OBJECTIVES: Esomeprazole, the S isomer of omeprazole, has been shown to have higher healing rates of erosive esophagitis than omeprazole. This study compared esomeprazole with lansoprazole for the healing of erosive esophagitis and resolution of heartburn.
This United States multicenter, randomized, double blind, parallel group trial was performed in 5241 adult patients (intent-to-treat population) with endoscopically documented erosive esophagitis, which was graded by severity at baseline (Los Angeles classification). Patients received 40 mg of esomeprazole (n = 2624) or 30 mg of lansoprazole (n = 2617) once daily before breakfast for up to 8 wk. The primary efficacy endpoint was healing of erosive esophagitis at week 8. Secondary assessments included proportion of patients healed at week 4, resolution of investigator-recorded heartburn, time to first and time to sustained resolution of patient diary-recorded heartburn, and proportion of heartburn-free days and nights.
Esomeprazole (40 mg) demonstrated significantly higher healing rates (92.6%, 95% CI = 91.5–93.6%) than lansoprazole (30 mg) (88.8%, 95% CI = 87.5–90.0%) at week 8 (p = 0.0001, life-table estimates, intent-to-treat analysis). A significant difference in healing rates favoring esomeprazole was also observed at week 4. The difference in healing rates between esomeprazole and lansoprazole increased as baseline severity of erosive esophagitis increased. Sustained resolution of heartburn occurred faster and in more patients treated with esomeprazole. Sustained resolution of nocturnal heartburn also occurred faster with esomeprazole. Both treatments were well tolerated.
Esomeprazole (40 mg) is more effective than lansoprazole (30 mg) in healing erosive esophagitis and resolving heartburn. Healing rates are consistently high with esomeprazole, irrespective of baseline disease severity.
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We gratefully acknowledge the assistance of Clara S. Hwang, M.S., and Ola Junghard, Ph.D., with statistical analyses; the study coordinators at the investigation sites; and all of the principal investigators. This study was supported by a grant from AstraZeneca LP, Wayne, PA.
The esomeprazole study investigators: D. R. Aarons; D. Abrahm, Newport Beach Orange Coast Endoscopy Center; J. Alcorn, Southwest GI Associates, PC; M. Ali; E. Ang; A. Arora, Sierra Medical Research; D. Avner; A. Bailey, Midstate Medical Building; L. Bank, United Medical Associates; C. F. Barish, Wake Research Associates; G. M. Barton, Arkansas Gastroenterology; I. Bassan; J. Beckman; J. Beckwith, M. D. S. Harris; T. Ben-Menachem, Henry Ford Health System; M. Bennett, Medical Associates Research Group; R. W. Bennetts, Northwest Gastroenterology Clinic; C. Berggreen; P. Berggreen; A. Berlin, Institute of HealthCare Assessment, Inc.; W. R. Berry, Longmont Clinic; T. D. Bianchi, Community Medical Arts Center; P. C. Bird, Research Associates of Norman, Inc.; D. Blalock, Lynn Health Science Institute; B. Bleau, Tacoma Digestive Disease Center; V. A. Botoman, Cleveland Clinic Florida; W. C. Bray, Digestive Health Specialists, PA; J. Breiter, Center for Medical Research LLC; M. Brown, Rush-Presbyterian/St. Luke's Medical Center; K. Buch; J. Caldwell; A. Caos; S. L. Carpenter, Southern Digestive & Liver Disease Institute; D. R. Cave, St. Elizabeth's Medical Center of Boston; A. Chak; T. Chami; R. Chasen, Maryland Digestive Disease Center; E. Cheng, VAMC Northport; D. Chua, Research Concepts, Inc.; N. Cirillo, Western Carolina Digestive Disease Center; L. Cohen, NYGA; C. Colip; C. B. Davis, Monroe Clinic; E. P. DeNoia, Healthcare Discoveries; K. DeVault, Mayo Clinic Jacksonville; P. Dharmarajah; M. R. Dosch, ICSL Clinical Studies; D. W. Dozer, Discovery Research International; M. Draelos, Cornerstone Research Care; S. L. Duckor; C. Eberhart, Doctor's Clinic Research Department; G. Eisen, Vanderbilt University Medical Center; M. Eisner, Clinical Research Division; D. Eskreis, Long Island Clinical Research Associates; P. Eweje, Johnson Digestive Disease Group; C. Fausel, The Oregon Clinic GI; S. Feldman, Gastroenterology Associates of Fairfield County; R. S. Fisher, Temple University Hospital; J. D. Fitterer; I. Flax, Breco Research, Inc.; C. E. Forsmark, University of Florida; F. C. Fowler; S. Frank; B. Freilich; S. Gaddam; L. Gelrud, GI Research; M. Georgetson, Guthrie Clinic, Ltd.; G. D. Gibbons, Remington-Davis, Inc.; L. I. Gilderman, University Clinical Research, Inc.; H. A. Giller, Digestive and Liver Disease Consultants, PC; J. Goff, Western States Clinical Research, Inc.; M. Goldhamer, Michael Goldhamer, MD, Inc.; J. Goldstein, Brachfeld Medical Associates; M. J. Goldstein, Long Island Gastrointestinal Research Group; P. Gonzalez; D. G. Gordon, Danbury Internal Medicine Associates, P.C.; M. Gorsky, Gastrointestinal and Liver Disease Consultants; P. R. Guenthner, The Linder Clinical Trial Center; M. S. Gurney; R. Hansen, Arapahoe Gastroenterology; R. Hardi, Metropolitan Gastroenterology Group, P.C.; A. Harrison; V. Hee, The Vancouver Clinic Inc. PS; E. A. Heller, Digestive Disease Associates of Rockland; E. Hirsh, Gastroenterology Consultants PC; J. Hsu, The ViaHealth Genesee Hospital; J. Hurtado, Advanced Therapeutic Research; D. James; V. Jayanty, Houston Endo. & Research Ctr., Inc.; J. E. Johanson, Rockford Gastroenterology Associates, Ltd.,; D. Johnson, Digestive and Liver Disease Specialists, Ltd.; J. H. Johnson, Mississippi Center for Clinical Research, LLC; R. B. Johnson, Sharp-Rees-Stealy Medical Group; J. Johnston; J. Jolley; J. Jones, Green Clinic; R. S. Jones, Little Rock Diagnostic Clinic; S. Kailas; M. Kajani; R. Kamyar, Institute of HealthCare Assessments, Inc.; R. Kaplan, LeBauer Research Associates, PA; P. Kiyasu, The Portland Clinic, LLP; T. C. Klein, Heartland Research Associates, LLC; R. Knox, Murfreesboro Medical Clinic; R. A. Kommor, Health Advance; K. Kormis; T. O. Kovacs, CURE Clinic/West LA VAMC; G. Koval, West Hills Gastroenterology Associates, PC; R. Krause, Clinsearch; S. Krumholz, Waterside Clinical Research Services Inc.; D. Kruss; F. Kucer, Upper Bucks Medical Arts Building; L. Laine, USC School of Medicine; M. Lamet; F. Lanza; J. S. Leavitt; P. J. Lebovitz, Allegheny Center for Digestive Health; M. S. LeVine, SouthEast Research Associates; R. Lindenberg; J. Lowe; D. Maccini; M. Madan, Rochester Clinical Research; H. N. Maimon, Targeted Research Inc.; S. Malhotra, GI and Hepatology Associate; D. Mangels, TQM Research Inc.; S. P. Marcuard, Carolina Research Center; R. D. Marks, Alabama Digestive Research Center; P. N. Maton, Digestive Diseases Research Institute; A. McElroy, Multi-Specialty Clinical Research; J. Medoff, Medoff Medical/Vital Research; P. B. Meier, VAMC GI Section; T. E. Mendolia; P. J. Milman; P. B. Miner, Oklahoma Foundation for Digestive Research; B. M. Miskin, Palm Beach Research Center; S. M. Mitchell, GI Associates of Colorado Springs, LLP; V. C. Motaparthy; S. E. Moussa; R. V. Movva, Midwest Clinical Research Associates; J. Mueller, Coastal Medical Group Ltd.; V. Narayen, Digestive Disease Associates; I. Newell, North Carolina Clinical Research; M. Noar, Endoscopic Microsurgery Associates; J. S. Novick, Charm City Research LLC; H. Offenberg, Gainsville Clinical Research Center; B. F. Overholt; D. J. Pambianco, Charlottesville Medical Research; P. M. Pardoll, Center for Digestive Diseases; R. Patel; W. Pearce, Rainier Clinical Research Center, Inc.; R. Peterson; J. M. Polito, Albany Gastroenterology Consultants; J. W. Popp, Carolina Clinical Research, Inc.; J. Poulos; V. Pratha, Clinical Applications Laboratories; J. M. Provenza, Louisiana Research Center, LLC; G. S. Raju, University of Kansas Medical Center; C. Randall, Gastroenterology Clinic of San Antonio; R. Rapier, Southern California Permanente Medical Center; J. Reddy; D. Rex, Indiana University Hospital; M. Reynolds, Radiant Research; D. Ricci; D. S. Riff, AGMG Clinical Research; M. A. Ringold, Medical Associates of Southwest Virginia; R. E. Ringrose; D. Ritt; M. Rodriguez; A. Rosen; D. J. Rosenberg; M. Z. Rosenberg, Research Foundation of America; W. Ross; V. Rustgi, Metropolitan Research Center; J. Sabel, South Denver Gastroenterology, PC; L. S. Saco, Watson Clinic LLP; S. Safavi, Doctors Research Associates of Maryland; M. Safdi, Consultants for Clinical Research; L. Y. Salazar; J. R. Saltzman, Brigham & Women's Hospital; B. A. Salzberg; B. Sanders; J. Santoro, Atlantic Gastroenterology Associates; P. Schleinitz; C. Schmitt, Southeastern Clinical Research; J. Schneier; M. I. Schulman; H. I. Schwartz, Miami Research Associates, Inc.; J. L. Schwartz, Northwestern Gastroenterologists, S.C.; M. E. Schwartz; A. R. Shah, Calvert Medical Office Building; U. K. Shah, Philip J. Bean Medical Center; R. Shaker; P. Sharma, Department of Veterans Affairs Medical Center; B. N. Shivakumar; D. Siegel; B. Silverman, Memorial Clinic Research Center; T. Simmons, West Gastroenterology Group; W. J. Snape, Long Beach Gastroenterology Associates; T. Sobieski; H. Sperber, Health Advance Institute, Inc.; G. A. Spiegelman; E. Spiotta; D. Stanton; W. Stassen, Radiant Research-Austin; R. Steller, Long Island GI Group, PC; W. Stern, Gastrointestinal Research Associates; R. J. Stitcher, Gastroenterology Specialties, PC; L. R. Strong; J. L. Taunk; R. W. Tobin; A. Tuch, Crozer Chester Medical Center; J. Turse, Health Advance Institute; N. B. Vakil, Sinai Samaritan Medical Center; R. Vender; J. B. Wagonfeld, Digestive Health Specialists; J. L. Wang; D. Weinberg, Thomas Jefferson University; L. M. Weiss; G. J. Wiener; S. Wilkofsky, Radiant Research Dallas; J. Winder, Toledo Center for Clinical Research; B. D. Winston, Houston Medical Research Associates; P. C. Witt, Greeley Medical Clinic; J. Wo, University of Louisville Health Sciences Center; R. A. Wohlman, Northwest Gastroenterology; J. Wolosin; L. D. Wruble, Memphis Gastroenterology Group, PC; M. Young, Carl Hayden VA; F. Zwas.