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
Nb. Vakil et al., 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, ALIM PHARM, 15(7), 2001, pp. 927-935
Background: Esomeprazole, the S-isomer of omeprazole, is the first proton p
ump inhibitor to be developed as an optical isomer, In patients with erosiv
e oesophagitis, esomeprazole has produced significantly greater healing rat
es and improved symptom resolution vs. omeprazole.
Aim: This study assesses the efficacy of esomeprazole for preventing relaps
e in patients with healed oesophagitis.
Methods: In this 6-month US multicentre randomized double-blind placebo-con
trolled trial, 375 Helicobacter pylori-negative patients with endoscopicall
y 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 s
afety and tolerability.
Results: Significantly (P < 0.001) more patients remained healed with esome
prazole 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 r
esolution of heartburn was observed in the 40 mg and 20 mg groups; there wa
s a high correlation between absence of heartburn and maintenance of healin
g. Adverse effects were mild, infrequent and not significantly different be
Conclusions: Esomeprazole is effective and well-tolerated in the maintenanc
e of healing of erosive oesophagitis, Esomeprazole 40 mg and 20 mg offer si
gnificant clinical benefit to patients.