ESOMEPRAZOLE 20 MG VERSUS LANSOPRAZOLE 15 MG FOR MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS

Abstract

Purpose: Maintenance-dose esomeprazole (20 mg) provides better intra-gastric acid control than maintenance-dose lansoprazole (15 mg).1 Higher remission rates through 6 months of therapy were achieved with esomeprazole in a previous study conducted in 1000 patients.2 This study compares the efficacy of the FDA-approved doses of esomeprazole (20 mg once daily) and lansoprazole (15 mg once daily) for maintenance of healing of erosive esophagitis (EE). Methods: Patients with a history of heartburn and EE confirmed by endoscopy (Los Angeles [LA] grades A-D) were included in this multicenter(143 centers), randomized, double-blind, double-dummy, parallel-group study (D9612L00048/Study 325). Patients with healed EE on endoscopy after 4 to 8 weeks of treatment with once daily oral esomeprazole 40 mg or lansoprazole 30 mg who did not have heartburn or acid regurgitation during the last 7 days (by investigator assessment) were randomized to receive double-blind maintenance treatment with once daily oral esomeprazole 20 mg or lansoprazole 15 mg for 6 months. Proportions of patients in remission (no EE [LA grade A-D] detected by endoscopy repeated at months 3 and 6 or discontinuance of treatment due to reflux symptoms) and number needed to treat (NNT) were calculated. Investigators assessed symptoms of heartburn, acid regurgitation, dysphagia, and epigastric pain (none, mild, moderate, severe) at months 1, 3, and 6. Results: The intention-to-treat analyses included 501 and 500 patients in the esomeprazole and lansoprazole groups, respectively. The proportion of patients at baseline with LA grade A, B, C, or D EE were 37%, 3 8%, 21%, and 5%, respectively. A significantly greater proportion of patients who received esomeprazole than those who received lansoprazole maintained healing of EE and had no symptoms through 6 months of treatment (86.2% vs 77.6%, respectively; P <.0001). One relapse was prevented for every 12 patients (NNT =12) treated with esomeprazole versus lansoprazole. Both treatments were well tolerated during the 6-month study period. Conclusions: Esomeprazole 20 mg once daily is more effective than lansoprazole 15 mg once daily in maintaining remission in patients with healed EE through 6 months of therapy. The results of the present study confirm those of the previous Metropole trial.2