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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

Subjects

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

Abstract

OBJECTIVE:

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.

METHODS:

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.

RESULTS:

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.

CONCLUSIONS:

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.

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Acknowledgements

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

Affiliations

  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

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Correspondence to David A Johnson.

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DOI

https://doi.org/10.1111/j.1572-0241.2001.03443.x