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Gut. 2014 Jul;63(7):1061-8. doi: 10.1136/gutjnl-2013-304722. Epub 2013 Dec 10.

Multinational, double-blind, randomised, placebo-controlled, prospective study of esomeprazole in the prevention of recurrent peptic ulcer in low-dose acetylsalicylic acid users: the LAVENDER study.

Author information

  • 1Department of Medicine, Jichi Medical University, Tochigi, Japan.
  • 2Department of Internal Medicine, The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, Korea.
  • 3School of Medicine, E-Da Hospital, Kaohsiung and Fu Jen Catholic University, Taipei, Taiwan.
  • 4Division of Cardiology, Department of Medicine, Tokai University School of Medicine, Kanagawa, Japan.
  • 5Department of Cerebrovascular Medicine and Neurology, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.
  • 6Department of Gastroenterology & Hepatology, Shimane University School of Medicine, Shimane, Japan.
  • 7Department of Internal Medicine, Hyogo College of Medicine, Hyogo, Japan.
  • 8Department of Medical Research and Education, Taipei Veterans General Hospital and National Yang-Ming University, Taipei, Taiwan.
  • 9Division of Gastroenterology & Hepatology, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
  • 10Osaka Medical Center, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan.
  • 11Department of Internal Medicine, Tokyo-Eki Center-building Clinic, Tokyo, Japan.
  • 12Division of Gastroenterology & Hepatology, Yonsei University Wonju College of Medicine, Wonju Christian Hospital, Wonju, Korea.
  • 13Division of Gastroenterology & Hepatology, E-Da Hospital and I-Shou University, Kaohsiung, Taiwan.
  • 14Research & Development, AstraZeneca, Osaka, Japan.



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.


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 (Kaplan-Meier analysis). Efficacy findings are presented up to week 48, as per a planned interim analysis within the study protocol.


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.


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.



Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to



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