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Volumn 27, Issue 6, 2011, Pages 1243-1253

Fixed-dose combination of enteric-coated naproxen and immediate-release esomeprazole has comparable efficacy to celecoxib for knee osteoarthritis: Two randomized trials

Author keywords

COX inhibitors; Esomeprazole magnesium; Naproxen; Non inferiority; Nonsteroidal anti inflammatory drugs (NSAIDs); Osteoarthritis

Indexed keywords

CELECOXIB; ESOMEPRAZOLE; NAPROXEN; PARACETAMOL; PLACEBO;

EID: 79956134847     PISSN: 03007995     EISSN: 14734877     Source Type: Journal    
DOI: 10.1185/03007995.2011.580340     Document Type: Article
Times cited : (41)

References (46)
  • 1
    • 0033710649 scopus 로고    scopus 로고
    • Recommendations for the medical management of osteoarthritis of the hip and knee: 2000 update American College of Rheumatology Subcommittee on Osteoarthritis Guidelines
    • Altman R, Hochberg MC, Moskowitz RW, et al. Recommendations for the medical management of osteoarthritis of the hip and knee: 2000 update. American College of Rheumatology Subcommittee on Osteoarthritis Guidelines. Arthritis Rheum 2000;43:1905-15
    • (2000) Arthritis Rheum , vol.43 , pp. 1905-15
    • Altman, R.1    Hochberg, M.C.2    Moskowitz, R.W.3
  • 2
    • 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. 1058-73
    • Desai, S.P.1    Solomon, D.H.2    Abramson, S.P.3
  • 3
    • 84860755063 scopus 로고    scopus 로고
    • The care and management of osteoarthritis in adults
    • National Institute for Health and Clinical Excellence Available at [Last accessed 17 Dec 2010]
    • National Institute for Health and Clinical Excellence. The care and management of osteoarthritis in adults. NICE clinical guideline 59. Available at: http://www.nice.org.uk/nicemedia/pdf/CG59NICEguideline.pdf [Last accessed 17 Dec 2010]
    • NICE Clinical Guideline 59
  • 6
    • 33847051340 scopus 로고    scopus 로고
    • Risk of Upper Gastrointestinal Complications Among Users of Traditional NSAIDs and COXIBs in the General Population
    • DOI 10.1053/j.gastro.2006.12.007, PII S0016508506025650
    • Garcia Rodriguez LA, Barreales Tolosa L. Risk of upper gastrointestinal complications among users of traditional NSAIDs and COXIBs in the general population. Gastroenterology 2007;132:498-506 (Pubitemid 46274667)
    • (2007) Gastroenterology , vol.132 , Issue.2 , pp. 498-506
    • Garcia Rodriguez, L.A.1    Barreales Tolosa, L.2
  • 8
    • 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
  • 9
    • 27844517049 scopus 로고    scopus 로고
    • Practical approaches to minimizing gastrointestinal and cardiovascular safety concerns with COX-2 inhibitors and NSAIDs
    • DOI 10.1186/ar1795
    • Scheiman JM, Fendrick AM. Practical approaches to minimizing gastrointestinal and cardiovascular safety concerns with COX-2 inhibitors and NSAIDs. Arthritis Res Ther 2005;7(Suppl. 4):S23-S29 (Pubitemid 41646251)
    • (2005) Arthritis Research and Therapy , vol.7 , Issue.SUPPL. 4
    • Scheiman, J.M.1    Fendrick, A.M.2
  • 10
    • 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. 1951-8
    • Straus, W.L.1    Ofman, J.J.2    MacLean, C.3
  • 11
    • 44149106595 scopus 로고    scopus 로고
    • Cyclooxygenase-2 selective nonsteroidal anti-inflammatory drugs (etodolac, meloxicam, celecoxib, rofecoxib, etoricoxib, valdecoxib and lumiracoxib) for osteoarthritis and rheumatoid arthritis: A systematic review and economic evaluation
    • iii
    • Chen Y-F, Jobanputra P, Barton P, et al. Cyclooxygenase-2 selective nonsteroidal 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 2008;12:1-278, iii
    • (2008) Health Technol Assess , vol.12 , pp. 1-278
    • Chen, Y.-F.1    Jobanputra, P.2    Barton, P.3
  • 12
    • 79956070286 scopus 로고    scopus 로고
    • Drug class review of cyclo-oxygenase (C0X)-2 inhibitors and non-steroidal anti-inflammatory drugs (NSAIDs)
    • Available at [Last accessed 2 Jul 2010]
    • Chou R, Helfand M, Peterson K, et al. Drug class review of cyclo-oxygenase (C0X)-2 inhibitors and non-steroidal anti-inflammatory drugs (NSAIDs).Final report. Available at: http://www.ncbi.nlm.nih.gov/pubmed/20496448 [Last accessed 2 Jul 2010]
    • Final Report
    • Chou, R.1    Helfand, M.2    Peterson, K.3
  • 14
    • 34247464709 scopus 로고    scopus 로고
    • Use of nonsteroidal antiinflammatory drugs: An update for clinicians: A scientific statement from the American Heart Association
    • DOI 10.1161/CIRCULATIONAHA.106.181424
    • Antman EM, Bennett JS, Daugherty A, et al. Use of nonsteroidal antiinflammatory drugs: an update for clinicians: a scientific statement from the American Heart Association. Circulation 2007;115:1634-42 (Pubitemid 46648649)
    • (2007) Circulation , vol.115 , Issue.12 , pp. 1634-1642
    • Antman, E.M.1    Bennett, J.S.2    Daugherty, A.3    Furberg, C.4    Roberts, H.5    Taubert, K.A.6
  • 15
    • 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. 1894-909
    • Bhatt, D.L.1    Scheiman, J.2    Abraham, N.S.3
  • 16
    • 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. 2908-18
    • Fkl, C.1    Abraham, N.S.2    Scheiman, J.M.3
  • 17
    • 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. 728-38
    • Lanza, F.L.1    Chan, F.K.2    Quigley, E.M.M.3
  • 18
    • 34248191173 scopus 로고    scopus 로고
    • Summing the risk of NSAID therapy
    • DOI 10.1016/S0140-6736(07)60722-3, PII S0140673607607223
    • Scheiman JM, Fendrick AM. Summing the risk of NSAID therapy. Lancet 2007;369:1580-1 (Pubitemid 46710106)
    • (2007) Lancet , vol.369 , Issue.9573 , pp. 1580-1581
    • Scheiman, J.M.1    Fendrick, A.M.2
  • 19
    • 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. 1520-8
    • Bombardier, C.1    Laine, L.2    Reicin, A.3
  • 21
    • 79956101784 scopus 로고    scopus 로고
    • Memorandum: Analysis and recommendations for Agency action regarding non-steroidal anti-inflammatory drugs and cardiovascular risk
    • Jenkins J, Seligman P. Memorandum: analysis and recommendations for Agency action regarding non-steroidal anti-inflammatory drugs and cardiovascular risk. FDA NDA files 2005:20-998
    • (2005) FDA NDA Files , pp. 20-998
    • Jenkins, J.1    Seligman, P.2
  • 22
    • 79956108700 scopus 로고    scopus 로고
    • Merck & Co. I Merck Announces Voluntary Worldwide Withdrawal of VIOXX. Available at [Last accessed 11 Dec 2009]
    • Merck & Co. I. Merck Announces Voluntary Worldwide Withdrawal of VIOXX. Available at: http://www.merck.com/newsroom/vioxx/pdf/vioxx-press-relea- se-final.pdf [Last accessed 11 Dec 2009]
  • 23
    • 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. 1302-8
    • Kearney, P.M.1    Baigent, C.2    Godwin, J.3
  • 24
    • 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
  • 25
    • 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. 1337-45
    • Goldstein, J.L.1    Howard, K.B.2    Walton, S.M.3
  • 28
    • 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. 414-24
    • Miner Jr., P.1    Plachetka, J.2    Orlemans, E.3
  • 29
    • 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. 401-13
    • Goldstein, J.L.1    Hochberg, M.C.2    Fort, J.G.3
  • 30
    • 0022465236 scopus 로고
    • Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association
    • Altman R, Asch E, Bloch D, et al. Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association. Arthritis Rheum 1986;29:1039-49
    • (1986) Arthritis Rheum , vol.29 , pp. 1039-49
    • Altman, R.1    Asch, E.2    Bloch, D.3
  • 31
    • 0036896066 scopus 로고    scopus 로고
    • WOMAC: A 20-year experiential review of a patient-centered self-reported health status questionnaire
    • Bellamy N. WOMAC: a 20-year experiential review of a patient-centered self-reported health status questionnaire. J Rheumatol 2002;29:2473-6 (Pubitemid 35416947)
    • (2002) Journal of Rheumatology , vol.29 , Issue.12 , pp. 2473-2476
    • Bellamy, N.1
  • 32
    • 0037256195 scopus 로고    scopus 로고
    • American pain society pain questionnaire and other pain measures in the assessment of osteoarthritis pain: A pooled analysis of three celecoxib pivotal studies
    • Moskowitz RW, Sunshine A, Brugger A, et al. American pain society pain questionnaire and other pain measures in the assessment of osteoarthritis pain: a pooled analysis of three celecoxib pivotal studies. Am J Ther 2003;10:12-20
    • (2003) Am J Ther , vol.10 , pp. 12-20
    • Moskowitz, R.W.1    Sunshine, A.2    Brugger, A.3
  • 33
    • 34548403757 scopus 로고    scopus 로고
    • A multidimensional health assessment questionnaire (MDHAQ) for all patients with rheumatic diseases to complete at all visits in standard clinical care
    • Pincus T. A multidimensional health assessment questionnaire (MDHAQ) for all patients with rheumatic diseases to complete at all visits in standard clinical care. Bull NYU Hosp Jt Dis 2007;65:150-60 (Pubitemid 350291162)
    • (2007) Bulletin of the NYU Hospital for Joint Diseases , vol.65 , Issue.2 , pp. 150-160
    • Pincus, T.1
  • 34
    • 0034528514 scopus 로고    scopus 로고
    • Response criteria for clinical trials on osteoarthritis of the knee and hip: A report of the Osteoarthritis Research Society International Standing Committee for Clinical Trials response criteria initiative
    • DOI 10.1053/joca.2000.0361
    • Dougados M, Leclaire P, van der Heijde D, et al. Response criteria for clinical trials on osteoarthritis of the knee and hip: a report of the Osteoarthritis Research Society International Standing Committee for Clinical Trials response criteria initiative. Osteoarthritis Cartilage 2000;8:395-403 (Pubitemid 32000962)
    • (2000) Osteoarthritis and Cartilage , vol.8 , Issue.6 , pp. 395-403
    • Dougados, M.1    LeClaire, P.2    Van Der Heijde, D.3    Bloch, D.A.4    Bellamy, N.5    Altman, R.D.6
  • 36
    • 33847420941 scopus 로고    scopus 로고
    • 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
    • DOI 10.1093/rheumatology/kel296
    • Bingham III CO, Sebba Al, Rubin BR, et al. 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) 2007;46:496-507 (Pubitemid 46344665)
    • (2007) Rheumatology , vol.46 , Issue.3 , pp. 496-507
    • Bingham III, C.O.1    Sebba, A.I.2    Rubin, B.R.3    Ruoff, G.E.4    Kremer, J.5    Bird, S.6    Smugar, S.S.7    Fitzgerald, B.J.8    O'Brien, K.9    Tershakovec, A.M.10
  • 40
    • 0034041594 scopus 로고    scopus 로고
    • Rofecoxib, a specific inhibitor of cyclooxygenase 2, with clinical efficacy comparable with that of diclofenac sodium: Results of a one-year, randomized, clinical trial in patients with osteoarthritis of the knee and hip
    • DOI 10.1002/1529-0131(200005)43 :5<978::AID-ANR4>3.0.CO;2-0
    • Cannon GW, Caldwell JR, Holt P, et al. Rofecoxib, a specific inhibitor of cyclooxygenase 2, with clinical efficacy comparable with that of diclofenac sodium: results of a one-year, randomized, clinical trial in patients with osteoarthritis of the knee and hip. Rofecoxib Phase III Protocol 035 Study Group. Arthritis Rheum 2000;43:978-87 (Pubitemid 30368173)
    • (2000) Arthritis and Rheumatism , vol.43 , Issue.5 , pp. 978-987
    • Cannon, G.W.1    Caldwell, J.R.2    Holt, P.3    McLean, B.4    Seidenberg, B.5    Bolognese, J.6    Ehrich, E.7    Mukhopadhyay, S.8    Daniels, B.9
  • 41
    • 0242552926 scopus 로고    scopus 로고
    • Comparing the Efficacy of Cyclooxygenase 2-Specific Inhibitors in Treating Osteoarthritis: Appropriate Trial Design Considerations and Results of a Randomized, Placebo-Controlled Trial
    • DOI 10.1002/art.11330
    • Gibofsky A, Williams GW, McKenna F, et al. Comparing the efficacy of cyclooxygenase 2-specific inhibitors in treating osteoarthritis: appropriate trial design considerations and results of a randomized, placebo-controlled trial. Arthritis Rheum 2003;48:3102-11 (Pubitemid 37409321)
    • (2003) Arthritis and Rheumatism , vol.48 , Issue.11 , pp. 3102-3111
    • Gibofsky, A.1    Williams, G.W.2    McKenna, F.3    Fort, J.G.4
  • 44
    • 56049109217 scopus 로고    scopus 로고
    • The placebo effect and its determinants in osteoarthritis: Meta-analysis of randomised controlled trials
    • Zhang W, Robertson J, Jones AC, et al. The placebo effect and its determinants in osteoarthritis: meta-analysis of randomised controlled trials. Ann Rheum Dis 2008;67:1716-23
    • (2008) Ann Rheum Dis , vol.67 , pp. 1716-23
    • Zhang, W.1    Robertson, J.2    Jones, A.C.3
  • 45
    • 77955302956 scopus 로고    scopus 로고
    • PN400 significantly reduces the incidence of gastric ulcers compared with enteric-coated naproxen in patients requiring chronic NSAID therapy regardless of low-dose aspirin use: Results from two prospective, randomized controlled trials
    • Goldstein JL, Hochberg MC, Fort JG, et al. PN400 significantly reduces the incidence of gastric ulcers compared with enteric-coated naproxen in patients requiring chronic NSAID therapy regardless of low-dose aspirin use: results from two prospective, randomized controlled trials. Arthritis Rheum 2009;60(Suppl. 10):S314
    • (2009) Arthritis Rheum , vol.60 , Issue.SUPPL. 10
    • Goldstein, J.L.1    Hochberg, M.C.2    Fort, J.G.3
  • 46
    • 77954345502 scopus 로고    scopus 로고
    • PN400 significantly improved upper gastrointestinal tolerability compared with enteric-coated naproxen alone in patients requiring chronic NSAID therapy: Results from two prospective, randomized controlled trials
    • Goldstein JL, Hochberg MC, Fort JG, et al. PN400 significantly improved upper gastrointestinal tolerability compared with enteric-coated naproxen alone in patients requiring chronic NSAID therapy: results from two prospective, randomized controlled trials. Am J Gastroenterol 2009; 104(Suppl. 3):S50
    • (2009) Am J Gastroenterol , vol.104 , Issue.SUPPL. 3
    • Goldstein, J.L.1    Hochberg, M.C.2    Fort, J.G.3


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