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 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 tween groups. 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.