in patients with rheumatoid arthritis

Alimentary Pharmacology and Therapeutics

Volumn 19, Issue 11, 2004, Pages 1189-1198

  Kivitz, A J ^a   Nayiager, S ^b   Schimansky, T ^c   Gimona, A ^c   Thurston, H J ^c   Hawkey, C ^d  

^a Altoona Center for Clinical Research   (United States)

^b St Augustine's Hospital   (South Africa)

^c NOVARTIS PHARMA AG   (Switzerland)

^d NOTTINGHAM UNIVERSITY HOSPITALS NHS TRUST   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; ANTACID AGENT; CELECOXIB; IBUPROFEN; LUMIRACOXIB; PARACETAMOL; RENNIE;

ABDOMINAL PAIN; ADULT; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG SAFETY; DYSPEPSIA; FEMALE; GASTRODUODENAL ULCER; HEADACHE; HUMAN; INCIDENCE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; PERITONITIS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHEUMATOID ARTHRITIS; RHINOPHARYNGITIS; SIDE EFFECT; STATISTICAL SIGNIFICANCE; VOMITING;

ADOLESCENT; ADULT; AGED; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; ARTHRITIS, RHEUMATOID; CYCLOOXYGENASE INHIBITORS; DICLOFENAC; DOUBLE-BLIND METHOD; HUMANS; IBUPROFEN; MIDDLE AGED; ORGANIC CHEMICALS; PEPTIC ULCER; TREATMENT OUTCOME;

EID: 2942512797     PISSN: 02692813     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1365-2036.2004.01956.x     Document Type: Article

References (46)

1. March LM, Bachmeier CJ. Economics of osteoarthritis: a global perspective. Baillieres Clin Rheumatol 1997; 11: 817-34.
2. Reginster JY. The prevalence and burden of arthritis. Rheumatology (Oxford) 2002; 41(Suppl. 1): 3-6.
3. Yelin E, Callahan LF. The economic cost and social and psychological impact of musculoskeletal conditions. National Arthritis Data Work Group. Arthritis Rheum 1995; 38: 1351-62.
4. Schappert SM. National Ambulatory Medical Care Survey: 1989 summary. Vital Health Stat 1992; 13: 1-80.
5. Gureje O, Von Korff M, Simon GE, Gater R. Persistent pain and well-being: a World Health Organization Study in primary care. JAMA 1998; 280: 147-51.
6. Bombardier C, Laine L, Reicin A, 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: 1520-8.
7. Wolfe MM, Lichtenstein DR, Singh G. Gastrointestinal toxicity of nonsteroidal antiinflammatory drugs. N Engl J Med 1999; 340: 1888-99.
8. Langman MJ, Weil J, Wainwright P, et al. Risks of bleeding peptic ulcer associated with individual non-steroidal anti-inflammatory drugs. Lancet 1994; 343: 1075-8.
9. Garcia Rodriguez LA, Jick H. Risk of upper gastrointestinal bleeding and perforation associated with individual non-steroidal anti-inflammatory drugs. Lancet 1994; 343: 769-72.
10. Singh G. Recent considerations in nonsteroidal anti-inflammatory drug gastropathy. Am J Med 1998; 105: 31S-8S.
11. Singh G, Ramey DR. NSAID induced gastrointestinal complications: The ARAMIS perspective. J Rheumatol 1998; 25 Suppl. 51: 8-16.
12. Bannwarth B. Gastrointestinal tolerance of nonsteroidal anti-inflammatory agents. Drugs 2000; 59 (Spec No. 1): 17-23.
13. Cryer B, Feldman M. Cyclooxygenase-1 and cyclooxygenase-2 selectivity of widely used nonsteroidal anti-inflammatory drugs. Am J Med 1998; 104: 413-21.
14. Vane JR. Inhibition of prostaglandin synthesis as a mechanism of action for aspirin-like drugs. Nature New Biol 1971; 231: 232-5.
15. Abramson SR, Weissmann G. The mechanism of action of anti-inflammatory drugs. Arthritis Rheum 1989; 32: 1-9.
16. Crofford LJ, Lipsky PE, Brooks P, Abramson SB, Simon LS, van de Putte LB. Basic biology and clinical application of specific cyclooxygenase-2 inhibitors. Arthritis Rheum 2000; 43: 4-13.
17. Vane J, Botting R. Inflammation and the mechanism of action of anti-inflammatory drugs. FASEB J 1987; 1: 89-96.
18. Meade EA, Smith WL, DeWitt DL. Differential inhibition of prostaglandin endoperoxide synthase (cyclooxygenase) isoenzymes by aspirin and other non-steroidal anti-inflammatory drugs. J Biol Chem 1993; 268: 6610-4.
19. Warner TD, Giuliano F, Vojnovic I, Bukasa A, Mitchell JA, Vane JR. Nonsteroid drug selectivities for cyclo-oxygenase-1 rather than cyclo-oxygenase-2 are associated with human gastrointestinal toxicity: a full in vitro analysis. Proc Natl Acad Sci USA 1999; 9: 7563-8.
20. Scott G, Rordorf C, Blood P, et al. Dose escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of COX189 in healthy subjects. Ann Rheum Dis 2002; 61(Suppl. 1): 242 (Abstract FRI0300).
21. Scott G, Rordorf C, Milsavljev S, et al. Pharmacokinetics and pharmacodynamics of COX189 in patients with knee or hip primary osteoarthritis. Ann Rheum Dis 2002; 61(Suppl. 1): 128 (Abstract THU0233).
22. Reynolds C, Scott G, Looby M, et al. Pharmacokinetics of lumiracoxib in synovial fluid and plasma of patients with rheumatoid arthritis. In: Tulunay, FC, Orme, M, eds. European collaboration: Towards Drug Development and Rational Drug Therapy. Proceedings of the Sixth Congress of the European Association for Clinical Pharmacology and Therapeutics, Berlin: Springer-Verlag, 2003; p. 123 (Abstract P-195).
23. Schnitzer TJ, Geusens P, Hasler P, et al. Efficacy and safety of COX189 in osteoarthritis: a multi-national study. Arthritis Rheum 2000; 43(Suppl. 9): 1616 (Abstract S336).
24. Benevolenskaya L, Tüzün S, Hagin E, Moore A, Gimona A. Lumiracoxib is effective in relieving symptoms of knee or hip osteoarthritis after 4 weeks of treatment: results from a randomized, placebo-controlled trial. Ann Rheum Dis 2003; 62(Suppl. 1): 270 (Abstract FRI0246).
25. Grifka J, Zacher J, Brown J, et al. Lumiracoxib is effective and well tolerated in patients with osteoarthritis of the hand: results from a randomized, placebo-controlled trial. Ann Rheum Dis 2003; 62(Suppl. 1): 263 (Abstract FRI0222).
26. Marshall PJ, Berry JC, Wasvary J, et al. The in vitro and in vivo selectivity of COX189, a new and highly selective inhibitor of COX-2. Ann Rheum Dis 2002; 61(Suppl. 1): 259 (Abstract SAT0013).
27. Scott G, Rordorf C, Milosavljev S, Chase W, Fleischmann R, Kivitz A. Multiple-dose lumiracoxib shows rapid absorption and cyclooxygenase-2 (COX-2) selectivity without accumulation in patients with rheumatoid arthritis. In: Tulunay, FC, Orme, M, eds. European Collaboration: Towards Drug Development and Rational Drug Therapy. Proceedings of the Sixth Congress of the European Association for Clinical Pharmacology and Therapeutics, Berlin: Springer-Verlag, 2003; 123p. (Abstract P-197).
28. Atherton CT, Jones JI, McKaig BC, et al. Pharmacology and gastrointestinal safety of lumiracoxib, a novel COX-2 selective inhibitor: a preliminary integrated study. Clin Gastroenterol Hepatol 2004; 2: 113-20.
29. Geusens P, Alten R, Rovensky J, et al. Efficacy, safety and tolerability of lumiracoxib in patients with rheumatoid arthritis: results of a randomized double-blind study. Arthritis Rheum 2003; 48(Suppl. 9): 242 (Abstract 544).
30. Tannenbaum H, Berenbaum F, Reginster JY, et al. Lumiracoxib (Prexige) is effective in the treatment of osteoarthritis of the knee: a 13-week, placebo-controlled, active-comparator, double-blind study. Arthritis Rheum 2002; 46(Suppl. 9): S212 (Abstract 487).
31. Hawkey CJ, Karàteev D, Codreanu C, et al. Improved upper gastrointestinal (UGI) safety and tolerability of a new coxib, COX189, compared with ibuprofen in osteoarthritis patients. Ann Rheum Dis 2002; 61(Suppl. 1): 126 (Abstract THU0226).
32. Rordorf C, Kellert N, Mair S, et al. Gastroduodenal tolerability of lumiracoxib versus placebo and naproxen: a pilot endoscopic study in healthy male subjects. Aliment Pharmacol Ther 2003; 18: 533-41.
33. Goldstein JL, Correa P, Zhao WW, et al. Reduced incidence of gastroduodenal ulcers with celecoxib, a novel cyclooxygenase-2 inhibitor, compared to naproxen in patients with arthritis. Am J Gastroenterol 2001; 96: 1019-27.
34. Laine L, Harper S, Simon T, 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. Gastroenterology 1999; 117: 776-83.
35. Deeks JJ, Smith LA, Bradley MD. Efficacy, tolerability, and upper gastrointestinal safety of celecoxib for treatment of osteoarthritis and rheumatoid arthritis: a systematic review of randomised controlled trials. Br Med J 2002; 325: 619-26.
36. Arnett FC, Edworthy SM, Bloch DA, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum 1988; 31: 315-24.
37. Simon LS, Lanza FL, Lipsky PE, et al. Preliminary study of the safety and efficacy of SC-58635, a novel cyclooxygenase 2 inhibitor. Arthritis Rheum 1998; 41: 1591-602.
38. Lanza F, Royer G, Nelson R. An endoscopic evaluation of the effects of nonsteroidal anti-inflammatory drugs on the gastric mucosa. Gastrointest Endosc 1975; 21: 103-5.
39. Hetzel DJ, Dent J, Reed WD, et al. Healing and relapse of severe peptic oesophagitis after treatment with omeprazole. Gastroenterology 1988; 95: 903-12.
40. Simon LS, Weaver AL, Graham DY, et al. Anti-inflammatory and upper gastrointestinal effects of celecoxib in rheumatoid arthritis: a randomized controlled trial. JAMA 1999; 282: 1921-8.
41. Hawkey CJ, Laine L, Simon T, Quan H, Shingo S, Evans J. Incidence of gastroduodenal ulcers in patients with rheumatoid arthritis after 12 weeks of rofecoxib, naproxen, or placebo: a multicentre, randomized, double blind study. Gut 2003; 52(6): 820-6.
42. Hawkey C, Laine L, Simon T, et al. Comparison of the effect of rofecoxib (a cyclooxygenase 2 inhibitor), ibuprofen, and placebo on the gastroduodenal mucosa of patients with osteoarthritis: a randomized, double-blind, placebo-controlled trial. The Rofecoxib Osteoarthritis Endoscopy Multinational Study Group. Arthritis Rheum 2000; 43(2): 370-7.
43. Langman MJ, Jensen DM, Watson DJ, et al. Adverse upper gastrointestinal effects of rofecoxib compared with NSAIDS. JAMA 1999; 282: 1929-33.
44. Hawkey CJ, Jackson L, Harper SE, Simon TJ, Mortensen E, Lines CR. Review article: the gastrointestinal safety profile of rofecoxib, a highly selective inhibitor of cyclooxygenase-2, in humans. Aliment Pharmacol Ther 2001; 15: 1-9.
45. Garcia Rodriguez LA. Nonsteroidal antiinflammatory drugs, ulcers and risk: a collaborative meta-analysis. Semin Arthritis Rheum 1997; 26(Suppl. 1): 16-20.
46. Hunt RH, Harper S, Watson DJ, et al. The gastrointestinal safety of the COX-2 selective inhibitor etoricoxib assessed by both endoscopy and analysis of upper gastrointestinal events. Am J Gastroenterol 2003; 98(8): 1725-33.