In patients with gastroesophageal reflux disease (GERD), esomeprazole, the S-isomer of omeprazole, has demonstrated pharmacological and clinical benefits beyond those seen with the racemic parent compound. This study was designed to further evaluate the efficacy and tolerability of esomeprazole relative to that of omeprazole in healing erosive esophagitis and resolving accompanying symptoms of GERD.
Esomeprazole 40 mg was compared with omeprazole 20 mg once daily in 2425 patients with erosive esophagitis (Helicobacter pylori negative by serology) in an 8-wk, multicenter, randomized, double-blind, parallel-group study conducted in 163 centers throughout the US. The primary efficacy endpoint was the proportion of patients with healed esophagitis at wk 8. Secondary endpoints were the proportion of patients healed at wk 4, resolution of heartburn at wk 4, time to first resolution and sustained resolution of heartburn, and proportion of heartburn-free days and nights. Safety and tolerability were also assessed.
Significantly more patients were healed with esomeprazole versus omeprazole at wk 8 (93.7% vs 84.2%, p < 0.001; life table estimates, intention-to-treat analysis). Healing rates at wk 4 were 81.7% and 68.7%, respectively. Esomeprazole was superior to omeprazole for all secondary measures and had a similar safety profile. The most common adverse events in both treatment groups were headache, diarrhea, and nausea.
Esomeprazole demonstrates significantly greater efficacy than omeprazole in the treatment of GERD patients with erosive esophagitis. The tolerability and safety of esomeprazole are comparable to that of omeprazole.
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We gratefully acknowledge the assistance of David J. Magner, M.S.Hyg., with statistical analyses, Robert Genta, M.D., with evaluating biopsy samples, as well as the diligent efforts of the study coordinators at the investigation sites.
This study was supported by a grant from AstraZeneca LP, Wayne, PA.
The esomeprazole study investigators
D. R. Abrahm, Newport Beach Gastroenterology Associates; M. Ali, A. Arora, Sierra Medical Research; K. Ashby, Harriman Jones Medical Group; R. D. Baerg, Tacoma Digestive Disease Center; C. F. Barish, Wake Research Associates; M. Barreiro, United Medical Associates, PC; I. Bassan, J. G. Beckwith, R. W. Bennetts, Northwest Gastroenterology Clinic; C. Berggreen, W. R. Berry, Longmont Clinic, PC; T. Bianchi, Southern Drug Research Network; D. Biery, C. A. Birbara, Clinical Pharmacology Study Group; P. C. Bird, Research Associates of Norman, Inc.; V. A. Botoman, J. Breiter, Center for Medical Research; J. R. Caldwell, A. Caos, S. Carlson, Coastal Medical Research Group, Inc.; R. Chasen, A. Y. Chen, Monroe Clinic; R. Chiprut, D. C. Chua, Summit Digestive and Liver Disease Specialists; N. Cirillo, L. B. Cohen, C. Colip, Portland Medical Associates; D. W. Collins, Western States Clinical Research, Inc.; D. Dalke, Gastroenterology Specialties, PC; V. A. DeLuca, Jr., Griffin Hospital; J. W. Dimitroff, St. Louis Center for Clinical Research; M. R. Dosch, Clinical Studies, Boynton Beach; J. Doyle, D. W. Dozer, Advanced Clinical Research, LLC; S. L. Duckor, AGMG Clinical Research; M. Efrusy, Olympia Fields Osteopathic Hospital; M. Eisner, Florida Medical Clinic; M. Epstein, Medlantic Investigators Network Inc.; J. F. Ervin, The Center for Pharmaceutical Research; C. Fausel, The Oregon Clinic; S. H. Feldman, Gastroenterology Associates of Fairfield County; R. Finlaw, Southern Colorado Clinic; R. Fogel, Henry Ford Hospital; R. D. Folan, Gastroenterology Association of CO; F. C. Fowler, University Gastroenterology; S. R. Freeman, Mile High Gastroenterology, PC; S. Gaddam, G. Gibbons; H. Giller, Digestive and Liver Disease Consultants, PC; O. D. Gilliam, Health Advance Institute, Inc.; E. Gillie, Medical Studies, Florida; P. B. Goldberg, M. Goldhamer, J. Goldstein, Brachfield Medical Associates; J. Goldstein, University of Illinois at Chicago Medical Center; M. Gorsky, A. Gottesman, Hill Top Research, Inc.; A. Harris, New York Hospital Medical Center; A. Harrison, E. H. Hirsh, R. B. Hogan, II, Mississippi Center for Clinical Research, LLC; J. J. Hsu, The Genesee Hospital; D. S. James, J. Johanson, Rockford Gastroenterology; R. B. Johnson, Sharp Rees Stealy Medical Group; D. A. Johnson, Gastrointestinal and Liver Specialists of Tidewater, PLLC; J. Jolley, J. V. Jones, Jr., Green Clinic; R. Kamyar, Institute of HealthCare Assessment, Inc.; R. D. Kaplan, LeBauer Health Care; S. Katz, Long Island Clinical Research Associates; H. Kavin, Advocate Medical Group-Gastroenterology; P. Kaye, C. S. Kelsey, San Diego Center for Research; P. Kiyasu, The Portland Clinic, LLP; R. Kommor, Health Advance Institute; T. Kovacs, CURE Clinic/West Los Angeles VAMC; G. Koval, West Hills Gastroenterology Associates, PC; R. Krause, The Center for Digestive Disorders and Clinical Research; S. Krumholz, D. Kruss, F. T. Kucer, M. Lamet, F. Lanza, Houston Institute for Clinical Research; J. Leavitt, Gastroenterology Care Center; M. S. Levine, SouthEast Research Associates, Inc.; T. Liebermann, Center for Clinical Research-Austin; L. Lifton, J. Linne, Community Research Management Associates, Inc.; W. R. Lumry, D. M. Maccini, Spokane Digestive Disease Center; M. K. Maden, H. N. Maimon, Dayton Area Research Associates; D. G. Mangels, TQM Research Center; S. Marcuard, Carolina Physicians, PA; R. D. Marks, Alabama Digestive Research Center, LLC; P. Maton, Digestive Disease Research Institute; J. L. Mauldin, ClinSites/SORRA Research Center; R. McCallum, University of Kansas Medical Center; A. McElroy, Multi-Specialty Clinical Research of NE Tennessee; P. Meier, VA Medical Center; T. Mendolia, Medical Park; P. J. Milman, P. B. Miner, Jr., Oklahoma Foundation for Digestive Research; L. Morton, S. Moussa, Advanced Clinical Therapeutics; R. V. Movva, Midwest Clinical Research Associates Ltd.; Z. Munk, Breco Research, Inc.; L. Newell, North Carolina Clinical Research, Inc.; T. Nichols, Jr., Center for Nutrition and Digestive Disorders; J. S. Novick, Charm City Research; C. Olson, Gould Medical Foundation; D. J. Pambianco, Charlottesville Gastroenterology Associates; P. M. Pardoll, Center for Digestive Diseases; W. A. Pearce, Rainier Clinical Research Center, Inc.; L. Peters, B. H. Plotnick, RUSH North Shore Medical Center; J. M. Provenza, Gastrointestinal Specialists, AMC; A. Reddy, Gastroenterology Research and Development Center; D. S. Riff, AGMG Clinical Research; M. A. Ringold, Lynn Health Science Institute; A. Rodriguez, Digestive Disease Clinic; R. D. Rothstein, University of Pennsylvania Hospital; H. A. Rubin, D. A. Ruff, Healthcare Discoveries, PA; V. Rustgi, S. Safavi, M. Safdi, Consultants for Clinical Research, Inc.; B. Sahba, California Research Foundation; B. Salzberg, P. Schleinitz, Gastroenterology Consultants, PC; C. M. Schmitt, Southeastern Clinical Research; J. Schneier, H. Schwartz, J. Schwartz, Northwest Gastroenterologists, SC; M. E. Schwartz, Jupiter Research Associates; A. Shah, U. K. Shah, Philip J. Bean Medical Center; R. Shaker, Medical College of Wisconsin; J. C. Shallcross, Jr., ClinSites/SORRA Research Center; B. Shivakumar, D. Siegel, Doctors Research Associates of Maryland; T. Simmons, S. Singh, W. J. Snape, Jr., E. J. Spiotta, D. B. Stanton, Community Clinical Trials; R. Steller, Long Island Gastroenterology Group, PC; L. Strong, Aspen Medical Group; R. W. Tobin, Seattle Gastroenterology Associates, PS; J. Turse, Health Advance Institute; N. B. Vakil, Sinai Samaritan Medical Center; J. B. Wagonfeld, Digestive Health Specialists; L. M. Weiss, Clinical Research of West Florida; S. Wilkofsky, Metroplex Clinical Research Center; P. E. Williams, Little Rock Diagnostic Clinic; J. A. Winder, Toledo Center for Clinical Research; B. D. Winston, Houston Medical Research Associates; P. Witt, Greeley Medical Clinic; R. A. Wohlman, Northwest Gastroenterology Associates.