Abstract
Objectives: Gastroprotective therapy is recommended for cardiovascular (CV) patients (pts) taking low-dose aspirin (LDA) and at increased gastrointestinal risk, eg history of peptic ulcer. This study assessed the potential effects of esomeprazole (ESO) in prevention of recurrent peptic (gastric and/or duodenal) ulcer in East Asian pts taking LDA for CV protection. Methods: Pts aged >=20y with history of endoscopically confirmed peptic ulcer and taking LDA (81-324mg/d) for CV protection were enrolled ( NCT01069939 ). Pts with serious heart failure/unstable hypertension/history of acute coronary syndromes were excluded. Eligible pts were randomized to ESO 20mg/d or placebo (PBO) for a maximum of 72 wks. All pts received concomitant mucosal protection (gefarnate 100mg/d). Primary end point was time to ulcer recurrence, analyzed by the Kaplan-Meier method. Findings are presented up to wk 60, as per a planned event-driven analysis. Results: A total of 427 pts (mean age 67y; 79% men) comprised the full analysis set (ESO, n=213; PBO, n=214). There was a statistically significant difference in the time to ulcer recurrence between ESO and PBO (hazard ratio, 0.14; 96.65% CI: 0.04-0.42; p<.001). Estimated ulcer-free rate up to wk 60 was 96.0% and 75.8%, respectively. Sub-analysis showed superior ulcer-free rates for ESO vs PBO regardless of LDA dose (81mg, 100mg, and >100mg) and reason for LDA treatment (primary vs secondary prevention). Treatment with ESO was well tolerated. The rate of serious cardiac-related adverse events with ESO was similar to PBO (1.4% and 1.9% of pts, respectively). No deaths were reported. Conclusions: Daily ESO 20mg is efficacious and well tolerated for reducing the recurrence of peptic ulcer in East Asian pts who have a history of ulcers and are taking LDA for cardioprotection. Supported by AstraZeneca K.K., Osaka, Japan. Medical writing support from in Science Communications was funded by AstraZeneca.
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