title: 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.
abstract: OBJECTIVE
  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.
  
  
  BACKGROUND
  NCT01069939.
authors: Department of Medicine, Jichi Medical University, Tochigi, Japan.
authors: Kentaro
authors: K
authors: Sugano
authors: Department of Internal Medicine, The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, Korea.
authors: Myung-Gyu
authors: MG
authors: Choi
authors: School of Medicine, E-Da Hospital, Kaohsiung and Fu Jen Catholic University, Taipei, Taiwan.
authors: Jaw-Town
authors: JT
authors: Lin
authors: Division of Cardiology, Department of Medicine, Tokai University School of Medicine, Kanagawa, Japan.
authors: Shinya
authors: S
authors: Goto
authors: Department of Cerebrovascular Medicine and Neurology, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.
authors: Yasushi
authors: Y
authors: Okada
authors: Department of Gastroenterology & Hepatology, Shimane University School of Medicine, Shimane, Japan.
authors: Yoshikazu
authors: Y
authors: Kinoshita
authors: Department of Internal Medicine, Hyogo College of Medicine, Hyogo, Japan.
authors: Hiroto
authors: H
authors: Miwa
authors: Department of Medical Research and Education, Taipei Veterans General Hospital and National Yang-Ming University, Taipei, Taiwan.
authors: Chern-En
authors: CE
authors: Chiang
authors: Division of Gastroenterology & Hepatology, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
authors: Tsutomu
authors: T
authors: Chiba
authors: Osaka Medical Center, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan.
authors: Masatsugu
authors: M
authors: Hori
authors: Department of Internal Medicine, Tokyo-Eki Center-building Clinic, Tokyo, Japan.
authors: Yasushi
authors: Y
authors: Fukushima
authors: Division of Gastroenterology & Hepatology, Yonsei University Wonju College of Medicine, Wonju Christian Hospital, Wonju, Korea.
authors: Hyun-Soo
authors: HS
authors: Kim
authors: Division of Gastroenterology & Hepatology, E-Da Hospital and I-Shou University, Kaohsiung, Taiwan.
authors: Chi-Yang
authors: CY
authors: Chang
authors: Research & Development, AstraZeneca, Osaka, Japan.
authors: Masataka
authors: M
authors: Date
mesh_terms: D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects*; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D044466:Asian People; D001241:Aspirin / Q000009:adverse effects*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D064098:Esomeprazole / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007564:Japan; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D010437:Peptic Ulcer / Q000139:chemically induced / Q000208:ethnology / Q000517:prevention & control*; D011446:Prospective Studies; D056910:Republic of Korea; D055502:Secondary Prevention; D013624:Taiwan; D016896:Treatment Outcome
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D000897:Anti-Ulcer Agents; D064098:Esomeprazole; D001241:Aspirin
keywords: ASPIRIN; CLINICAL TRIALS; GASTRIC AND DUODENAL ULCERS; PROTON PUMP INHIBITION