Faculty Collaboration Database

The new proton pump inhibitor esomeprazole is effective as a maintenance therapy in GERD patients with healed erosive oesophagitis: a 6-month, randomized, double-blind, placebo-controlled study of efficacy and safety. Aliment Pharmacol Ther 2001 Jul;15(7):927-35

Date

06/26/2001

Pubmed ID

11421866

DOI

10.1046/j.1365-2036.2001.01024.x

Scopus ID

2-s2.0-0034949404 (requires institutional sign-in at Scopus site)   126 Citations

Abstract

BACKGROUND: Esomeprazole, the S-isomer of omeprazole, is the first proton pump inhibitor to be developed as an optical isomer. In patients with erosive oesophagitis, esomeprazole has produced significantly greater healing rates and improved symptom resolution vs. omeprazole.

AIM: This study assesses the efficacy of esomeprazole for preventing relapse in patients with healed oesophagitis.

METHODS: In this 6-month US multicentre randomized double-blind placebo-controlled trial, 375 Helicobacter pylori-negative patients with endoscopically healed oesophagitis received esomeprazole 40 mg, 20 mg, 10 mg, or placebo once daily. The primary efficacy end-point was maintenance of healing at 6 months. Secondary end-points assessed changes in symptoms, and long-term safety and tolerability.

RESULTS: Significantly (P < 0.001) more patients remained healed with esomeprazole 40 mg (87.9%), 20 mg (78.7%), or 10 mg (54.2%), than with placebo (29.1%). Relapse, when it occurred, was later with esomeprazole. Sustained resolution of heartburn was observed in the 40 mg and 20 mg groups; there was a high correlation between absence of heartburn and maintenance of healing. Adverse effects were mild, infrequent and not significantly different between groups.

CONCLUSIONS: Esomeprazole is effective and well-tolerated in the maintenance of healing of erosive oesophagitis. Esomeprazole 40 mg and 20 mg offer significant clinical benefit to patients.

Author List

Vakil NB, Shaker R, Johnson DA, Kovacs T, Baerg RD, Hwang C, D'Amico D, Hamelin B

Author

Reza Shaker MD Assoc Provost, Sr Assoc Dean, Ctr Dir, Chief, Prof in the Medicine department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Administration, Oral
Adolescent
Adult
Aged
Aged, 80 and over
Dose-Response Relationship, Drug
Double-Blind Method
Esomeprazole
Esophagitis, Peptic
Female
Gastroesophageal Reflux
Heartburn
Humans
Isomerism
Male
Middle Aged
Placebos
Proton Pump Inhibitors
Recurrence
Treatment Outcome