Case-control study on the association of upper gastrointestinal bleeding and nonsteroidal anti-inflammatory drugs in Japan

European Journal of Clinical Pharmacology

Volumn 62, Issue 9, 2006, Pages 765-772

  Sakamoto, Choitsu ^a   Sugano, Kentaro ^b   Ota, Shinichi ^c   Sakaki, Nobuhiro ^d   Takahashi, Shin'ichi ^e   Yoshida, Yukio ^b   Tsukui, Taku ^a   Osawa, Hiroyuki ^b   Sakurai, Yukihiro ^f   Yoshino, Junji ^g   Mizokami, Yuji ^h   Mine, Tetsuya ⁱ   Arakawa, Tetsuo ^j   Kuwayama, Hajime ^k   Saigenji, Katsunori ^l   Yakabi, Koji ^m   Chiba, Tsutomu ⁿ   Shimosegawa, Tooru ^o   Sheehan, Jane E ^p   Perez Gutthann, Susana ^q   Yamaguchi, Takuhiro ^r   Kaufman, David W ^p   Sato, Tsugumichi ^s,t   Kubota, Kiyoshi ^s,t   Terano, Akira ^k   more..

^a NIPPON MEDICAL SCHOOL   (Japan)

^b JICHI MEDICAL UNIVERSITY   (Japan)

^c SAITAMA MEDICAL UNIVERSITY   (Japan)

^d TOKYO METROPOLITAN BOKUTOH HOSPITAL   (Japan)

^e KYORIN UNIVERSITY   (Japan)

^f Kanto Teishin Hospital   (Japan)

^g FUJITA HEALTH UNIVERSITY   (Japan)

^h TOKYO MEDICAL UNIVERSITY   (Japan)

ⁱ TOKAI UNIVERSITY   (Japan)

^j OSAKA CITY UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^k DOKKYO MEDICAL UNIVERSITY   (Japan)

^l KITASATO UNIVERSITY HOSPITAL   (Japan)

^m TEIKYO UNIVERSITY   (Japan)

ⁿ KYOTO UNIVERSITY   (Japan)

^o TOHOKU UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^p BOSTON UNIVERSITY   (United States)

^q PFIZER INC   (United States)

^r UNIVERSITY OF TOKYO   (Japan)

^s UNIVERSITY OF TOKYO   (Japan)

^t NPO (Nonprofit Organization) Drug Safety Research Unit Japan   (Japan)

more..

Author keywords

Adverse drug effects; Anti inflammatory agents, non steroidal; Case control studies; Gastrointestinal hemorrhage; Japan

Indexed keywords

ACETYLSALICYLIC ACID; AMPIROXICAM; DICLOFENAC; ETODOLAC; IBUPROFEN; INDOMETACIN; KETOPROFEN; LORNOXICAM; LOXOPROFEN; MELOXICAM; NONSTEROID ANTIINFLAMMATORY AGENT; PARACETAMOL; PRANOPROFEN; ZALTOPROFEN;

ARTICLE; CASE CONTROL STUDY; CONTROLLED STUDY; DUODENUM ULCER; FEMALE; HELICOBACTER INFECTION; HELICOBACTER PYLORI; HUMAN; JAPAN; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; RHEUMATOID ARTHRITIS; STOMACH ULCER; UPPER GASTROINTESTINAL BLEEDING;

ADULT; AGED; AGED, 80 AND OVER; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; CASE-CONTROL STUDIES; FEMALE; GASTROINTESTINAL HEMORRHAGE; HELICOBACTER INFECTIONS; HELICOBACTER PYLORI; HUMANS; MALE; MIDDLE AGED; ODDS RATIO;

EID: 33746855708     PISSN: 00316970     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00228-006-0171-6     Document Type: Article

References (54)

1. Aalykke C, Lauritsen JM, Hallas J, Reinholdt S, Krogfelt K, Lauritsen K (1999) Helicobacter pylori and risk of ulcer bleeding among users of nonsteroidal anti-nflammatory drugs: a case-control study. Gastroenterology 116:1305-1309. DOI: 10.1016/S0016-5085(99)70494-4
2. Asaka M, Kimura T, Kudo M, Takeda H, Mitani T, Miki K, Graham DY (1992) Relationship of Helicobacter pylori to serum pepsinogens in an asymptomatic Japanese population. Gastroenterology 102:760-766
3. Asaki S, Toyota T, Fukao A, Hisamichi S, Sato S, Sato K, Karino A, Kasukawa R, Obara K (1991) A case control study of risk factors associated with serious upper gastrointestinal lesions and bleeding: Relation to NSAID intake. Jpn J Med Pharm Sci 26:865-874
4. Bresalier RS, Sandler RS, Quan H, Bolognese JA, Oxenius B, Horgan K, Lines C, Riddell R, Morton D, Lanas A, Konstam MA, Baron JA (2005) Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial. N Engl J Med 352:1092-1102. DOI:10.1056/NEJMoa050493
5. Chaudhury TK, Robert A (1980) Prevention by mild irritants of gastric necrosis in rats by sodium tauro cholate. Dig Dis Sci 25:830-836. DOI:10.1007/BF01338524
6. Colin B (2005) Aspirin for everyone older than 50?: AGAINST. BMJ 330:1442-1443. DOI:10.1136/bmj.330.7505.1442
7. Cooke AR (1976) Drugs and gastric damage. Drugs 11:36-44
8. Cullen DJE, Hawkey GM, Greenwood DC, Humphreys H, Shepherd V, Logan RFA, Hawkey CJ (1997) Peptic ulcer bleeding in the elderly: relative roles of Helicobacter pylori and non-steroidal anti-inflammatory drugs. Gut 41:459-462
9. de Abajo FJ, Rodriguez LAG (2001) Risk of upper gastrointestinal bleeding and perforation associated with low-dose aspirin as plain and enteric coated formulations. BMC Clinical Pharmacology 1:1. DOI:10.1186/1472-6904-1-1
10. Epstein M (2005) Guidelines for good pharmacoepidemiology practices (GPP). Pharmacoepidemiol Drug Safety 14:589-595
11. Graham DJ, Campen D, Hui R, Spence M, Cheetham C, Levy G, Shoor S, Ray WA (2005) Risk of acute myocardial infarction and sudden cardiac death in patients treated with cyclooxygenase 2 selective and non-selective non-steroidal antiinflammatory drugs: nested case-control study. Lancet 365:475-481. DOI:10.1016/S0140-6736(05)17864-7
12. Griffin MR, Yared A, Ray WA (2000) Nonsteroidal antiinflammatory drugs and acute renal failure in elderly persons. Am J Epidemiol 151:488-496
13. Hernandez-Diaz S, Rodriguez LA (2000) Association between nonsteroidal anti-inflammatory drugs and upper gastrointestinal tract bleeding/perforation: an overview of epidemiologic studies published in the 1990s. Arch Intern Med 160:2093-2099
14. Hernandez-Diaz S, Garcia Rodriguez LA (2002) Incidence of serious upper gastrointestinal bleeding/perforation in the general population: review of epidemiologic studies. J Clin Epidemiol 55:157-163. DOI:10.1016/S0895-4356(01) 00461-9
15. Hosmer DW, Lemeshow S (1992) Confidence interval estimation of interaction. Epidemiology 3:452-456
16. Hunang J-Q, Sridhar S, Hunt RH (2002) Role of Helicobacter pylori infection and non-steroidal anti-inflammatory drugs in peptic-ulcer disease: a meta-analysis. Lancet 359:14-22. DOI:10.1016/S0140-6736(02)07273-2
17. Kato M, Asaka M, Saito M, Sekine H, Ohara S, Toyota T, Akamatsu T, Kaneko T, Kiyosawa K, Nishizawa O, Kumagai T, Katsuyama T, Abe M, Kosaka M, Hariya S, Minami K, Sanai Y, Sawamura M, Tachikawa T (2000) Clinical usefulness of urine-based enzyme-linked immunosorbent assay for detection of antibody to Helicobacter pylori: a collaborative study in nine medical institutions in Japan. Helicobacter 5:109-119. DOI:10.1046/j.1523-5378.2000.00017.x
18. Katsuragi K, Noda A, Tacikawa T, Azuma A, Mukai F, Murakami K, Fujioka T, Kato M, Asaka M (1998) Highly sensitive urine-based enzyme-linked immunoabsorbent assay for detection of antibody to Helicobacter pylori. Helicobacter 3:289-295. DOI:10.1046/j.1523-5378.1998.08045.x
19. Kaufman DW, Kelly JP, Levy M, Shapiro S (1991) The drug etiology of agranulocytosis and aplastic anemia: the international agranulocytosis and aplastic anemia study. Oxford University Press, New York
20. Kaufman DW, Kelly JP, Sheehan JE, Laszlo A, Wilholm B-E, Alfredsson L, Koff RS, Shapiro S (1993) Nonsteroidal antiinflammatory drug use in relation to major upper gastrointestinal bleeding. Clin Pharmacol Ther 53:485-494
21. Kaufman DW, Kelly JP, Wiholm BE, Laszlo A, Sheehan JE, Koff RS, Shapiro S (1999) The risk of acute major upper gastrointestinal bleeding among users of aspirin and ibuprofen at various levels of alcohol consumption. Am J Gastroenterol 94:3189-3196. DOI:10.1016/S0002-9270(99)00576-6
22. Kelly JP, Kaufman DW, Jurgelon JM, Sheehan J, Koff RS, Shapiro S (1996) Risk of aspirin-associated major upper-gastrointetstinal bleeding with enteric-coated or buffered product. Lancet 358:1413-1416. DOI:10.1016/S0140- 6736(96)01254-8
23. Khuder SA, Mutgi AB (2001) Breast cancer and NSAID use: a meta-analysis. Br J Cancer 84:1188-1192. DOI:10.1054/bjoc.2001.1709
24. Kimmey MB (2004) Cardioprotective effects and gastrointestinal risks of aspirin: maintaining the delicate balance. Am J Med 117:72S-78S. DOI:10.1016/j.amjmed.2004.07.012
25. Kokoska ER, Smith GS, Deshpande Y, Rieckenberg CL, Miller T (1998) Adaptive cytoprotection induced by ethanol in human intestinal cells: role of prostaglandins and calcium homeostasis. Ann Surg 228:123-130. DOI:10.1097/00000658-199807000-00018
26. Labenz J, Peitz U, Kohl H, Kaser J, Malfertheiner P, Hackelsberer A, Borsch G (1999) Helicobacter pylori increases the risk of peptic ulcer bleeding: a case-control study. Ital J Gastroenterol Hepatol 31:110-115
27. Lanas A, Bajador E, Serrano P, Fuentes J, Carreño S, Guardia J, Sanz M, Montoro M, Sáinz R (2000) Nitrovasodilators, lowdose aspirin, other nonsteroidal antiinflammatory drugs, and the risk of upper gastrointestinal bleeding. N Engl J Med 343:834-839. DOI:10.1056/ NEJM200009213431202
28. Langman MJS, Weil J, Wainwright P, Lawson DH, Rawlins MD, Logan RFA, Murphy M, Vessey MP, Colin-Jones DG (1994) Risks of bleeding peptic ulcer associated with individual non-steroidal anti-inflammatory drugs. Lancet 343:1075-1078. DOI:10.1016/S0140-6736(94)90185-6
29. Laporte J-R, Carne X, Vidal X, Moreno V, Juan J (1991) Upper gastrointestinal bleeding in relation to previous use of analgesics and non-steroidal anti-inflammatory drugs. Lancet 337:58-59. DOI:10.1016/0140- 6736(91)90744-A
30. Laporte J-R, Ibanez L, Vidal X, Vendrell L, Leone R (2004) Upper gastrointestinal bleedings associated with the use of NSAIDs. Drug Saf 27:411-420. DOI:10.2165/00002018-200427060-00005
31. Lewis SC, Langman MJS, Laporte J-R, Matthews JNS, Rawlins MD, Wilholm B-E (2002) Dose-response relationship between individual nonaspirin non steroidal anti-inflammatory drugs (NANSAIDs) and serious upper gastrointestinal bleeding: a meta-analysis based on individual patient data. Br J Clin Pharmacol 54:320-326. DOI:10.1046/j.1365-2125.2002.01636.x
32. Midanik L (1982) The validity of self-reported alcohol consumption and alcohol problems: a literature review. Br J Addict 77:357-382
33. Mockenhaupt M, Kelly JP, Kaufman D, Stern RS; SCAR Study Group (2003) The risk of Stevens-Johnson syndrome and toxic epidermal necrolysis associated with nonsteroidal anti-inflammatory drugs: a multinational perspective. J Rheumatol 30:2234-2240
34. Nussmeier NA, Whelton AA, Brown MT, Langford RM, Hoeft A, Parlow JL, Boyce SW, Verburg KM (2005) Complications of the COX-2 inhibitors parecoxib and valdecoxib after cardiac surgery. N Engl J Med 352:1081-1091. DOI:10.1056/NEJMoa050330
35. Ofman JJ, MacLean CH, Straus WL, Morton SC, Berger ML, Roth EA, Shekelle P (2002) A metaanalysis of severe upper gastrointestinal complications of nonsteroidal anti-inflammatory drugs. J Rheumatol 29:804-812
36. Okan A, Tankurt E, Aslan BU, Akpinar H, Simsek I, Gonen O (2003) Relationship between non-steroidal anti-inflammatory drug use and Helicobacter pylori infection in bleeding or uncomplicated peptic ulcers: a case-control study. J Gastroentrol Hepatol 18:18-25
37. Paffenbarger RS, Wing AL, Hyde RT (1974) Chronic disease in former college students. XIII early precursors of peptic ulcer. Am J Epidemiol 100:307-315
38. Pérez Gutthann S, García Rodríguez LA, Raiford DS, Duque Oliart A (1996) Non-steroidal anti-inflammatory drugs and risk of hospitalization for acute renal failure. Arch Int Med 156:2433-2439. DOI:10.1001/archinte.156.21.2433
39. Peura DA (2004) Prevention of nonsteroidal anti-inflammatory drug - associated gastrointestinal symptoms and ulcer complication. Am J Med 117:63S-71S. DOI:10.1016/j.amjmed.2004.07.010
40. Pilotto A, Leandro G, DiMario F, Franceschi M, Bozzola L, Valerio G (1997) Role of Helicobacter pylori infection on upper gastroinetestinal bleeding in the elderly: a case-control study. Dig Dis Sci 42:586-591. DOI:10.1023/A:1018807412030
41. Ray WA, Stein CM, Daugherty JR, Hall K, Arbogast PG, Griffin MR (2002) COX-2 selective non-steroidal anti-inflammatory drugs and the risk of serious coronary heart disease. Lancet 360:1071-1073. DOI:10.1016/S0140-6736(02)11131-7
42. Rodriguez LAG (1998) Variability in risk of gastrointestinal complications with different nonsteroidal anti-inflammatory drugs. Am J Med 104:30S-34S. DOI:10.1016/S0002-9343(97)00208-8
43. Rosenberg L, Palmer JR, Zauber AG, Warshauer ME, Stolley PD, Shapiro S (1991) A hypothesis: nonsteroidal anti-inflammatory drugs reduce the incidence of large bowel cancer. J Natl Cancer Inst 83:355-358
44. Rothman KJ (2002) Measuring interaction. In: Epidemiology: an introduction, Oxford university press, Oxford, pp 168-80
45. Santolaria S, Lanas A, Benito R, Perez-Aisa MA, Montoro M, Sainz R (1999) Helicobacter pylori infection is a protective factor for bleeding gastric ulcer but not for bleeding duodenal ulcers in NSAID users. Aliment Pharmacol Ther 13:1511-1518. DOI:10.1046/j.1365-2036.1999.00631.x
46. Sato T, Kubota K, Kaufman DW, Perez-Gutthann S (2003) A population-based case-control study of the association between NSAIDs and upper gastro-intestinal bleeding in Japan: methodological lessons from the pilot phase. Pharmacoepidemiol Drug Safety 12(suppl. 1):101
47. Shiokawa Y, Nobunaga T, Saito T, Asaki S, Ogawa N (1991) An epidemiological study of non-steroidal anti-inflammatory drug-induced upper gastro intestinal bleeding. Rheumachi 31:96-111
48. Solomon SD, McMurray JJ, Pfeffer MA, Wittes J, Fowler R, Finn P, Anderson WF, Zauber A, Hawk E, Bertagnolli M (2005) Cardiovascular risk associated with celecoxib in a clinical trial for colorectal adenoma prevention. N Engl J Med 352:1071-1080. DOI:10.1056/NEJMoa050405
49. Stack WA, Atherton JC, Hawkey GM, Logan RFA, Hawkey CJ (2002) Interactions between Helicobacter pylori and other risk factors for peptic ulcer bleeding. Aliment Pharmacol Ther 16:497-506. DOI:10.1046/j.1365-2036.2002. 01197.x
50. Tanaka K, Nishimoto K, Tomisato W, Tsutsumi S, Hoshino T, Tsuchiya T, Mizushima T (2004) Adaptive cytoprotection induced by pretreatment with ethanol protects against gastric cell damage by NSAIDs. Dig Dis Sci 49:210-217. DOI:10.1023/B:DDAS.0000017440.46863.56
51. Tarone RE, Blot WJ, McLaughlin JK (2004) Nonselective nonaspirin nonsteroidal anti-inflammatory drugs and gastrointestinal bleeding: relative and absolute risk estimates from recent epidemiologic studies. Am J Ther 11:17-25. DOI:10.1097/00045391-200401000-00007
52. Thun MJ, Namboodiri MM, Heath CW Jr (1991) Aspirin use and reduced risk of fatal colon cancer. N Engl J Med 325:1593-1596
53. Wu CY, Poon SK, Chen GH, Chang CS, Yeh HZ (1999) Interaction between Helicobacter pylori and non-steroidal antiinflammatory drugs in peptic ulcer bleeding. Scand J Gastroenterol 33:234-237
54. Yanagawa A, Fukumura T, Matui H, Uemura H, Endo T, Nakagawa T, Mizushima Y (1992) Possible mechanisms of gastroduodenal mucosal damage in volunteers treated with nonsteroidal anti-inflammatory drugs: the usefulness of prodrugs. J Rheumatol 19:1075-1082