A turbulent decade for NSAIDs: Update on current concepts of classification, epidemiology, comparative efficacy, and toxicity

Rheumatology International

Volumn 32, Issue 6, 2012, Pages 1491-1502

  Conaghan, Philip G ^a,b  

^a UNIVERSITY OF LEEDS   (United Kingdom)

^b Chapel Allerton Hospital   (United Kingdom)

Author keywords

Anti inflammatory agents; Comparative efficacy; Comparative safety; Cyclooxygenase 2 inhibitors; Non steroidal

Indexed keywords

ACETYLSALICYLIC ACID; ANTICOAGULANT AGENT; ARTHROTEC; CELECOXIB; CORTICOSTEROID; CYCLOOXYGENASE 2 INHIBITOR; DICLOFENAC; DUEXA; ESOMEPRAZOLE PLUS NAPROXEN; ETODOLAC; ETORICOXIB; FAMOTIDINE PLUS IBUPROFEN; FLURBIPROFEN; IBUPROFEN; INDOMETACIN; KETOPROFEN; KETOROLAC; LUMIRACOXIB; MELOXICAM; MISOPROSTOL; NABUMETONE; NAPROXEN; NIMESULIDE; NONSTEROID ANTIINFLAMMATORY AGENT; OMEPRAZOLE; PARACETAMOL; PROTON PUMP INHIBITOR; ROFECOXIB; SULINDAC; UNCLASSIFIED DRUG; VALDECOXIB;

ALGORITHM; ANALGESIC ACTIVITY; ANKYLOSING SPONDYLITIS; ANTIINFLAMMATORY ACTIVITY; ANTIPYRETIC ACTIVITY; ARTHRITIC PAIN; BACKACHE; CARDIOTOXICITY; CARDIOVASCULAR DISEASE; CHRONIC PAIN; DIGESTIVE SYSTEM INJURY; DIGESTIVE SYSTEM PERFORATION; DRUG CLEARANCE; DRUG EFFICACY; DRUG ELIMINATION; DRUG HALF LIFE; DRUG INDUCED DISEASE; DRUG MEGADOSE; DRUG SAFETY; DRUG USE; DRUG WITHDRAWAL; EVIDENCE BASED MEDICINE; FLUID RETENTION; GASTROINTESTINAL HEMORRHAGE; GASTROINTESTINAL TOXICITY; HEART FAILURE; HEART INFARCTION; HELICOBACTER INFECTION; HIP PAIN; HUMAN; HYPERTENSION; KNEE OSTEOARTHRITIS; KNEE PAIN; LIVER FUNCTION TEST; LIVER TOXICITY; LOW DRUG DOSE; NEPHROTOXICITY; OSTEOARTHRITIS; PAIN; PRACTICE GUIDELINE; PRESCRIPTION; PRIORITY JOURNAL; PSORIATIC ARTHRITIS; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; RHEUMATOID ARTHRITIS; RISK FACTOR; SIDE EFFECT; STOMACH ULCER; THROMBOSIS; ULCER; VASCULAR DISEASE;

ANIMALS; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; CARDIOVASCULAR DISEASES; CYCLOOXYGENASE 2 INHIBITORS; EVIDENCE-BASED MEDICINE; GASTROINTESTINAL HEMORRHAGE; GUIDELINE ADHERENCE; HUMANS; NONPRESCRIPTION DRUGS; PAIN; PATIENT SAFETY; PHYSICIAN'S PRACTICE PATTERNS; PRACTICE GUIDELINES AS TOPIC; RISK ASSESSMENT; RISK FACTORS; SAFETY-BASED DRUG WITHDRAWALS;

EID: 84863868163     PISSN: 01728172     EISSN: 1437160X     Source Type: Journal    
DOI: 10.1007/s00296-011-2263-6     Document Type: Review

References (115)

1. Laine L (2001) Approaches to nonsteroidal anti-inflammatory drug use in the high-risk patient. Gastroenterology 120:594-606
2. Singh G (2000) Gastrointestinal complications of prescription and over-the-counter nonsteroidal anti-inflammatory drugs: a view from the ARAMIS database. Arthritis, Rheumatism, and Aging Medical Information System. Am J Ther 7:115-121
3. Bjordal JM, Ljunggren AE, Klovning A, Slordal L (2004) Nonsteroidal anti-inflammatory drugs, including cyclo-oxygenase-2 inhibitors, in osteoarthritic knee pain: meta-analysis of randomised placebo controlled trials. BMJ 329:1317
4. Altman R, Hochberg MC, Moskowitz RW, Schnitzer TJ (2000) Recommendations for the medical management of osteoarthritis of the hip and knee: 2000 update. American College of Rheumatology Subcommittee on Osteoarthritis Guidelines. Arthritis Rheum 43:1905-1915
5. Zhang W, Doherty M, Arden N, Bannwarth B, Bijlsma J, Gunther K-P, Hauselmann HJ, Herrero-Beaumont G, Jordan K, Kaklamanis P, Leeb B, Lequesne M, Lohmander S, Mazieres B, Martin-Mola E, Pavelka K, Pendleton A, Punzi L, Swoboda B, Varatojo R, Verbruggen G, Zimmermann-Gorska I, Dougados M (2005) EULAR evidence based recommendations for the management of hip osteoarthritis: report of a task force of the EULAR Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT). Ann Rheum Dis 64:669-681
6. Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P (2008) OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthr Cartil 16:137-162
7. National Institute for Health and Clinical Excellence (2008) The care and management of osteoarthritis in adults. NICE clinical guideline 59. http://www.nice.org.uk/nicemedia/pdf/CG59NIC Eguideline.pdf. Accessed 17 December 2010
8. National Institute for Health and Clinical Excellence (2009) The management of rheumatoid arthritis in adults. NICE clinical guideline 79. http://www.nice.org.uk/nicemedia/live/12131/43327/43327.pdf. Accessed 4 November 2010
9. García Rodríguez LA, Barreales Tolosa L (2007) Risk of upper gastrointestinal complications among users of traditional NSAIDs and COXIBs in the general population. Gastroenterology 132:498-506
10. Merck & Co. Inc. (2004) Merck announces voluntary worldwide withdrawal of VIOXX®. http://www.merck.com/newsroom/vioxx/pdf/vioxx-press- release-final.pdf. Accessed 11 December 2009
11. Sun SX, Lee KY, Bertram CT, Goldstein JL (2007) Withdrawal of COX-2 selective inhibitors rofecoxib and valdecoxib: impact on NSAID and gastroprotective drug prescribing and utilization. Curr Med Res Opin 23:1859-1866
12. Greenberg JD, Fisher MC, Kremer J, Chang H, Rosenstein ED, Kishimoto M, Lee S, Yazici Y, Kavanaugh A, Abramson SB (2009) The COX-2 inhibitor market withdrawals and prescribing patterns by rheumatologists in patients with gastrointestinal and cardiovascular risk. Clin Exp Rheumatol 27:395-401
13. Schüssel K, Schulz M (2006) Prescribing of COX-2 inhibitors in Germany after safety warnings and market withdrawals. Pharmazie 61:878-886
14. Brune K, Hinz B (2004) The discovery and development of antiinflammatory drugs. Arthritis Rheum 50:2391-2399
15. Jones R (2001) Nonsteroidal anti-inflammatory drug prescribing: past, present, and future. Am J Med 110:4S-7S
16. Vane JR (2000) The fight against rheumatism: from willow bark to COX-1 sparing drugs. J Physiol Pharmacol 51:573-586
17. Vane JR, Botting RM (1998) Mechanism of action of nonsteroidal anti-inflammatory drugs. Am J Med 104(Suppl 3A): 2S-8S
18. Rao PNP, Knaus EE (2008) Evolution of nonsteroidal antiinflammatory drugs (NSAIDs): cycloxygenase (COX) inhibition and beyond. J Pharm Pharmaceut Sci 11:81s-110s
19. Davies NM, Good RL, Roupe KA, Yanez JA (2004) Cyclooxygenase-3: axiom, dogma, anomaly, enigma or splice error? Not as easy as 1, 2, 3. J Pharm Pharm Sci 7:217-226
20. Day RO, Graham GG, Williams KM (1988) Pharmacokinetics of non-steroidal anti-inflammatory drugs. Clin Rheumatol 2:363-393
21. Davies NM, Anderson KE (1997) Clinical pharmacokinetics of naproxen. Clin Pharmacokinet 32:268-293
22. Davies NM, McLachlan AJ, Day RO, Williams KM (2000) Clinical pharmacokinetics and pharmacodynamics of celecoxib: a selective cyclo-oxygenase-2 inhibitor. Clin Pharmacokinet 38:225-242
23. Rainsford KD (2009) Ibuprofen: pharmacology, efficacy and safety. Inflammopharmacol 17:275-342
24. IMS Health (2008) IMS MIDAS Quantum based on selected markets (ATC = M1A oral solid forms only. US$ Actual, growth in US$ CER.). Q4
25. Mamdani M, Rochon P, Laupacis A, Anderson G (2002) Initial patterns of use of COX-2 inhibitors by elderly patients in Ontario: findings and implications. CMAJ 167:1125-1126
26. Hawkey CJ, Cullen DJE, Pearson G, Holmes S, Doherty S, Wilson JV, Garrud P, Garner S, Maynard A, Logan RFA (2000) Pharmacoepidemiology of non-steroidal anti-inflammatory drug use in Nottingham general practices. Aliment Pharmacol Ther 14:177-185
27. Lanas A, Ferrandez A (2007) Inappropriate prevention of NSAID-induced gastrointestinal events among long-term users in the elderly. Drugs Aging 24:121-131
28. Jordan KM, Sawyer S, Coakley P, Smith HE, Cooper C, Arden NK (2004) The use of conventional and complementary treatments for knee osteoarthritis in the community. Rheumatology (Oxford) 43:381-384
29. van Staa TP, Leufkens HG, Zhang B, Smeeth L (2009) A comparison of cost effectiveness using data from randomized trials or actual clinical practice: selective cox-2 inhibitors as an example. PLoS Med 6:e1000194
30. Harris Interactive (2005) The public has doubts about the pharmaceutical industry's willingness to publish safety information about their drugs in a timely manner. http://www.harrisinteractive.com/news/printerfriend/index.asp? NewsID=882 Accessed 14 April 2010
31. Wilcox CM, Cryer B, Triadafilopoulos G (2005) Patterns of use and public perception of over-the-counter pain relievers: focus on nonsteroidal antiinflammatory drugs. J Rheumatol 32:2218-2224
32. Chou R, Helfand M, Peterson K, Dana T, Roberts C (2006) Comparative effectiveness and safety of analgesics for osteoarthritis: comparative effectiveness review: agency for healthcare research and quality. http://effectivehealthcare.ahrq.gov/repFiles/AnalgesicsFinal.pdf. Accessed 29 June 2010
33. Chou R, Helfand M, Peterson K, Dana T, Roberts C (2006) Drug class review of cyclo-oxygenase (COX)-2 inhibitors and nonsteroidal anti-inflammatory drugs (NSAIDs). Final report. http://www.ncbi.nlm.nih.gov/pubmed/20496448. Accessed 2 July 2010
34. Chen Y-F, Jobanputra P, Barton P, Bryan S, Fry-Smith A, Harris G, Taylor RS (2008) Cyclooxygenase-2 selective non-steroidal anti-inflammatory drugs (etodolac, meloxicam, celecoxib, rofecoxib, etoricoxib, valdecoxib and lumiracoxib) for osteoarthritis and rheumatoid arthritis: a systematic review and economic evaluation. Health Technol Assess 12:1-278
35. Singh G, Fort JG, Goldstein JL, Levy RA, Hanrahan PS, Bello AE, Andrade-Ortega L, Wallemark C, Agrawal NM, Eisen GM, Stenson WF, Triadafilopoulos G, for the SUCCESS-I Investigators (2006) Celecoxib versus naproxen and diclofenac in osteoarthritis patients: SUCCESS-I Study. Am J Med 119:255-266
36. Collantes E, Curtis SP, Lee KW, Casas N, McCarthy T, Melian A, Zhao PL, Rodgers DB, McCormick CL, Lee M, Lines CR, Gertz BJ, Etoricoxib Rheumatoid Arthritis Study Group (2002) A multinational randomized, controlled, clinical trial of etoricoxib in the treatment of rheumatoid arthritis [ISRCTN 25142273]. BMC Fam Pract 3:10
37. Gottesdiener K, Schnitzer T, Fisher C, Bockow B, Markenson J, Ko A, DeTora L, Curtis S, Geissler L, Gertz BJ, Protocol 007 Study Group (2002) Results of a randomized, dose-ranging trial of etoricoxib in patients with osteoarthritis. Rheumatology (Oxford) 41:1052-1061
38. Hunt RH, Harper S, Watson DJ, Yu C, Quan H, Lee M, Evans JK, Oxenius B (2003) The gastrointestinal safety of the COX-2 selective inhibitor etoricoxib assessed by both endoscopy and analysis of upper gastrointestinal events. Am J Gastroenterol 98:1725-1733
39. Hunt RH, Harper S, Callegari P, Yu C, Quan H, Evans J, James C, Bowen B, Rashid F (2003) Complementary studies of the gastrointestinal safety of the cyclo-oxygenase-2-selective inhibitor etoricoxib. Aliment Pharmacol Ther 17:201-210
40. Matsumoto AK, Melian A, Mandel DR, McIlwain HH, Borenstein D, Zhao PL, Lines CR, Gertz BJ, Curtis S (2002) A randomized, controlled, clinical trial of etoricoxib in the treatment of rheumatoid arthritis. J Rheumatol 29:1623-1630
41. Zacher J, Feldman D, Gerli R, Scott D, Hou SM, Uebelhart D, Rodger IW, Ozturk ZE (2003) A comparison of the therapeutic efficacy and tolerability of etoricoxib and diclofenac in patients with osteoarthritis. Curr Med Res Opin 19:725-736
42. Leung AT, Malmstrom K, Gallacher AE, Sarembock B, Poor G, Beaulieu A, Castro R, Sanchez M, Detora LM, Ng J (2002) Efficacy and tolerability profile of etoricoxib in patients with osteoarthritis: a randomized, double-blind, placebo and activecomparator controlled 12-week efficacy trial. Curr Med Res Opin 18:49-58
43. Matsumoto A, Melian A, Shah A, Curtis SP (2007) Etoricoxib versus naproxen in patients with rheumatoid arthritis: a prospective, randomized, comparator-controlled 121-week trial. Curr Med Res Opin 23:2259-2268
44. Bingham CO III, Sebba AI, Rubin BR, Ruoff GE, Kremer J, Bird S, Smugar SS, Fitzgerald BJ, O'Brien K, Tershakovec AM (2007) Efficacy and safety of etoricoxib 30 mg and celecoxib 200 mg in the treatment of osteoarthritis in two identically designed, randomized, placebo-controlled, non-inferiority studies. Rheumatology (Oxford) 46:496-507
45. Fleischmann R, Sheldon E, Maldonado-Cocco J, Dutta D, Yu S, Sloan VS (2006) Lumiracoxib is effective in the treatment of osteoarthritis of the knee: a prospective randomized 13-week study versus placebo and celecoxib. Clin Rheumatol 25:42-53
46. Moore RA, Moore OA, Derry S, Peloso PM, Gammaitoni AR, Wang H (2010) Responder analysis for pain relief and numbers needed to treat in a meta-analysis of etoricoxib osteoarthritis trials: bridging a gap between clinical trials and clinical practice. Ann Rheum Dis 69:374-379
47. Ward R (2010) Identifying and assessing benefit-risk in primary care-a family physician's perspective. Rheumatology (Oxford) 49(Suppl 2):ii18-ii23
48. Laine L (1996) Nonsteroidal anti-inflammatory drug gastropathy. Gastrointest Endosc Clin N Am 6:489-504
49. Silverstein FE, Graham DY, Senior JR, Davies HW, Struthers BJ, Bittman RM, Geis GS (1995) 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 123:241-249
50. Lanas A, García-Rodríguez LA, Polo-Tomás M, Ponce M, Alonso-Abreu I, Perez-Aisa MA, Perez-Gisbert J, Bujanda L, Castro M, Muñoz M, Rodrigo L, Calvet X, Del-Pino D, Garcia S (2009) Time trends and impact of upper and lower gastrointestinal bleeding and perforation in clinical practice. Am J Gastroenterol 104:1633-1641
51. Chan FK, Lanas A, Scheiman J, Berger MF, Nguyen H, Goldstein JL (2010) Celecoxib versus omeprazole and diclofenac in patients with osteoarthritis and rheumatoid arthritis (CONDOR): a randomised trial. Lancet 376:173-179
52. Laine L, Connors LG, Reicin A, Hawkey CJ, Burgos-Vargas R, Schnitzer TJ, Yu Q, Bombardier C (2003) Serious lower gastrointestinal clinical events with nonselective NSAID or coxib use. Gastroenterology 124:288-292
53. Laine L, Smith R, Min K, Chen C, Dubois RW (2006) Systematic review: the lower gastrointestinal adverse effects of nonsteroidal anti-inflammatory drugs. Aliment Pharmacol Ther 24:751-767
54. Singh G (1998) Recent considerations in nonsteroidal antiinflammatory drug gastropathy. Am J Med 105:31S-38S
55. Lanas A, Perez-Aisa MA, Feu F, Ponce J, Saperas E, Santolaria S, Rodrigo L, Balanzo J, Bajador E, Almela P, Navarro JM, Carballo F, Castro M, Quintero E (2005) 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 100:1685-1693
56. Scheiman JM (2001) The impact of nonsteroidal anti-inflammatory drug-induced gastropathy. Am J Manag Care 7:S10-S14
57. Spiegel BMR, Farid M, Dulai GS, Gralnek IM, Kanwal F (2006) Comparing rates of dyspepsia with coxibs vs NSAID ? PPI: a meta-analysis. Am J Med 119:448.e27-448.e36
58. Moskowitz RW, Abramson SB, Berenbaum F, Simon LS, Hochberg M (2007) Coxibs and NSAIDs-is the air any clearer? Perspectives from the OARSI/International COX-2 Study Group Workshop 2007. Osteoarthr Cartil 15:849-856
59. Massó González EL, Patrignani P, Tacconelli S, García-Rodrí-guez LA (2010) Variability of risk of upper gastrointestinal bleeding among nonsteroidal anti-inflammatory drugs. Arthritis Rheum 62:1592-1601
60. Bombardier C, Laine L, Reicin A, Shapiro D, Burgos-Vargas R, Davis B, Day R, Ferraz MB, Hawkey CJ, Hochberg MC, Kvien TK, Schnitzer TJ, for the VIGOR Study Group (2000) Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. N Engl J Med 343:1520-1528
61. Laine L, Curtis SP, Cryer B, Kaur A, Cannon CP (2007) 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 369:465-473
62. Schnitzer TJ, Burmester GR, Mysler E, Hochberg MC, Doherty M, Ehrsam E, Gitton X, Krammer G, Mellein B, Matchaba P, Gimona A, Hawkey CJ (2004) 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 364:665-674
63. Silverstein FE, Faich G, Goldstein JL, Simon LS, Pincus T, Whelton A, Makuch R, Eisen G, Agrawal NM, Stenson WF, Burr AM, Zhao WW, Kent JD, Lefkowith JB, Verburg KM, Geis GS (2000) 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 284:1247-1255
64. Laine L, White WB, Rostom A, Hochberg M (2008) COX-2 selective inhibitors in the treatment of osteoarthritis. Semin Arthritis Rheum 38:165-187
65. Gutthann SP, Garcia Rodriguez LA, Raiford DS (1997) Individual nonsteroidal antiinflammatory drugs and other risk factors for upper gastrointestinal bleeding and perforation. Epidemiology 8:18-24
66. Huang JQ, 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
67. Weil J, Colin-Jones D, Langman M, Lawson D, Logan R, Murphy M, Rawlins M, Vessey M, Wainwright P (1995) Prophylactic aspirin and risk of peptic ulcer bleeding. BMJ 310:827-830
68. Goldstein JL, Hochberg MC, Fort JG, Zhang Y, Hwang C, Sostek M (2010) Clinical trial: incidence of NSAID-associated endoscopic gastric ulcers in patients treated with PN 400 (naproxen plus esomeprazole magnesium) vs. enteric-coated naproxen alone. Aliment Pharmacol Ther 32:401-413
69. Ajani UA, Ford ES, Greenland KJ, Giles WH, Mokdad AH (2006) Aspirin use among US adults: behavioral risk factor surveillance system. Am J Prev Med 30:74-77
70. Goldstein JL, Lowry SC, Lanza FL, Schwartz HI, Dodge WE (2006) 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 23:1489-1498
71. Teoh NC, Farrell GC (2003) Hepatotoxicity associated with non-steroidal anti-inflammatory drugs. Clin Liver Dis 7:401-413
72. Aithal GP, Day CP (2007) Nonsteroidal anti-inflammatory druginduced hepatotoxicity. Clin Liver Dis 11:563-575
73. European Medicines Agency (2007) European Medicines Agency recommends withdrawal of marketing authorisations for lumiracoxib-containing medicines. http://www.ema.europa.eu/pdfs/human/press/pr/PR-Lumiracoxib-57930107en.pdf. Accessed 2 July 2010
74. Antman EM, Bennett JS, Daugherty A, Furberg C, Roberts H, Taubert KA (2007) Use of nonsteroidal antiinflammatory drugs: an update for clinicians: a scientific statement from the American Heart Association. Circulation 115:1634-1642
75. FitzGerald GA (2004) Coxibs and cardiovascular disease. N Engl J Med 351:1709-1711
76. Strand V, Hochberg MC (2002) The risk of cardiovascular thrombotic events with selective cyclooxygenase-2 inhibitors. Arthritis Rheum 47:349-355
77. Warner TD, Mitchell JA (2008) COX-2 selectivity alone does not define the cardiovascular risks associated with non-steroidal anti-inflammatory drugs. Lancet 371:270-273
78. Kearney PM, Baigent C, Godwin J, Halls H, Emberson JR, Patrono C (2006) Do selective cyclo-oxygenase-2 inhibitors and traditional non-steroidal anti-inflammatory drugs increase the risk of atherothrombosis? Meta-analysis of randomised trials. BMJ 332:1302-1308
79. 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
80. Jenkins J, Seligman P (2005) Memorandum: analysis and recommendations for Agency action regarding non-steroidal antiinflammatory drugs and cardiovascular risk. FDA NDA files, pp 20-998
81. ADAPT Research Group (2006) Cardiovascular and cerebrovascular events in the randomized, controlled Alzheimer's Disease Anti-Inflammatory Prevention Trial (ADAPT). PLoS Clin Trials 1:e33
82. Bertagnolli MM, Eagle CJ, Zauber AG, Redston M, Solomon SD, Kim K, Tang J, Rosenstein RB, Wittes J, Corle D, Hess TM, Woloj GM, Boisserie F, Anderson WF, Viner JL, Bagheri D, Burn J, Chung DC, Dewar T, Foley TR, Hoffman N, Macrae F, Pruitt RE, Saltzman JR, Salzberg B, Sylwestrowicz T, Gordon GB, Hawk ET, APC Study Investigators (2006) Celecoxib for the prevention of sporadic colorectal adenomas. N Engl J Med 355:873-884
83. Arber N, Eagle CJ, Spicak J, Rácz I, Dite P, Hajer J, Zavoral M, Lechuga MJ, Gerletti P, Tang J, Rosenstein RB, Macdonald K, Bhadra P, Fowler R, Wittes J, Zauber AG, Solomon SD, Levin B, PreSAP Trial Investigators (2006) Celecoxib for the prevention of colorectal adenomatous polyps. N Engl J Med 355:885-895
84. Frampton JE, Keating GM (2007) Celecoxib: a review of its use in the management of arthritis and acute pain. Drugs 67:2433-2472
85. White WB, West CR, Borer JS, Gorelick PB, Lavange L, Pan SX, Weiner E, Verburg KM (2007) Risk of cardiovascular events in patients receiving celecoxib: a meta-analysis of randomized clinical trials. Am J Cardiol 99:91-98
86. Cannon CP, Curtis SP, FitzGerald GA, Krum H, Kaur A, Bolognese JA, Reicin AS, Bombardier C, Weinblatt ME, van der Heijde D, Erdmann E, Laine L, MEDAL Steering Committee (2006) 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 368:1771-1781
87. McGettigan P, Henry D (2006) Cardiovascular risk and inhibition of cyclooxygenase: a systematic review of the observational studies of selective and nonselective inhibitors of cyclooxygenase 2. JAMA 296:1633-1644
88. Catella-Lawson F, Reilly MP, Kapoor SC, Cucchiara AJ, DeMarco S, Tournier B, Vyas SN, FitzGerald GA (2001) Cyclooxygenase inhibitors and the antiplatelet effects of aspirin. N Engl J Med 345:1809-1817
89. Desai SP, Solomon DH, Abramson SP, Buckley L, Crofford L, Cush JJ, Lovell DJ, Saag KG (2008) Recommendations for use of selective and nonselective nonsteroidal antiinflammatory drugs: an American College of Rheumatology white paper. Arthritis Rheum 59:1058-1073
90. Chan FKL, Abraham NS, Scheiman JM, Laine L (2008) Management of patients on nonsteroidal anti-inflammatory drugs: a clinical practice recommendation from the first international working party on gastrointestinal and cardiovascular effects of nonsteroidal anti-inflammatory drugs and anti-platelet agents. Am J Gastroenterol 103:2908-2918
91. Lanza FL, Chan FK, Quigley EMM (2009) Guidelines for prevention of NSAID-related ulcer complications. Am J Gastroenterol 104:728-738
92. Yeomans ND, Tulassay Z, Juhasz L, Racz I, Howard JM, van Rensburg CJ, Swannell AJ, Hawkey CJ (1998) A comparison of omeprazole with ranitidine for ulcers associated with nonsteroidal antiinflammatory drugs. Acid suppression trial: ranitidine versus Omeprazole for NSAID-associated Ulcer Treatment (ASTRONAUT) Study Group. N Engl J Med 338:719-726
93. Agrawal NM, Campbell DR, Safdi MA, Lukasik NL, Huang B, Haber MM (2000) 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 160:1455-1461
94. Ehsanullah RS, Page MC, Tildesley G, Wood JR (1988) Prevention of gastroduodenal damage induced by non-steroidal anti-inflammatory drugs: controlled trial of ranitidine. BMJ 297:1017-1021
95. Robinson MG, Griffin JW Jr, Bowers J, Kogan FJ, Kogut DG, Lanza FL, Warner CW (1989) Effect of ranitidine on gastroduodenal mucosal damage induced by nonsteroidal antiinflammatory drugs. Dig Dis Sci 34:424-428
96. Taha AS, Hudson N, Hawkey CJ, Swannell AJ, Trye PN, Cottrell J, Mann SG, Simon TJ, Sturrock RD, Russell RI (1996) Famotidine for the prevention of gastric and duodenal ulcers caused by nonsteroidal antiinflammatory drugs. N Engl J Med 334:1435-1439
97. Graham DY, Agrawal NM, Campbell DR, Haber MM, Collis C, Lukasik NL, Huang B (2002) Ulcer prevention in long-term users of nonsteroidal anti-inflammatory drugs: results of a double-blind, randomized, multicenter, active-and placebocontrolled study of misoprostol vs lansoprazole. Arch Intern Med 162:169-175
98. Ray WA, Chung CP, Stein CM, Smalley WE, Hall K, Arbogast PG, Griffin MR (2007) Risk of peptic ulcer hospitalizations in users of NSAIDs with gastroprotective cotherapy versus coxibs. Gastroenterology 133:790-798
99. Latimer N, Lord J, Grant RL, O'Mahony R, Dickson J, Conaghan PG, National Institute for Health and Excellence Osteoarthritis Development Group (2009) Cost effectiveness of COX 2 selective inhibitors and traditional NSAIDs alone or in combination with a proton pump inhibitor for people with osteoarthritis. BMJ 339:b2538
100. Scheiman JM, Yeomans ND, Talley NJ, Vakil N, Chan FKL, Tulassay Z, Rainoldi JL, Szczepanski L, Ung KA, Kleczkowski D, Ahlbom H, Næsdal J, Hawkey C (2006) Prevention of ulcers by esomeprazole in at-risk patients using non-selective NSAIDs and COX-2 inhibitors. Am J Gastroenterol 101:701-710
101. Charlot M, Grove EL, Hansen PR, Olesen JB, Ahlehoff O, Selmer C, Lindhardsen J, Madsen JK, Kober L, Torp-Pedersen C, Gislason GH (2011) Proton pump inhibitor use and risk of adverse cardiovascular events in aspirin treated patients with first time myocardial infarction: nationwide propensity score matched study. BMJ 342:d2690
102. Abraham NS, El-Serag HB, Johnson ML, Hartman C, Richardson P, Ray WA, Smalley W (2005) National adherence to evidence-based guidelines for the prescription of nonsteroidal anti-inflammatory drugs. Gastroenterology 129:1171-1178
103. Sturkenboom MCJM, Burke TA, Dieleman JP, Tangelder MJD, Lee F, Goldstein JL (2003) Underutilization of preventive strategies in patients receiving NSAIDs. Rheumatology (Oxford) 42(Suppl 3):iii23-iii31
104. Goldstein JL, Howard KB, Walton SM, McLaughlin TP, Kruzikas DT (2006) Impact of adherence to concomitant gastroprotective therapy on nonsteroidal-related gastroduodenal ulcer complications. Clin Gastroenterol Hepatol 4:1337-1345
105. Sturkenboom MCJM, Burke TA, Tangelder MJD, Dieleman JP, Walton S, Goldstein JL (2003) Adherence to proton pump inhibitors or H2-receptor antagonists during the use of nonsteroidal anti-inflammatory drugs. Aliment Pharmacol Ther 18:1137-1147
106. Bocanegra TS, Weaver AL, Tindall EA, Sikes DH, Ball JA, Wallemark CB, Geis GS, Fort JG, for the Arthrotec Arthritis Study Group (1998) Diclofenac/misoprostol compared with diclofenac in the treatment of osteoarthritis of the knee or hip: a randomized, placebo controlled trial. J Rheumatol 25:1602-1611
107. Food and Drug Administration (FDA) (1997) Arthrotec: drug details. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction= Search.DrugDetails. Accessed 3 June 2010
108. Food and Drug Administration (FDA) (2010) VIMOVO TM prescribing information. http://www.accessdata.fda.gov/drugsatfda-docs/label/2010/022511lbl. pdf. Accessed 17 December 2010
109. Laine LA, Schiff M, Genovese M, Kivitz A, Tidmarsh G, Weinblatt ME (2009) Does high-dose famotidine reduce gastric and duodenal ulcers in NSAID users? Two double-blind sixmonth trials of single-tablet combination ibuprofen-famotidine vs. ibuprofen alone (Reduce-1 and 2) [abstract 407]. Gastroenterology 136(Suppl 1):A-69
110. Scheiman JM, Fendrick AM (2007) Summing the risk of NSAID therapy. Lancet 369:1580-1581
111. Facts & Comparisons 4.0 [Online] (2009) Nonsteroidal antiinflammatory agents. http://online.factsandcomparisons.com/. Accessed 15 July 2009
112. Agrawal NG, Porras AG, Matthews CZ, Rose MJ, Woolf EJ, Musser BJ, Dynder AL, Mazina KE, Lasseter KC, Hunt TL, Schwartz JI, McCrea JB, Gottesdiener KM (2003) Single-and multiple-dose pharmacokinetics of etoricoxib, a selective inhibitor of cyclooxygenase-2, in man. J Clin Pharmacol 43:268-276
113. Brooks P, Kubler P (2006) Etoricoxib for arthritis and pain management. Ther Clin Risk Manag 2:45-57
114. Patrignani P, Capone ML, Tacconelli S (2003) Clinical pharmacology of etoricoxib: a novel selective COX2 inhibitor. Expert Opin Pharmacother 4:265-284
115. Takemoto JK, Reynolds JK, Remsberg CM, Vega-Villa KR, Davies NM (2008) Clinical pharmacokinetic and pharmacodynamic profile of etoricoxib. Clin Pharmacokinet 47:703-720