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

Research output: Contribution to journalArticle

31 Citations (Scopus)

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 Jan 1

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Esomeprazole
Lavandula
Peptic Ulcer
Aspirin
Prospective Studies
Ulcer
Placebos
Recurrence
Gefarnate
Far East
Korea
Taiwan
Japan

All Science Journal Classification (ASJC) codes

  • Gastroenterology

Cite this

Sugano, Kentaro ; Choi, Myung Gyu ; Lin, Jaw Town ; Goto, Shinya ; Okada, Yasushi ; Kinoshita, Yoshikazu ; Miwa, Hiroto ; Chiang, Chern En ; Chiba, Tsutomu ; Hori, Masatsugu ; Fukushima, Yasushi ; Kim, Hyun Soo ; Chang, Chi Yang ; Date, Masataka. / 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. In: Gut. 2014 ; Vol. 63, No. 7. pp. 1061-1068.
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title = "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",
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.",
author = "Kentaro Sugano and Choi, {Myung Gyu} and Lin, {Jaw Town} and Shinya Goto and Yasushi Okada and Yoshikazu Kinoshita and Hiroto Miwa and Chiang, {Chern En} and Tsutomu Chiba and Masatsugu Hori and Yasushi Fukushima and Kim, {Hyun Soo} and Chang, {Chi Yang} and Masataka Date",
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doi = "10.1136/gutjnl-2013-304722",
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Sugano, K, Choi, MG, Lin, JT, Goto, S, Okada, Y, Kinoshita, Y, Miwa, H, Chiang, CE, Chiba, T, Hori, M, Fukushima, Y, Kim, HS, Chang, CY & 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, vol. 63, no. 7, pp. 1061-1068. https://doi.org/10.1136/gutjnl-2013-304722

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

In: Gut, Vol. 63, No. 7, 01.01.2014, p. 1061-1068.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Multinational, double-blind, randomised, placebocontrolled, prospective study of esomeprazole in the prevention of recurrent peptic ulcer in low-dose acetylsalicylic acid users

T2 - The lavender* study

AU - Sugano, Kentaro

AU - Choi, Myung Gyu

AU - Lin, Jaw Town

AU - Goto, Shinya

AU - Okada, Yasushi

AU - Kinoshita, Yoshikazu

AU - Miwa, Hiroto

AU - Chiang, Chern En

AU - Chiba, Tsutomu

AU - Hori, Masatsugu

AU - Fukushima, Yasushi

AU - Kim, Hyun Soo

AU - Chang, Chi Yang

AU - Date, Masataka

PY - 2014/1/1

Y1 - 2014/1/1

N2 - 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.

AB - 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.

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DO - 10.1136/gutjnl-2013-304722

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