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A Multicenter, Randomized, Double-Blind, 8-Week Comparative Trial of Standard Doses of Esomeprazole (40 mg) and Omeprazole (20 mg) for the Treatment of Erosive Esophagitis

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An Erratum to this article was published on 01 May 2006

An Erratum to this article was published on 01 May 2006

An Erratum to this article was published on 01 May 2006

Abstract

To compare esomeprazole with omeprazole for healing erosive esophagitis (EE), 1148 patients with endoscopically confirmed EE were randomized to once-daily esomeprazole, 40 mg, or omeprazole, 20 mg, for 8 weeks in this multicenter, double-blind, parallel-group trial. The primary outcome was the proportion of patients with healed EE at week 8. Secondary outcomes included diary and investigator assessments of heartburn symptoms. At week 8, estimated healing rates were 92.2% (95% CI, 89.9%–94.5%) with esomeprazole and 89.8% (95% CI, 87.2%–92.4%) with omeprazole. Healing rates with esomeprazole were significantly higher than those with omeprazole at weeks 8 (88.4% vs 77.5%; P = 0.007) and 4 (60.8% vs 47.9%; P = 0.02) in patients with moderate to severe (Los Angeles grade C or D) EE at baseline but were not significantly different for patients with mild (Los Angeles grade A or B) EE. Both treatments were comparable for other secondary measures and had similar tolerability profiles.

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Acknowledgments

The authors thank Robert Genta, MD (Houston, TX), and Roberto Fiocia, MD, and Guido Rindo, MD (Pavia, Italy), for evaluation of slides; Caroline Spencer and Mary Wiggin for editorial assistance (supported by AstraZeneca LP); the study coordinators and patients for their participation; and the following trial investigators: Jeffrey Adelglass, Dallas, TX; Marcelo Barreiro, Binghamton, NY; Charles Berggreen, Baton Rouge, LA; Arthur L. Berman, Clearwater, FL; John Birk, Stony Brook, NY; Charles Bliss, Boston, MA; Jeffrey Breiter, Manchester, CT; Craig E. Chamberlain, Eugene, OR; Edward Cheng, Northport, NY; Steven Chetham, Boulder, CO; David Chang Chua, Oakbrook Terrace, IL; Doug Dalke, Lincoln, NE; Stephen E. Deal, Charlotte, NC; Caroline Diamant, La Jolla, CA; James Doyle, Spokane, WA; David Wesley Dozer, Milwaukee, WI; John Ervin, Kansas City, MO; Saul Feldman, Bridgeport, CT; Duane Fitch, Wilson, NC; Oliver Gilliam, South Bend, IN; Edward Gillie, Ft. Myers, FL; Jay Goldstein, Chicago, IL; Michael Gorsky, Beavercreek, OH; Ronald Griffin, Loma Linda, CA; Louis Gringeri, Newtown, PA; Aaron Harrison, Bay Shore, NY; Susan Hole, South Daytona, FL; Joseph J. Hsu, Rochester, NY; Richard Jaszewski, Detroit, MI; James Harvey Johnston, III, Jackson, MS; James V. Jones, Ruston, LA; Maria A. Jurado, Boynton Beach, FL; Peter Kaufman, Silver Springs, MD; Christopher S. Kelsey, San Diego, CA; Philip Kiyasu, Portland, OR; Dennis Kokenes, Charlotte, NC; Richard Krause, Chattanooga, TN; Michael Lawson, Sacramento, CA; Robert A. Levine, Syracuse, NY; Boris Libster, Haddon Heights, NJ; Thomas Ma, Long Beach, CA; David G. Mangels, Cincinnati, OH; Aubrey McElroy, Johnson City, TN; Dale McGinty, Shreveport, LA; Philip Miner, Jr., Oklahoma City, OK; Barry M. Miskin, West Palm Beach, FL; Luette Morton, Englewood, CO; Morry Moskovitz, Beaver, PA; Zev Munk, Houston, TX; Mark Murphy, Savannah, GA; Howard L. Offenberg, Gainesville, FL; Lenin Peters, High Point, NC; Martin Poleski, La Jolla, CA; Joseph Reddy, San Diego, CA; Seymour Sabesin, Chicago, IL; Michael Safdi, Cincinnati, OH; Bruce Salzberg, Atlanta, GA; Paul Schleinitz, Medford, OR; Michael Schwartz, Jupiter, FL; Larry Scott, Houston, TX; Bavikatte Shivakumar, Davenport, IA; Roger Soloway, Galveston, TX; David Stanton, Mission Viejo, CA; Lewis Strong, Loveland, CO; Arthur Talansky, Great Neck, NY; David Talenti, Sayre, PA; Thomas Tietjen, Cheyenne, WY; Steven J. Wegley, Seattle, WA; Paul E. Williams, Little Rock, AR; Barry Winston, Houston, TX; Richard Wright, Louisville, KY; and Marc Zuckerman, El Paso, TX.

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Authors and Affiliations

  1. Galen Medical Group, 979 East 3rd Street, Suite C-520, Chattanooga, Tennessee, 37403, USA

    Colleen Schmitt

  2. Columbia-Presbyterian Medical Center, New York, New York, USA

    Charles J. Lightdale

  3. AstraZeneca LP, Wilmington, Delaware, USA

    Clara Hwang

  4. AstraZeneca, France

    Bernard Hamelin

Authors
  1. Colleen Schmitt
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  2. Charles J. Lightdale
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  3. Clara Hwang
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  4. Bernard Hamelin
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Corresponding author

Correspondence to Colleen Schmitt.

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An erratum to this article can be found at http://dx.doi.org/10.1007/s10620-006-9434-4

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Schmitt, C., Lightdale, C.J., Hwang, C. et al. A Multicenter, Randomized, Double-Blind, 8-Week Comparative Trial of Standard Doses of Esomeprazole (40 mg) and Omeprazole (20 mg) for the Treatment of Erosive Esophagitis. Dig Dis Sci 51, 844–850 (2006). https://doi.org/10.1007/s10620-005-9062-4

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  • DOI: https://doi.org/10.1007/s10620-005-9062-4

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