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ORIGINAL ARTICLE

A fixed-dose combination of naproxen and esomeprazole magnesium has comparable upper gastrointestinal tolerability to celecoxib in patients with osteoarthritis of the knee: Results from two randomized, parallel-group, placebo-controlled trials

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Pages 594-605 | Received 29 Jul 2011, Accepted 16 Sep 2011, Published online: 22 Oct 2011

References

  • Altman R, Hochberg MC, Moskowitz RW, Schnitzer TJ. 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.
  • Desai SP, Solomon DH, Abramson SP, Buckley L, Crofford L, Cush JJ, . Recommendations for use of selective and nonselective nonsteroidal antiinflammatory drugs: an American College of Rheumatology white paper. Arthritis Rheum. 2008;59:1058–73.
  • Lanza FL, Chan FK, Quigley EMM. Guidelines for prevention of NSAID-related ulcer complications. Am J Gastroenterol. 2009;104:728–38.
  • 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 (accessed 17 December 2010).
  • Zhang W, Doherty M, Arden N, Bannwarth B, Bijlsma J, Gunther K-P, . 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;64:669–81.
  • Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, . OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage. 2008;16:137–62.
  • Straus WL, Ofman JJ, MacLean C, Morton S, Berger ML, Roth EA, . Do NSAIDs cause dyspepsia? A meta-analysis evaluating alternative dyspepsia definitions. Am J Gastroenterol. 2002;97:1951–8.
  • Silverstein FE, Graham DY, Senior JR, Davies HW, Struthers BJ, Bittman RM, . 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;123:241–9.
  • Talley NJ; American Gastroenterological Association. American Gastroenterological Association medical position statement: evaluation of dyspepsia. Gastroenterology. 2005;129: 1753–5.
  • Scheiman JM. The impact of nonsteroidal anti-inflammatory drug-induced gastropathy. Am J Manag Care. 2001;7: S10–14.
  • Spiegel BMR, Farid M, Dulai GS, Gralnek IM, Kanwal F. Comparing rates of dyspepsia with coxibs vs NSAID + PPI: a meta-analysis. Am J Med. 2006;119:448.e27–36.
  • Laine L, Curtis SP, Cryer B, Kaur A, Cannon CP. Risk factors for NSAID-associated upper GI clinical events in a long-term prospective study of 34 701 arthritis patients. Aliment Pharmacol Ther. 2010;32:1240–8.
  • Antman EM, Bennett JS, Daugherty A, Furberg C, Roberts H, Taubert KA. Use of nonsteroidal antiinflammatory drugs: an update for clinicians: a scientific statement from the American Heart Association. Circulation. 2007;115:1634–42.
  • Bhatt DL, Scheiman J, Abraham NS, Antman EM, Chan FK, Furberg CD, . 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.
  • Chan FKL, Abraham NS, Scheiman JM, Laine L. 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.
  • Scheiman JM, Fendrick AM. Summing the risk of NSAID therapy. Lancet. 2007;369:1580–1.
  • Lai K-C, Chu K-M, Hui W-M, Wong BCY, Hu WHC, Wong W-M, . Celecoxib compared with lansoprazole and naproxen to prevent gastrointestinal ulcer complications. Am J Med. 2005;118:1271–8.
  • Hawkey CJ, Jones RH, Yeomans ND, Scheiman JM, Talley NJ, Goldstein JL, . 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;25:813–21.
  • Hawkey C, Talley NJ, Yeomans ND, Jones R, Sung JJ, Langstrom G, . Improvements with esomeprazole in patients with upper gastrointestinal symptoms taking non-steroidal antiinflammatory drugs, including selective COX-2 inhibitors. Am J Gastroenterol. 2005;100:1028–36.
  • Latimer N, Lord J, Grant RL, O'Mahony R, Dickson J, Conaghan PG, . Cost effectiveness of COX 2 selective inhibitors and traditional NSAIDs alone or in combination with a proton pump inhibitor for people with osteoarthritis. BMJ. 2009;339:b2538.
  • Sturkenboom MCJM, Burke TA, Dieleman JP, Tangelder MJD, Lee F, Goldstein JL. Underutilization of preventive strategies in patients receiving NSAIDs. Rheumatology (Oxford). 2003;42 (Suppl 3):iii23–31.
  • Goldstein JL, Howard KB, Walton SM, McLaughlin TP, Kruzikas DT. Impact of adherence to concomitant gastroprotective therapy on nonsteroidal-related gastroduodenal ulcer complications. Clin Gastroenterol Hepatol. 2006;4:1337–45.
  • Sturkenboom MCJM, Burke TA, Tangelder MJD, Dieleman JP, Walton S, Goldstein JL. Adherence to proton pump inhibitors or H2-receptor antagonists during the use of non-steroidal anti-inflammatory drugs. Aliment Pharmacol Ther. 2003;18:1137–47.
  • Abraham NS, El-Serag HB, Johnson ML, Hartman C, Richardson P, Ray WA, . National adherence to evidence-based guidelines for the prescription of nonsteroidal anti-inflammatory drugs. Gastroenterology. 2005;129:1171–8.
  • Abraham NS, Hartman C, Castillo D, Richardson P, Smalley W. Effectiveness of national provider prescription of PPI gastroprotection among elderly NSAID users. Am J Gastroenterol. 2008;103:323–32.
  • van Soest EM, Sturkenboom MCJM, Dieleman JP, Verhamme KMC, Siersema PD, Kuipers EJ. Adherence to gastroprotection and the risk of NSAID-related upper gastrointestinal ulcers and haemorrhage. Aliment Pharmacol Ther. 2007;26:265–75.
  • Food and Drug Administration (FDA). VIMOVO™ prescribing information. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022511lbl.pdf (accessed 17 December 2010).
  • Electronic Medicines Compendium (eMC). Summary of Product Characteristics. VIMOVO 500 mg/20 mg modified-release tablets. Available at: http://www.medicines.org.uk/EMC/medicine/23883/SPC/VIMOVO+500+mg+20+mg+modified-release+tablets (accessed 17 December 2010).
  • Hochberg MC, Fort JG, Svensson O, Hwang C, Sostek M. Fixed-dose combination of enteric-coated naproxen and immediate-release esomeprazole has comparable efficacy to celecoxib for knee osteoarthritis: two randomized trials. Curr Med Res Opin. 2011;27:1243–53.
  • Welle J, Fort J, Crawley J, Cryer B, Dickerhoof R, Turner MP, . Modified Severity of Dyspepsia Assessment pain scale: a new tool for measuring upper abdominal pain in osteoarthritis patients taking NSAIDs. Patient Relat Outcome Meas. 2011;2:135–43.
  • Rabeneck L, Cook KF, Wristers K, Souchek J, Menke T, Wray NP. SODA (severity of dyspepsia assessment): a new effective outcome measure for dyspepsia-related health. J Clin Epidemiol. 2001;54:755–65.
  • Rabeneck L. Measuring dyspepsia-related health in randomized trials: the Severity of Dyspepsia Assessment (SODA) and its use in treatment with NSAIDs and COX-2-specific inhibitors. Rheumatology (Oxford). 2003;42 (Suppl 3):iii32–9.
  • Rabeneck L, Goldstein JL, Vu A, Mayne TJ, Rublee DA. Valdecoxib is associated with improved dyspepsia-related health compared with nonspecific NSAIDs in patients with osteoarthritis or rheumatoid arthritis. Am J Gastroenterol. 2005;100:1043–50.
  • Rabeneck L, Wristers K, Goldstein JL, Eisen G, Dedhiya SD, Burke TA. 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.
  • Goldstein JL, Hochberg MC, Fort JG, Zhang Y, Hwang C, Sostek M. 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.
  • Goldstein JL, Hwang C, Datto C. Correlation of two patient-reported outcomes to assess dyspepsia: patients listening to their gut feeling. Poster presented at the American College of Gastroenterology Annual Scientific Meeting, San Antonio, TX, USA, 15–20 October 2010.
  • Sostek M, Fort J, Estborn L, Vikman K. Long-term safety of naproxen and esomeprazole magnesium fixed-dose combination: phase III study in patients at risk for NSAID-associated gastric ulcers. Curr Med Res Opin. 2011;27: 847–54.

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