A novel composite endpoint to evaluate the gastrointestinal (GI) effects of nonsteroidal antiinflammatory drugs through the entire GI tract

Journal of Rheumatology

Volumn 37, Issue 1, 2010, Pages 167-174

  Chan, Francis K L ^a   Cryer, Byron ^b   Goldstein, Jay L ^c   Lanas, Angel ^d   Peura, David A ^e   Scheiman, James M ^f   Simon, Lee S ^g   Singh, Gurkirpal ^h   Stillman, Martin J ⁱ   Wilcox, Charles M ^j   Berger, Manuela F ^k   Breazna, Aurora ^k   Dodge, William ^k  

^a CHINESE UNIVERSITY OF HONG KONG   (Hong Kong)

^b UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER   (United States)

^c UNIVERSITY OF ILLINOIS AT CHICAGO   (United States)

^d UNIVERSITY OF ZARAGOZA   (Spain)

^e UNIVERSITY OF VIRGINIA   (United States)

^f UNIVERSITY OF MICHIGAN HEALTH SYSTEM   (United States)

^g HARVARD MEDICAL SCHOOL   (United States)

^h STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

ⁱ HENNEPIN COUNTY MEDICAL CENTER   (United States)

^j UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^k PFIZER INC   (United States)

more..

Author keywords

Cyclooxygenase inhibitors; Nonsteroidal antiinflammatory agents; Osteoarthritis; Rheumatoid arthritis; Upper lower gastrointestinal tract

Indexed keywords

CELECOXIB; DICLOFENAC; ETORICOXIB; IBUPROFEN; LUMIRACOXIB; MISOPROSTOL; NAPROXEN; OMEPRAZOLE; ROFECOXIB;

ADULT; ANEMIA; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIGESTIVE SYSTEM PERFORATION; DIGESTIVE SYSTEM ULCER; DOUBLE BLIND PROCEDURE; DRUG EFFECT; DRUG SAFETY; DRUG USE; GASTROINTESTINAL HEMORRHAGE; GASTROINTESTINAL OBSTRUCTION; GASTROINTESTINAL TRACT; HUMAN; LANGUAGE; MULTICENTER STUDY; OPEN STUDY; OSTEOARTHRITIS; PHYSICIAN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHEUMATOID ARTHRITIS;

ADOLESCENT; ADULT; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; GASTROINTESTINAL DISEASES; GASTROINTESTINAL TRACT; HUMANS; MIDDLE AGED; MULTICENTER STUDIES AS TOPIC; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN;

EID: 73649103431     PISSN: 0315162X     EISSN: None     Source Type: Journal    
DOI: 10.3899/jrheum.090168     Document Type: Article

References (34)

1. Hadjibabaie M, Rastkari N, Rezaie A, Abdollahi M. The adverse drug reaction in the gastrointestinal tract: an overview. Int J Pharmacol 2005;1:1-8.
2. Peura D, Goldkind L. Balancing the gastrointestinal benefits and risks of nonselective NSAIDs. Arthritis Res Ther 2005;7 Suppl:S7-13.
3. Lanas A, Perez-Aisa MA, Feu F, Ponce J, Saperas E, Santolaria S, et al. A nationwide study of mortality associated with hospital admission due to severe gastrointestinal events and those associated with nonsteroidal antiinflammatory drug use. Am J Gastroenterol 2005;100:1685-93.
4. Singh G, Triadafilopoulos G. Epidemiology of NSAID induced gastrointestinal complications. J Rheumatol 1999;26 Suppl 56:18-24.
5. Vonkeman HE, Klok RM, Postma MJ, Brouwers JR, van de Laar MA. Direct medical costs of serious gastrointestinal ulcers among users of NSAIDs. Drugs Aging 2007;24:681-90.
6. 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. JAMA 2000;284:1247-55.
7. Garcia Rodriguez LA, Jick H. Risk of upper gastrointestinal bleeding and perforation associated with individual nonsteroidal anti-inflammatory drugs. Lancet 1994;343:769-72.
8. Laine L. Proton pump inhibitor co-therapy with nonsteroidal anti-inflammatory drugs - nice or necessary? Rev Gastroenterol Disord 2004;4 Suppl:S33-41.
9. Bjarnason I, Williams P, So A, Zanelli G, Levi A, Gumpel J, et al. Intestinal permeability and inflammation in rheumatoid arthritis: effects of non-steroidal anti-inflammatory drugs. Lancet 1984;24:1171-4.
10. Allison MC, Howatson AG, Torrance CJ, Lee FD, Russell RI. Gastrointestinal damage associated with the use of nonsteroidal anti-inflammatory drugs. N Engl J Med 1992;327:749-54.
11. Lanas A, Sekar MC, Hirschowitz BI. Objective evidence of aspirin use in both ulcer and nonulcer upper and lower gastrointestinal bleeding. Gastroenterology 1992;103:862-9.
12. Wilcox CM, Alexander LN, Cotsonis GA, Clark WS. Nonsteroidal antiinflammatory drugs are associated with both upper and lower gastrointestinal bleeding. Dig Dis Sci 1997;42:990-7.
13. Laine L, Connors LG, Reicin A, Hawkey CJ, Burgos-Vargas R, Schnitzer TJ, et al. Serious lower gastrointestinal clinical events with nonselective NSAID or coxib use. Gastroenterology 2003;124:288-92.
14. Laine L, Smith R, Min K, Chen C, Dubois RW. Systematic review: the lower gastrointestinal adverse effects of non-steroidal anti-inflammatory drugs. Aliment Pharmacol Ther 2006;24:751-67.
15. Lanas A, Panes J, Pique JM. Clinical implications of COX-1 and/or COX-2 inhibition for the distal gastrointestinal tract. Curr Pharm Des 2003;9:2253-66.
16. Adebayo D, Bjarnason I. Is non-steroidal anti-inflammatory drug (NSAID) enteropathy clinically more important than NSAID gastropathy? Postgrad Med J 2006;82:186-91.
17. Fortun PJ, Hawkey CJ. Nonsteroidal antiinflammatory drugs and the small intestine. Curr Opin Gastroenterol 2005;21:169-75.
18. Maiden L, Thjodleifsson B, Theodors A, Gonzalez J, Bjarnason I. A quantitative analysis of NSAID-induced small bowel pathology by capsule enteroscopy. Gastroenterology 2005;128:1172-8.
19. Lanas A, Sopena F. Nonsteroidal anti-inflammatory drugs and lower gastrointestinal complications. Gastroenterol Clin North Am 2009;38:333-52.
20. Langman MJ, Morgan L, Worral A. Use of anti-inflammatory drugs by patients admitted with small or large bowel perforations and haemorrhage. Br Med J (Clin Res Ed) 1985;290:347-9.
21. Holt S, Rigoglioso V, Sidhu M, Irshad M, Howden CW, Mainero M. Nonsteroidal antiinflammatory drugs and lower gastrointestinal bleeding. Dig Dis Sci 1993;38:1619-23.
22. Lanas A, Serrano P, Bajador E, Esteva F, Benito R, Sainz R. Evidence of aspirin use in both upper and lower gastrointestinal perforation. Gastroenterology 1997;112:683-9.
23. Chan FK, Hung LC, Suen BY, Wu JC, Lee KC, Leung VK, et al. Celecoxib versus diclofenac and omeprazole in reducing the risk of recurrent ulcer bleeding in patients with arthritis. N Engl J Med 2002;347:2104-10.
24. Bjarnason I, Hayllar J, MacPherson AJ, Russell AS. Side effects of nonsteroidal anti-inflammatory drugs on the small and large intestine in humans. Gastroenterology 1993;104:1832-47.
25. Chong AK, Chin BW, Meredith CG. Clinically significant small-bowel pathology identified by double-balloon enteroscopy but missed by capsule endoscopy. Gastrointest Endosc 2006;64:445-9.
26. Viazis N, Papaxoinis K, Vlachogiannakos J, Efthymiou A, Theodoropoulos I, Karamanolis DG. Is there a role for second-look capsule endoscopy in patients with obscure GI bleeding after a nondiagnostic first test? Gastrointest Endosc 2009;69:850-6.
27. Tanaka S, Mitsui K, Tatsuguchi A, Kobayashi T, Ehara A, Gudis K, et al. Current status of double balloon endoscopy - indications, insertion route, sedation, complications, technical matters. Gastrointest Endosc 2007;66 Suppl:S30-3.
28. Lanas A, García-Rodríguez LA, Polo-Tomás M, Ponce M, Alonso-Abreu I, Perez-Aisa MA, et al. Time trends and impact of upper and lower gastrointestinal bleeding and perforation in clinical practice. Am J Gastroenterol 2009;104:1633-41.
29. Zhao Y, Encinosa W. Hospitalizations for gastrointestinal bleeding in 1998 and 2006. Healthcare Cost and Utilization Project (HCUP) Statistical Brief #65 [report on the Internet]. Agency for Healthcare Research and Quality, Rockville, MD. [Internet. Accessed Sept 11, 2009.] Available from: http://www.hcup-us.ahrq. gov/reports/statbriefs/sb65.pdf
30. Silverstein FE, Graham DY, Senior JR, Davies HW, Struthers BJ, Bittman RM, et al. Misoprostol reduces serious gastrointestinal complications in patients with rheumatoid arthritis receiving nonsteroidal anti-inflammatory drugs. A randomized, double-blind, placebo-controlled trial. Ann Intern Med 1995;123:241-9.
31. 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. N Engl J Med 2000;343:1520-8.
32. Schnitzer TJ, Burmester GR, Mysler E, Hochberg MC, Doherty M, Ehrsam E, et al. Comparison of lumiracoxib with naproxen and ibuprofen in the Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET), reduction in ulcer complications: randomised controlled trial. Lancet 2004;364:665-74.
33. Singh G, Fort JG, Goldstein JL, Levy RA, Hanrahan PS, Bello AE, et al. Celecoxib versus naproxen and diclofenac in osteoarthritis patients: SUCCESS-I Study. Am J Med 2006;119:255-66.
34. Cannon CP, Curtis SP, FitzGerald GA, Krum H, Kaur A, Bolognese JA, et al. Cardiovascular outcomes with etoricoxib and diclofenac in patients with osteoarthritis and rheumatoid arthritis in the Multinational Etoricoxib and Diclofenac Arthritis Long-term (MEDAL) programme: a randomised comparison. Lancet 2006;368:1771-81.