Corrigendum to: Clinical trial: the 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, (2010), 32, 10.1111/j.1365-2036.2010.04378.x);Clinical trial: The incidence of NSAID-associated endoscopic gastric ulcers in patients treated with PN 400 (naproxen plus esomeprazole magnesium) vs. enteric-coated naproxen alone

Alimentary Pharmacology and Therapeutics

Volumn 32, Issue 3, 2010, Pages 401-413

  Goldstein, J L ^a   Hochberg, M C ^b   Fort, J G ^c   Zhang, Y ^c   Hwang, C ^d   Sostek, M ^d  

^a UNIVERSITY OF ILLINOIS AT CHICAGO   (United States)

^b UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE   (United States)

^c POZEN Inc   (United States)

^d ASTRAZENECA   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; ESOMEPRAZOLE; ESOMEPRAZOLE PLUS NAPROXEN; NAPROXEN; PN 400; UNCLASSIFIED DRUG;

ARTICLE; CLINICAL TRIAL; DIGESTIVE TRACT ENDOSCOPY; DRUG TOLERABILITY; DUODENITIS; DUODENUM ULCER; DYSPEPSIA; ENTERIC COATED TABLET; EROSIVE GASTRITIS; GASTRITIS; HEARTBURN; HUMAN; INCIDENCE; LOW DRUG DOSE; OUTCOME ASSESSMENT; PRIORITY JOURNAL; SELF REPORT; STOMACH ULCER; THORAX PAIN; UPPER ABDOMINAL PAIN;

EID: 77954331288     PISSN: 02692813     EISSN: 13652036     Source Type: Journal    
DOI: 10.1111/apt.13724     Document Type: Erratum

References (45)

1. Hootman JM, Helmick CG. Projections of US prevalence of arthritis and associated activity limitations. Arthritis Rheum 2006 54:226 229.
2. Woolf AD, Pfleger B. Burden of major musculoskeletal conditions. Bull World Health Organ 2003 81:646 656.
3. World Health Organization. The Global Burden of Disease: 2004 Update, 2008. Available at: http://www.who.int/healthinfo/global-burden-disease/2004- report-update/en/index.html. Accessed November 3, 2008.
4. Desai SP, Solomon DH, Abramson SP, et al. Recommendations for use of selective and nonselective nonsteroidal antiinflammatory drugs: an American College of Rheumatology white paper. Arthritis Rheum 2008 59:1058 1073.
5. National Institute for Health and Clinical Excellence. The Care and Management of Osteoarthritis in Adults. NICE Clinical Guideline 59, 2008. Available at: http://www.nice.org.uk/nicemedia/pdf/CG59NICEguideline.pdf. Accessed September 12, 2008.
6. Zhang W, Doherty M, Arden N, et al. 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 2005 64:669 681.
7. Zhang W, Moskowitz RW, Nuki G, et al. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthr Cartil 2008 16:137 162.
8. Chan FKL, Abraham NS, Scheiman JM, et al. 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 2008 103:2908 2918.
9. Lanza FL, Chan FK, Quigley EMM. Guidelines for prevention of NSAID-related ulcer complications. Am J Gastroenterol 2009 104:728 738.
10. Laine L. Approaches to nonsteroidal anti-inflammatory drug use in the high-risk patient. Gastroenterology 2001 120:594 606.
11. Silverstein FE, Graham DY, Senior JR, 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 1995 123:241 249.
12. Laine L, Bombardier C, Hawkey CJ, 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.
13. Rahme E, Nedjar H, Bizzi A, et al. Hospitalization for gastrointestinal adverse events attributable to the use of low-dose aspirin among patients 50 years or older also using non-steroidal anti-inflammatory drugs: a retrospective cohort study. Aliment Pharmacol Ther 2007 26:1387 1398. (Pubitemid 350045614)
14. Scheiman JM, Yeomans ND, Talley NJ, et al. Prevention of ulcers by esomeprazole in at-risk patients using non-selective NSAIDs and COX-2 inhibitors. Am J Gastroenterol 2006 101:701 710.
15. Graham DY, Agrawal NM, Campbell DR, 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.
16. Hawkey CJ, Karrasch JA, Szczepanski L, et al. Omeprazole compared with misoprostol for ulcers associated with nonsteroidal antiinflammatory drugs. Omeprazole versus Misoprostol for NSAID-induced Ulcer Management (OMNIUM) Study Group. N Engl J Med 1998 338:727 734.
17. Scheiman JM, Fendrick AM. Summing the risk of NSAID therapy. Lancet 2007 369:1580 1581.
18. Abraham NS, El-Serag HB, Johnson ML, et al. National adherence to evidence-based guidelines for the prescription of nonsteroidal anti-inflammatory drugs. Gastroenterology 2005 129:1171 1178.
19. Dries AM, Richardson P, Cavazos J, et al. Therapeutic intent of proton pump inhibitor prescription among elderly nonsteroidal anti-inflammatory drug users. Aliment Pharmacol Ther 2009 30:652 661.
20. Laine L, Connors L, Griffin MR, et al. Prescription rates of protective co-therapy for NSAID users at high GI risk and results of attempts to improve adherence to guidelines. Aliment Pharmacol Ther 2009 30:767 774.
21. Lanas A, Polo-Tomás M, Roncales P, et al. Types of prescription and levels of adherence to NSAIDs and gastroprotectors in at-risk GI patients. Gastroenterology 2010 138 (Suppl. 1 S108 9 (abs 776).
22. Sturkenboom MCJM, Burke TA, Dieleman JP, et al. Underutilization of preventive strategies in patients receiving NSAIDs. Rheumatology (Oxford) 2003 42 (Suppl. 3 iii23 31.
23. Targownik LE, Metge CJ, Leung S. Underutilization of gastroprotective strategies in aspirin users at increased risk of upper gastrointestinal complications. Aliment Pharmacol Ther 2008 28:88 96.
24. Goldstein JL, Howard KB, Walton SM, et al. Impact of adherence to concomitant gastroprotective therapy on nonsteroidal-related gastroduodenal ulcer complications. Clin Gastroenterol Hepatol 2006 4:1337 1345.
25. Sturkenboom MCJM, Burke TA, Tangelder MJD, et al. Adherence to proton pump inhibitors or H2-receptor antagonists during the use of non-steroidal anti-inflammatory drugs. Aliment Pharmacol Ther 2003 18:1137 1147.
26. Miner PB, Plachetka JR, Orlemans E, et al. Pharmacokinetics of naproxen and esomeprazole in PN400, a single-tablet, multilayer formulation of enteric-coated naproxen coupled with immediate-release esomeprazole. Gastroenterology 2009 136 (Suppl. 1 A-611 (abs T1972).
27. Miner PB, Plachetka JR, Orlemans E, et al. Gastric acid suppression with PN400, a single-tablet, multilayer, fixed-dose formulation combining an immediate-release esomeprazole layer and an enteric-coated (EC) naproxen core. Gastroenterology 2009 136 (Suppl. 1 A-611 (abs T1969).
28. Rabeneck L, Cook KF, Wristers K, et al. SODA (severity of dyspepsia assessment): a new effective outcome measure for dyspepsia-related health. J Clin Epidemiol 2001 54:755 765.
29. Rabeneck L, Wristers K, Goldstein JL, et al. Reliability, validity, and responsiveness of severity of dyspepsia assessment (SODA) in a randomized clinical trial of a COX-2-specific inhibitor and traditional NSAID therapy. Am J Gastroenterol 2002 97:32 9.
30. Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials 1989 10:407 415.
31. Graham DY. Endoscopic ulcers are neither meaningful nor validated as a surrogate for clinically significant upper gastrointestinal harm. Clin Gastroenterol Hepatol 2009 7:1147 1150.
32. Moore A, Bjarnason I, Cryer B, et al. Evidence for endoscopic ulcers as meaningful surrogate endpoint for clinically significant upper gastrointestinal harm. Clin Gastroenterol Hepatol 2009 7:1156 1163.
33. Hawkey CJ, Jones RH, Yeomans ND, et al. Efficacy of esomeprazole for resolution of symptoms of heartburn and acid regurgitation in continuous users of non-steroidal anti-inflammatory drugs. Aliment Pharmacol Ther 2007 25:813 821.
34. Lai KC, Chu KM, Hui WM, et al. Celecoxib compared with lansoprazole and naproxen to prevent gastrointestinal ulcer complications. Am J Med 2005 118:1271 1278.
35. Chan FK, Hung LC, Suen BY, 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.
36. Chan FK, Hung LC, Suen BY, et al. Celecoxib versus diclofenac plus omeprazole in high-risk arthritis patients: results of a randomized double-blind trial. Gastroenterology 2004 127:1038 1043.
37. Chan FK, Wong VW, Suen BY, 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 2007 369:1621 1626.
38. Massó González EL, García Rodríguez LA. Proton pump inhibitors reduce the long-term risk of recurrent upper gastrointestinal bleeding: an observational study. Aliment Pharmacol Ther 2008 28:629 637.
39. Ray WA, Chung CP, Stein CM, et al. Risk of peptic ulcer hospitalizations in users of NSAIDs with gastroprotective cotherapy versus coxibs. Gastroenterology 2007 133:790 798.
40. Bocanegra TS, Weaver AL, Tindall EA, et al. Diclofenacmisoprostol compared with diclofenac in the treatment of osteoarthritis of the knee or hip: a randomized, placebo controlled trial. Arthrotec Osteoarthritis Study Group. J Rheumatol 1998 25:1602 1611.
41. Laine LA, Schiff M, Genovese M, et al. Does High-Dose Famotidine Reduce Gastric and Duodenal Ulcers in NSAID Users? Two Double-Blind six-Month Trials of Single-Tablet Combination Ibuprofen-Famotidine vs Ibuprofen Alone (Reduce-1 and 2). Abstract presented at the Digestive Disease Week, Chicago, IL, USA 2009 (abs 407).
42. Goldstein JL, Huang B, Amer F, et al. Ulcer recurrence in high-risk patients receiving nonsteroidal anti-inflammatory drugs plus low-dose aspirin: results of a post hoc subanalysis. Clin Ther 2004 26:1637 1643.
43. Scheiman JM. The impact of nonsteroidal anti-inflammatory drug-induced gastropathy. Am J Manag Care 2001 7:S10 4.
44. Spiegel BMR, Farid M, Dulai GS, et al. Comparing rates of dyspepsia with coxibs vs NSAID+PPI: a meta-analysis. Am J Med 2006 119:448.e27 448.e36.
45. Wolfe F, Kong SX, Watson DJ. Gastrointestinal symptoms and health related quality of life in patients with arthritis. J Rheumatol 2000 27:1373 1378.