Evidence for Endoscopic Ulcers as Meaningful Surrogate Endpoint for Clinically Significant Upper Gastrointestinal Harm

Clinical Gastroenterology and Hepatology

Volumn 7, Issue 11, 2009, Pages 1156-1163

  Moore, Andrew ^a   Bjarnason, Ingvar ^b   Cryer, Byron ^c   Garcia Rodriguez, Luis ^d   Goldkind, Larry ^e   Lanas, Angel ^f   Simon, Lee ^g  

^a UNIVERSITY OF OXFORD   (United Kingdom)

^b KING S COLLEGE HOSPITAL   (United Kingdom)

^c VA NORTH TEXAS HEALTH CARE SYSTEM   (United States)

^d Department of Pharmacoepidemiology   (Spain)

^e Uniformed Services University of the Health Sciences and the Walter Reed National Military Medical Center   (United States)

^f HOSPITAL CLÍNICO UNIVERSITARIO LOZANO BLESA   (Spain)

^g BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; CELECOXIB; CYCLOOXYGENASE 2 INHIBITOR; DICLOFENAC; ESOMEPRAZOLE; ETORICOXIB; HISTAMINE H2 RECEPTOR ANTAGONIST; IBUPROFEN; LUMIRACOXIB; MISOPROSTOL; NAPROXEN; NONSTEROID ANTIINFLAMMATORY AGENT; OMEPRAZOLE; PROTON PUMP INHIBITOR; ROFECOXIB; VALDECOXIB;

AGE DISTRIBUTION; CLINICAL TRIAL; DIGESTIVE SYSTEM PERFORATION; DIGESTIVE SYSTEM ULCER; ENDOSCOPIC ULCER; GASTROINTESTINAL ENDOSCOPY; GASTROINTESTINAL HEMORRHAGE; HELICOBACTER INFECTION; HELICOBACTER PYLORI; HIGH RISK POPULATION; HUMAN; META ANALYSIS; PEPTIC ULCER BLEEDING; REVIEW; RISK FACTOR; STOMACH ULCER; SYSTEMATIC REVIEW; UPPER GASTROINTESTINAL BLEEDING;

BIOLOGICAL MARKERS; CLINICAL TRIALS AS TOPIC; DISEASE PROGRESSION; GASTROINTESTINAL DISEASES; HUMANS; PROGNOSIS; RISK ASSESSMENT; ULCER;

EID: 70349667386     PISSN: 15423565     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.cgh.2009.03.032     Document Type: Review

References (68)

1. Biomarkers Definitions Working Group. Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clin Pharm Ther 69 (2001) 89-95
2. Prentice R.L. Surrogate endpoints in clinical trials: definition and operational criteria. Stat Med 8 (1989) 431-440
3. Temple R. Are surrogate markers adequate to assess cardiovascular disease drugs?. JAMA 282 (1999) 790-795
4. International Conference on Surrogate Endpoints and Biomarkers. Remarks by: Jane E. Henney, MD, Commissioner of Food and Drugs. http://www.fda.gov/oc/speeches/surrogates8.html Accessed September 2008
5. Bren L. The advancement of controlled clinical trials. FDA Consumer Magazine. Last updated March-April 2007. http://www.fda.gov/fdac/features/2007/207_trials.html Accessed September 2008
6. Points to consider: clinical development and labelling of anti-infective drug products. Helicobacter pylori-associated peptic ulcer disease. Last updated June 1995. http://www.fda.gov/cder/guidance/hpptc.htm Accessed September 2008
7. FDA Gastrointestinal Advisory Committee. Chemoprevention of colorectal cancer. Last updated March 2002. http://www.fda.gov/ohrms/dockets/ac/02/transcripts/3845t1.pdf Accessed September 2008
8. Tramer M.R., Moore R.A., Reynolds D.J., et al. Quantitative estimation of rare adverse events which follow a biological progression: a new model applied to chronic NSAID use. Pain 85 (2000) 169-182
9. Hawkey C.J. Non-steroidal anti-inflammatory drugs and peptic ulcers. BMJ 300 (1990) 278-284
10. Boers M., Tangelder M.J., van Ingen H., et al. The rate of NSAID-induced endoscopic ulcers increases linearly, but not exponentially with age: a pooled analysis of 12 randomized trials. Ann Rheum Dis 66 (2006) 417-418
11. Cheatum D.E., Arvanitakis C., Gumpel M., et al. An endoscopic study of gastroduodenal lesions induced by nonsteroidal anti-inflammatory drugs. Clin Ther 21 (1999) 992-1003
12. Silverstein F.E., Graham D.Y., Senior J.R., 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 123 (1995) 241-249
13. Hawkey C.J., Laine L., Harper S.E., et al. Influence of risk factors on endoscopic and clinical ulcers in patients taking rofecoxib or ibuprofen in two randomized controlled trials. Aliment Pharmacol Ther 15 (2001) 1593-1601
14. MacDonald T.M., Morant S.V., Robinson G.C., et al. Association of upper gastrointestinal toxicity of non-steroidal anti-inflammatory drugs with continued exposure: cohort study. BMJ 315 (1997) 1333-1337
15. Hernandez-Diaz S., and Rodriguez L.A. Association between nonsteroidal anti-inflammatory drugs and upper gastrointestinal tract bleeding/perforation: an overview of epidemiologic studies published in the 1990s. Arch Intern Med 160 (2000) 2093-2099
16. Hernandez-Diaz S., and Rodriguez L.A. Incidence of serious upper gastrointestinal bleeding/perforation in the general population: review of epidemiologic studies. J Clin Epidemiol 55 (2002) 157-163
17. Perez-Gutthann S., Garcia-Rodriguez L.A., and Raiford D.S. Individual nonsteroidal antiinflammatory drugs and other risk factors for upper gastrointestinal bleeding and perforation. Epidemiology 8 (1997) 18-24
18. Lanas A., Garcia-Rodriguez L.A., Arroyo M.T., et al. Risk of upper gastrointestinal ulcer bleeding associated with selective COX-2 inhibitors, traditional non-aspirin NSAIDs, aspirin, and combinations. Gut 55 (2006) 1731-1738
19. Moayyedi P., Soo S., Deeks J., et al. Eradication of Helicobacter pylori for non-ulcer dyspepsia. Cochrane Database Syst Rev 2 (2006) CD002096
20. Graham D.Y., Lew G.M., Klein P.D., et al. Effect of treatment of Helicobacter pylori infection on the long-term recurrence of gastric or duodenal ulcer. A randomized, controlled study. Ann Intern Med 116 (1992) 705-708
21. Chan F.K., To K.F., Wu J.C., et al. Eradication of Helicobacter pylori and risk of peptic ulcers in patients starting long-term treatment with non-steroidal anti-inflammatory drugs: a randomised trial. Lancet 539 (2002) 9-13
22. Labenz J., Blum A.L., Bolten W.W., et al. Primary prevention of diclofenac associated ulcers and dyspepsia by omeprazole or triple therapy in Helicobacter pylori positive patients: a randomised, double blind, placebo controlled, clinical trial. Gut 51 (2002) 329-335
23. Chan F.K., Sung J.J., Chung S.C., et al. Randomised trial of eradication of Helicobacter pylori before non-steroidal anti-inflammatory drug therapy to prevent peptic ulcers. Lancet 350 (1997) 975-979
24. Graham D.Y., Hepps K.S., Ramirez F.C., et al. Treatment of Helicobacter pylori reduces the rate of rebleeding in peptic ulcer disease. Scand J Gastroenterol 28 (1993) 939-942
25. Riemann J.F., Schilling D., Schauwecker P., et al. Cure with omeprazole plus amoxicillin versus long-term ranitidine therapy in Helicobacter pylori-associated peptic ulcer bleeding. Gastrointest Endosc 46 (1997) 299-304
26. Yeomans N.D., Lanas A.I., Talley N.J., et al. Prevalence and incidence of gastroduodenal ulcers during treatment with vascular protective doses of aspirin. Aliment Pharmacol Ther 22 (2005) 795-801
27. Garcia Rodriguez L.A., Hernandez-Diaz S., and de Abajo F.J. Association between aspirin and upper gastrointestinal complications: systematic review of epidemiologic studies. Br J Clin Pharmacol 52 (2001) 563-571
28. Derry S., and Loke Y.K. Risk of gastrointestinal haemorrhage with long term use of aspirin: meta-analysis. BMJ 321 (2000) 1183-1187
29. Tramèr M. Aspirin, like all other drugs, is a poison. BMJ 321 (2000) 1170-1171
30. Lanza F.L., Royer G.L., and Nelson R.S. Endoscopic evaluation of the effects of aspirin, buffered aspirin, and enteric-coated aspirin on gastric and duodenal mucosa. N Eng J Med 303 (1980) 136-138
31. Lanas A., Bajador E., Serrano P., et al. Nitrovasodilators, low-dose aspirin, other nonsteroidal antiinflammatory drugs, and the risk of upper gastrointestinal bleeding. N Engl J Med 343 (2000) 834-839
32. Hernández-Díaz S., and García Rodríguez L.A. Cardioprotective aspirin users and their excess risk of upper gastrointestinal complications. BMC Medicine 4 (2006) 22
33. Goldstein J.L., Aisenberg J., Zakko S.F., et al. Endoscopic ulcer rates in healthy subjects associated with use of aspirin (81 mg q.d.) alone or coadministered with celecoxib or naproxen: a randomized, 1-week trial. Dig Dis Sci 53 (2008) 647-656
34. Goldstein J.L., Lowry S.C., Lanza F.L., et al. The impact of low-dose aspirin on endoscopic gastric and duodenal ulcer rates in users of a non-selective non-steroidal anti-inflammatory drug or a cyclo-oxygenase-2-selective inhibitor. Aliment Pharmacol Ther 23 (2006) 1489-1498
35. Silverstein F.E., Faich G., Goldstein J.L., 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 284 (2000) 1247-1255
36. Rahme E., Bardou M., Dasgupta K., et al. Hospitalization for gastrointestinal bleeding associated with non-steroidal anti-inflammatory drugs among elderly patients using low-dose aspirin: a retrospective cohort study. Rheumatology (Oxford) 46 (2007) 265-272
37. de Abajo F.J., and Garcia Rodriguez L.A. Risk of upper gastrointestinal bleeding and perforation associated with low-dose aspirin as plain and enteric-coated formulations. BMC Clin Pharmacol 1 (2001) 1
38. Rostom A., Dube C., Wells G., et al. Prevention of NSAID-induced gastroduodenal ulcers. Cochrane Database Syst Rev 4 (2002) CD002296
39. Brown T.J., Hooper L., Elliott R.A., et al. A comparison of the cost-effectiveness of five strategies for the prevention of non-steroidal anti-inflammatory drug-induced gastrointestinal toxicity: a systematic review with economic modelling. Health Technol Assess 10 (2006) iii-xiii 1
40. Elliott S.L., Yeomans N.D., Buchanan R.R., et al. Efficacy of 12 months' misoprostol as prophylaxis against NSAID-induced gastric ulcers: a placebo-controlled trial. Scand J Rheumatol 23 (1994) 171-176
41. Agrawal N.M., Van Kerckhove H.E., Erhardt L.J., et al. Misoprostol coadministered with diclofenac for prevention of gastroduodenal ulcers. A one-year study. Dig Dis Sci 40 (1995) 1125-1131
42. Lanas A., García-Rodríguez L.A., Arroyo M.T., et al. Effect of antisecretory drugs and nitrates on the risk of ulcer bleeding associated with nonsteroidal anti-inflammatory drugs, antiplatelet agents, and anticoagulants. Am J Gastroenterol 102 (2007) 507-515
43. Scheiman J.M., Yeomans N.D., Talley N.J., et al. Prevention of ulcers by esomeprazole in at-risk patients using non-selective NSAIDs and COX-2 inhibitors. Am J Gastroenterol 101 (2006) 701-710
44. Chan F.K., Wong V.W., Suen B.Y., et al. Combination of a cyclo-oxygenase-2 inhibitor and a proton-pump inhibitor for prevention of recurrent ulcer bleeding in patients at very high risk: a double-blind, randomised trial. Lancet 369 (2007) 1621-1626
45. García-Rodríguez L., and Barreales Tolosa L. Risk of upper gastrointestinal complications among users of traditional NSAIDs and COXIBs in the general population. Gastroenterology 132 (2007) 498-506
46. García-Rodríguez L.A., and Ruigómez A. Secondary prevention of upper gastrointestinal bleeding associated with maintenance acid-suppressing treatment in patients with peptic ulcer bleed. Epidemiology 10 (1999) 228-232
47. Massó-Gónzalez E.L., and García-Rodríguez L.A. PPIs reduce the long-term risk of recurrent UGIB: an observational study. Aliment Pharmacol Ther 28 (2008) 629-637
48. Rostom A., Muir K., Dube C., et al. Gastrointestinal safety of cyclooxygenase-2 inhibitors: a Cochrane Collaboration systematic review. Clin Gastroenterol Hepatol 5 (2007) 818-828
49. Mamdani M., Rochon P.A., Juurlink D.N., 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 325 (2002) 624
50. MacDonald T.M., Morant S.V., Goldstein J.L., et al. Channelling bias and the incidence of gastrointestinal haemorrhage in users of meloxicam, coxibs, and older, non-specific non-steroidal anti-inflammatory drugs. Gut 52 (2003) 1265-1270
51. Norgard B., Pedersen L., Johnsen S.P., et al. COX-2-selective inhibitors and the risk of upper gastrointestinal bleeding in high-risk patients with previous gastrointestinal diseases: a population-based case-control study. Aliment Pharmacol Ther 19 (2004) 817-825
52. American College of Rheumatology Subcommittee on Osteoarthritis Guidelines: recommendations for the medical management of osteoarthritis of the hip and knee: 2000 update. Arthritis Rheum 43 (2000) 1905-1915
53. National Collaborating Centre for Chronic Conditions. Osteoarthritis: national clinical guideline for care and management in adults (2008), Royal College of Physicians, London
54. Chan F.K., Hung L.C., Suen B.Y., et al. Celecoxib versus diclofenac plus omeprazole in high-risk arthritis patients: results of a randomized double-blind trial. Gastroenterology 127 (2004) 1038-1043
55. Chan F.K., Hung L.C., Suen B.Y., et al. Celecoxib versus diclofenac and omeprazole in reducing the risk of recurrent ulcer bleeding in patients with arthritis. N Engl J Med 347 (2002) 2104-2110
56. Molenberghs G., Buyse M., Geys H., et al. Statistical challenges in the evaluation of surrogate endpoints in randomized trials. Control Clin Trials 23 (2002) 607-625
57. Hackshaw A., Knight A., Barrett-Lee P., et al. Surrogate markers and survival in women receiving first-line combination anthracycline chemotherapy for advanced breast cancer. Br J Cancer 93 (2005) 1215-1221
58. Pocock S.J., Lansky A.J., Mehran R., et al. Angiographic surrogate end points in drug-eluting stent trials: a systematic evaluation based on individual patient data from 11 randomized, controlled trials. J Am Coll Cardiol 51 (2008) 23-32
59. Moore R.A., Derry S., Phillips C.J., et al. Nonsteroidal anti-inflammatory drugs (NSAIDs), cyxlooxygenase-2 selective inhibitors (coxibs) and gastrointestinal harm: review of clinical trials and clinical practice. BMC Musculoskelet Disord 7 (2006) 79
60. Yeomans N.D., and Naesdal J. Systematic review: ulcer definition in NSAID ulcer prevention trials. Aliment Pharmacol Ther 27 (2008) 465-472
61. 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 343 (2000) 1520-1528
62. Laine L., Curtis S.P., Cryer B., et al., MEDAL Steering Committee. Assessment of upper gastrointestinal safety of 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 369 (2007) 465-473
63. Schnitzer T.J., Burmester G.R., 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 364 (2004) 665-674
64. Schaefer M., DeLattre M., Gao X., et al. Assessing the cost-effectiveness of COX-2 specific inhibitors for arthritis in the Veterans Health Administration. Curr Med Res Opin 21 (2005) 47-60
65. Antiplatelet Trialists' Collaboration. 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. BMJ 308 (1994) 81-106
66. Laine L., White W.B., Rostom A., et al. COX-2 selective inhibitors in the treatment of osteoarthritis. Semin Arthritis Rheum 38 (2008) 165-187
67. Moore R.A., Gavaghan D., Tramèr M.R., et al. Size is everything-large amounts of information are needed to overcome random effects in estimating direction and magnitude of treatment effects. Pain 78 (1998) 209-216
68. Flather M.D., Farkouh M.E., Pogue J.M., et al. Strengths and limitations of meta-analysis: larger studies may be more reliable. Control Clin Trials 18 (1997) 568-579