COX-2 inhibition versus gastroprotection with dual COX inhibitors: An evidence-based approach

Current Pharmaceutical Design

Volumn 9, Issue 27, 2003, Pages 2221-2228

  Thompsin, Alexander J V ^a   Yeomans, Neville D ^a  

^a UNIVERSITY OF MELBOURNE   (Australia)

Author keywords

Cost effectiveness; COX 2 inhibitors; Histamine H2 receptor antagonists; Misoprostol; NSAIDs; Peptic ulcer; Proton pump inhibitors; Ulcer hemorrhage

Indexed keywords

ACETYLSALICYLIC ACID; CELECOXIB; CIMETIDINE; CYCLOOXYGENASE 2 INHIBITOR; DICLOFENAC; FAMOTIDINE; HISTAMINE H2 RECEPTOR ANTAGONIST; IBUPROFEN; LANSOPRAZOLE; MISOPROSTOL; NONSTEROID ANTIINFLAMMATORY AGENT; OMEPRAZOLE; PANTOPRAZOLE; PROSTAGLANDIN DERIVATIVE; PROSTAGLANDIN SYNTHASE INHIBITOR; PROTON PUMP INHIBITOR; RANITIDINE; ROFECOXIB; VALDECOXIB;

CLINICAL TRIAL; COST BENEFIT ANALYSIS; COST CONTROL; COST EFFECTIVENESS ANALYSIS; DIGESTIVE SYSTEM ULCER; DRUG ABSORPTION; DRUG COST; DRUG EFFICACY; DRUG SELECTIVITY; EVIDENCE BASED MEDICINE; HEALTH CARE COST; HELICOBACTER INFECTION; HELICOBACTER PYLORI; HIGH RISK PATIENT; HUMAN; PEPTIC ULCER; PRESCRIPTION; PRIORITY JOURNAL; RECURRENT DISEASE; REVIEW; RISK ASSESSMENT; STOMACH PROTECTION; UPPER GASTROINTESTINAL BLEEDING; WESTERN HEMISPHERE;

ANIMALS; ANTI-ULCER AGENTS; CYCLOOXYGENASE 1; CYCLOOXYGENASE 2; CYCLOOXYGENASE 2 INHIBITORS; CYCLOOXYGENASE INHIBITORS; EVIDENCE-BASED MEDICINE; GASTROINTESTINAL TRACT; HUMANS; ISOENZYMES; MEMBRANE PROTEINS; PEPTIC ULCER; PROSTAGLANDIN-ENDOPEROXIDE SYNTHASES;

EID: 0141538097     PISSN: 13816128     EISSN: None     Source Type: Journal    
DOI: 10.2174/1381612033453956     Document Type: Review

References (45)

1. Tanaka A, Araki H, Hase S, Komoike Y, Takeuchi K. Up-regulation of COX-2 by inhibition of COX-1 in the rat: a key to NSAID-induced gastric injury. Aliment Pharmacology Ther 2002, 6 Suppl, 2: 90-101.
2. Wallace JL, McKnight W, Reuter BK, Vergnolle N. NSAID-induced gastric damage in rats: requirement for inhibition of both cyclooxygenase 1 and 2. Gastroenterology 2000; 119: 706-714.
3. Chan FKL, Hung LCT, Suen BY, Wu JCY, Lee KC, Leung VKS, 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: 2104-2110.
4. Laine L. GI medical co-therapy use in 14,001 patients switching from chronic traditional NSAID therapy to chronic coxib therapy. Gastroenterology 2002; 122: A53.
5. Laine L, Bombardier C, Hawkey CJ, Davis B, Shapiro D, Brett C, et al. Stratifying the risk of NSAID-related upper gastrointestinal clinical events: results of a double-blind outcomes study in patients with rheumatoid arthritis. Gastroenterology 2002; 123: 1006-1012.
6. Elliott SL, Ferris RJ, Giraud AS, Skeljo MV, Yeomans ND. Indomethacin damage to rat gastric mucosa is markedly dependent on luminal pH. Clin Exper Pharmacology Physiology 1996; 23: 432-434.
7. Schanker LS, Shore PA, Brodie BB, Hogben CAM. Absorption of drugs from the stomach. I.The Rat. J Pharmacology Exp Ther 1957; 120: 528-539.
8. Walt RP, Male PJ, Rawlings J, Hunt RH, Milton-Thompson GJ, Misiewicz JJ. Comparison of the effects of ranitidine, cimetidine and placebo on the 24 hour intagastric acidity and nocturnal acid secretion in patients with duodenal ulcer. Gut 1981; 22: 49-54.
9. Agrawal NM, Campbell DR, Safdi MA, Lukasik NL, Huang B, Haber MM. Superiority of lansoprazole vs ranitidine in healing nonsteroidal anti-inflammatory drug-associated gastric ulcers: results of a double-blind, randomized, multicenter study. NSAID-Associated Gastric Ulcer Study Group. Arch Intern Med 2000; 160: 1455-1461.
10. Yeomans ND, Tulassay Z, Juhász L, Rácz I, Howard JM, Van Rensburg CJ, et al. A comparison of omeprazole with ranitidine for ulcers associated with nonsteroidal antiinflammatory drugs. N Engl J Med 1998; 338: 719-726.
11. Roth SH, Bennett RE, Mitchell CS, Hartman RJ. Cimetidine therapy in nonsteroidal anti-inflammatory drug gastropathy: double-blind long-term evaluation. Arch Intern Med 1987; 147: 1798-1801.
12. Ehsanullah RSB, Page MC, Tildesley G, Wood JR. Prevention of gastroduodenal damage induced by non-steroidal anti-inflammatory drugs: controlled trial of ranitidine. Br Med J 1988; 297: 1017-1021.
13. Robinson MG, Griffin JWJ, Bowers J, Kogan FJ, Kogut DG, Lanza FL, et al. Effect of ranitidine on gastroduodenal mucosal damage induced by nonsteroidal antiinflammatory drugs. Dig Dis Sci 1989; 34: 424-428.
14. Taha AS, Hudson N, Hawkey CJ, Swannell AJ, Trye PN, Cottrell J, et al. Famotidine for the prevention of gastric and duodenal ulcers caused by non steroidal antiinflammatory drugs. N Engl J Med 1996; 34: 1435-1439.
15. Singh G, Ramey DR, Morfeld D, Shi H, Hatoum HT, Fries JF. Gastrointestinal tract complications of nonsteroidal anti-inflammatory drug treatment in rheumatoid arthritis: a prospective observational cohort study. Arch Intern Med 1996; 156: 1530-1536.
16. Hawkey CJ, Karrasch JA, Szczepañski L, Walker DG, Barkun A, Swannell AJ et al. Omeprazole compared with misoprostol for ulcers associated with nonsteroidal antiinflammatory drugs. N Engl J Med 1998; 338: 727-734.
17. Graham DY, Agrawal NM, Campbell DR, Haber MM, Collis C, Lukasik NL, et al. Ulcer prevention in long-term users of nonsteroidal anti-inflammatory drugs: results of a double-blind, randomized, multicenter, active- and placebo-controlled study of misoprostol vs lansoprazole. Arch Intern Med 2002; 162: 169-175.
18. Chan FKL, Chung SCS, Suen BY, Lee YT, Leung WK, Leung VKS, et al. Preventing recurrent upper gastrointestinal bleeding in patients with Helicobacter pylori infection who are taking low-dose aspirin or naproxen. N Engl J Med.2001; 344: 967-973.
19. Graham DY, Agrawal NM, Roth SH. Prevention of NSAID induced gastric ulcer with misoprostol: multicentre,double-blind, placebo-controlled trial. Lancet 1988; 2: 1277-1280.
20. Elliott SL, Yeomans ND, Buchanan RRC, Smallwood RA. Efficacy of 12 months misoprostol as prophylaxis against NSAID-induced gastric ulcers: a placebo controlled trial. Scand J Gastroenterology 1994; 23: 171-176.
21. 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 non-steroidal anti-inflammatory drugs. A randomized, double-blind, placebo-controlled trial. Ann Intern Med 1995; 123; 241-249.
22. Walan A, Bader JP, Classen M, Lamaers CB, Piper DW. Effect of omeprazole and ranitidine on ulcer healing and relapse rates in patients with benign gastric ulcer. N Engl J Med 1989; 320: 69-75.
23. Avigan M. FDA Medical officer's consult review, NDA 21-341, valdecoxib. US Food and Drug Administration, Center for Drug Evaluation and Research 2002, http://www.fda.gov/cder/foi/nda/2001/21-341_Bextra.htm part 1, 38-51, part 32, 31-34.
24. Deeks JJ, Smith LA, Bradley MD. Efficacy, tolerability, and upper gastrointestinal safety of celecoxib for treatment of osteoarthritis and rheumatoid arthritis: systematic review of randomised controlled trials. Br Med J 2002; 325: 619-626.
25. Emery P, Zeidler H, Kvien TK, Guslandi M, Naudin R, Stead H, et al. Celecoxib versus diclofena in long-term management of rheumatoid arthritis: randomised double-blind comparison. Lancet 1999; 354: 2106-2111.
26. Hawkey C, Laine L, Simon T, Maldonado-Cocco J, Acevedo E, Shahane A, et al. Comparison of the effect of rofecoxib (a cyclooxygenase 2 inhibitor), ibuprofen and placebo on the gastroduodenal mucosa of patients with osteoarthritis: a randomized, double-blind, placebo-controlled trial: the rofecoxib osteoarthritis endoscopy multinational study group. Arthritis Rheum 2000; 43: 370-377.
27. Kivitz A, Eisen G, Zhao WW, Bevirt T, Recker DP. Randomized placebo-controlled trial comparing efficacy and safety of valdecoxib with naproxen in patients with osteoarthritis. J Fam Pract 2002; 51: 530-537.
28. Laine L, Harper S, Simon T, Bath R, Johanson J, Schwartz H, et al. A randomized trial comparing the effects of rofecoxib, a cyclooxygenase 2-pecific inhibitor, with that of ibuprofen on the gastroduodenal mucosa of patients with osteoarthritis. Gastroenterology 1999; 117: 776-783.
29. Sikes DH, Agrawal NM, Zhao WW, Kent JD, Recker DP, Verburg KM. Incidence of gastroduodenal ulcers associated with valdecoxib compared with that of ibuprofen and diclofenac in patients with osteoarthritis. Eur J Gastroenterology Hepatology 2002; 14: 1101-1111.
30. Simon LS, Weaver AL, Graham DY, Kivitz AJ, Lipsky PE, Hubbard RC, et al. Anti-inflammatory and upper gastrointestinal effects of celecoxib in rheumatoid arthritis: a randomized controlled trial. JAMA 1999; 282: 1921-1928.
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: 1520-1528.
32. 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: 1247-1255.
33. Singh G, Goldstein J, Bensen W, Agrawal N, Eisen G, Fort J, et al. Success-1 in osteoarthritis (OA) trial: celecoxib significantly reduces the risk of serious upper GI complications compared to NSAIDs while providing similar efficacy in 13,274 randomized patients. Ann Rheum Di. 2001; 60 (Suppl. 1) OP0053.
34. Goldstein JL, Silverstein FE, Agrawal NM, Hubbard RC, Kaiser J, Maurath CJ, et al. Reduced risk of upper gastrointestinal ulcer complications with celecoxib, a novel COX-2 inhibitor. Am.J Gastroenterology 2000; 95: 1681-1690.
35. Langman MJ, Jensen DM, Watson DM, Harper SE, Zhao PL, Quan H, et al. Adverse upper gastrointestinal effects of rofecoxib compared with NSAIDs. JAMA 1999; 282: 1929-1933.
36. Fendrick AM, Bandekar RR, Chernew MES. Role of initial NSAID choice and patient risk factors in the prevention of NSAID gastropathy: a decision analysis. Arthritis Rheum 2002; 47: (1), February 36-43.
37. You JHS, Lee KKC, Chan TYK, Lau WH, Chan FKL. Arthritis treatment in Hong Kong: cost analysis of celecoxib versus conventional NSAIDs, with or without gastroprotective agents. Aliment Pharmacology Ther 2002; 16: 2089-2096.
38. Ekström P, Carling L, Wetterhus S, Wingren PE, Anker-Hansen O, Lundergardh G, et al. Prevention of peptic ulcer and dyspeptic symptoms with omeprazole in patients receiving continuous non-steroidal anti-inflammatory drug therapy - a Nordic multicentre study. Scand J Gastroenterology 1996; 31: 753-758.
39. Cullen D, Bardhan KD, Eisner M, Kogut DG, Peacock RA, Thomson JM, et al. Primary gastroduodenal prophylaxis with omeprazole for non-steroidal anti-inflammatory drug users. Aliment Pharmacology Ther 1998; 12: 135-140.
40. Bianchi Porro G, Lazzaroni M, Petrillo M, Manzionna G, Montrone F, Caruso I. Prevention of gastroduodenal damage with omeprazole in patients receiving continuous NSAIDs treatment. A double blind placebo controlled study. Ital. J Gastroenterology Hepatology 1998; 30: 43-47.
41. Cullen DJ, Hawkey GM, Greenwood DC, Humphreys H, Shepherd V, Logan RF, et al. Peptic ulcer bleeding in the elderly: relative roles of Helicobacter pylori and non-steroidal anti-inflammatory drugs. Gut 1997; 41: 459-462.
42. Singh P, Xu Z, Dai B, Rajaraman S, Rubin N, Dhruva B. Incomplete processing of progastrin expressed by human colon cancer cells: role of noncarboxyamidated gastrins. Am. J Physiology 1994; 266: (3 Pt 1) G459-468.
43. Hawkey CJ, Skelly MM. Gastrointestinal safety of selective COX-2 inhibitors. Curr Pharm Design 2002; 8(12): 1077-89.
44. Lanas A, Santolaria S. Gastroesophageal reflux disease (GERD): current agents and future perspective. Curr Pharm Design 2001; 7(1): 1-18.
45. Williamson JS. Helicobacter pylori: current chemotherapy and new targets for drug design. Curr Pharm Design 2001; 7(5): 355-92.