The October issue of Alimentary Pharmacology and Therapeutics contains the first full clinical publication about esomeprazole - the latest proton pump inhibitor from Astra-Zeneca.
1960 United States patients with endoscopy-confirmed reflux esophagitis were 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 reflux esophagitis. The patients were treated for up to eight weeks in a multicentre, double-blind trial.
The primary efficacy variable was the proportion of patients healed at week eight. Secondary variables included healing and heartburn resolution at week four, time to first resolution and sustained resolution of heartburn, and per cent of heartburn-free days and nights. Safety and tolerability were also evaluated.
Esophagitis 8-week healing
Esomeprazole 40 mg 94.1%
Esomeprazole 20 mg 89.9%
Omeprazole 20 mg 86.9%
Significantly more patients were healed at week eight with esomeprazole 40 mg (94.1%) and 20 mg (89.9%) vs. omeprazole 20 mg (86.9%), using cumulative life table estimates, ITT analysis (each P < 0.05). Esomeprazole 40 mg was also significantly more effective than omeprazole for healing at week four and for all secondary variables evaluating heartburn resolution.
The most common adverse events in all treatment groups were headache, abdominal pain and diarrhea. The team of investigators concludes that esomeprazole is more effective than omeprazole, with a comparable tolerability profile.