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Review of the selective COX-2 inhibitors celecoxib and rofecoxib: focus on clinical aspects

Published online by Cambridge University Press:  21 May 2015

Peter S. Loewen
Peter S. Loewen*
Affiliation:
Internal Medicine, Pharmaceutical Sciences Clinical Service Unit, Vancouver Hospital and Health Sciences Centre, Vancouver, BC; University of British Columbia, Vancouver; Advanced Pharma-cotherapeutics, Doctor of Pharmacy Program, UBC Chair, UBC Clinical Research Ethics Board; The Journal of Informed Pharmacotherapy
*
Rm. G261A, University of British Columbia Hospital, 2211 Wesbrook Mall, Vancouver BC V6T 2B5; 604 822-7985, fax 604 822-9742, [email protected]

Abstract:

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The selective cyclooxygenase-2 (COX-2) inhibitors celecoxib and rofecoxib were designed to have similar efficacy but less gastrointestinal toxicity than traditional nonsteroidal anti-inflammatory drugs (NSAIDs). Their efficacy has been demonstrated in the treatment of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, postoperative dental pain and dysmenorrhea. These agents produce fewer endoscopic ulcers, symptomatic ulcers and gastrointestinal bleeds than traditional NSAIDs; although the absolute benefit is small and the gastropreserving effect is negated by concurrent use of low-dose aspirin for cardiovascular risk reduction. Nephrotoxicity and hyptertension remain concerns with COX-2 inhibitors, as they are with traditional NSAIDs. COX-2 inhibitors may be safe alternatives to traditional NSAIDs for patients with aspirin-sensitive asthma.

Keywords

celecoxibrofecoxibosteoarthritisrheumatoid arthritisgastrointestinal bleedinghypertensionnephrotoxicitycyclooxygenasenonsteroidal anti-inflammatory
Type
Pharmacotherapy • Pharmacothérapie
Information
Canadian Journal of Emergency Medicine , Volume 4 , Issue 4 , July 2002 , pp. 268 - 275
Copyright
Copyright © Canadian Association of Emergency Physicians 2002

References

1.Ashcroft, DM, Chapman, SR, Clark, WK, Millson, DS.Upper gastrointestinal ulceration in arthritis patients treated with celecoxib. Ann Pharmacother 2001;35:829–34.CrossRefGoogle Scholar
2.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. JAMA 1999;282:1921–8.CrossRefGoogle ScholarPubMed
3.Laine, L, Harper, S, Simon, T, Bath, R, Johanson, J, Schwartz, H, et al. A randomized trial comparing the effect of rofecoxib, a COX-2–speciofic inhibitor, with that of ibuprofen on the gastroduodenal mucosa of patients with osteoarthiritis. Gastroenterology 1999;117;776–83.CrossRefGoogle Scholar
4.Jackson, LM.Hawkey, CJ.COX-2 selective nonsteroidal anti-inflammatory drugs. Do they really offer any advantages? Drugs 2000;59:1207–16.CrossRefGoogle ScholarPubMed
5.Kosnik, M, Music, E, Matjaz, F, Suskovic, S.Relative safety of meloxicam in NSAID-intolerant patients. Allergy 1998;53:1231–3.CrossRefGoogle ScholarPubMed
6.Tannenbaum, H, Peloso, PMJ, Russel, AS, Marlow, B.An evidence-based approach to prescribing NSAIDs in the treatment of osteoarthritis and rheumatoid arthritis: The Second Canadian Consensus Conference. Can J Clin Pharmacol 2000;7(suppl A):4A–16A.Google ScholarPubMed
7.McConnell, S, Kolopack, P, Davis, AM.The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): a review of its utility and measurement properties. Arthritis Rheum 2001;45:453–61.Google Scholar
8.Geba, GP, Weaver, AL, Polis, AB, Dixon, ME, Schnitzer, TJ; Vioxx, Acetaminophen, Celecoxib Trial (VACT) Group. Efficacy of rofecoxib, celecoxib, and acetaminophen in osteoarthritis of the knee: a randomized trial [published erratum in JAMA 2002;287(9):989]. JAMA 2002;287(1):64–71.Google Scholar
9.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;343:1520–8.Google Scholar
10.Lexchin, J.Journal supplements and evidence-based medicine. Can J Clin Pharmacol 2001;8(3):162–3.Google ScholarPubMed
11.Subcommittee on Osteoarthritis Guidelines, American College of Rheumatology. Recommendations for the medical management of osteoarthritis of the hip and knee. Arthritis Rheum 2000;9:1905–15.Google Scholar
12.Morrison, BW, Daniels, SE, Kotey, P, Cantu, N, Seidenberg, B.Rofecoxib, a specific COX-2 inhibitor, in primary dysmenorrhea: a randomized controlled trial. Obstet Gynecol 1999;94:504–8.Google ScholarPubMed
13.Morrison, BW, Fricke, J, Brown, J, Yuan, W, Kotey, P, Mehlisch, D.The optimal analgesic dose of rofecoxib: overview of six randomized controlled trials. J Am Dent Assoc 2000;131:1729–37.CrossRefGoogle ScholarPubMed
14.Huang, JJ, Taguchi, A, Hsu, H, Andriole, GL Jr, Kurz, A.Preoperative oral rofecoxib does not decrease postoperative pain or morphine consumption in patients after radical prostatectomy: a prospective, randomized, double-blinded, placebo-controlled trial. J Clin Anesthesia 2001;13:94–7.CrossRefGoogle ScholarPubMed
15.Reuben, SS, Connelly, NR.Postoperative analgesic effects of celecoxib or rofecoxib after spinal fusion surgery. Anesth Analg 2000;91:1221–5.Google Scholar
16.Gimbel, JS, Brugger, A, Zhao, W.Efficacy and tolerability of celecoxib versus hydrocodone/acetaminophen in the treatment of pain after ambulatory orthopedic surgery in adults. Clin Therapeut 2001;23:228–41.CrossRefGoogle ScholarPubMed
17.Schwartz, JI, Chan, CC, Mukhopadhyay, S, McBride, KJ, Jones, TM, Adcock, S, et al. Cyclooxygenase-2 inhibition by rofecoxib reverses naturally occurring fever in humans. Clin Pharmacol Therapeut 1999;65:653–60.Google Scholar
18.Sandler, RS, Galanko, JC, Murray, SC, Helm, JF, Woosley, JT.Aspirin and nonsteroidal anti-inflammatory agents and risk for colorectal adenomas. Gastroenterology 1998;114:441–7.Google Scholar
19.Thun, MJ, Namboodiri, MM, Heath, CW.Aspirin use and reduced risk of fatal colon cancer. N Engl J Med 1991;325:1593–6.Google Scholar
20.Smalley, WE, DuBois, RN.Colorectal cancer and nonsteroidal anti-inflammatory drugs. Adv Pharmacol 1997;39:1–20.Google Scholar
21.Steinbach, G, Lynch, PM, Phillips, RKS, Wallace, MH, Hawk, E, Gordon, GB.Effect of celecoxib, a cyclooxygenase-2 inhibitor, in familiar adenomatous polyposis (FAP). N Engl J Med 2000; 342:1946–52.CrossRefGoogle Scholar
22.National Cancer Institute. NCI-sponsored clinical studies of Celecoxib for cancer prevention. Available: www.cancer.gov/templates/doc.aspx?viewid=D2C2E396-8B9E-4D43-9F1B-7C4485354688 (accessed 2002 May 20).Google Scholar
23.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.Google Scholar
24.Witter, J.Medical officer review: Celebrex capsules (celecoxib) NDA 20-998/S-009. Available: www.fda.gov/ohrms/dockets/ac/01/briefing/3677b1_03_med.pdf (accessed 2002 May 14).Google Scholar
25.Hrachovec, JB, Mora, M.Reporting of 6-month vs 12-month data in a clinical trial of celecoxib [letter]. JAMA 2001;286:2398.Google Scholar
26.Wright, JM, Perry, TL, Basset, KL, Chambers, GK.Reporting of 6-month vs 12-month data in a clinical trial of celecoxib [letter]. JAMA 2001;286:2398–9.Google Scholar
27.Perry, T.Selective reporting of pharmaceutical data leads major medical journals to change editorial policy. CJEM 2001; 3(4):321–2.CrossRefGoogle ScholarPubMed
28.Silverstein, F, Simon, L, Faich, G.Reporting of 6-month vs 12-month data in a clinical trial of celecoxib [letter]. JAMA 2001;286:2399–400.Google Scholar
29.FDA Panel finds no safety benefit for Celebrex. Scrip World Pharm News 2001;Feb 9 (2616):19.Google Scholar
30.Hong, LL.Statistical reviewer briefing document for the federal drug advisory committee. Available: www.fda.gov/ohrms/dockets/ac/01/briefing/3677b1_04_stats.doc (accessed 2002 May 20).Google Scholar
31.VIOXX gastrointestinal safety. FDA Advisory Committee Briefing Document. NDA 21–042, s007. Available: www.fda.gov/ohrms/dockets/ac/01/briefing/3677b2_03_med.pdf (accessed 2002 May 30).Google Scholar
32.Derry, S, Loke, YK.Risk of gastrointestinal haemorrhage with long term use of aspirin: meta-analysis. BMJ 2000;321:183–7.Google Scholar
33.Laine, L, Peterson, WL.Bleeding peptic ulcer. N Engl J Med 1994;331:717–25.CrossRefGoogle ScholarPubMed
34.Marshall, JK, Collins, SM, Gafni, A.Prediction of resource utilization and case cost for acute nonvariceal upper gastrointestinal hemorrhage at a Canadian community hospital. Am J Gastroenterol 1999;94:1841–6.Google Scholar
35.Mizuno, H, Sakamoto, C, Matsuda, K.Induction of cyclooxygenase-2 in gastric mucosal lesions and its inhibition by the specific antagonist delays healing in mice. Gastroenterology 1997; 112:387√97.CrossRefGoogle ScholarPubMed
36.Schmassmann, A, Peskar, BM, Stettler, C, Natzer, P, Stroff, T, Flogerzi, B, et al. Effects of inhibition of prostaglandin endoperoxide synthase-2 in chronic gastro-intestinal ulcer models in rats. Br J Pharmacol 1998;123:795√804.CrossRefGoogle ScholarPubMed
37.Caroli, A, Monica, F.Severe upper gastrointestinal bleeding during treatment with rofecoxib for osteoarthritis. Am J Gastroenterol 2001;96:1663–5.CrossRefGoogle ScholarPubMed
38.Mohammed, S, Croom, DW.Gastropathy due to celecoxib, a cyclooxygenase-2 inhibitor. N Engl J Med 1999;340:2005–6.CrossRefGoogle ScholarPubMed
39.Bates, DE, Lemaire, JB.Possible celecoxib-induced gastroduodenal ulceration. Ann Pharmacother 2001;35:782–3.CrossRefGoogle ScholarPubMed
40.Hawkey, CJ.COX-2 inhibitors. Lancet 1999;353:307–14.Google Scholar
41.Mukherjee, D, Nissen, SE, Topol, EJ.Risk of cardiovascular events associated with selective COX-2 inhibitors. JAMA 2001;286:954–9.Google Scholar
42.Burnakis, TG.Cardiovascular events and COX-2 inhibitors [letter]. JAMA 2001;286:2808.Google ScholarPubMed
43.Fleming, M.Cardiovascular events and COX-2 inhibitors [letter]. JAMA 2001;286:2808.Google ScholarPubMed
44.Konstam, MA, Demopoulos, LA.Cardiovascular events and COX-2 inhibitors [letter]. JAMA 2001;286:2809.Google ScholarPubMed
45.Hadley, JE, Pappagallo, M.Cardiovascular events and COX-2 inhibitors [letter]. JAMA 2001;286:2808.Google Scholar
46.Minic, M.Cardiovascular events and COX-2 inhibitors [letter]. JAMA 2001;286:2810.Google ScholarPubMed
47.McGeer, PL, McGeer, EG.Cardiovascular events and COX-2 inhibitors [letter]. JAMA 2001;286:2810.Google ScholarPubMed
48.Grant, KD.Cardiovascular events and COX-2 inhibitors [letter]. JAMA 2001;286:2809.Google ScholarPubMed
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;104:2280–8.Google Scholar
50.VanHecken, A, Schwartz, JI, Depre, M, De Lepeleire, I, Dallob, A, Tanaka, W, et al. Comparative inhibitory effect of rofecoxib, meloxicam, diclofenac, ibuprofen, and naproxen on COX-2 versus COX-1 in healthy volunteers. J Clin Pharmacol 2000;40: 1109–20.Google Scholar
51.Catella-Lawson, F, Reilly, MP, Kapoor, SC, et al. Cyclooxygenase inhibitors and the antiplatelet effects of aspirin. N Engl J Med 2001;345:1809–17.CrossRefGoogle ScholarPubMed
52.Chan, CC, Boyce, S, Brideau, C, Charleson, S, Cromlish, W, Ethier, D, et al. Rofecoxib [Vioxx, MK-0966; 4-(4’-methylsulfonylphenyl)-3-phenyl-2-(5H)-furanone]: a potent and orally active cyclooxygenase-2 inhibitor. Pharmacological and biochemical profiles. J Pharmacol Exp Ther 1999;290:551–60.Google Scholar
53.Leese, PT, Hubbard, RC, Karim, A, Isakson Pc, Yu, SS, Geis, GS.Effects of celecoxib, a novel cyclooxygenase-2 inhibitor, on platelet function in healthy adults: A randomized, controlled trial. J Clin Pharmacol 2000;40:124–32.CrossRefGoogle ScholarPubMed
54.Komhoff, M, Grone, HJ, 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.Google Scholar
55.Abassi, Z, Brodsky, S, Gaelekman, O, Rubinstein, I, Hoffman, A, Winaver, J.Intrarenal expression and distribution of cyclooxygenase isofroms in rats with experimental heart failure. Am J Physiol 2001;280:F43–5.Google Scholar
56.Swan, SK, Rudy, DW, Lasseter, KC, Ryan, CF, Buechel, KL, Lambrecht, LJ, et al. Effect of COX-2 inhibition on renal function in elderly persons receiving a low-salt diet: a randomized controlled trial. Ann Int Med 2000;133:1–9.Google Scholar
57.Rossat, J, Maillard, M, Nussberger, J, Brunner, HR, Burier, M.Renal effects of selective COX-2 inhibition in normotensive salt-depleted subjects. Clin Pharmacol Therapeut 1999;66(1):76–84.Google Scholar
58.Whelton, A, Schulman, G, Wallemark, C, Drower, EJ, Isakson, PC, Verburg, KM, et al. Effects of celecoxib and naproxen on renal function in the elderly. Arch Intern Med 2000;160:1465–70.Google Scholar
59.Catella-Lawson, F, McAdam, B, Morrison, BW, Kapoor, S, Kujubu, D, Antes, L, et al. Effects of specific inhibition of COX-2 on sodium balance, hemodynamics, and vasoactive eicosanoids. J Pharmacol Exp Therapeut 1999;289:735–41.Google Scholar
60.Whelton, A, Fort, JG, Puma, JA, Normandin, D, Bello, AE, Verburg KM; SUCCESS VI Study Group. Cyclooxygenase-2–specific inhibitors and cardiorenal function: a randomized, controlled trial of celecoxib and rofecoxib in older hypertensive osteoarthritis patients [published erratum in Am J Ther 2001;8 (3):220]. Am J Ther 2001;8(2):85–95.Google Scholar
61.Perazella, MA, Tray, K.Selective cyclooxygenase-2 inhibitors: a pattern of nephrotoxicity similar to traditional nonsteroidal anti-inflammatory drugs. Am J Med 2001;111:64–7.Google Scholar
62.Graham, MG.Acute renal failure related to high-dose celecoxib. Ann Intern Med 2001;135:69–70.Google Scholar
63.Rocha, JL, Fernandez-Alonso, J.Acute tubulointerstitial nephritis associated with the selective COX-2 enzyme inhibitor, rofecoxib. Lancet 2001;357:1946–7.Google Scholar
64.Pfister, AK, Crisalli, RJ, Carter, WH.Cyclooxygenase-2 inhibition and renal function [letter]. Ann Intern Med 2001;134:1077.CrossRefGoogle ScholarPubMed
65.Perazella, MA, Eras, J.Are selective COX-2 inhibitors nephrotoxic? Am J Kidney Dis 2000;35:937–40.Google Scholar
66.Wolf, G, Porth, J, Stahl, R.Acute renal failure associated with rofecoxib [letter]. Ann Intern Med 2000;133:394.Google Scholar
67.Truitt, K, Ettinger, W, Schnitzer, T.Rofecoxib, a selective COX-2 inhibitor, had clinical efficacy and overall safety in treating osteoarthritis patients 80 years and older [abstract]. XIV European League Against Rheumatism Congress, June 6–11, 1999, Glasgow.Google Scholar
68.Page, J, Henry, D.Consumption of NSAIDs and the development of congestive heart failure in elderly patients. Arch Intern Med 2000;160:777–84.Google Scholar
69.Kammerl, MC, Nusing, RM, Richthammer, W, Kramer, BK, Kurtz, A.Inhibition of COX-2 counteracts the effects of diuretics in rats. Kidney Int 2001;60:1684–91.Google Scholar
70.McMorran, M, Morawiecka, I.Celecoxib (Celebrex™): 1 year later. Can Adv Drug React Newsl 2000;10(2):1–3. Also in CMAJ 2000;162(7):1044–6.Google Scholar
71.Patterson, R, Bello, AE, Lefkowith, J.Immunologic tolerability profile of celecoxib. Clin Therapeut 1999;21:2065–77.Google Scholar
72.Stevenson, DD, Simon, RA.Lack of cross-reactivity between rofecoxib and aspirin in aspirin-sensitive patients with asthma. J Allergy Clin Immunol 2001;108:47–51.CrossRefGoogle ScholarPubMed
73.Dahlen, B, Szczeklik, A, Murray, JJ; The Celecoxib in Aspirin-Intolerant Asthma Study Group. Celecoxib in patients with asthma and aspirin intolerance [letter]. N Engl J Med 2001;344(2):142.CrossRefGoogle Scholar
74.Hinrichs, R, Ritzkowsky, A, Hunzelmann, N, Krieg, T, Scharffetter-Kochanek, K.Rofecoxib as an alternative in aspirin hypersensitivity. Allergy 2001;56(8):789.Google Scholar
75.Berges-Gimeno, MP, Camacho-Garrido, E, Garcia-Rodriguez, RM, Alfaya, T, Martin Garcia, C, Hinojosa, M.Rofecoxib safe in NSAID hypersensitivity. Allergy 2001;56:1017–8.CrossRefGoogle ScholarPubMed
76.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;282:1929–33.CrossRefGoogle ScholarPubMed
77.Watson, DJ, Harper, SE, Zhao, PL, Quan, H, Bolognese, JA, Simon, TJ.Gastrointestinal tolerability of the selective COX-2 inhibitor rofecoxib compared with nonselective COX-1 and COX-2 inhibitors in osteoarthritis. Arch Intern Med 2000;160:2998–3003.Google Scholar