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

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.

CLINICALTRIALGOV IDENTIFIER:

NCT01069939.

• Authors: 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, LAVENDER Study Group
• Journal: Gut (Gut) Vol. 63 Issue 7 Pg. 1061-8 (Jul 2014) ISSN: 1468-3288 [Electronic] England
• PMID: 24326741 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Chemical References

• Anti-Inflammatory Agents, Non-Steroidal
• Anti-Ulcer Agents
• Esomeprazole
• Aspirin

Topics

• Adult
• Aged
• Anti-Inflammatory Agents, Non-Steroidal (adverse effects)
• Anti-Ulcer Agents (therapeutic use)
• Asian People
• Aspirin (adverse effects)
• Double-Blind Method
• Drug Administration Schedule
• Esomeprazole (therapeutic use)
• Female
• Humans
• Japan
• Kaplan-Meier Estimate
• Male
• Middle Aged
• Peptic Ulcer (chemically induced, ethnology, prevention & control)
• Prospective Studies
• Republic of Korea
• Secondary Prevention
• Taiwan
• Treatment Outcome