4.7 Article

Maintenance of healed erosive esophagitis: A randomized six-month comparison of esomeprazole twenty milligrams with lansoprazole fifteen milligrams

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CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
卷 4, 期 7, 页码 852-859

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ELSEVIER SCIENCE INC
DOI: 10.1016/j.cgh.2006.03.006

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Background & Aims: The aim was to compare esomeprazole with lansoprazole for the maintenance of healed erosive esophagitis and resolution of gastroesophageal reflux disease-related symptoms in a United States population. Methods: Patients who entered this double-blind, randomized, parallel-group, multicenter, maintenance trial had been treated and healed (no endoscopic evidence of erosive esophagitis) with esomeprazole 40 mg or lansoprazole 30 mg once daily (patients with Los Angeles grades C and D erosive esophagitis at baseline) or esomeprazole 40 mg (patients with Los Angeles grades A and B erosive esophagitis at baseline) and had no heartburn or acid regurgitation symptoms during the previous week. Patients were randomized to maintenance once-daily therapy with esomeprazole 20 mg (n = 512) or lansoprazole 15 mg (n = 514) for up to 6 months. Esophagogastroduodenoscopies were done at months 3 and 6, and investigators assessed symptom severity at months 1, 3, and 6. Endoscopic/symptomatic remission was defined as no erosive esophagitis and no study withdrawal as a result of reflux symptoms. Results: The estimated endoscopic/symptomatic remission rate during a period of 6 months was significantly higher (P =.0007) for patients who received esomeprazole 20 mg once daily (84.8%) compared with those who received lansoprazole 15 mg (75.9%). Most patients had no heartburn (383/462 and 369/466) or acid regurgitation (401/462 and 400/466) symptoms at 6 months, and there were no significant differences between treatments. Both treatments were well-tolerated. Conclusion. Esomeprazole 20 mg is more effective than lansoprazole 15 mg in maintaining endoscopic/symptomatic remission in patients with healed erosive esophagitis.

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