Risk of serious NSAID-related gastrointestinal events during long-term exposure: A systematic review

Medical Journal of Australia

Volumn 185, Issue 9, 2006, Pages 501-506

  Schaffer, Delia ^a   Florin, Timothy ^b,c   Eagle, Craig ^a   Marschner, Ian ^a   Singh, Gurkirpal ^d   Grobler, Mendel ^a   Fenn, Chris ^a   Schou, Manjula ^a   Curnow, Kathleen M ^a  

^a PFIZER INC   (United States)

^b UNIVERSITY OF QUEENSLAND   (Australia)

^c MATER HOSPITAL   (Australia)

^d STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; CYCLOOXYGENASE 2 INHIBITOR; DICLOFENAC; ETODOLAC; IBUPROFEN; MISOPROSTOL; NAPROXEN; NONSTEROID ANTIINFLAMMATORY AGENT; PLACEBO;

CLINICAL TRIAL; COCHRANE LIBRARY; CONFIDENCE INTERVAL; DIGESTIVE SYSTEM PERFORATION; DIGESTIVE SYSTEM ULCER; DISEASE SEVERITY; DRUG INTERMITTENT THERAPY; EMBASE; EVIDENCE BASED MEDICINE; EXTERNAL VALIDITY; GASTROINTESTINAL HEMORRHAGE; GASTROINTESTINAL TOXICITY; HUMAN; INCIDENCE; INFORMATION RETRIEVAL; INTERNAL VALIDITY; LONG TERM CARE; LONG TERM EXPOSURE; MEDLINE; OSTEOARTHRITIS; PAIN; QUANTITATIVE ANALYSIS; REGRESSION ANALYSIS; REVIEW; RHEUMATOID ARTHRITIS; RISK ASSESSMENT; RISK REDUCTION; SCISEARCH; SENSITIVITY ANALYSIS; SYSTEMATIC REVIEW; THROMBOSIS; TREATMENT DURATION;

EID: 33751064759     PISSN: 0025729X     EISSN: None     Source Type: Journal    
DOI: 10.5694/j.1326-5377.2006.tb00665.x     Document Type: Review

References (57)

1. Goldstein JL, Silverstein FE, Agrawal NM, et al. Reduced risk of upper gastrointestinal ulcer complications with celecoxib, a novel COX-2 inhibitor. Am J Gastroenterol 2000; 95: 1681-1690.
2. Singh G, Triadafilopoulos G. Epidemiology of NSAID induced gastrointestinal complications. J Rheumatol Suppl 1999; 26:18-24.
3. Hernandez-Diaz S, Garcia Rodriguez LA. Incidence of serious upper gastrointestinal bleeding/perforation in the general population: review of epidemiologic studies. J Clin Epidemiol 2002; 55:157-163.
4. Mamdani M, Rochon PA, Juurlink DN, et al. Observational study of upper gastrointestinal haemorrhage in elderly patients given selective cyclo-oxygenase-2 inhibitors or conventional non-steroidal anti-inflammatory drugs. BMJ 2002; 325: 624-629.
5. Shorr RI, Ray WA, Daugherty JR, et al. Concurrent use of nonsteroidal anti-inflammatory drugs and oral anticoagulants places elderly persons at high risk for hemorraghic peptic ulcer disease. Arch Intern Med 1993; 153:1665-1670.
6. Garcia Rodriguez LA, Hernandez-Diaz S. Relative risk of upper gastrointestinal complications among users of acetaminophen and nonsteroidal anti-inflammatory drugs. Epidemiology 2001; 12: 570-576.
7. Henry D, Lim LL, Garcia Rodriguez LA, et al. Variability in risk of gastrointestinal complications with individual non-steroidal anti-inflammatory drugs: results of a collaborative meta-analysis. BMJ 1996; 312: 1563-1566.
8. Langman MJ, Brooks P, Hawkey CJ, et al. Non-steroidal anti-inflammatory drug associated ulcer: epidemiology, causation and treatment. J Gastroenterol Hepatol 1991; 6:442-449.
9. Graham DJ, Campen D, Hui R, et al. Risk of acute myocardial infarction and sudden cardiac death in patients treated with cyclo-oxygenase 2 selective and non-selective non-steroidal anti-inflammatory drugs: nested case-control study. Lancet 2005; 365: 475-481.
10. Hippisley-Cox J, Coupland C. Risk of myocardial infarction in patients taking cyclo-oxygenase-2 inhibitors or conventional non-steroical anti-inflammatory drugs: population based nested case-control analysis. BMJ 2005; 330:1366-1369.
11. Hudson M, Hugues R, Pilote L. Differences in outcomes of patients with congestive heart failure prescribed celecoxib, rofecoxib, or non-steroidal anti-inflammatory drugs: population based study. BMJ 2005; 330:1370-1373.
12. Johnsen SP, Larsson H, Tarone RE, et al. Risk of hospitalization for myocardial infarction among users of rofecoxib, celecoxib, and other NSAIDs: a population-based case-control study. Arch Intern Med 2005; 165:978-984.
13. Shorrock CJ, Prescott RJ, Rees WD. The effects of indomethacin on gastroduodenal morphology and mucosal pH gradient in the healthy human stomach. Gastroenterology 1990; 99: 334-339.
14. Skeljo MV, Giraud AS, Yeomans ND. Adaptation of rat gastric mucosa to repeated doses of non-salicylate non-steroidal anti-inflammatory drugs. J Gastroenterol Hepatol 1992; 7: 586-590.
15. Carson JL, Strom BL, Soper KA, et al. The association of nonsteroidal anti-inflammatory drugs with upper gastrointestinal tract bleeding. Arch Intern Med 1987; 147: 85-88.
16. Elliott SL, Yeomans IND, Buchanan RR, Smallwood RA. Efficacy of 12 months' misoprostol as prophylaxis against NSAID-incluced gastric ulcers. A pla-cebo-controlled trial. Scand J Rheumatol 1994; 23: 171-176.
17. 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: randomised controlled trial. Lancet 2004; 364:665-674.
18. Paulus HE. Government Affairs. FDA Arthritis Advisory Committee meeting: risks of agranulocytosis/ aplastic anemia, flank pain, and adverse gastrointestinal effects with the use of nonsteroidal antiinflammatory drugs. Arthritis Rheum 1987; 30: 593-595.
19. Fries JF, Williams CA, Bloch DA, Michel BA. Nonsteroidal anti-inflammatory drug-associated gastropathy: incidence and risk factor models. Am J Med 1991; 91: 213-222.
20. Garcia Rodriguez LA, Jick H. Risk of upper gastrointestinal bleeding and perforation associated with individual non-steroidal anti-inflammatory drugs. Lancet 1994; 343: 769-772.
21. Garcia Rodriguez LA, Walker AM, Perez Gutthann S. Nonsteroical anti-inflammatory drugs and gastrointestinal hospitalizations in Saskatchewan: a cohort study Epidemiology 1992; 3: 337-342.
22. Griffin MR, Ray WA, Schaffner W. Nonsteroidal anti-inflammatory drug use and death from peptic ulcer in elderly persons. Ann Intern Med 1988; 109: 359-363.
23. Griffin MR, Piper JM, Daugherty JR, et al. Non-steroidal anti-inflammatory drug use and increased risk for peptic ulcer disease in elderly persons. Ann Intern Med 1991; 114: 257-263.
24. McMahon AD, Evans JM, White G, et al. A cohort study (with resampled comparator groups) to measure the association between new NSAID use prescribing and upper gastrointestinal hemorrhage and perforation. J Clin Epidemiol 1997; 50:351-356.
25. Perez Gutthann S, Rodriguez LA, Raiford DS. Individual non-steroidal anti-inflammatory drugs and the risk of hospitalisation for upper gastrointestinal bleeding and perforation in Saskatchewan: a nested case-control study Pharmacoepidemiol Drug Saf 1994;3:S63.
26. Singh G, Fries JF, Spitz PW, et al. Toxic effects of azathioprine in rheumatoid arthritis: a national post-marketing perspective. Arthritis Rheum 1989; 32: 837-841.
27. Singh G, Fries JF, Spitz PW, et al. Toxicity profiles of disease modifying antirheumatic drugs in rheumatoid arthritis. J Rheumatol 1991; 18:188-194.
28. Singh G, Ramey DR, Morfeld D, et al. Gastrointestinal tract complications of nonsteroidal anti-inflammatory drug treatment in rheumatoid arthritis: a prospective observational cohort study. Arch Intern Med 1996; 156:1530-1536.
29. Singh G, Terry R, Ramey DR, et al. Epidemiology of serious NSAID-related complications: a prospective multivariate lifetable analysis. Arthritis Rheum 1997; 40 (9 Suppl); S213.
30. Singh G. Recent considerations in nonsteroidal anti-inflammatory drug gastropathy. Am J Med 1998; 105: 31S-38S.
31. Christie D, Gordon I, Heller H. Randomised controlled trials and longitudinal studies. In: Madjar N, editor. Epidemiology: an introductory text for medical and other health science students. 2nd ed. Sydney: UNSW Press, 1997:93,94,64-78.
32. Australian Government Department of Health and Ageing. Appendices Q and R. In: Guidelines for the pharmaceutical industry on preparation of submissions to the Pharmaceutical Benefits Advisory Committee including major submissions involving economic analyses. Canberra: Department of Health and Ageing, 2002. http://www.health.gov.au/internet/wcms/ publishing.nsf/Content/health-pbs-general-pubs-guidelines-content.htm (accessed Sep 2002).
33. Jadad AR, Moore A, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials 1996; 17:1-12.
34. Moher D, Cook DJ, Eastwood S, et al. Improving the quality of reports of meta-analyses of randamised controlled trials: the QUOROM statement. Quality of Reporting of Meta-analyses. Lancet 1999; 354: 1896-1900.
35. 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 2DOO; 343:1520-1528.
36. Silverstein FE, Faich G, Goldstein JL, et al. Gastrointestinal toxicity with celecoxib versus nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: the Celecoxib Long-Term Arthritis Safety Study: a randomised controlled trial. JAMA 2000; 284:1247-1255.
37. Kurata JJ, Abbey DE. The effect of chronic aspirin use on duodenal and gastric ulcer hospitalizations. J Clin Gastroenterol 1990; 12: 260-266.
38. Neustadt DH. Double blind evaluation of the long-term effects of etodolac versus ibuprofen in patients with rheumatoid arthritis. J Rheumatol Suppl 1997; 47:17-22.
39. MacDonald TM, Morant SV, Goldstein JL, et al. Channelling bias and the incidence of gastrointestinal haemorrhage in users of meloxicam, coxib, and older, non-specific non-steroidal anti-inflammatory drugs. Gut 2003; 52: 1265-1270.
40. Hallas J, Lauritsen J, Dalsgard Villadsen H, Freng Gram L. Nonsteroidal anti-inflammatory drugs and upper gastrointestinal bleeding, identifying high-risk groups by excess risk estimates. Scand J Gastroenterol 1995; 30: 438-444.
41. MacDonald TM, Morant SV, Robinson GC, et al. Association of upper gastrointestinal toxicity of non-steroidal anti-inflammatory drugs with continued exposure: cohort study BMJ 1997, 315:1333-1337.
42. Mellemkjaer L, Blot WJ, Toft Sorensen H, et al. Upper gastrointestinal bleeding among users of NSAIDs: a population-based cohort study in Denmark. Br J Clin Pharmacol 2002; 53:173-181.
43. Smalley WE, Ray WA, Daugherty JR, Griffin MR. Nonsteroidal anti-inflammatory drugs and the incidence of hospitalizations for peptic ulcer disease in elderly persons. Am J Epidemiol 1995; 141: 539-545.
44. Perez Gutthann S, Garcia Rodriguez LA, Raiford DS. Individual nonsteroidal antiinflammatory drugs and other risk factors for upper gastrointestinal bleeding and perforation. Epidemiology 1997; 8:18-24.
45. Garcia Rodriguez LA, Cattaruzzi C, Troncon MG Agostinis L. Risk of hospitalization for upper gastrointestinal tract bleeding associated with ketorolac, other nonsteroidal anti-inflammatory drugs, calcium antagonists, and other anti hypertensive drugs. Arch Intern Med 1998; 158: 33-39.
46. Li Q. Statistical reviewer briefing document for the advisory committee for NDA # 21-042 s-007. 2000. http://www.fda.gov/ohrms/dockets/ac/01/ briefing/3677b2_04_stats.pdf (accessed Nov 2002).
47. Liang KY Zeger SL. Longitudinal data analysis using generalized linear models. Biometrika 1986; 73: 13-22.
48. Cox DR, Oakes D. Analysis of survival data. London: Chapman and Hall, 1984.
49. Gabriel SE, Jaakkimainen L, Bombardier C. Risk for serious gastrointestinal complications related to use of nonsteroical anti-inflammatory drugs. Ann Intern Med 1991; 115: 787-796.
50. Hernandez-Diaz S, Garcia Rodriguez LA. Association between nonsteroical anti-inflammatory drugs and upper gastrointestinal tract bleeding/ perforation: an overview of epidemiologic studies published in the 1990s. Arch Intern Med2000; 160:2093-2099.
51. Richy F, Bruyere O, Ethgen O, et al. Time dependent risk of gastrointestinal complications induced by non-steroidal anti-inflammatory drug use: a consensus statement using a meta-analytic approach. Ann Rheum Dis 2004; 63:759-766.
52. Freston JW Rationalizing cyclooxygenase (COX) inhibition for maximal efficacy and minimal adverse events. Am J Med 1999; 107(6A): 78S-88S.
53. Lipani JA, Poland M. Clinical update of the relative safety of nabumetone in long-term clinical trials. Inflammopharmacology 1995; 3: 351-361.
54. Palmer RH, MacDonald B, DeLapp R. Peptic ulcers with nabumetone: experience in 1677 patients with 4033 years of exposure. Gastroenterology 1998; 114 (4 Suppl): A252.
55. Higgins JPT, Green S, editors. Cochrane handbook for systematic reviews of interventions 4.2.5 [updated May 20051. In: The Cochrane Library Issue 3, 2005. Chichester, UK. John Wiley & Sons, 2005.
56. Fletcher RH, Fletcher SW, Wagner EH. Clinical epidemiology: the essentials. 3rd ed. Baltimore, Md: Williams and Wilkins, 1996.
57. Eypasch E, Lefering R, Kum CK, Troidl H. Probability of adverse events that have not yet occurred: a statistical reminder. BMJ 1995; 311: 619-620.