Multinational, double-blind, randomised, placebocontrolled, prospective study of esomeprazole in the prevention of recurrent peptic ulcer in low-dose acetylsalicylic acid users: The lavender* study

Kentaro Sugano, Myung Gyu Choi, Jaw Town Lin, Shinya Goto, Yasushi Okada, Yoshikazu Kinoshita, Hiroto Miwa, Chern En Chiang, Tsutomu Chiba, Masatsugu Hori, Yasushi Fukushima, Hyun Soo Kim, Chi Yang Chang, Masataka Date

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Abstract

Objectives: To evaluate if esomeprazole prevents recurrent peptic ulcer in adult patients with a history of peptic ulcer receiving low-dose acetylsalicylic acid (ASA, aspirin) for cardiovascular protection in East Asia. Methods: In this prospective, randomised, double-blind, placebo-controlled trial conducted in Japan, Korea and Taiwan, eligible patients receiving low-dose ASA for cardiovascular protection (81-324 mg/day) were randomised to esomeprazole 20 mg/day or placebo for ≤72 weeks. All patients received concomitant mucosal protection (gefarnate 100 mg/day). The primary endpoint was time to ulcer recurrence (Kaplan̈CMeier analysis). Efficacy findings are presented up to week 48, as per a planned interim analysis within the study protocol. Results: A total of 364 patients (79.9% men; mean age, 67.1 years) comprised the full analysis set (esomeprazole, n=182; placebo, n=182). There was a statistically significant difference in the time to ulcer recurrence between esomeprazole and placebo (HR 0.09; 96.65% CI 0.02 to 0.41; p<0.001). The estimated ulcer-free rate at week 12 was 99.3% (esomeprazole) and 89.0% (placebo). The high estimated ulcer-free rate for esomeprazole was maintained through to week 48 (98.3% vs 81.2% of placebo-treated patients). No factors, other than female gender, reduced time to ulcer recurrence in addition to the effect of esomeprazole (p<0.001). Treatment with esomeprazole was generally well tolerated. Conclusions: Daily esomeprazole 20 mg is efficacious and well tolerated in reducing the recurrence of peptic ulcer in East-Asian patients with a history of ulcers who are taking low-dose ASA for cardiovascular protection.

Original languageEnglish
Pages (from-to)1061-1068
Number of pages8
JournalGut
Volume63
Issue number7
DOIs
Publication statusPublished - 2014 Jul

All Science Journal Classification (ASJC) codes

  • Gastroenterology

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    Sugano, K., Choi, M. G., Lin, J. T., Goto, S., Okada, Y., Kinoshita, Y., Miwa, H., Chiang, C. E., Chiba, T., Hori, M., Fukushima, Y., Kim, H. S., Chang, C. Y., & Date, M. (2014). Multinational, double-blind, randomised, placebocontrolled, prospective study of esomeprazole in the prevention of recurrent peptic ulcer in low-dose acetylsalicylic acid users: The lavender* study. Gut, 63(7), 1061-1068. https://doi.org/10.1136/gutjnl-2013-304722