Original Contribution | Published:

Efficacy and safety of esomeprazole compared with omeprazole in GERD patients with erosive esophagitis: a randomized controlled trial

American Journal of Gastroenterology volume 96, pages 656665 (2001) | Download Citation

This study has been presented as a poster at Digestive Disease Week 2000.

Subjects

Abstract

OBJECTIVE:

In patients with gastroesophageal reflux disease (GERD), esomeprazole, the S-isomer of omeprazole, has demonstrated pharmacological and clinical benefits beyond those seen with the racemic parent compound. This study was designed to further evaluate the efficacy and tolerability of esomeprazole relative to that of omeprazole in healing erosive esophagitis and resolving accompanying symptoms of GERD.

METHODS:

Esomeprazole 40 mg was compared with omeprazole 20 mg once daily in 2425 patients with erosive esophagitis (Helicobacter pylori negative by serology) in an 8-wk, multicenter, randomized, double-blind, parallel-group study conducted in 163 centers throughout the US. The primary efficacy endpoint was the proportion of patients with healed esophagitis at wk 8. Secondary endpoints were the proportion of patients healed at wk 4, resolution of heartburn at wk 4, time to first resolution and sustained resolution of heartburn, and proportion of heartburn-free days and nights. Safety and tolerability were also assessed.

RESULTS:

Significantly more patients were healed with esomeprazole versus omeprazole at wk 8 (93.7% vs 84.2%, p < 0.001; life table estimates, intention-to-treat analysis). Healing rates at wk 4 were 81.7% and 68.7%, respectively. Esomeprazole was superior to omeprazole for all secondary measures and had a similar safety profile. The most common adverse events in both treatment groups were headache, diarrhea, and nausea.

CONCLUSIONS:

Esomeprazole demonstrates significantly greater efficacy than omeprazole in the treatment of GERD patients with erosive esophagitis. The tolerability and safety of esomeprazole are comparable to that of omeprazole.

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References

  1. 1.

    . Epidemiology and natural history of gastro-oesophageal reflux disease. Digestion 1992;51: 24–29.

  2. 2.

    , . Current diagnosis and treatment of gastroesophageal reflux disease. Mayo Clin Proc 1994;69: 867–876.

  3. 3.

    , . Gastroesophageal reflux disease. Curr Opin Gastroenterol 1998;14: 326–333.

  4. 4.

    , , , et al. The Second Canadian Gastroesophageal Reflux Disease Consensus: Moving forward to new concepts. Can J Gastroenterol 1998;12: 551–556.

  5. 5.

    . Medical treatment of gastroesophageal reflux in the managed care environment. Semin Gastrointest Dis 1997;8: 90–99.

  6. 6.

    , , , et al. The diagnosis and treatment of gastroesophageal reflux disease in a managed care environment: Suggested disease management guidelines. Arch Intern Med 1996;156: 477–484.

  7. 7.

    , , , et al. Cost and quality effects of alternative treatments for persistent gastroesophageal reflux disease. Arch Intern Med 1992;152: 1467–1472.

  8. 8.

    . The pathogenesis of gastroesophageal reflux disease: The relationship between epithelial defense, dysmotility, and acid exposure. Am J Gastroenterol 1997;92: 3S–5S(discussion 5S–7S).

  9. 9.

    , , , et al. Relation between oesophageal acid exposure and healing of oesophagitis with omeprazole in patients with severe reflux oesophagitis (see comments). Gut 1996;38: 649–654.

  10. 10.

    , , , et al. Are esophageal symptoms reflux-related? A study of different scoring systems in a cohort of patients with heartburn. Am J Gastroenterol 1994;89: 497–502.

  11. 11.

    , , , et al. Critical issues in the management of gastroesophageal reflux disease. Eur J Gastroenterol Hepatol 1995;7: 577–586.

  12. 12.

    , . Progress with proton pump inhibition. Yale J Biol Med 1992;65: 649–657(discussion 689–92).

  13. 13.

    . Proton pump inhibitors in acute healing and maintenance of erosive or worse esophagitis: A systematic overview. Can J Gastroenterol 1997;11(suppl B):66B–73B.

  14. 14.

    , , , et al. Two doses of omeprazole versus placebo in symptomatic erosive esophagitis: The U.S. Multicenter Study. Gastroenterology 1992;102: 109–118.

  15. 15.

    , , , et al. Reflux symptom relief with omeprazole in patients without unequivocal oesophagitis. Aliment Pharmacol Ther 1996;10: 547–555.

  16. 16.

    , , , et al. Gastro-oesophageal reflux disease in primary care: An international study of different treatment strategies with omeprazole. International GORD Study Group. Eur J Gastroenterol Hepatol 1998;10: 119–124.

  17. 17.

    , , , et al. Comparison of rabeprazole 20 mg versus omeprazole 20 mg in the treatment of active duodenal ulcer: A European multicentre study. Aliment Pharmacol Ther 1999;13: 179–186.

  18. 18.

    , , , et al. Pantoprazole and omeprazole in the treatment of reflux oesophagitis: A European multicentre study. Aliment Pharmacol Ther 1995;9: 667–671.

  19. 19.

    , , , et al. Lansoprazole and omeprazole in the prevention of relapse of reflux oesophagitis: A long-term comparative study. Aliment Pharmacol Ther 1998;12: 985–990.

  20. 20.

    , , , et al. Efficacy and safety of lansoprazole in the treatment of erosive reflux esophagitis. The Lansoprazole Group. Am J Gastroenterol 1996;91: 1749–1757.

  21. 21.

    , , , et al. Esomeprazole provides improved acid control vs omeprazole in patients with symptoms of gastro-oesophageal reflux disease. Aliment Pharmacol Ther 2000;14: 861–867.

  22. 22.

    , , , et al. Esomeprazole 40 mg provides more effective acid control than omeprazole 40 mg (abstract). Presented at the XXXIInd Nordic Meeting of Gastroenterology, June 18–21, 2000, Goteborg, Sweden.

  23. 23.

    , , , et al. Esomeprazole improves healing and symptom resolution as compared with omeprazole in reflux oesophagitis patients: A randomised controlled trial. Aliment Pharmacol Ther 2000 2000;14: 1249–1258.

  24. 24.

    , , , et al. Endoscopic assessment of oesophagitis: Clinical and functional correlates and further validation of the Los Angeles classification. Gut 1999;45: 172–180.

  25. 25.

    , , , et al. The endoscopic assessment of esophagitis: A progress report on observer agreement. Gastroenterology 1996;111: 85–92.

  26. 26.

    , , , et al. An evidence-based appraisal of reflux disease management—the Gerval Workshop Report. Gut 1999;44: S1–S15.

  27. 27.

    . Pharmacokinetics, metabolism and interactions of acid pump inhibitors. Focus on omeprazole, lansoprazole and pantoprazole (published erratum appears in Clin Pharmacokinet 1996;31:274). Clin Pharmacokinet 1996;31: 9–28.

  28. 28.

    , . Rapid symptom relief in reflux oesophagitis: A comparison of lansoprazole and omeprazole. Aliment Pharmacol Ther 1996;10: 757–763.

  29. 29.

    , , , et al. Lansoprazole versus omeprazole in short-term treatment of reflux oesophagitis. Results of a Scandinavian multicentre trial. Scand J Gastroenterol 1993;28: 224–228.

  30. 30.

    , , . Lansoprazole 30 mg versus omeprazole 40 mg in the treatment of reflux oesophagitis grade II, III and IVa (a Dutch multicentre trial). Dutch Study Group. Eur J Gastroenterol Hepatol 1996;8: 1101–1106.

  31. 31.

    , , , et al. A comparison of omeprazole MUPS 20 mg, lansoprazole 30 mg and pantoprazole 40 mg in the treatment of reflux oesophagitis: A multicenter trial. Gut 1999;45: A39 (abstract).

  32. 32.

    , , . Are there any differences in symptom relief and healing esophagitis between proton pump inhibitors (PPIs): A meta-analysis of comparative trials. Gut 1999;45: A177 (abstract).

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Acknowledgements

We gratefully acknowledge the assistance of David J. Magner, M.S.Hyg., with statistical analyses, Robert Genta, M.D., with evaluating biopsy samples, as well as the diligent efforts of the study coordinators at the investigation sites.

This study was supported by a grant from AstraZeneca LP, Wayne, PA.

Author information

Author notes

Affiliations

  1. Department of Gastroenterology, Cleveland Clinic Foundation, Cleveland, Ohio, USA

    • Joel E Richter
  2. Northwestern University Medical School, Chicago, Illinois, USA

    • Peter J Kahrilas
  3. Rockford Gastroenterology Association, Rockford, Illinois, USA

    • John Johanson
  4. Digestive Disease Research Institute, Oklahoma City, Oklahoma, USA

    • Paul Maton
  5. Center for Medical Research, Manchester, Connecticut, USA

    • Jeffrey R Breiter
  6. AstraZeneca LP, Wayne, Pennsylvania, USA

    • Clara Hwang
    • , Victoria Marino
    • , Bernard Hamelin
    •  & Jeffrey G Levine

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Corresponding author

Correspondence to Joel E Richter.

Appendices

Appendix

The esomeprazole study investigators

D. R. Abrahm, Newport Beach Gastroenterology Associates; M. Ali, A. Arora, Sierra Medical Research; K. Ashby, Harriman Jones Medical Group; R. D. Baerg, Tacoma Digestive Disease Center; C. F. Barish, Wake Research Associates; M. Barreiro, United Medical Associates, PC; I. Bassan, J. G. Beckwith, R. W. Bennetts, Northwest Gastroenterology Clinic; C. Berggreen, W. R. Berry, Longmont Clinic, PC; T. Bianchi, Southern Drug Research Network; D. Biery, C. A. Birbara, Clinical Pharmacology Study Group; P. C. Bird, Research Associates of Norman, Inc.; V. A. Botoman, J. Breiter, Center for Medical Research; J. R. Caldwell, A. Caos, S. Carlson, Coastal Medical Research Group, Inc.; R. Chasen, A. Y. Chen, Monroe Clinic; R. Chiprut, D. C. Chua, Summit Digestive and Liver Disease Specialists; N. Cirillo, L. B. Cohen, C. Colip, Portland Medical Associates; D. W. Collins, Western States Clinical Research, Inc.; D. Dalke, Gastroenterology Specialties, PC; V. A. DeLuca, Jr., Griffin Hospital; J. W. Dimitroff, St. Louis Center for Clinical Research; M. R. Dosch, Clinical Studies, Boynton Beach; J. Doyle, D. W. Dozer, Advanced Clinical Research, LLC; S. L. Duckor, AGMG Clinical Research; M. Efrusy, Olympia Fields Osteopathic Hospital; M. Eisner, Florida Medical Clinic; M. Epstein, Medlantic Investigators Network Inc.; J. F. Ervin, The Center for Pharmaceutical Research; C. Fausel, The Oregon Clinic; S. H. Feldman, Gastroenterology Associates of Fairfield County; R. Finlaw, Southern Colorado Clinic; R. Fogel, Henry Ford Hospital; R. D. Folan, Gastroenterology Association of CO; F. C. Fowler, University Gastroenterology; S. R. Freeman, Mile High Gastroenterology, PC; S. Gaddam, G. Gibbons; H. Giller, Digestive and Liver Disease Consultants, PC; O. D. Gilliam, Health Advance Institute, Inc.; E. Gillie, Medical Studies, Florida; P. B. Goldberg, M. Goldhamer, J. Goldstein, Brachfield Medical Associates; J. Goldstein, University of Illinois at Chicago Medical Center; M. Gorsky, A. Gottesman, Hill Top Research, Inc.; A. Harris, New York Hospital Medical Center; A. Harrison, E. H. Hirsh, R. B. Hogan, II, Mississippi Center for Clinical Research, LLC; J. J. Hsu, The Genesee Hospital; D. S. James, J. Johanson, Rockford Gastroenterology; R. B. Johnson, Sharp Rees Stealy Medical Group; D. A. Johnson, Gastrointestinal and Liver Specialists of Tidewater, PLLC; J. Jolley, J. V. Jones, Jr., Green Clinic; R. Kamyar, Institute of HealthCare Assessment, Inc.; R. D. Kaplan, LeBauer Health Care; S. Katz, Long Island Clinical Research Associates; H. Kavin, Advocate Medical Group-Gastroenterology; P. Kaye, C. S. Kelsey, San Diego Center for Research; P. Kiyasu, The Portland Clinic, LLP; R. Kommor, Health Advance Institute; T. Kovacs, CURE Clinic/West Los Angeles VAMC; G. Koval, West Hills Gastroenterology Associates, PC; R. Krause, The Center for Digestive Disorders and Clinical Research; S. Krumholz, D. Kruss, F. T. Kucer, M. Lamet, F. Lanza, Houston Institute for Clinical Research; J. Leavitt, Gastroenterology Care Center; M. S. Levine, SouthEast Research Associates, Inc.; T. Liebermann, Center for Clinical Research-Austin; L. Lifton, J. Linne, Community Research Management Associates, Inc.; W. R. Lumry, D. M. Maccini, Spokane Digestive Disease Center; M. K. Maden, H. N. Maimon, Dayton Area Research Associates; D. G. Mangels, TQM Research Center; S. Marcuard, Carolina Physicians, PA; R. D. Marks, Alabama Digestive Research Center, LLC; P. Maton, Digestive Disease Research Institute; J. L. Mauldin, ClinSites/SORRA Research Center; R. McCallum, University of Kansas Medical Center; A. McElroy, Multi-Specialty Clinical Research of NE Tennessee; P. Meier, VA Medical Center; T. Mendolia, Medical Park; P. J. Milman, P. B. Miner, Jr., Oklahoma Foundation for Digestive Research; L. Morton, S. Moussa, Advanced Clinical Therapeutics; R. V. Movva, Midwest Clinical Research Associates Ltd.; Z. Munk, Breco Research, Inc.; L. Newell, North Carolina Clinical Research, Inc.; T. Nichols, Jr., Center for Nutrition and Digestive Disorders; J. S. Novick, Charm City Research; C. Olson, Gould Medical Foundation; D. J. Pambianco, Charlottesville Gastroenterology Associates; P. M. Pardoll, Center for Digestive Diseases; W. A. Pearce, Rainier Clinical Research Center, Inc.; L. Peters, B. H. Plotnick, RUSH North Shore Medical Center; J. M. Provenza, Gastrointestinal Specialists, AMC; A. Reddy, Gastroenterology Research and Development Center; D. S. Riff, AGMG Clinical Research; M. A. Ringold, Lynn Health Science Institute; A. Rodriguez, Digestive Disease Clinic; R. D. Rothstein, University of Pennsylvania Hospital; H. A. Rubin, D. A. Ruff, Healthcare Discoveries, PA; V. Rustgi, S. Safavi, M. Safdi, Consultants for Clinical Research, Inc.; B. Sahba, California Research Foundation; B. Salzberg, P. Schleinitz, Gastroenterology Consultants, PC; C. M. Schmitt, Southeastern Clinical Research; J. Schneier, H. Schwartz, J. Schwartz, Northwest Gastroenterologists, SC; M. E. Schwartz, Jupiter Research Associates; A. Shah, U. K. Shah, Philip J. Bean Medical Center; R. Shaker, Medical College of Wisconsin; J. C. Shallcross, Jr., ClinSites/SORRA Research Center; B. Shivakumar, D. Siegel, Doctors Research Associates of Maryland; T. Simmons, S. Singh, W. J. Snape, Jr., E. J. Spiotta, D. B. Stanton, Community Clinical Trials; R. Steller, Long Island Gastroenterology Group, PC; L. Strong, Aspen Medical Group; R. W. Tobin, Seattle Gastroenterology Associates, PS; J. Turse, Health Advance Institute; N. B. Vakil, Sinai Samaritan Medical Center; J. B. Wagonfeld, Digestive Health Specialists; L. M. Weiss, Clinical Research of West Florida; S. Wilkofsky, Metroplex Clinical Research Center; P. E. Williams, Little Rock Diagnostic Clinic; J. A. Winder, Toledo Center for Clinical Research; B. D. Winston, Houston Medical Research Associates; P. Witt, Greeley Medical Clinic; R. A. Wohlman, Northwest Gastroenterology Associates.

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DOI

https://doi.org/10.1111/j.1572-0241.2001.3600_b.x