Esomeprazole once daily for 6 months is effective therapy for maintaining healed erosive esophagitis and for controlling gastroesophageal reflux disease symptoms: A randomized, double-blind, placebo-controlled study of efficacy and safety

Citation
Da. Johnson et al., Esomeprazole once daily for 6 months is effective therapy for maintaining healed erosive esophagitis and for controlling gastroesophageal reflux disease symptoms: A randomized, double-blind, placebo-controlled study of efficacy and safety, AM J GASTRO, 96(1), 2001, pp. 27-34
Citations number
17
Language
INGLESE
art.tipo
Article
Categorie Soggetti
Gastroenerology and Hepatology
Journal title
AMERICAN JOURNAL OF GASTROENTEROLOGY
ISSN journal
0002-9270 → ACNP
Volume
96
Issue
1
Year of publication
2001
Pages
27 - 34
Database
ISI
SICI code
0002-9270(200101)96:1<27:EODF6M>2.0.ZU;2-V
Abstract
OBJECTIVE: Esomeprazole, the S-isomer of omeprazole, achieves a significant ly greater healing rate and symptom resolution of erosive esophagitis than that achieved by omeprazole. The objective of this study is to assess the e fficacy of the new proton pump inhibitor esomeprazole in preventing relapse over a prolonged period in patients with healed erosive esophagitis. METHODS: A total of 318 gastroesophageal reflux patients whose erosive esop hagitis was healed in a comparative study of esomeprazole 40 mg, 20 mg, or omeprazole 20 mg, were randomized to maintenance therapy with once daily es omeprazole 40 mg, 20 mg, or 10 mg, or placebo in a U.S., double-blind multi center trial. RESULTS: After 6 months, healing was maintained (cumulative life table rate s) in 93.6% (95% CI 87.4-99.7) of patients treated with esomeprazole 40 mg, 93.2% (95% CI 87.4-99.0) treated with esomeprazole 20 mg, and 57.1% (95% C I 45.2-69) treated with esomeprazole 10 mg; p < 0.001 vs placebo (29.1%; 95 % CI 17.7-40.3). Of patients relapsing, mean time to first recurrence of es ophagitis increased with dose, from 34 days (placebo) to 78 days (10 mg), 1 15 days (20 mg), and 163 days (40 mg). Patients treated with esomeprazole h ad less frequent and less severe heartburn than those treated with placebo. At month 6, more than 70% of patients being treated with esomeprazole rema ined symptom-free. CONCLUSIONS: Esomeprazole is effective and well tolerated in the maintenanc e of a healing erosive esophagitis. Esomeprazole 40 mg and 20 mg maintain h ealing in over 90% of patients while providing effective control of heartbu rn symptoms. (Am J Gastroenterol 2001;96:27-34. (C) 2001 by Am. Coll. of Ga stroenterology).