Esomeprazole improves healing and symptom resolution as compared with omeprazole in reflux oesophagitis patients: a randomized controlled trial

Background: The pharmacologic profile of the new proton pump inhibitor esom eprazole has demonstrated advantages over omeprazole that suggest clinical benefits for patients with acid-related disease. Methods: 1960 patients with endoscopy-confirmed reflux oesophagitis (RO) we re randomized to once daily esomeprazole 40 mg (n=654) or 20 mg (n=656), or omeprazole 20 mg (n=650), the standard recommended dose for RO, for up to 8 weeks in a US, multicentre, double-blind trial. The primary efficacy vari able was the proportion of patients healed at week 8. Secondary variables i ncluded healing and heartburn resolution at week 4, time to first resolutio n and sustained resolution of heartburn, and per cent of heartburn-free day s and nights. Safety and tolerability were also evaluated. Results: Significantly more patients were healed at week 8 with esomeprazol e 40 mg (94.1%) and 20 mg (89.9%) vs. omeprazole 20 mg (86.9%), using cumul ative life table estimates, ITT analysis (each P < 0.05). Esomeprazole 40 m g was also significantly more effective than omeprazole for healing at week 4 and for all secondary variables evaluating heartburn resolution. The mos t common adverse events in all treatment groups were headache, abdominal pa in and diarrhoea. Conclusions: Esomeprazole was more effective than omeprazole in healing and symptom resolution in GERD patients with reflux oesophagitis, and had a to lerability profile comparable to that of omeprazole.