Effect of specific COX-2 inhibition in osteoarthritis of the knee: A 6 week double blind, placebo controlled pilot study of rofecoxib

Journal of Rheumatology

Volumn 26, Issue 11, 1999, Pages 2438-2447

  Ehrich, Elliot W ^a   Schnitzer, Thomas J ^b   McIlwain, Harris ^b   Levy, Robert ^b   Wolfe, Frederick ^b   Weisman, Michael ^b   Zeng, Qi ^b   Morrison, Briggs ^b   Bolognese, James ^b   Seidenberg, Beth ^b   Gertz, Barry J ^b  

^a MERCK RESEARCH LABORATORIES   (United States)

^b NONE

Author keywords

Cyclooxygenase inhibitors; Osteoarthritis; Prostaglandin endoperoxide synthase; Rofecoxib; Treatment outcome

Indexed keywords

CYCLOOXYGENASE 2 INHIBITOR; ROFECOXIB; UNCLASSIFIED DRUG;

ADULT; AGED; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; ENZYME INHIBITION; FEMALE; GASTROINTESTINAL HEMORRHAGE; HUMAN; KNEE OSTEOARTHRITIS; LEG EDEMA; MALE; MULTICENTER STUDY; PAIN ASSESSMENT; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME;

ADULT; AGED; AGED, 80 AND OVER; CYCLOOXYGENASE 2; CYCLOOXYGENASE 2 INHIBITORS; CYCLOOXYGENASE INHIBITORS; DOUBLE-BLIND METHOD; FEMALE; HUMANS; ISOENZYMES; LACTONES; MALE; MEMBRANE PROTEINS; MIDDLE AGED; OSTEOARTHRITIS, KNEE; PILOT PROJECTS; PROSTAGLANDIN-ENDOPEROXIDE SYNTHASES; SULFONES; TREATMENT OUTCOME;

EID: 0032732126     PISSN: 0315162X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (61)

1. Vane JR. Inhibition of prostaglandin synthesis as a mechanism of action of aspirin-like drugs. Nature 1971;231:232-5.
2. Smith JB, Willis AL. Aspirin selectivity inhibits prostaglandin production in human platelets. Chest 1971;59:12S.
3. Sirios J, Simmons DL, Richards J. Hormonal regulation of messenger ribonucleic acid encoding a novel isoform of prostaglandin endoperoxide H synthase in rat preovulatory follicles. Induction in vivo and in vitro. J Biol Chem 1992;267:11586-92.
4. Kujubu DA, Fletcher BS, Varnum BC, Lim RW, Herschman HR. TIS10, a phorbol ester tumor promoter-inducible mRNA from Swiss 3T3 cells, encodes a novel prostaglandin synthase/cyclooxygenase homologue. J Biol Chem 1991;266:12866-72.
5. Xie WL, Chipman JG, Robertson DL, Erikson RL, Simmons DL. Expression of a mitogen-responsive gene encoding prostaglandin synthase is regulated by mRNA splicing. Proc Natl Acad Sci USA 1991;88:2692-6.
6. O'Banion MK, Winn VD, Young DA. cDNA cloning and functional activity of a glucocorticoid-regulated inflammatory cyclooxygenase. Proc Natl Acad Sci USA 1992;89:4888-92.
7. Jones DA, Carlton DP. McIntyre TM, Zimmerman GA, Prescott SM. Molecular cloning of human prostaglandin endoperoxide synthase type II and demonstration of expression in response to cytokines. J Biol Chem 1993;268:9049-54.
8. Luong C, Miller A, Barnett J, Chow J, Ramesha C, Browner MF. Flexibility of the NSAID binding site in the structure of human cyclooxygenase-2. Nature Structural Biology 1996;11:927-33.
9. Kurumbail RG, Stevens AM, Gierse JK, et al. Structural basis for selective inhibition of cyclooxygenase-2 by anti-inflammatory agents. Nature 1996;384:644-7.
10. Seibert K, Masferrer JL. Role of inducible cyclooxygenase in inflammation. Receptor 1994;4:17-23.
11. Kargman S, Charleson S, Cartwright M, et al. Characterization of prostaglandin G/H synthase 1 and 2 in rat, dog, monkey, and human gastrointestinal tracts. Gastroenterology 1996;111:445-54.
12. DeWitt D. Prostaglandin endoperoxide synthase: regulation of enzyme expression. Biochim Biophys Acta 1991;1083:121-34.
13. Wu KK, Sanduja R, Tsai AL, Ferhanoglu B, Loose-Mitchell DS. Aspirin inhibits interleukin-1-induced prostaglandin H synthase expression in cultured endothelial cells. Proc Natl Acad Sci USA 1991;88:2384-7.
14. Yamagata K, Andreasson KI, Kaufmann WE, Barnes CA. Worley PF. Expression of a mitogen-inducible cyclooxygenase in brain neurons: regulation by synaptic activity and glucocorticoids. Neuron 1993;11:371-86.
15. Kaufman WE, Worley PF, Pegg J, Bremer M, Isakson P. COX-2, a synaptically induced enzyme, is expressed by excitatory neurons at postsynaptic sites in rat cerebral cortex. Proc Natl Acad Sci USA 1996;93:2317-21.
16. Simmons DL, Xie W, Chipman JG, Evett GE. Multiple cyclooxygenases: cloning of a mitogen-inducible form. In: Bailey M, editor. Prostaglandins, leukotrienes, lipoxins and PAF. New York: Plenum Press; 1991:67-78.
17. Komhoff M, Grone H-J, Klein T, Seyberth HW, Nusing RM. Localization of cyclooxygenase-1 and -2 in adult and fetal human kidney: implication for renal function. Am J Physiol 1997;272:F460-8.
18. Walenga RW, Kester M, Coroneos E, Butcher S, Dwivedi R, Stall C. Constitutive expression of prostaglandin endoperoxide G/H synthetase (PGHS)-2 but not PGHS-1 in human tracheal epithelial cells in vitro. Prostaglandins 1996;52:341-59.
19. Akaraserennont P, Mitchell JA, Appleton I, Thiemermann C, Vane JR. Involvement of tyrosine kinase in the induction of cyclo-oxygenase and nitric oxide synthase by endotoxin in cultured cells. Br J Pharmacol 1994;113:1522-8.
20. Blanco A, Habib A, Levy-Toledano S, Maclouf J. Involvement of tyrosine kinases in the induction of cyclo-oxygenase-2 in human endothelial cells. Biochem J 1995;312:419-23.
21. 2. Exp Cell Res 1993;206:58-62.
22. Mitchell JA, Akarasereenont P, Thiemermann C, Flower RJ, Vane JR. Selectivity of nonsteroidal anti-inflammatory drugs as inhibitors of constitutive and inducible cyclo-oxygenase. Proc Natl Acad Sci USA 1994;90:11693-7.
23. 2 stimulation. Exp Cell Res 1996;222:379-84.
24. 2 and cylooxygenase-2 expression by tracheobronchial smooth muscle cells. Eur J Biochem 1996;235:557-63.
25. Meade EA, Smith WL, deWitt DL. Differential inhibition of prostaglandin endoperoxide synthase (cyclooxygenase) isozymes by aspirin and other non-steroidal anti-inflammatory drugs. J Biol Chem 1993;268:6610-14.
26. Griswold DE, Adams JL. Constitutive cyclooxygenase (COX-1) and inducible cyclooxygenase (COX-2): rationale for selective inhibition and progress to date. Med Res Rev 1996;16:181-206.
27. O'Neill GP, Mancini JA, Kargman S, et al. Overexpression of human prostaglandin G/H synthase-1 and -2 by recombinant vaccinia virus: inhibition by nonsteroidal anti-inflammatory drugs and biosynthesis of 15-hydroxyeicosatetraenoic acid. Molec Pharmacol 1994;45:245-54.
28. Laneuville O, Breuer DK, Dewitt DL, Hla T, Funk CD, Smith WL. Differential inhibition of human prostaglandin endo-peroxide H synthases-1 and -2 by nonsteroidal anti-inflammatory drugs. J Pharmacol Exp Ther 1994;271:927-34.
29. Kargman S, Wong E, Greig GM, et al. Mechanism of selective inhibition of human prostaglandin G/H synthase-1 and -2 in intact cells. Biochem Pharmacol 1996b;52:1113-25.
30. Berg J, Christoph T, Widerna M, Bodenteich A. Isoenzyme specific cyclooxygenase inhibitors: a whole cell assay system using the human erythroleukemic cell line HEL and the human monocytic cell line mono mac 6. J Pharmacol Toxicol Meth 1997;37:179-86.
31. Wong E, DeLuca C, Boily C, et al. Characterization of autocrine inducible prostaglandin H synthase-2 in human osteosarcoma cells. Inflamm Res 1997;46:51-9.
32. Miralpeix M, Camacho M, Lopez-Belmonte J, et al. Selective induction of cyclo-oxygenase-2 activity in the permanent human endothelial cell line HUV-EC-C. Biochemical and pharmacological characterization. Br J Pharmacol 1997;121:171-80.
33. Langman MJS, Weil J, Wainwright P, et al. Risks of bleeding peptic ulcer associated with individual non-steroidal anti-inflammatory drugs. Lancet 1994;343:1075-8.
34. Fries JF. Assessing and understanding patient risk. Scand J Rheumatol 1992;Suppl 92:21-4.
35. 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;15:787-96.
36. Bakhle YS, Botting RM. Cyclooxygenase-2 and its regulation in inflammation. Med Inflamm 1996;305-23.
37. Seibert K, Zhang Y, Leahy K, et al. Pharmacological and biochemical demonstration of the role of cyclooxygenase 2 in inflammation and pain. Proc Natl Acad Sci USA 1994;91:12013-7.
38. Masferrer JL, Zweifel BS, Manning PT, et al. Selective inhibition of inducible cyclooxygenase 2 in vivo is anti-inflammatory and non-ulcerogenic. Proc Natl Acad Sci USA 1994;91:3228-32.
39. Chan CC, Boyce S, Brideau C, et al. Pharmacology of a selective cyclooxygenase-2 inhibitor, L745.337 - a novel nonsteroidal anti-inflammatory agent with an ulcerogenic sparing effect in rat and nonhuman primate stomach. J Pharmacol Exp Ther 1995; 273:1531-7.
40. Vane JR, Botting RM. New insights into the mode of action of anti-inflammatory drugs. Inflamm Res 1995;44:1-10.
41. Prasit P, Riendeau D. Selective cyclooxygenase-2 inhibitors. Ann Rep Med Chem 1997;30:179-88.
42. Ehrich EW, Dallob A, DeLepeleire I, et al. Characterization of rofecoxib as a cylcooxygenase-2 isoform inhibitor and demonstration of analgesia in the dental pain model. Clin Pharm Ther 1999;65:336-47.
43. Depré M, Ehrich E, DeLepeleire I, et al. Demonstration of specific COX-2 inhibition by MK-966 (VIOXX™) in humans with supratherapeutic doses [abstract]. Rheumatol Eur 1988;27 Suppl 2:196.
44. Burnett S, Hart DJ, Cooper C, Spector TD. A radiographic atlas of osteoarthritis, London: Springer; 1994.
45. Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol 1988;15:1833-40.
46. Kang RY, Freire-Moar J, Sigal E, Chu C-Q. Expression of cyclooxygenase-2 in human and an animal model of rheumatoid arthritis. Br J Rheumatol 1996;35:711-8.
47. Siegle I, Klein T, Backman JT, Saal JG, Nüsing RM, Fritz P. Expression of cyclooxygenase 1 and cyclooxygenase 2 in human synovial tissue. Arthritis Rheum 1998;41:122-9.
48. Franz JK, Hummel KM, Aicher WK. In-situ detection and quantification of cyclooxygenase 1 and 2 mRNA in rheumatoid arthritis and osteoarthritis synovium [abstract]. Arthritis Rheum 1997;40 Suppl 9:S249.
49. Amin AR, Attur M, Patel RN, et al. Superinduction of cyclooxygenase-2 activity in human osteoarthritis affected cartilage. J Clin Invest 1997;99:1231-7.
50. Siegle I, Klein T, Backman JT, Saal JG, Nüsing RM, Fritz P. Expression of cyclooxygenase 1 and cyclooxygenase 2 in human synovial tissue. Arthritis Rheum 1998;41:122-9.
51. Geng Y, Blanco FJ, Cornelisson M, Lotz M. Regulation of cyclooxygenase-2 expression in normal human articular chondrocytes. J Immunol 1995;155:796-801.
52. Onoe Y, Miyaura C, Kaminakayashiki T, et al. IL-13 and IL-4 inhibit bone resorption by suppressing cyclooxygenase-2-dependent prostaglandin synthesis in osteoblasts. J Immunol 1996;156:758-64.
53. Bellamy N, Buchanan WW, Chalmers A, et al. A multicenter study of tenoxicam and diclofenac in patients with osteoarthritis of the knee. J Rheumatol 1993;20:999-1004.
54. Bellamy N, Kean WF, Buchanan WW, Gerecz-Simon E, Campbell J. Double blind randomized controlled trial of sodium meclofenamate (Meclomen) and diclofenac sodium (Voltaren): post validation reapplication of the WOMAC Osteoarthritis Index. J Rheumatol 1992;19:153-9.
55. Busquier PM, Calero E, Rodriguez M, et al. Comparison of aceclofenac with piroxicam in the treatment of osteoarthritis. Clin Rheumatol 1997;16:154-9.
56. Lanza FL, Rack MF, Simon T, et al. Specific inhibition of COX-2 with MK-0966 is associated with less gastroduodenal damage than either aspirin or ibuprofen. Aliment Pharmacol Ther 1999;13:761-7.
57. Mizuno H, Sakamoto C, Matsuda K. et al. Induction of cyclooxygenase 2 in gastric mucosal lesions and its inhibition by the specific antagonist delays healing in mice. Gastroenterology 1997;112:387-97.
58. 2 synthesis in MKN 28 gastric mucosal cells in vitro. J Biol Chem 1998;273:28560-2.
59. Bennett WM, Henrich WL, Stoff JS. The renal effects of nonsteroidal anti-inflammatory drugs: summary and recommendations. Am J Kidney Dis 1996;28 Suppl 1:S56-S62.
60. Whelton A, Hamilton CW. Nonsteroidal anti-inflammatory drugs: effects on kidney function. J Clin Pharmacol 1991;31:588-98.
61. Harris RC, McKanna JA, Akai Y, Jacobson HR, Bubois RN, Breyer MD. Cyclooxygenase-2 is associated with macula densa of rat kidney and increase with salt restriction. J Clin Invest 1994;94:2504-10.