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
- Kentaro Sugano1,
- Myung-Gyu Choi2,
- Jaw-Town Lin3,
- Shinya Goto4,
- Yasushi Okada5,
- Yoshikazu Kinoshita6,
- Hiroto Miwa7,
- Chern-En Chiang8,
- Tsutomu Chiba9,
- Masatsugu Hori10,
- Yasushi Fukushima11,
- Hyun-Soo Kim12,
- Chi-Yang Chang13,
- Masataka Date14,
- on behalf of the LAVENDER Study Group
- 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
- Correspondence to Professor Kentaro Sugano, Department of Medicine, Jichi Medical University, 3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498, Japan;
- Received 18 February 2013
- Revised 10 November 2013
- Accepted 20 November 2013
- Published Online First 10 December 2013
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.