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

Volumn 117, Issue 4, 1999, Pages 776-783

  Laine, L ^a   Harper, S ^a   Simon, T ^a   Bath, R ^a   Johanson, J ^a   Schwartz, H ^a   Stern, S ^a   Quan, H ^a   Bolognese, J ^a  

^a UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CYCLOOXYGENASE 2 INHIBITOR; IBUPROFEN; ROFECOXIB; UNCLASSIFIED DRUG;

ADULT; AGED; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFICACY; DRUG SCREENING; DUODENOSCOPY; DUODENUM MUCOSA; FEMALE; GASTRODUODENAL ULCER; GASTROSCOPY; HUMAN; INCIDENCE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; ORAL DRUG ADMINISTRATION; OSTEOARTHRITIS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; STOMACH MUCOSA;

EID: 0032851480     PISSN: 00165085     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0016-5085(99)70334-3     Document Type: Article

References (35)

1. JF Fries NSAID gastropathy: the second most deadly rheumatic disease? Epidemiology and risk appraisal J Rheumatol 18 suppl 28 1991 6 10
2. L Laine Nonsteroidal anti-inflammatory drug gastropathy Gastrointest Endosc Clin North Am 6 1996 489 504
3. HE Paulus FDA arthritis advisory committee meeting: postmarketing surveillance of nonsteroidal antiinflammatory drugs Ar thritis Rheum 28 1985 1168 1169
4. FE Silverstein DY Graham JR Senior HW Davies BJ Struthers RM Bittman GS Geis Misoprostol reduces serious gastrointestinal complications in patients with rheumatoid ar thritis receiving nonsteroidal anti-inflammatory drugs Ann Intern Med 123 1995 241 249
5. G Singh DR Ramey NSAID induced gastrointestinal complications: the ARAMIS perspective—1997 J Rheumatol 25 suppl 51 1998 8 16
6. B Cryer Nonsteroidal anti-inflammatory drugs and gastrointestinal disease 6th ed M Feldman BF Scharschmidt MH Sleisenger Sleisenger and Fordtran's gastrointestinal and liver disease 1998 Saunders Philadelphia 343 357
7. EA Meade WL Smith DL DeWitt Dif ferential inhibition of prostaglandin endoperoxide synthase (cyclooxygenase) isozymes by aspirin and other non-steroidal anti-inflammatory drugs J Biol Chem 268 1993 6610 6614
8. E Fosslien Adverse effects of nonsteroidal anti-inflammatory drugs on the gastrointestinal system Ann Clin Lab Sci 28 1998 67 81
9. JA Mitchell P Akarasereenont C Thiemermann RJ Flower JR Vane Selectivity of nonsteroidal antiinflammatory drugs as inhibitors of constitutive and inducible cyclooxygenase Proc Natl Acad Sci USA 90 1994 11693 11697
10. C Brideau S Kargman S Liu AL Dallob EW Ehrich IW Rodger C-C Chan A human whole blood assay for clinical evaluation of biochemical efficacy of cyclooxygenase inhibitors Inflamm Res 45 1996 68 74
11. CC Chan S Boyce C Brideau S Charleson W Cromlish D Ethier J Evans AW Ford-Hutchinson MJ Forrest JY Gauthier R Gordon M Gresser J Guay S Kargman B Kennedy Y Leblanc S Leger Mancini J, O'Neill GP, Ouellet M, Patrick D, Percival MD, Perrier H, Prasit P, Rodger I, Tagari P, Therien M, Vickers P, Visco D, Wang Z, Webb J, Wong E, Xu LJ, Young RN, Zamboni R, Riendeau D. Rofecoxib (Vioxx™, MK-0966, 4-(4'-methylsulfonylphenyl)-3-phenyl-2-(5H)-furanone): a potent, selective and orally active cyclooxygen-ase-2 inhibitor—pharmacological and biochemical profiles J Pharmacol Exp Ther 290 1999 551 560
12. EW Ehrich A Dallob I De Lepeleire A Van Hecken D Riendeau W Yuan A Porras J Wittreich JR Seibold P De Schepper DR Mehlisch BJ Gertz Characterization of rofecoxib as a cyclooxy-genase-2 isoform inhibitor and demonstration of analgesia in the dental pain model Clin Pharmacol Ther 65 1999 336 347
13. E Ehrich T Schnitzer A Kivitz A Weaver F Wolfe B Morrison Q Zeng J Bolognese B Seidenberg MK-966, a highly selective COX-2 inhibitor, was effective in the treatment of osteoarthritis (OA) of the knee and hip in a 6-week placebo controlled study Ar thritis Rheum 40 suppl 1997 S85
14. K Saag C Fisher J Mckay E Ehrich P-L Zhao J Bolognese B Seidenberg B Daniels MK-0966, a specific COX-2 inhibitor, has clinical efficacy comparable to ibuprofen in the treatment of knee and hip osteoarthritis (OA) in a 6-week controlled clinical trial Arthritis Rheum 41 suppl 1998 S196
15. 2) synthesis in healthy humans (abstr) Gastroenterology 116 1999 A141
16. F Lanza MF Rack T Simon H Quan J Bolognese M Hoover F Wilson S Harper Specific inhibition of cyclooxygenase-2 with MK-0966 is associated with less gastroduodenal damage than either aspirin or ibuprofen Aliment Pharmacol Ther 13 1999 761 767
17. R Hunt B Bowen C James S Sridhar T Simon E Mortensen A Cagliola H Quan J Bolognese COX-2 specific inhibition with MK-0966 25 or 50 mg QD over 4 weeks does not increase fecal blood loss. A controlled study with placebo and ibuprofen 800 mg TID (abstr) Am J Gastroenterol 93 1998 1671
18. I Bjarnason G Sigthorsson R Crane T Simon M Hoover J Bolognese H Quan COX-2 specific inhibition with MK-0966 25 or 50 mg QD does not increase intestinal permeability: a controlled study with placebo (PBO) and indomethacin 50 mg TID (INDO) (abstr) Am J Gastroenterol 93 1998 1670
19. DY Graham High-dose famotidine for prevention of NSAID ulcers? Gastroenterology 112 1997 2143 2145
20. D Henry LL-Y Lim LAG Rodriguez SP Gutthann JL Carson M Griffin R Savage R Logan Y Moride C Hawkey S Hill JT Fries Variability in risk of gastrointestinal complications with individual non-steroidal anti-inflammatory drugs: results of a collaborative meta-analysis BMJ 312 1996 1563 1566
21. B Cryer M Goldschmiedt JS Redfern M Feldman Comparison of salsalate and aspirin on mucosal injury and gastroduodenal mucosal prostaglandins Gastroenterology 99 1990 1616 1621
22. L Laine R Sloane M Ferretti F Cominelli A randomized double-blind comparison of placebo, etodolac, and naproxen on gastrointestinal injury and prostaglandin production Gastrointest Endosc 42 1995 428 433
23. G Bianchi Porro I Caruso M Petrillo F Montrone S Ardizzone A double-blind gastroscopic evaluation of the effects of etodolac and naproxen on the gastrointestinal mucosa of rheumatic patients J Intern Med 229 1991 5 8
24. RI Russell Endoscopic evaluation of etodolac and naproxen, and their relative effects on gastric and duodenal prostaglandins Rheumatol Int 10 suppl 1990 17 21
25. S Roth EA Tindall AK Jain G McMahon PA April BI Bockow SB Cohen RM Fleischmann A controlled study comparing the effects of nabumetone, ibuprofen, and ibuprofen plus misoprostol on the upper gastrointestinal tract mucosa Arch Intern Med 153 1993 2565 2571
26. NM Agrawal J Caldwell AJ Kivitz AL Weaver TS Bocanegra J Ball S Dhadda S Hurley L Hancock for the Ar throtec Study Group Comparison of the upper gastrointestinal safety of Ar throtec 75 and nabumetone in osteoarthritis patients at high risk for developing nonsteroidal anti-inflammatory drug–induced gastrointestinal ulcers Clin Ther 21 1999 659 674
27. DY Graham RH White LW Moreland TT Schubert R Katz R Jaszewski E Tindall G Triadafilopoulos SC Stromatt LS Teoh Duodenal and gastric ulcer prevention with misoprostol in arthritis patients taking NSAIDs Ann Intern Med 119 1993 257 262
28. NM Agrawal HEJM Van Kerckhove LJ Erhardt GS Geis Misoprostol coadministered with diclofenac for prevention of gastroduodenal ulcers: a one-year study Dig Dis Sci 40 1995 1125 1131
29. GM Van Deventer JD Elashoff TJ Reedy D Schneidman J Walsh A randomized study of maintenance therapy with ranitidine to prevent the recurrence of duodenal ulcer N Engl J Med 320 1989 1113 1119
30. DM Jensen S Cheng TO Kovacs G Randall ME Jensen T Reedy H Frankl G Machicado J Smith M Silpa A controlled study of ranitidine for the prevention of recurrent hemorrhage from duodenal ulcer N Engl J Med 330 1994 382 386
31. L Laine RJ Hopkins LS Girardi Has the impact of Helicobacter pylori therapy on ulcer recurrence in the United States been overstated: a meta-analysis of rigorously designed trials Am J Gastroenterol 93 1998 1409 1415
32. L Laine Helicobacter pylori and complicated ulcer diseases Am J Med 100 1996 52S 59S
33. S Takahashi J Shigeta N Kobayashi S Okabe Localization of cyclooxygenase-2 and regulation of its expression in gastric ulcers in rats (abstr) Gastroenterology 114 1998 A303
34. J-I Shigeta S Takahashi S Okabe Role of cyclooxygenase-2 in the healing of gastric ulcers in rats J Pharmacol Exp Ther 286 1998 1383 1390
35. A Schmassmann Ch Stettler P Netzer B Flogerzi BM Peskar F Halter L-745,337, a selective inhibitor of COX-2, delays healing of experimental gastric ulcers comparable to traditional NSAIDs (abstr) Gastroenterology 110 1996 A252