Treatment of patients with osteoarthritis with rofecoxib compared with nabumetone

Journal of Clinical Rheumatology

Volumn 12, Issue 1, 2006, Pages 17-25

  Weaver, Arthur L ^a,e   Messner, Ronald P ^b   Storms, William W ^c   Polis, Adam B ^d   Najarian, Daryl K ^d   Petruschke, Richard A ^d   Geba, Gregory P ^d   Tershakovec, Andrew M ^d  

^a UNIVERSITY OF NEBRASKA MEDICAL CENTER   (United States)

^b UNIVERSITY OF MINNESOTA   (United States)

^c Asthma & Allergy Associates PC and Research Center   (United States)

^d MERCK RESEARCH LABORATORIES   (United States)

^e NONE   (United States)

Author keywords

Nabumetone; Onset; Osteoarthritis; PGART; Rofecoxib

Indexed keywords

CYCLOOXYGENASE 2 INHIBITOR; NABUMETONE; NONSTEROID ANTIINFLAMMATORY AGENT; PARACETAMOL; PLACEBO; ROFECOXIB; ALKANONE; LACTONE; SULFONE;

ADULT; APPENDICITIS; ARTICLE; CARDIOVASCULAR DISEASE; CLINICAL ASSESSMENT; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DYSPEPSIA; EPIGASTRIC DISCOMFORT; FEMALE; FLATULENCE; GASTROINTESTINAL DISEASE; HEADACHE; HEART INFARCTION; HEARTBURN; HUMAN; KNEE OSTEOARTHRITIS; MAJOR CLINICAL STUDY; MALE; MOUTH ULCER; MULTICENTER STUDY; NAUSEA; OSTEOARTHRITIS; PAIN ASSESSMENT; PATIENT GLOBAL ASSESSMENT OF RESPONSE TO THERAPY; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RASH; RATING SCALE; REFLUX ESOPHAGITIS; STOMACH DISEASE; THROMBOSIS; TREATMENT OUTCOME; UPPER RESPIRATORY TRACT INFECTION; VISUAL ANALOG SCALE; VOMITING; WESTERN ONTARIO AND MACMASTER UNIVERSITIES OSTEOARTHRITIS INDEX; ANALYSIS OF VARIANCE; COMPARATIVE STUDY; MIDDLE AGED;

ANALYSIS OF VARIANCE; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; BUTANONES; CYCLOOXYGENASE 2 INHIBITORS; DOUBLE-BLIND METHOD; FEMALE; HUMANS; LACTONES; MALE; MIDDLE AGED; OSTEOARTHRITIS, KNEE; QUALITY OF LIFE; SULFONES; TREATMENT OUTCOME;

EID: 33745905627     PISSN: 10761608     EISSN: None     Source Type: Journal    
DOI: 10.1097/01.rhu.0000200384.79405.33     Document Type: Article

References (46)

1. Felson DT, Lawrence RC, Dieppe PA, et al. Osteoarthritis: new insights. Part 1: the disease and its risk factors. Ann Intern Med. 2000;133:635-646.
2. Hinton R, Moody RL, Davis AW, et al. Osteoarthritis: diagnosis and therapeutic considerations. Am Fam Physician. 2002;65:841-848.
3. Summers MN, Haley WE, Reveille JD, et al. Radiographic assessment and psychologic variables as predictors of pain and functional impairment in osteoarthritis of the knee or hip. Arthritis Rheum. 1988;31:204-209.
4. Dekker J, Boot B, van der Woude LH, et al. Pain and disability in osteoarthritis: a review of biobehavioral mechanisms. J Behav Med. 1992;15:189-214.
5. Salaffi F, Cavalieri F, Nolli M, et al. Analysis of disability in knee osteoarthritis. Relationship with age and psychological variables but not with radiographic score. J Rheumatol. 1991;18:1581-1586.
6. Manek NJ, Lane NE. Osteoarthritis: current concepts in diagnosis and management. Am Fam Physician. 2000;61:1795-1804.
7. Williams DA, Farrell MJ, Cunningham J, et al. Knee pain and radiographic osteoarthritis interact in the prediction of levels of self-reported disability. Arthritis Rheum. 2004;51:558-561.
8. Hopman-Rock M, Kraaimaat FW, Bijlsma JW. Quality of life in elderly subjects with pain in the hip or knee. Qual Life Res. 1997;6:67-76.
9. 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;43:1905-1915.
10. Sharma S, Prasad A, Anand KS. Nonsteroidal anti-inflammatory drugs in the management of pain and inflammation: a basis for drug selection. Am J Ther. 1999;6:3-11.
11. Hawkey CJ. Quality of life in users of non-steroidal anti-inflammatory drugs. Scand J Gastroenterol Suppl. 1996;221:23-24.
12. Hawkey CJ, Jones JI. Gastrointestinal safety of COX-2 specific inhibitors. Gastroenterol Clin North Am. 2001;30:921-936.
13. Jackson LM, Hawkey CJ. COX-2 selective nonsteroidal anti-inflammatory drugs: do they really offer any advantages? Drugs. 2000;59:1207-1216.
14. Matheson AJ, Figget DP. Rofecoxib: a review of its use in the management of osteoarthritis, acute pain and rheumatoid arthritis. Drugs. 2005;61:833-865.
15. Wight NJ, Gottesdiener K, Garlick NM, et al. Rofecoxib, a COX-2 inhibitor, does not inhibit human gastric mucosal prostaglandin production. Gastroenterology. 2001;120:867-873.
16. 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;343:1520-1528.
17. Lisse JR, Perlman M, Johansson G, et al. Gastrointestinal tolerability and effectiveness of rofecoxib versus naproxen in the treatment of osteoarthritis: a randomized, controlled trial. Ann Intern Med. 2003;139:539-546.
18. Watson DJ, Harper SE, Zhao PL, et al. Gastrointestinal tolerability of the selective cyclooxygenase-2 (COX-2) inhibitor rofecoxib compared with nonselective COX-1 and COX-2 inhibitors in osteoarthritis. Arch Intern Med. 2000;160:2998-3003.
19. Lister BJ, Poland M, DeLapp RE. Efficacy of nabumetone versus diclofenac, naproxen, ibuprofen, and piroxicam in osteoarthritis and rheumatoid arthritis. Am J Med. 1993;95:2S-9S.
20. Scott DL, Palmer RH. Safety and efficacy of nabumetone in osteoarthritis: emphasis on gastrointestinal safety. Aliment Pharmacol Ther. 2000;14:443-452.
21. Huang JQ, Sridhar S, Hunt RH. Gastrointestinal safety profile of nabumetone: a meta-analysis. Am J Med. 1999;107:55S-64S.
22. Roth SH. Upper gastrointestinal safety with nabumetone. J Rheumatol. 1992;19:74-79.
23. Vioxx (rofecoxib) Prescribing Information. 2004 Physicians' Desk Reference, 58th ed. Montvale, NJ: Medical Economics Co, Inc; 2004:2108-2113.
24. Relafen (nabumetone) Prescribing Information. 2004 Physician's Desk Reference, 58th ed. Montvale, NJ: Medical Economics Co, Inc; 2004:1600-1602.
25. 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.
26. Kivitz AJ, Greenwald MW, Cohen SB, et al. Efficacy and safety of rofecoxib 12. 5 mg versus nabumetone 1,000 mg in patients with osteoarthritis of the knee: a randomized controlled trial. J Am Geriatr Soc. 2004;52:666-674.
27. Geba GP, Polis AB, Najarian DK, et al. Onset of efficacy and patient assessment of clinical response in osteoarthritis (OA): comparison of rofecoxib to nabumetone. Annual Meeting of the American Geriatric Society; Chicago; May 9-13, 2001.
28. Konstam MA, Weir MR, Reicin A, et al. Cardiovascular thrombotic events in controlled, clinical trials of rofecoxib. Circulation. 2001;104:2280-2288.
29. Mukherjee D, Nissen SE, Topol EJ. Risk of cardiovascular events associated with selective COX-2 inhibitors. JAMA. 2001;286:954-959.
30. Targum SL. Review of the cardiovascular safety database: rofecoxib. Food and Drug Administration Center for Drug Evaluation and Research: Arthritis Advisory Committee, Gaithersburg, MD. Available at: http://fda.gov/ohrms/ dockets/ac/01/briefing/3677b2.htm. Accessed February 8, 2001.
31. 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;160:1781-1787.
32. 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;9:1124-1134.
33. Helfgott SM. Nabumetone: a clinical appraisal. Semin Arthritis Rheum. 1994;23:341-346.
34. Truitt KE, Sperling RS, Ettinger WH Jr, et al. A multicenter, randomized, controlled trial to evaluate the safety profile, tolerability, and efficacy of rofecoxib in advanced elderly patients with osteoarthritis. Aging (Milano). 2001;13:112-121.
35. Blower PR. The unique pharmacologic profile of nabumetone. J Rheumatol. 1992;19(suppl 36):13-19.
36. Kosinski M, Keller SD, Hatoum HT, et al. The SF-36 Health Survey as a generic outcome measure in clinical trials of patients with osteoarthritis and rheumatoid arthritis: tests of data quality, scaling assumptions and score reliability. Med Care. 1999;37:MS10-MS22.
37. Kosinski M, Keller SD, Ware JE Jr, et al. The SF-36 Health Survey as a generic outcome measure in clinical trials of patients with osteoarthritis and rheumatoid arthritis: relative validity of scales in relation to clinical measures of arthritis severity. Med Care. 1999;37:MS23-MS39.
38. Ehrich EW, Bolognese JA, Watson DJ, et al. Effect of rofecoxib therapy on measures of health-related quality of life in patients with osteoarthritis. Am J Manag Care. 2001;7:609-616.
39. Bresalier RS, Sandler RS, Quan H, et al. Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial. N Engl J Med. 2005;352:1092-1102.
40. 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;352:1071-1080.
41. 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;284:1247-1255.
42. Farkouh ME, Kirshner H, Harrington RA, et al. Comparison of lumiracoxib with naproxen and ibuprofen in the Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET), cardiovascular outcomes: randomised controlled trial. Lancet. 2004;364:675-684.
43. Baraf HSB, Fuentealva C, Greenwald M, et al. Tolerability and effectiveness of etoricoxib compared to diclofenac sodium in patients with osteoarthritis: a randomized controlled study (EDGE trial). Arthritis Rheum. 2004;50(suppl):S346.
44. Food and Drug Administration Center for Drug Evaluation and Research: Joint Meeting of the Arthritis Advisory committee and the Drug Safety and Risk Management Advisory Committee; Gaithersburg, MD; February 16-18, 2005. Available at: http://www.fda.gov/oc/advisory/acccalendar/2005/cder12532ddd0216171805.html
45. Jenkins JK, Seligman PJ. Analysis and recommendations for Agency action regarding nonsteroidal anti-inflammatory drugs and cardiovascular risk. Available at: http://www.fda.gov/cder/drug/infopage/COX2/NSAIDdecisionMemo.pdf. Accessed April 6, 2005.
46. US Food and Drug Administration. FDA Talk Paper: FDA issues public health advisory recommending limited use of Cox-2 inhibitors. Available at: http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01336.html.