Comparing lansoprazole and omeprazole in onset of heartburn relief: Results of a randomized, controlled trial in erosive esophagitis patients

OBJECTIVE: This randomized, double-blind, multicenter study was conducted t o confirm a previous finding that lansoprazole relieves heartburn faster th an omeprazole in patients with erosive esophagitis. METHODS: A total of 3510 patients with erosive esophagitis and at least one episode of moderate to very severe daytime and/or nighttime heartburn duri ng the 3 days immediately before the screening, visit were randomized to la nsoprazole 30 mg once daily or omeprazole 20 mg once daily for 8 wk. Patien ts recorded the presence and severity of daytime and nighttime heartburn in daily diaries. On treatment days 1-4, patients were telephoned to confirm the completion of their daily diary. The primary efficacy parameters were t he percentage of heartbum-free days and heartburn-free nights, as well as t he average severity of daytime and nighttime heartburn. RESULTS: During treatment day 1 and all evaluation time points including, t he entire 8-wk treatment period, significantly (p < 0.05) higher percentage s of patients treated with lansoprazole than those treated with omeprazole did not experience a single episode of heartburn. Onset of heartburn relief was more rapid in lansoprazole-treated versus omeprazole-treated patients: on day 1, 33% versus 25% of lansoprazole- versus omeprazole-treated patien ts were heartbum-free. The percentages of heartburn-free days and heartburn -free nights were also significantly (p < 0.01) greater for patients treate d with lansoprazole at all evaluation time points. Heartburn severity was s ignificantly less among those treated with lansoprazole compared with omepr azole. Both treatments were safe and well tolerated. CONCLUSIONS: Over 8 wk, lansoprazole 30 mg once daily relieved heartburn sy mptoms faster and more effectively than 20 mg once daily in patients with e rosive esophagitis. (C) 2001 by Am. Coll. of Gastroenterology.