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Volumn 27, Issue 4, 2011, Pages 847-854

Long-term safety of naproxen and esomeprazole magnesium fixed-dose combination: Phase III study in patients at risk for NSAID-associated gastric ulcers

Author keywords

Drug combinations; Drug safety; Esomeprazole; Long term; Naproxen; NSAIDs; Upper gastrointestinal

Indexed keywords

ANTACID AGENT; ESOMEPRAZOLE PLUS NAPROXEN; NONSTEROID ANTIINFLAMMATORY AGENT; PARACETAMOL;

EID: 79952650345     PISSN: 03007995     EISSN: 14734877     Source Type: Journal    
DOI: 10.1185/03007995.2011.555756     Document Type: Article
Times cited : (16)

References (33)
  • 1
    • 55349127823 scopus 로고    scopus 로고
    • 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
    • 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;103:2908-18
    • (2008) Am J Gastroenterol , vol.103 , pp. 2908-2918
    • Chan, F.K.L.1    Abraham, N.S.2    Scheiman, J.M.3
  • 2
    • 0035112660 scopus 로고    scopus 로고
    • Approaches to nonsteroidal anti-inflammatory drug use in the high-risk patient
    • Laine L. Approaches to nonsteroidal anti-inflammatory drug use in the high-risk patient. Gastroenterology 2001;120:594-606 (Pubitemid 32171634)
    • (2001) Gastroenterology , vol.120 , Issue.3 , pp. 594-606
    • Laine, L.1
  • 3
    • 61949239030 scopus 로고    scopus 로고
    • Guidelines for prevention of NSAID-related ulcer complications
    • Lanza FL, Chan FK, Quigley EMM. Guidelines for prevention of NSAID-related ulcer complications. Am J Gastroenterol 2009;104:728-38
    • (2009) Am J Gastroenterol , vol.104 , pp. 728-738
    • Lanza, F.L.1    Chan, F.K.2    Quigley, E.M.M.3
  • 4
    • 0036789104 scopus 로고    scopus 로고
    • Stratifying the risk of NSAID-related upper gastrointestinal clinical events: Results of a double-blind outcomes study in patients with rheumatoid arthritis
    • 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;123:1006-12
    • (2002) Gastroenterology , vol.123 , pp. 1006-1012
    • Laine, L.1    Bombardier, C.2    Hawkey, C.J.3
  • 5
    • 35748970724 scopus 로고    scopus 로고
    • 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
    • DOI 10.1111/j.1365-2036.2007.03523.x
    • 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;26:1387-98 (Pubitemid 350045614)
    • (2007) Alimentary Pharmacology and Therapeutics , vol.26 , Issue.10 , pp. 1387-1398
    • Rahme, E.1    Nedjar, H.2    Bizzi, A.3    Morin, S.4
  • 6
    • 56749183852 scopus 로고    scopus 로고
    • ACCF/ACG/AHA 2008 Expert Consensus Document on reducing the gastrointestinal risks of antiplatelet therapy and NSAID use. A report of the American College of Cardiology Foundation Task Force on Clinical Expert Consensus Documents
    • Bhatt DL, Scheiman J, Abraham NS, et al. ACCF/ACG/AHA 2008 Expert Consensus Document on reducing the gastrointestinal risks of antiplatelet therapy and NSAID use. A report of the American College of Cardiology Foundation Task Force on Clinical Expert Consensus Documents. Circulation 2008;118:1894-909
    • (2008) Circulation , vol.118 , pp. 1894-1909
    • Bhatt, D.L.1    Scheiman, J.2    Abraham, N.S.3
  • 7
    • 49549125649 scopus 로고    scopus 로고
    • Recommendations for use of selective and nonselective nonsteroidal antiinflammatory drugs: An American College of Rheumatology white paper
    • 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: 1058-73
    • (2008) Arthritis Rheum , vol.59 , pp. 1058-1073
    • Desai, S.P.1    Solomon, D.H.2    Abramson, S.P.3
  • 8
    • 84860755063 scopus 로고    scopus 로고
    • The care and management of osteoarthritis in adults
    • [online]. Available from Accessed 3 Jun 2010
    • National Institute for Health and Clinical Excellence. The care and management of osteoarthritis in adults. NICE clinical guideline 59 [online]. Available from http://www.nice.org.uk/nicemedia/pdf/CG59NICEguideline.pdf [Accessed 3 Jun 2010]
    • NICE Clinical Guideline , vol.59
  • 10
    • 26844442288 scopus 로고    scopus 로고
    • National adherence to evidence-based guidelines for the prescription of nonsteroidal anti-inflammatory drugs
    • DOI 10.1053/j.gastro.2005.08.003, PII S0016508505015787
    • 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;129:1171-8 (Pubitemid 41446857)
    • (2005) Gastroenterology , vol.129 , Issue.4 , pp. 1171-1178
    • Abraham, N.S.1    El-Serag, H.B.2    Johnson, M.L.3    Hartman, C.4    Richardson, P.5    Ray, W.A.6    Smalley, W.7
  • 11
    • 0242609399 scopus 로고    scopus 로고
    • Underutilization of preventive strategies in patients receiving NSAIDs
    • Oxford
    • Sturkenboom MCJM, Burke TA, Dieleman JP, et al. Underutilization of preventive strategies in patients receiving NSAIDs. Rheumatology (Oxford) 2003;42 (Suppl 3):iii23-31
    • (2003) Rheumatology , vol.42 , Issue.SUPPL. 3
    • Sturkenboom, M.C.J.M.1    Burke, T.A.2    Dieleman, J.P.3
  • 12
    • 33750796675 scopus 로고    scopus 로고
    • Impact of adherence to concomitant gastroprotective therapy on nonsteroidal-related gastroduodenal ulcer complications
    • 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;4:1337-45
    • (2006) Clin Gastroenterol Hepatol , vol.4 , pp. 1337-1345
    • Goldstein, J.L.1    Howard, K.B.2    Walton, S.M.3
  • 15
    • 77954346981 scopus 로고    scopus 로고
    • Clinical trial: Evaluation of gastric acid suppression with three doses of immediate-release esomeprazole in the fixed-dose combination of PN 400 (naproxen/esomeprazole magnesium) compared with naproxen 500 mg and enteric-coated esomeprazole 20 mg: A randomised, open-label, Phase I study in healthy volunteers
    • Miner Jr P, Plachetka J, Orlemans E, et al. Clinical trial: evaluation of gastric acid suppression with three doses of immediate-release esomeprazole in the fixed-dose combination of PN 400 (naproxen/esomeprazole magnesium) compared with naproxen 500 mg and enteric-coated esomeprazole 20 mg: a randomised, open-label, Phase I study in healthy volunteers. Aliment Pharmacol Ther 2010;32:414-24
    • (2010) Aliment Pharmacol Ther , vol.32 , pp. 414-424
    • Miner Jr., P.1    Plachetka, J.2    Orlemans, E.3
  • 16
    • 79951913071 scopus 로고    scopus 로고
    • A fixed-dose combination of naproxen and esomeprazole magnesium (VIMOVOTM) has comparable efficacy and tolerability to celecoxib in patients with osteoarthritis (OA) of the knee: Results from two randomized, controlled trials
    • abs 937
    • Hochberg M, Cryer B, Fort JG, et al. A fixed-dose combination of naproxen and esomeprazole magnesium (VIMOVOTM) has comparable efficacy and tolerability to celecoxib in patients with osteoarthritis (OA) of the knee: results from two randomized, controlled trials. Arthritis Rheum 2010;62 (Suppl 10): S388, abs 937
    • (2010) Arthritis Rheum , vol.62 , Issue.SUPPL. 10
    • Hochberg, M.1    Cryer, B.2    Fort, J.G.3
  • 17
    • 77954331288 scopus 로고    scopus 로고
    • Clinical trial: Incidence of NSAID-associated endoscopic gastric ulcers in patients treated with PN 400 (naproxen plus esomeprazole magnesium) vs. enteric-coated naproxen alone
    • Goldstein JL, Hochberg MC, Fort JG, et al. 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 2010;32:401-13
    • (2010) Aliment Pharmacol Ther , vol.32 , pp. 401-413
    • Goldstein, J.L.1    Hochberg, M.C.2    Fort, J.G.3
  • 18
    • 0003443998 scopus 로고    scopus 로고
    • [online]. Available from Accessed 19 Nov 2010
    • Electronic Medicines Compendium (eMC). Summary of Product Characteristics. VIMOVO 500 mg/20 mg modified-release tablets [online]. Available from http://www.medicines.org.uk/EMC/medicine/23883/SPC/ VIMOVO+500+mg+20+mg+modified-release+tablets [Accessed 19 Nov 2010]
    • Summary of Product Characteristics. VIMOVO 500 Mg/20 Mg Modified-release Tablets
  • 19
    • 79952659962 scopus 로고    scopus 로고
    • [online]. Available from Accessed 9 Jun 2010
    • Food and Drug Administration (FDA). VIMOVOTM prescribing information [online]. Available from http://www.accessdata.fda.gov/drugsatfda-docs/ label/2010/022511lbl.pdf [Accessed 9 Jun 2010]
    • VIMOVOTM Prescribing Information
  • 21
    • 0034644396 scopus 로고    scopus 로고
    • 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
    • Silverstein FE, Faich G, Goldstein JL, 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;284:1247-55
    • (2000) JAMA , vol.284 , pp. 1247-1255
    • Silverstein, F.E.1    Faich, G.2    Goldstein, J.L.3
  • 22
    • 41149123885 scopus 로고    scopus 로고
    • Safety profile of esomeprazole: Results of a prescription-event monitoring study of 11 595 patients in England
    • DOI 10.2165/00002018-200831040-00005
    • Davies M, Wilton LV, Shakir SA. Safety profile of esomeprazole: results of a prescription-event monitoring study of 11 595 patients in England. Drug Saf 2008;31:313-23 (Pubitemid 351441579)
    • (2008) Drug Safety , vol.31 , Issue.4 , pp. 313-323
    • Davies, M.1    Wilton, L.V.2    Shakir, S.A.W.3
  • 24
    • 0034933665 scopus 로고    scopus 로고
    • Safety and efficacy of long term esomeprazole therapy in patients with healed erosive oesophagitis
    • Maton PN, Vakil NB, Levine JG, et al. Safety and efficacy of long term esomeprazole therapy in patients with healed erosive oesophagitis. Drug Saf 2001;24:625-35 (Pubitemid 32656075)
    • (2001) Drug Safety , vol.24 , Issue.8 , pp. 625-635
    • Maton, P.N.1    Vakil, N.B.2    Levine, J.G.3    Hwang, C.4    Skammer, W.5    Lundborg, P.6
  • 25
    • 0036678344 scopus 로고    scopus 로고
    • Do NSAIDs cause dyspepsia? A meta-analysis evaluating alternative dyspepsia definitions
    • Straus WL, Ofman JJ, MacLean C, et al. Do NSAIDs cause dyspepsia? A meta-analysis evaluating alternative dyspepsia definitions. Am J Gastroenterol 2002;97:1951-8
    • (2002) Am J Gastroenterol , vol.97 , pp. 1951-1958
    • Straus, W.L.1    Ofman, J.J.2    MacLean, C.3
  • 26
    • 33645449670 scopus 로고    scopus 로고
    • Prevention of ulcers by esomeprazole in at-risk patients using non-selective NSAIDs and COX-2 inhibitors
    • 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;101:701-10
    • (2006) Am J Gastroenterol , vol.101 , pp. 701-710
    • Scheiman, J.M.1    Yeomans, N.D.2    Talley, N.J.3
  • 27
    • 54849436450 scopus 로고    scopus 로고
    • Association between proton pump inhibitors and respiratory infections: A systematic review and meta-analysis of clinical trials
    • Sultan N, Nazareno J, Gregor J. Association between proton pump inhibitors and respiratory infections: a systematic review and meta-analysis of clinical trials. Can J Gastroenterol 2008;22:761-6
    • (2008) Can J Gastroenterol , vol.22 , pp. 761-766
    • Sultan, N.1    Nazareno, J.2    Gregor, J.3
  • 28
    • 0034707105 scopus 로고    scopus 로고
    • Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis
    • Bombardier C, Laine L, Reicin A, et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. N Engl J Med 2000;343:1520-8
    • (2000) N Engl J Med , vol.343 , pp. 1520-1528
    • Bombardier, C.1    Laine, L.2    Reicin, A.3
  • 29
    • 34147207550 scopus 로고    scopus 로고
    • The rate of NSAID-induced endoscopic ulcers increases linearly but not exponentially with age: A pooled analysis of 12 randomised trials
    • DOI 10.1136/ard.2006.055012
    • Boers M, Tangelder MJ, van Ingen H, et al. The rate of NSAID-induced endoscopic ulcers increases linearly but not exponentially with age: a pooled analysis of 12 randomised trials. Ann Rheum Dis 2007;66:417-18 (Pubitemid 46579647)
    • (2007) Annals of the Rheumatic Diseases , vol.66 , Issue.3 , pp. 417-418
    • Boers, M.1    Tangelder, M.J.D.2    Van Ingen, H.3    Fort, J.G.4    Goldstein, J.L.5
  • 30
    • 79952660923 scopus 로고    scopus 로고
    • Prevalence of Doctor- Diagnosed Arthritis and Arthritis-Attributable Activity Limitation - United States, 2007-2009
    • [online]. Available from Accessed 25 Oct 2010
    • Centers for Disease Control and Prevention (CDC). Prevalence of Doctor- Diagnosed Arthritis and Arthritis-Attributable Activity Limitation - United States, 2007-2009. Morbidity and Mortality Weekly Report [online]. Available from http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5939a1. htm [Accessed 25 Oct 2010]
    • Morbidity and Mortality Weekly Report
  • 32
    • 79952640555 scopus 로고    scopus 로고
    • Is age a predictor of endoscopic gastric ulcers in patients taking chronic NSAIDs? A pooled analysis including 854 patients from two phase 3 studies comparing PN400 and enteric-coated naproxen
    • abs THU0430
    • Goldstein JL, Fort JG, Zhang Y, et al. Is age a predictor of endoscopic gastric ulcers in patients taking chronic NSAIDs? A pooled analysis including 854 patients from two phase 3 studies comparing PN400 and enteric-coated naproxen. Ann Rheum Dis 2010;69 (Suppl 3):287, abs THU0430
    • (2010) Ann Rheum Dis , vol.69 , Issue.SUPPL. 3 , pp. 287
    • Goldstein, J.L.1    Fort, J.G.2    Zhang, Y.3
  • 33
    • 33744976771 scopus 로고    scopus 로고
    • Do selective cyclo-oxygenase-2 inhibitors and traditional non-steroidal anti-inflammatory drugs increase the risk of atherothrombosis? Meta-analysis of randomised trials
    • Kearney PM, Baigent C, Godwin J, et al. Do selective cyclo-oxygenase-2 inhibitors and traditional non-steroidal anti-inflammatory drugs increase the risk of atherothrombosis? Meta-analysis of randomised trials. BMJ 2006; 332:1302-8
    • (2006) BMJ , vol.332 , pp. 1302-1308
    • Kearney, P.M.1    Baigent, C.2    Godwin, J.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.