Rapid Communication | Published:

Esomeprazole once daily for 6 months is effective therapy for maintaining healed erosive esophagitis and for controlling gastroesophageal reflux disease symptoms: a randomized, double-blind, placebo-controlled study of efficacy and safety

American Journal of Gastroenterology volume 96, pages 2734 (2001) | Download Citation


  • An Addendum to this article was published on 01 March 2001



Esomeprazole, the S-isomer of omeprazole, achieves a significantly greater healing rate and symptom resolution of erosive esophagitis than that achieved by omeprazole. The objective of this study is to assess the efficacy of the new proton pump inhibitor esomeprazole in preventing relapse over a prolonged period in patients with healed erosive esophagitis.


A total of 318 gastroesophageal reflux patients whose erosive esophagitis was healed in a comparative study of esomeprazole 40 mg, 20 mg, or omeprazole 20 mg, were randomized to maintenance therapy with once daily esomeprazole 40 mg, 20 mg, or 10 mg, or placebo in a U.S., double-blind multicenter trial.


After 6 months, healing was maintained (cumulative life table rates) in 93.6% (95% CI 87.4–99.7) of patients treated with esomeprazole 40 mg, 93.2% (95% CI 87.4–99.0) treated with esomeprazole 20 mg, and 57.1% (95% CI 45.2–69) treated with esomeprazole 10 mg; p < 0.001 vs placebo (29.1%; 95% CI 17.7–40.3). Of patients relapsing, mean time to first recurrence of esophagitis increased with dose, from 34 days (placebo) to 78 days (10 mg), 115 days (20 mg), and 163 days (40 mg). Patients treated with esomeprazole had less frequent and less severe heartburn than those treated with placebo. At month 6, more than 70% of patients being treated with esomeprazole remained symptom-free.


Esomeprazole is effective and well tolerated in the maintenance of a healing erosive esophagitis. Esomeprazole 40 mg and 20 mg maintain healing in over 90% of patients while providing effective control of heartburn symptoms.

Access optionsAccess options

Rent or Buy article

Get time limited or full article access on ReadCube.


All prices are NET prices.


  1. 1.

    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.

  2. 2.

    , , , 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.

  3. 3.

    Duodenal ulcer and gastroesophageal reflux disease today: Long-term therapy—a sideways glance. Yale J Biol Med 1996;69:211–224.

  4. 4.

    , , , et al. An evidence-based appraisal of reflux disease management—the Genval Workshop report. Gut 1999;44(suppl 2):S1–S16.

  5. 5.

    , , , et al. A comparison of five maintenance therapies for reflux esophagitis(comments). N Engl J Med 1995;333:1106–1110

  6. 6.

    , , , et al. Pharmacokinetics and dose-response relationship of esomeprazole. Presented at the VIIth World Congress on Clinical Pharmacology and Therapeutics, July 15–20, 2000, Florence, Italy (CPT Abstract page 241).

  7. 7.

    , , , et al. Pharmacokinetics (PK) and effect on pentagastrin stimulated peak acid output (PAO) of omeprazole (O) and its two optical isomers, S-omeprazole/esomeprazole (E) and R-omeprazole (R-O). Presented at the VIIth World Congress on Clinical Pharmacology and Therapeutics, July 15–20, 2000, Florence, Italy (CPT Abstract page 241).

  8. 8.

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

  9. 9.

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

  10. 10.

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

  11. 11.

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

  12. 12.

    , , , et al. Classification and grading of gastritis. The updated Sydney System. International Workshop on the Histopathology of Gastritis, Houston 1994. Am J Surg Pathol 1996;20:1161–1181.

  13. 13.

    , , , et al. Hyperplastic, dysplastic, and neoplastic enterochromafin-like cell proliferation of the gastric mucosa. Classification and histogenesis. Am J Surg Pathol 1995;19(suppl 1):S1–S7.

  14. 14.

    , , , et al. Natural history, clinicopathologic classification and prognosis of gastric ECL cell tumors. Yale J Biol Med 1998;71:285–290.

  15. 15.

    , , , et al. Safety of long-term treatment with a new PPI, esomeprazole in GERD patients. Gastroenterology 2000;118:A–16 (abstract).

  16. 16.

    , , Quality of life in patients with upper gastrointestinal symptoms: Results from the Domestic/International Gastroenterology Surveillance Study (DIGEST). Scand J Gastroenterol 1999;34(suppl 231):48–54.

  17. 17.

    , , , et al. The usefulness of a structured questionnaire in the assessment of symptomatic gastroesophageal reflux disease. Scand J Gastroenterol 1998;33:1023–1029.

  18. 18.

    , , , et al. Safety and efficacy of long-term treatment with esomeprazole in patients with healed erosive esophagitis (EE). Gastroenterology 2000;118:A–16 (abstract).

Download references


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

An abstract of this study has been presented at a poster session at Digestive Disease Week, San Diego, California, May 15–17, 2000.

The Esomeprazole Study Investigators are: S. Bank, Long Island Jewish Medical Center; C.F. Barish; M.M. Berenson, University of Utah Hospital; T. Bianchi, Community Med Arts Center; C.A. Birbara, Clinical Pharmacology Study Group; P.C. Bird, Research Associates of Norman, Inc.; J.R. Caldwell; A. Caos; R. Chiprut, Research Foundation of America, LLC; J. Davis, Jackson Foundation/Physicians Plus; D.S. Dickinson, Alabama Gastroenterology; M. Draelos, Cornerstone Research Care; M. Eisner, Florida Medical Clinic, Clinical Research; C. Fausel, The Oregon Clinic, P.C.-GI Division; S. Fitzgerald, Piedmont Medical Research Association; F.C. Fowler, University of Gastroenterology; M. Goldhamer; J. Goldstein, Brachfeld Medical Associates; A. Gottesman, Hill Top Research, Inc.; P.J. Gulden, Southeastern Clinical Research Consultants; W.V. Harford, Dallas VAMC; D. Hassman, FPA Medical Group; R.B. Johnson, Sharp Rees-Stealy Medical Group; R. Kamyar, Institute of HealthCare Assessment, Inc; J. Klingenstein; G. Koval, St. Vincent Hospital; F.T. Kucer, Grand View Medical Research; M.D. Kurtz, Research Across America; M. Lamet; S. Levenson; J.S. Levine, University of Colorado Health Sciences Center; M.S. Levine, Digestive Care Associates; D. Maccini; S. Marcuard, Medical Center Gastroenterology, R. Marks, ClinSites/SORRA Research Center; D.J. Pambianco, CGA Research; P.M. Pardoll, Center for Digestive Diseases; W.A. Pearce, Rainier Clinical Research Center, Inc; R.E. Pruitt; D.S. Riff, Associated Gastroenterology Medical Group; J.D. Rogge, Indianapolis Gastroenterology & Hepatology; S. Safavi; T. Simmons, G. Taubman, Allenmore Medical Center; M.S. Touger, Hill Top Research, Inc; P.J. Winkle, Associated Gastroenterology Medical Group; F.R. Zwas.

Author information


  1. Eastern Virginia School of Medicine, Norfolk, Virginia, USA

    • David A Johnson
  2. Georgetown University Medical School, Washington, DC, USA

    • Stanley B Benjamin
  3. University of Wisconsin Medical School, Milwaukee, Wisconsin, USA

    • Nimish B Vakil
  4. University of Illinois at Chicago Medical Center, Chicago, Illinois, USA

    • Jay L Goldstein
  5. Private Practice, Hollywood, Florida, USA

    • Mark Lamet
  6. AstraZeneca LP, Wayne, Pennsylvania, USA

    • James Whipple
    • , Donald D'Amico
    •  & Bernard Hamelin


  1. Search for David A Johnson in:

  2. Search for Stanley B Benjamin in:

  3. Search for Nimish B Vakil in:

  4. Search for Jay L Goldstein in:

  5. Search for Mark Lamet in:

  6. Search for James Whipple in:

  7. Search for Donald D'Amico in:

  8. Search for Bernard Hamelin in:

Corresponding author

Correspondence to David A Johnson.

About this article

Publication history






Further reading