N Vakil1. 1. University of Wisconsin Medical School, Aurora Sinai Medical Center, 945 North 12th Street, Room 4040, Milwaukee, WI 53233, USA. nvakil@facstaff.wisc.edu
Abstract
BACKGROUND:Proton pump inhibitors are the most effective agents for treating erosive oesophagitis, but their relative efficacies have not been well characterized in large clinical trials. AIM: To compare standard doses of esomeprazole and lansoprazole in healing oesophagitis and resolving accompanying symptoms. METHODS: This was a US, multicentre, randomized, double-blind trial and included 5241 adult patients (intention-to-treat) with endoscopically documented erosive oesophagitis. Patients were randomized to esomeprazole, 40 mg once daily, or lansoprazole, 30 mg once daily, for up to 8 weeks. The primary end-point, endoscopic healing at Week 8, was assessed using life-table analysis and a log-rank test. Secondary endpoints included healing at Week 4, healing according to baseline severity of oesophagitis, control of heartburn and side-effects. RESULTS:Healing rates were 92.6% with esomeprazole and 88.8% with lansoprazole at Week 8 (P = 0.0001, log-rank test). A significant difference was also observed at Week 4. Sustained resolution of heartburn occurred faster and in a larger proportion of patients treated with esomeprazole. Both agents were well tolerated. CONCLUSIONS:Esomeprazole produced significantly higher oesophagitis healing rates than lansoprazole over all grades of oesophagitis. Esomeprazole also provided better control of heartburn and was associated with a greater proportion of patients with sustained resolution of symptoms.
RCT Entities:
BACKGROUND: Proton pump inhibitors are the most effective agents for treating erosive oesophagitis, but their relative efficacies have not been well characterized in large clinical trials. AIM: To compare standard doses of esomeprazole and lansoprazole in healing oesophagitis and resolving accompanying symptoms. METHODS: This was a US, multicentre, randomized, double-blind trial and included 5241 adult patients (intention-to-treat) with endoscopically documented erosive oesophagitis. Patients were randomized to esomeprazole, 40 mg once daily, or lansoprazole, 30 mg once daily, for up to 8 weeks. The primary end-point, endoscopic healing at Week 8, was assessed using life-table analysis and a log-rank test. Secondary endpoints included healing at Week 4, healing according to baseline severity of oesophagitis, control of heartburn and side-effects. RESULTS: Healing rates were 92.6% with esomeprazole and 88.8% with lansoprazole at Week 8 (P = 0.0001, log-rank test). A significant difference was also observed at Week 4. Sustained resolution of heartburn occurred faster and in a larger proportion of patients treated with esomeprazole. Both agents were well tolerated. CONCLUSIONS:Esomeprazole produced significantly higher oesophagitis healing rates than lansoprazole over all grades of oesophagitis. Esomeprazole also provided better control of heartburn and was associated with a greater proportion of patients with sustained resolution of symptoms.