Question: In patients with erosive esophagitis, is lansoprazole better than omeprazole for relieving heartburn?
Design: Randomized {allocation concealed*}†, blinded {patients, clinicians, data collectors, outcome assessors, and data safety and monitoring committee}†,* controlled trial with 8-week follow-up.
Setting: 162 clinical centers in the United States.
Patients: 3510 patients who were ≥ 18 years of age (mean age 47 y, 57% men), had endoscopically confirmed erosive esophagitis ≥ grade 2, and had had ≥ 1 episode of moderate-to-very-severe heartburn during the previous 3 days or nights, or both. Exclusion criteria included duodenal or gastric ulcers ≥ 3 mm in diameter; systemic disease affecting the esophagus; history of gastrointestinal bleeding or gastric, duodenal, or esophageal surgery; and long-term use of ulcerogenic drugs. 96% of patients completed the study.
Intervention: Patients were allocated to lansoprazole, 30 mg (n = 1754), or omeprazole, 20 mg (n = 1756), once daily before breakfast for 8 weeks.
Main outcome measures: Presence and severity (none [score 0] to very severe [score 4]) of daytime and nighttime heartburn, which were recorded in daily diaries.
Main results: More patients in the lansoprazole group than in the omeprazole group had no episodes of heartburn throughout the treatment period ({14% vs 11%}†P < 0.05) and were free of heartburn on day 1 (33% vs 25%, P≤ 0.001). The lansoprazole group had a greater percentage of heartburn-free days (mean 66% vs 62% of days, P < 0.001) and heartburn-free nights (mean 69% vs 64% of nights, P < 0.001) than did the omeprazole group during week 1. Severity of heartburn was lower in the lansoprazole group than in the omeprazole group during the day (mean severity score 0.46 vs 0.53, P < 0.001) and night (mean severity score 0.44 vs 0.51, P < 0.001) in week 1.
Conclusion: In patients with erosive esophagitis, lansoprazole was better than omeprazole for providing heartburn relief quickly.