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A Multicenter, Randomized, Double-Blind, 8-Week Comparative Trial of Low-Dose Esomeprazole (20 mg) and Standard-Dose Omeprazole (20 mg) in Patients with Erosive Esophagitis

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Abstract

The objective of this trial was to compare the efficacy of esomeprazole, 20 mg, with that of omeprazole, 20 mg, in patients with erosive esophagitis (EE). In this multicenter, double-blind, parallel-group trial, 1176 patients with EE confirmed by endoscopy (Helicobacter pylori-negative by serology) were randomized to once-daily treatment with 20 mg esomeprazole or 20 mg omeprazole for 8 weeks. The primary outcome was the proportion of patients with healed EE through week 8. Secondary outcomes included diary and investigator assessments of heartburn symptoms. Cumulative life-table healing rates at week 8 were similarly high for 20 mg esomeprazole (90.6%; 95% confidence interval, 88.1%–93%) and 20 mg omeprazole (88.3%; 95% confidence interval, 85.5%–91.0%). The two treatments were comparable for other secondary measures and had similar tolerability profiles.

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Acknowledgments

The authors thank Robert Genta, M.D. (Houston, TX), and Roberto Fiocia, M.D., and Guido Rindo, M.D. (Pavia, Italy), for evaluation of slides; Caroline Spencer and Mary Wiggin for editorial assistance (supported by AstraZeneca); the study coordinators and patients for their participation; and the following trial investigators—David Aarons, Lodi, CA; H. Steven Aharonian, Mission Hills, CA; Ajit Arora, Fresno, CA; Richard D. Baerg, Tacoma, WA; Jay Beckwith, Fort Worth, TX; William Berry, Longmont, CO; William Bray, Charlotte, NC; Steven W. Carlson, San Luis Obispo, CA; Richard Chasen, Laurel, MD; An Yu Chen, Monroe, WI; Yang Chen, Loma Linda, CA; Gene Chiao, Indianapolis, IN; Nicolas Cirillo, Wilkesboro, NC; Charles Colip, Portland, OR; Florian Cortese, Butte, MT; Michael G. DeLissio, Cary, NC; Vincent DeLuca, Derby, CT; James Dimitroff, St. Louis, MO; Ben Dolin, Peoria, IL; Mark Eisner, Zephyrills, FL; Michael Epstein, Annapolis, MD; Gary Falk, Cleveland, OH; Steven Fein, Pasadena, TX; Robert Finlaw, Puebleo, CO; Ronald Fogel, Detroit, MI; Harvey Giller, Clive, IA; Howard Gogel, Albuquerque, NM; Michael Goodman, Chattanooga, TN; Eugene Hirsh, Atlanta, GA; Lynne Hopkins, Winter Park, FL; Keith Hussey, Naples, FL; Rokay Kamyar, La Mesa, CA; Seymour Katz, Great Neck, NY; Lloyd King, Decatur, GA; Ross Kommor, Marietta, GA; Robert Kornfield, Rochester, NY; Thomas Kovacs, Los Angeles, CA; Steven Krumholz, West Palm Beach, FL; Daniel Kruss, Oak Park, IL; Mark Lamet, Hollywood, FL; Frank Lanza, Houston, TX; Loth E. Lieberstein, Reno, NV; James Linne, Cincinnati, OH; Stefan Marcuard, Greenville, NC; Paul Maton, Oklahoma City, OK; Richard McCallum, Kansas City, KS; Hooshang Meshkinpour, Orange, CA; Sam E. Moussa, Tucson, AZ; Rao Movva, Moline, IL; Lanning Newell, Raleigh, NC; Trent Nichols, Jr., Hanover, PA; James S. Novick, Baltimore, MD; Calvin Olson, Modesto, CA; Terryl Jean Ortego, Springdale, AR; Marcos Pedrosa, Boston, MA; J. Mark Provenza, Shreveport, LA; Charles Randall, San Antonio, TX; Roderick Rapier, San Diego, CA; Jean-Pierre Raufman, Little Rock, AR; Adisesha Reddy, Tuscaloosa, AL; Dennis S. Riff, Anaheim, CA; Mark Ringold, Oklahoma City, OK; Gary Rosman, Egg Harbor Township, NJ; Herbert A. Rubin, Beverly Hills, CA; Vinod Rustgi, Fairfax, VA; Bruce Sahba, San Diego, CA; James Scheiman, Ann Arbor, MI; Jerrold L. Schwartz, Arlington Heights, IL; Ronald Schwarz, Raleigh NC; Ann Silverman, Royal Oak, MI; David R. Silvers, Metairier, LA; Sudeep Singh, Fresno, CA; Jack Soterakis, Manhasset, NY; Richard Stellar, Merrick, NY; Abdul Thannoun, Amarillo, TX; James Wagonfield, Tacoma, WA; Steven Wilkofsky, Dallas, TX; John Winder, Sylvania, OH; Robert Wohlman, Bellevue, WA.

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Authors and Affiliations

  1. Columbia-Presbyterian Medical Center, Harkness Pavillion, 7th Floor, Room 712, New York, New York 10032, USA

    Charles J. Lightdale

  2. Galen Medical Group, Chattanooga, Tennessee, USA

    Colleen Schmitt

  3. AstraZeneca LP, Wilmington, Delaware, USA

    Clara Hwang

  4. AstraZeneca, 1, place Louis Renault, 92844, Rueil-Malmaison, France

    Bernard Hamelin

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  1. Charles J. Lightdale
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  2. Colleen Schmitt
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  3. Clara Hwang
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  4. Bernard Hamelin
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Correspondence to Charles J. Lightdale.

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Lightdale, C.J., Schmitt, C., Hwang, C. et al. A Multicenter, Randomized, Double-Blind, 8-Week Comparative Trial of Low-Dose Esomeprazole (20 mg) and Standard-Dose Omeprazole (20 mg) in Patients with Erosive Esophagitis. Dig Dis Sci 51, 852–857 (2006). https://doi.org/10.1007/s10620-005-9071-3

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  • DOI: https://doi.org/10.1007/s10620-005-9071-3

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