Efficacy and safety of lansoprazole in the treatment of erosive reflux esophagitis. The Lansoprazole Group.

ABSTRACT

OBJECTIVES: This study was designed to compare lansoprazole 30 mg, lansoprazole 15 mg, omeprazole 20 mg, and placebo in the treatment of erosive reflux esophagitis. METHODS: In a double-blind, multicenter study, 1284 patients with endoscopically diagnosed erosive reflux esophagitis were randomized to received lansoprazole 30 mg (n = 422), lansoprazole 15 mg (n = 218), omeprazole 20 mg (n = 431), or placebo (n = 213) once daily for 8 wk. At 2, 4, 6, and 8 wk, healing was evaluated endoscopically. Patients kept daily diaries of symptoms. RESULTS: Healing rates at 2, 4, 6, and 8 wk were 65.3%, 83.3%, 89.4%, and 90.0%, respectively, for lansoprazole 30 mg; 56.3%, 74.6%, 80.3%, and 78.8% for lansoprazole 15 mg; 60.9%, 82.0%, 89.7%, and 90.7% for omeprazole 20 mg; and 23.9%, 32.8%, 36.6%, and 40.0% for placebo (all active treatments higher than placebo, p < 0.001). Healing rates with lansoprazole 30 mg were significantly higher than with lansoprazole 15 mg at all time points (p < 0.05). Healing rates with omeprazole 20 mg were significantly higher than with lansoprazole 15 mg at 4, 6, and 8 wk and were similar to those with lansoprazole 30 mg. Based on patient diaries, lansoprazole 30 mg produced better symptomatic relief than lansoprazole 15 mg or omeprazole 20 mg, primarily early in the treatment course. CONCLUSIONS: Both lansoprazole 30 mg and omeprazole 20 mg were more effective than lansoprazole 15 mg in esophageal mucosal healing. Compared with omeprazole 20 mg, lansoprazole 30 mg was as safe, was similarly effective with respect to esophageal healing, and provided superior symptomatic relief, primarily early in treatment. Lansoprazole 30 mg provided greater symptomatic relief than lansoprazole 15 mg.