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Gut 63:1061-1068 doi:10.1136/gutjnl-2013-304722
  • Stomach
  • Original article

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

  1. on behalf of the LAVENDER Study Group
  1. 1Department of Medicine, Jichi Medical University, Tochigi, Japan
  2. 2Department of Internal Medicine, The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, Korea
  3. 3School of Medicine, E-Da Hospital, Kaohsiung and Fu Jen Catholic University, Taipei, Taiwan
  4. 4Division of Cardiology, Department of Medicine, Tokai University School of Medicine, Kanagawa, Japan
  5. 5Department of Cerebrovascular Medicine and Neurology, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan
  6. 6Department of Gastroenterology & Hepatology, Shimane University School of Medicine, Shimane, Japan
  7. 7Department of Internal Medicine, Hyogo College of Medicine, Hyogo, Japan
  8. 8Department of Medical Research and Education, Taipei Veterans General Hospital and National Yang-Ming University, Taipei, Taiwan
  9. 9Division of Gastroenterology & Hepatology, Graduate School of Medicine, Kyoto University, Kyoto, Japan
  10. 10Osaka Medical Center, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan
  11. 11Department of Internal Medicine, Tokyo-Eki Center-building Clinic, Tokyo, Japan
  12. 12Division of Gastroenterology & Hepatology, Yonsei University Wonju College of Medicine, Wonju Christian Hospital, Wonju, Korea
  13. 13Division of Gastroenterology & Hepatology, E-Da Hospital and I-Shou University, Kaohsiung, Taiwan
  14. 14Research & Development, AstraZeneca, Osaka, Japan
  1. Correspondence to Professor Kentaro Sugano, Department of Medicine, Jichi Medical University, 3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498, Japan; sugano{at}jichi.ac.jp
  • Received 18 February 2013
  • Revised 10 November 2013
  • Accepted 20 November 2013
  • Published Online First 10 December 2013

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 (Kaplan–Meier 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.

ClinicalTrial.gov identifier NCT01069939.


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