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.
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.


OBJECTIVE
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.
Vakil
N B
NB
University of Wisconsin Medical School, Milwaukee, WI, USA. nvakil@facstaff.wisc.edu
Shaker
R
R
Johnson
D A
DA
Kovacs
T
T
Baerg
R D
RD
Hwang
C
C
D'Amico
D
D
Hamelin
B
B
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D064098:Esomeprazole / Q000008:administration & dosage* / Q000009:adverse effects; D004942:Esophagitis, Peptic / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D005764:Gastroesophageal Reflux / Q000150:complications / Q000188:drug therapy*; D006356:Heartburn; D006801:Humans; D007536:Isomerism; D008297:Male; D008875:Middle Aged; D010919:Placebos; D054328:Proton Pump Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D012008:Recurrence; D016896:Treatment Outcome
D010919:Placebos; D054328:Proton Pump Inhibitors; D064098:Esomeprazole