Rofecoxib 12.5 mg, rofecoxib 25 mg, and celecoxib 200 mg in the treatment of symptomatic osteoarthritis: results of two similarly designed studies

References

• Lawrence RC, Helmick CG, Arnett FC, et al. Estimates of the prevalence of arthritis and selected musculoskeletal disorders in the United States. Arthritis Rheum 1998;41:778–99
   PubMed Web of Science ®Google Scholar
• Felson DT. Epidemiology of hip and knee osteoarthritis. Epidemiol Rev 1988;10:1–28
   PubMed Web of Science ®Google Scholar
• Moskowitz RW. Primary osteoarthritis: epidemiology, clinical aspects, and general management. Am J Med 1987;83:5–10
   PubMed Web of Science ®Google Scholar
• Hochberg MC, Altman RD, Brandt KD, et al. Guidelines for the medical management of osteoarthritis. Part II. Osteoarthritis of the knee. American College of Rheumatology. Arthritis Rheum 1995;38:1541–6
   PubMed Web of Science ®Google Scholar
• Recommendations for the medical management of osteoarthritis of the hip and knee: 2000 update. American College of Rheumatology Subcommittee on Osteoarthritis Guidelines. Arthritis Rheum 2000;43:1905–15
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• Hawkey CJ. COX-2 inhibitors. Lancet 1999;353:307–14
   PubMed Web of Science ®Google Scholar
• Silverstein FE, Faich G, Goldstein JL, 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;284:1247–55
   Google Scholar
• Schnitzer TJ, Burmester GR, Mysler E, et al. Comparison of lumiracoxib with naproxen and ibuprofen in the Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET), reduction in ulcer complications: randomized controlled trial. Lancet 2004;364:665–74
   PubMed Web of Science ®Google Scholar
• Ehrich EW, Schnitzer TJ, McIlwain H, et al. Effect of specific COX-2 inhibition in osteoarthritis of the knee: a 6 week double blind, placebo controlled pilot study of rofecoxib. Rofecoxib Osteoarthritis Pilot Study Group. J Rheumatol 1999;26:2438–47
   Google Scholar
• Truitt KE, Ettinger WH Jr, Schnitzer T, et al. Rofecoxib, a COX-2-specific inhibitor, has clinical efficacy and overall safety in treating OA patients aged 80 years and older. Presented at the European League Against Rheumatism 14th Congress. 6–12 June 1999, Glasgow, Scotland
   Google Scholar
• Day R, Morrison B, Luza A, et al. A randomized trial of the efficacy and tolerability of the COX-2 inhibitor rofecoxib vs ibuprofen in patients with osteoarthritis. Rofecoxib/Ibuprofen Comparator Study Group. Arch Intern Med 2000;160:1781–7
   PubMed Web of Science ®Google Scholar
• Saag K, van der Heijde D, Fisher C, et al. Rofecoxib, a new cyclooxygenase 2 inhibitor, shows sustained efficacy, comparable with other nonsteroidal anti-inflammatory drugs: a 6-week and a 1-year trial in patients with osteoarthritis. Osteoarthritis Studies Group. Arch Fam Med 2000;9:1124–34
   PubMedGoogle Scholar
• Cannon GW. Rofecoxib: a specific cyclooxygenase inhibitor. Drugs Today (Barc) 2000;36:255–62
   PubMed Web of Science ®Google Scholar
• Myllykangas-Luosujarvi R, Lu HS, Chen SL, et al. Comparison of low-dose rofecoxib versus 1000 mg naproxen in patients with osteoarthritis. Results of two randomized treatment trials of six weeks duration. Scand J Rheumatol 2002;31: 337–44
   Google Scholar
• Bensen WG, Fiechtner JJ, McMillen JI, et al. Treatment of OA with celecoxib, a cylcooxygenase-2 inhibitor: a randomized controlled trial. Mayo Clin Proc 1999;74:1095–105
   PubMed Web of Science ®Google Scholar
• Clemett D, Goa KL. Celecoxib: a review of its use in osteoarthritis, rheumatoid arthritis and acute pain. Drugs 2000;59:957–80
   PubMed Web of Science ®Google Scholar
• Zhao SZ, McMillen JI, Markenson JA, et al. Evaluation of the functional status aspects of health-related quality of life of patients with osteoarthritis treated with celecoxib. Pharmacotherapy 1999;19:1269–78
   PubMed Web of Science ®Google Scholar
• Williams GW, Ettlinger RE, Ruderman EM, et al. Treatment of osteoarthritis with a once-daily dosing regimen of celecoxib: A randomized, controlled trial. J Clin Rheum 2000;6:65–74
   PubMed Web of Science ®Google Scholar
• IMS Health. NDTI (TM) based on osteoarthritis drug uses for the period of October 1999–September 2000
   Google Scholar
• Labrecque G, Vanier MC. Biological rhythms in pain and in the effects of opioid analgesics. Pharmacol Ther 1995;68:129–47
   PubMed Web of Science ®Google Scholar
• Labrecque G, Bureau JP, Reinberg AE. Biological rhythms in the inflammatory response and in the effects of non-steroidal anti-inflammatory drugs. Pharmacol Ther 1995;66:285–300
   Google Scholar
• Moerchel J, Karrasch KF. ‘Morning type’ and ‘evening type’ in activated osteoarthritis. Analysis and practice-related conclusions of an open, multicenter study with ibuprofen. Fortschr Med 1989;107:644–8
   Google Scholar
• Bellamy N, Sothern RB, Cambell J, et al. Rhythmic variations in pain, stiffness, and manual dexterity in hand osteoarthritis. Ann Rheum Dis 2002;61:1075–80
   PubMed Web of Science ®Google Scholar
• Cramer JA. Enhancing patient compliance in the elderly. Role of packaging aids and monitoring. Drugs Aging 1998;12:7–15
   PubMed Web of Science ®Google Scholar
• Mallion JM, Baguet JP, Siche JP, et al. Compliance, electronic monitoring and antihypertensive drugs. J Hypertens Suppl 1998;16:S75–9
   PubMedGoogle Scholar
• Vioxx (rofecoxib tablets and oral suspension) product information. Whitehouse Station, NJ: Merck & Co. Inc., 2002
   Google Scholar
• Celebrex (celecoxib capsules) product information. New York: Pfizer, NY;2005
   Google Scholar
• Bresalier RS, Sandler RS, Quan H, et al. Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial. N Engl J Med 2005;352:1092–102
   PubMed Web of Science ®Google Scholar
• Bellamy N. WOMAC osteoarthritis index. Users guide V. Copyright 2002. Available from http://www.womac.org [Last accessed 18 July 2005]
   Google Scholar
• Bellamy N, Kirwan J, Boers M, et al. Recommendations for a core set of outcome measures for future phase III clinical trials in knee, hip, and hand osteoarthritis. Consensus development at OMERACT III. J Rheumatol 1997;24:799–802
   Web of Science ®Google Scholar
• Geba GP, Weaver AL, Polis AB, et al. Efficacy of rofecoxib, celecoxib, and acetaminophen in osteoarthritis of the knee: a randomized trial. JAMA 2002;287:64–71
   PubMed Web of Science ®Google Scholar
• Schnitzer TJ, Weaver AL, Polis AB, et al. Efficacy of rofecoxib, celecoxib, and acetaminophen in patients with osteoarthritis of the knee. A combined analysis of the VACT studies. J Rheumatol 2005;32:1093–105
   PubMedGoogle Scholar
• McKenna F, Weaver A, Fiechtner J, et al. COX-2 specific inhibitors in the management of osteoarthritis of the knee: a placebo-controlled, randomized, double-blind study. J Clin Rheum 2001;7:151–9
   PubMed Web of Science ®Google Scholar
• Gibofsky A, Williams GW, McKenna F, et al. Comparing the efficacy of cyclooxygenase 2-specific inhibitors in treating osteoarthritis: Appropriate trial design considerations and results of a randomized, placebo-controlled trial. Arthritis Rheum 2003;48:3102–11
   PubMed Web of Science ®Google Scholar
• Onen SH, Onen F, Courpron P, et al. How pain and analgesics disturb sleep. Clin J Pain 2005;21:422–31
   PubMed Web of Science ®Google Scholar
• Roehrs T, Roth T. Sleep and pain: interaction of two vital functions. Semin Neurol 2005;25:106–16
   PubMed Web of Science ®Google Scholar
• Harding IJ, Davies E, Buchanan E, et al. The symptom of night pain in a back pain triage clinic. Spine 2005;30:1985–8
   PubMed Web of Science ®Google Scholar
• Silber MH. Clinical practice. Chronic insomnia. N Engl J Med 2005;353:803–10
   PubMed Web of Science ®Google Scholar
• Buscemi N, Vandermeer B, Friesen C, et al. Manifestations and management of chronic insomnia in adults. Evid Rep Technol Assess (Summ) 2005;1–10
   PubMedGoogle Scholar
• Cannon GW, Caldwell JR, Holt P, et al. Rofecoxib, a specific inhibitor of cyclooxygenase 2, with clinical efficacy comparable with that of diclofenac sodium: results of a one-year, randomized, clinical trial in patients with osteoarthritis of the knee and hip. Rofecoxib Phase III Protocol 035 Study Group. Arthritis Rheum 2000;43: 978–87
   Google Scholar
• Kivitz AJ, Greenwald MW, Cohen SB, et al. Efficacy and safety of rofecoxib 12.5 mg versus nabumetone 1000 mg in patients with osteoarthritis of the knee: a randomized controlled trial. J Am Geriatr Soc 2004;52: 666–74
   Google Scholar
• Weaver AL, Messner RP, Storms WW, et al. Treatment of patients with osteoarthritis with rofecoxib compared with nabumetone. J Clin Rheum 2006;12:17–25
   PubMed Web of Science ®Google Scholar
• Battisti WP, Katz NP, Weaver AL, et al. Pain management in osteoarthritis: a focus on onset of efficacy – a comparison of rofecoxib, celecoxib, acetaminophen, and nabumetone across four clinical trials. J Pain 2004;5:511–20
   PubMed Web of Science ®Google Scholar
• Solomon SD, McMurray JJ, Pfeffer MA, et al. Cardiovascular risk associated with celecoxib in a clinical trial for colorectal adenoma prevention. N Engl J Med 2005;352:1071–80
   PubMed Web of Science ®Google Scholar
• Weir MR, Sperling RS, Reicin A, et al. Selective COX-2 inhibition and cardiovascular effects: a review of the rofecoxib development program. Am Heart J 2003;146:591–604
   PubMed Web of Science ®Google Scholar
• Food and Drug Administration Center for Drug Evaluation and Research: joint meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Committee [online]. Available from http://www.fda.gov/ohrms/dockets/ac/cder05.html#DrugSafetyRiskMgmt [Last accessed 12 December 2005]
   Google Scholar
• Food and Drug Administration Center for Drug Evaluation and Research Decision Memo: analysis and recommendations for agency action: COX-2 selective and non-selective NSAIDs. Food and Drug Administration [online]. Available from http://www.fda.gov/cder/drug/infopage/COX2/NSAIDdecisionMemo.pdf [Last Accessed 12 December 2005]
   Google Scholar
• Johnson AG, Nguyen TV, Day RO. Do nonsteroidal anti-inflammatory drugs affect blood pressure? A meta-analysis. Ann Intern Med 1994;121:289–300
   Google Scholar
• Pope JE, Anderson JJ, Felson DT. A meta-analysis of the effects of nonsteroidal anti-inflammatory drugs on blood pressure. Arch Intern Med 1993;153:477–84
   PubMed Web of Science ®Google Scholar
• de Leeuw PW. Nonsteroidal anti-inflammatory drugs and hypertension. The risks in perspective. Drugs 1996;51:179–87
   Google Scholar
• Harris RC. Cyclooxygenase-2 inhibition and renal physiology. Am J Cardiol 2002;89:10–7
   PubMed Web of Science ®Google Scholar
• Johnson AG. NSAIDs and increased blood pressure. What is the clinical significance? Drug Saf 1997;17:277–89
   PubMed Web of Science ®Google Scholar
• Frishman WH. Effects of nonsteroidal anti-inflammatory drug therapy on blood pressure and peripheral edema. Am J Cardiol 2002;89:18D–25
   Google Scholar
• Whelton A, White WB, Bello AE, et al. Effects of celecoxib and rofecoxib on blood pressure and edema in patients > or = 65 years of age with systemic hypertension and osteoarthritis. Am J Cardiol 2002;90:959–63
   PubMed Web of Science ®Google Scholar
• Gambaro G, Perazella MA. Adverse renal effects of anti-inflammatory agents: evaluation of selective and nonselective cyclooxygenase inhibitors. J Intern Med 2003;253:643–52
   PubMed Web of Science ®Google Scholar
• Weir MR. Renal effects of nonselective NSAIDs and coxibs. Cleve Clin J Med 2002;69\(Suppl 1):SI53–8
   Google Scholar
• Dedier J, Stampfer MJ, Hankinson SE, et al. Nonnarcotic analgesic use and the risk of hypertension in US women. Hypertension 2002;40:604–8
   PubMed Web of Science ®Google Scholar
• Solomon DH, Schneeweiss S, Levin R, et al. Relationship between COX-2 specific inhibitors and hypertension. Hypertension 2004;44:140–5
   PubMed Web of Science ®Google Scholar
• Brinker A, Goldkind L, Bonnel R, et al. Spontaneous reports of hypertension leading to hospitalisation in association with rofecoxib, celecoxib, nabumetone and oxaprozin. Drugs Aging 2004;21:479–84
   PubMed Web of Science ®Google Scholar
• Sowers JR, White WB, Pitt B, et al. The effects of cyclooxygenase-2 inhibitors and nonsteroidal anti-inflammatory therapy on 24-hour blood pressure in patients with hypertension, osteoarthritis, and type 2 diabetes mellitus. Arch Intern Med 2005;165:161–8
   PubMed Web of Science ®Google Scholar
• Fredy J, Diggins DA Jr, Morrill GB. Blood pressure in Native Americans switched from celecoxib to rofecoxib. Ann Pharmacother 2005;39:797–802
   PubMed Web of Science ®Google Scholar
• Wolfe F, Zhao S, Pettitt D. Blood pressure destabilization and edema among 8538 users of celecoxib, rofecoxib, and nonselective nonsteroidal antiinflammatory drugs (NSAID) and nonusers of NSAID receiving ordinary clinical care. J Rheumatol 2004;31: 1143–51
   Google Scholar
• Aw TJ, Haas SJ, Liew D, et al. Meta-analysis of cyclooxygenase-2 inhibitors and their effects on blood pressure. Arch Intern Med 2005;165:490–6
   PubMed Web of Science ®Google Scholar