Gastrointestinal Tolerability and Effectiveness of Rofecoxib versus Naproxen in the Treatment of Osteoarthritis: A Randomized, Controlled Trial

Annals of Internal Medicine

Volumn 139, Issue 7, 2003, Pages

  Lisse, Jeffrey R ^b   Perlman, Monica ^b   Johansson, Gunnar ^b   Shoemaker, James R ^b   Schechtman, Joy ^b   Skalky, Carol S ^b   Dixon, Mary E ^b   Polis, Adam B ^b   Mollen, Arthur J ^b   Geba, Gregory P ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; ANTACID AGENT; CYCLOOXYGENASE 1; CYCLOOXYGENASE 2; HISTAMINE H2 RECEPTOR ANTAGONIST; NAPROXEN; PARACETAMOL; PROTON PUMP INHIBITOR; ROFECOXIB; LACTONE; NONSTEROID ANTIINFLAMMATORY AGENT; PROSTAGLANDIN SYNTHASE INHIBITOR; SULFONE;

ABDOMINAL PAIN; ADULT; AGED; ARTICLE; DIARRHEA; DIGESTIVE SYSTEM PERFORATION; DIGESTIVE SYSTEM ULCER; DRUG EFFICACY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPEPSIA; ENZYME INHIBITION; EPIGASTRIC PAIN; FEMALE; GASTROINTESTINAL HEMORRHAGE; GASTROINTESTINAL TOXICITY; HAND; HEART INFARCTION; HEARTBURN; HIP; HUMAN; KNEE; MAJOR CLINICAL STUDY; MALE; NAUSEA; OSTEOARTHRITIS; PRIORITY JOURNAL; SPINE; STROKE; THROMBOSIS; CARDIOVASCULAR DISEASE; CHEMICALLY INDUCED DISORDER; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG COMBINATION; GASTROINTESTINAL DISEASE; HYPERTENSION; MIDDLE AGED; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL;

ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; ASPIRIN; CARDIOVASCULAR DISEASES; CYCLOOXYGENASE INHIBITORS; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FEMALE; GASTROINTESTINAL DISEASES; HUMANS; HYPERTENSION; LACTONES; MALE; MIDDLE AGED; NAPROXEN; OSTEOARTHRITIS; PROSPECTIVE STUDIES; SULFONES;

EID: 0142028961     PISSN: 00034819     EISSN: None     Source Type: Journal    
DOI: 10.7326/0003-4819-139-7-200310070-00005     Document Type: Article

References (37)

1. Felson DT. The course of osteoarthritis and factors that affect it. Rheum Dis Clin North Am. 1993;19:607-15. [PMID: 8210577]
2. Felson DT. Epidemiology of osteoporosis. In: Brandt KD, Doherty M, Lohmander LS, eds. Osteoarthritis. Bath, Great Britain: Bath Pt; 1998:13-23.
3. Dieppe P, Lim K. Osteoarthritis and related disorders: clinical features and diagnostic problems. In: Klippel JH, Dieppe PA, Arnett FC, Brooks PM, Canosa JJ, Carette S, et al., eds. Rheumatology. 2nd ed. St. Louis, MO: Mosby-Year Book; 1998: 8.3-1-8.3-16.
4. Pincus T, Swearingen C, Cummins P, Callahan LF. Preference for nonsteroidal antiinflammatory drugs versus acetaminophen and concomitant use of both types of drugs in patients with osteoarthritis. J Rheumatol. 2000;27:1020-7. [PMID: 10782831]
5. Vane JR, Botting RM. Mechanism of action of anti-inflammatory drugs. Scand J Rheumatol Suppl. 1996;102:9-21. [PMID: 8628981]
6. Vane JR, Bakhle YS, Botting RM. Cyclooxygenases 1 and 2. Annu Rev Pharmacol Toxicol. 1998;38:97-120. [PMID: 9597150]
7. 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;268:6610-4. [PMID: 8454631]
8. Mitchell JA, Akarasereenont P, Thiemermann C, Flower RJ, Vane JR. Selectivity of nonsteroidal antiinflammatory drugs as inhibitors of constitutive and inducible cyclooxygenase. Proc Nad Acad Sci U S A. 1993;90:11693-7. [PMID: 8265610]
9. Seibert K, Masferrer J, Zhang Y, Gregory S, Olson G, Hauser S, et al. Mediation of inflammation by cyclooxygenase-2. Agents Actions Suppl. 1995;46: 41-50. [PMID: 7610990]
10. Lee SH, Soyoola E, Chanmugam P, Hart S, San W, Zhong H, et al. Selective expression of mitogen-inducible cyclooxygenase in macrophages stimulated with lipopolysaccharide. J Biol Chem. 1992;267:25934-8. [PMID: 1464605]
11. Masferrer JL, Zweifel BS, Manning PT, Hauser SD, Leahy KM, Smith WG, et al. Selective inhibition of inducible cyclooxygenase 2 in vivo is antiinflammatory and nonulcerogenic. Proc Natl Acad Sci U S A. 1994;91:3228-32. [PMID: 8159730]
12. Hawkey CJ. Non-steroidal anti-inflammatory drug gastropathy: causes and treatment. Scand J Gastroenterol Suppl. 1996;220:124-7. [PMID: 8898449]
13. 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;115:787-96. [PMID: 1834002]
14. 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. [PMID: 10580458]
15. 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. [PMID: 11087881]
16. Hochberg MC, Vignon E, Maheu E. Session 2: clinical aspects. Clinical assessment of hand OA. Osteoarthritis Cartilage. 2000;8 Suppl A:S38-40. [PMID: 11156493]
17. Collaborative overview of randomised trials of antiplatelet therapy - I: Prevention of death, myocardial infarction, and stroke by prolonged antiplatelet therapy in various categories of patients. Antiplatelet Trialists' Collaboration. BMJ. 1994;308:81-106. [PMID: 8298418]
18. Saag K, van der Heijde D, Fisher C, Samara A, DeTora L, Bolognese J, 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. [PMID: 11115219]
19. Day R, Morrison B, Luza A, Castaneda O, Strusberg A, Nahir M, 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. [PMID: 10871971]
20. Lanza FL, Rack MF, Simon TJ, Quan H, Bolognese JA, Hoover ME, et al. Specific inhibition of cyclooxygenase-2 with MK-0966 is associated with less gastroduodenal damage than either aspirin or ibuprofen. Aliment Pharmacol Ther. 1999;13:761-7. [PMID: 10383505]
21. 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: 1247-55. [PMID: 10979111]
22. Juni P, Rutjes AW, Dieppe PA. Are selective COX 2 inhibitors superior to traditional non steroidal anti-inflammatory drugs? [Editorial] BMJ. 2002;324: 1287-8. [PMID: 12039807]
23. Singh G, Miller JD, Lee FH, Pettitt D, Russell MW. Prevalence of cardiovascular disease risk factors among US adults with self-reported osteoarthritis: data from the Third National Health and Nutrition Examination Survey. Am J Manag Care. 2002;8:S383-91. [PMID: 12416788]
24. Watson DJ, Harper SE, Zhao PL, Quan H, Bolognese JA, Simon TJ. Gastrointestinal tolerability of the selective cyclooxygenase-2 (COX-2) inhibitor rofecoxib compared with nonselective COX-1 and COX-2 inhibitors in osreoarthritis. Arch Intern Med. 2000;160:2998-3003. [PMID: 11041909]
25. Lichtenstein DR, Wolfe MM. COX-2-Selecrive NSAIDs: new and improved? [Editorial]. JAMA. 2000;284:1297-9. [PMID: 10980759]
26. Wolfe MM, Lichtenstein DR, Singh G. Gastrointestinal toxicity of nonsteroidal antiinflammatory drugs. N Engl J Med. 1999;340:1888-99. [PMID: 10369853]
27. Singh G, Rosen Ramey D, NSAID induced gastrointestinal complications: the ARAMIS perspective - 1997. Arthritis, Rheumatism, and Aging Medical Information System. J Rheumatol Suppl. 1998;51:8-16. PMID: 9596549]
28. Griffin MR. Epidemiology of nonsteroidal anti-inflammatory drug-associated gastrointestinal injury. Am J Med. 1998;104:23S-29S; discussion 41S-42S. [PMID: 9572317]
29. Chevat C, Pena BM, Al MJ, Rutten FF. Healthcare resource utilisation and costs of treating NSAID-associated gastrointestinal toxicity. A multinational perspective. Pharmacoeconomics. 2001;19 Suppl 1:17-32. [PMID: 11280103]
30. Sheen CL, MacDonald TM. Gastrointestinal side effects of NSAIDs - pharmacoeconomic implications. Expert Opin Pharmacother. 2002;3:265-9. [PMID: 11866677]
31. Cappell MS, Schein JR. Diagnosis and treatment of nonsteroidal anti-inflammatory drug-associated upper gastrointestinal toxicity. Gastroenterol Clin North Am. 2000;29:97-124. [PMID: 10752019]
32. Graham DY. Prevention of gastroduodenal injury induced by chronic non-steroidal antiinflammatory drug therapy. Gastroenterology. 1989;96:675-81. [PMID: 2642452]
33. Fendrick AM. Developing an economic rationale for the use of selective COX-2 inhibitors for patients at risk for NSAID gastropathy. Cleve Clin J Med. 2002;69 Suppl 1:S159-64. [PMID: 12086296]
34. Marshall JK, Pellissier JM, Attard CL, Kong SX, Marentette MA. Incremental cost-effectiveness analysis comparing rofecoxib with nonselective NSAIDs in osteoarthritis: Ontario Ministry of Health perspective. Pharmacoeconomics. 2001;19:1039-49. [PMID: 11735672]
35. Brater DC, Harris C, Redfern JS, Gertz BJ. Renal effects of COX-2-selective inhibitors. Am J Nephrol. 2001;21:1-15. [PMID: 11275626]
36. 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. [PMID: 11696466]
37. Reicin AS, Shapiro D, Sperling RS, Barr E, Yu Q. Comparison of cardiovascular thrombotic events in patients with osteoarthritis treated with rofecoxib versus nonselective nonsteroidal anti-inflammatory drugs (ibuprofen, diclofenac, and nabumetone). Am J Cardiol. 2002;89:204-9. [PMID: 11792343]