A randomized trial of the efficacy and tolerability of the COX-2 inhibitor rofecoxib vs ibuprofen in patients with osteoarthritis

Archives of Internal Medicine

Volumn 160, Issue 12, 2000, Pages 1781-1787

  Day, Ric ^a   Morrison, Briggs ^b   Luza, Armando ^c   Castaneda, Oswaldo ^d   Strusberg, Alberto ^g   Nahir, Menachem ^e   Helgetveit, Knut Bjorn ^f   Kress, Barbara ^b   Daniels, Brian ^b   Bolognese, James ^b   Krupa, Dave ^b   Seidenberg, Beth ^b   Ehrich, Elliot ^b  

^a ST VINCENT S HOSPITAL   (Australia)

^b MERCK RESEARCH LABORATORIES   (United States)

^c Clinica San Pablo ^*  (Peru)

^d Medicina Fetal Peru Fetal Medicine Unit at Clínica Internacional and Clinica Anglo Americana   (Peru)

^e RAMBAM MEDICAL CENTER   (Israel)

^f MARTINA HANSENS HOSPITAL   (Norway)

^g Merck and Co Inc ^*

Author keywords

[No Author keywords available]

Indexed keywords

CYCLOOXYGENASE 2 INHIBITOR; IBUPROFEN; ROFECOXIB;

ADULT; AGED; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; OSTEOARTHRITIS; PAIN; PAIN ASSESSMENT; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SCORING SYSTEM;

EID: 0034717664     PISSN: 00039926     EISSN: None     Source Type: Journal    
DOI: 10.1001/archinte.160.12.1781     Document Type: Article

References (39)

1. Vane JR. Inhibition of prostaglandin synthesis as a mechanism of action of aspirin-like drugs. Nat New Biol. 1971;231:232-235.
2. 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; 267:11586-11592.
3. 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: 12866-12872.
4. 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 U S A. 1991;88:2692-2696.
5. O'Banion MK, Winn VD, Young DA. cDNA cloning and functional activity of a glucocorticoid-regulated inflammatory cyclooxygenase. Proc Natl Acad Scid U S A. 1992;89:4888-4892.
6. Seibert K, Masferrer JL. Role of inducible cyclooxygenase (COX-2) in inflammation. Receptor. 1994;4:17-23.
7. 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;111:445-454.
8. DeWitt D. Prostaglandin endoperoxide synthase: regulation of enzyme expression. Biochim Biophys Acta. 1991;1083:121-134.
9. 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 U S A. 1991;88:2384-2387.
10. 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;11:371-386.
11. 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 U S A. 1996;93:2317-2321.
12. Lim H, Paria BC, Das SK, et al. Multiple female reproductive failures in cyclooxygenase 2-deficient mice. Cell. 1997;91:197-208.
13. Kömhoff M, Gröne H-J, Klein T, Seyberth HW, Nüsing RM. Localization of cyclooxygenase-1 and -2 in adult and fetal human kidney: implication for renal function. Am J Physiol. 1997;272:F460-F468.
14. Robertson EP. Dominance of cyclooxygenase-2 in the regulation of pancreatic islet prostaglandin synthesis. Diabetes. 1998;47:1379-1383.
15. 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;113:1522-1528.
16. 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; 312:419-423.
17. Lyons-Giordano B, Pratta MA, Galbraith W, Davis GL, Arner EC. Interleukin-1 differentially modulates chondrocyte expression of cyclo-oxygenase-2 and phospholipase A2. Exp Cell Res. 1993;206:58-62.
18. 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 U S A. 1994;90:11693-11697.
19. Berenbaum F, Jacquyes C, Thomas G, Corvol MT, Bereziat G, Masliah J. Synergistic effect of interleukin-1 β and tumor necrosis factor α or PGE2 production by articular chondrocytes does not involve PLA2 stimulation. Exp Cell Res. 1996; 222:379-384.
20. Vadas P, Stefanski E, Wloch M, Grouix B, van den Bosch H, Kennedy B. Secretory non-pancreatic phospholipase A2and cyclooxygenase-2 expression by tracheobronchial smooth muscle cells. Eur J Biochem. 1996;235:557-563.
21. 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;268:6610-6614.
22. 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 nonsteroibal anti-inflammatory drugs and biosynthesis of 15-hydroxyeicosatetraenoic acid. Mol Pharmacol. 1994;45:245-254.
23. 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 non-steroidal anti-inflammatory drugs. J Pharmacol Exp Ther. 1994;271:927-934.
24. 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. 1996;52:1113-1125.
25. 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 Methods. 1997;37:179-186.
26. 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;15:787-796.
27. Bakhle YS, Botting RM. Cyclooxygenase-2 and its regulation in inflammation. Mediators Inflamm. 1996;5:305-323.
28. 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 U S A 1994;91:3228-3232.
29. 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;273:1531-1537.
30. Ehrich EW, Dallob A, de Lepeleire I, et al. Characterization of rofecoxib as a cyclooxygenase-2 isoform inhibitor and demonstration of analgesia in the dental pain model. Clin Pharmacol Ther. 1999;65:336-347.
31. Laine L, Hawkey C, Harper S, et al. Effect of the COX-2 specific inhibitor (C-2SI) rofecoxib on ulcer formation: a double-blind comparison with ibuprofen and placebo [abstract]. Gastroenterology. 1999;116:A232.
32. Hawkey C, Laine L, Mortensen E, et al. Treatment of osteoarthritis with rofecoxib, a cyclooxygenase-2 (COX-2) specific inhibitor, was associated with a lower incidence of gastroduodenal ulcers compared to ibuprofen and was comparable to placebo treatment [abstract]. In: Proceedings of the 14th Congress of the European League Against Rheumatism; 14th Congress; June 6-12, 1999; Glasgow, Scotland.
33. 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;15:1833-1840.
34. Arnett FC, Edworthy SM, Bloch DA, et al. The American Rheumatism Association 1987 Revised Criteria for the Classification of Rheumatoid Arthritis. Arthritis Rheum. 1988;31:313-324.
35. Rodda BE, Davis RL. Determining the probability of an important difference in bioavailability. Clin Pharmacol Ther. 1980;28:247-252.
36. Bellamy N, Carette S, Ford PM, et al. Osteoarthritis antirheumatic drug trials, III: setting the delta for clinical trials, results of a consensus development (Delphi) exercise. J Rheumatol. 1992;19:451-457.
37. Ehrich E, Schnitzer T, Kivitz A, et al, for the Rofecoxib Osteoarthritis Pilot Study Group. Effect of specific COX-2 inhibition in osteoarthritis of the knee: a 6 week double blind, placebo controlled pilot study. J Rheumatol. 1999;11:2438-2447.
38. Rofecoxib prescribing information. West Point, Pa: Merck & Co Inc.
39. Langman M, Jensen D, Harper S, et al. Lower incidence of clinically evident upper-GI perforations, ulcers and bleeds in patients treated with rofecoxib vs. non-specific cyclooxygenase inhibitors [abstract]. Gastroenterology. 1999;116: A232.