Clinical—Alimentary TractEsomeprazole With Clopidogrel Reduces Peptic Ulcer Recurrence, Compared With Clopidogrel Alone, in Patients With Atherosclerosis
Section snippets
Study Population
This open-labeled trial was conducted at the Kaohsiung Veterans General Hospital in Taiwan in accordance with the principles of good clinical practice from the Declaration of Helsinki. The study protocol was approved by the Ethics Committee of the Kaohsiung Veterans General Hospital. All patients gave written informed consent before participating in the study. This trial is registered as a standard randomized Clinical Trial (ClinicalTrials.gov.identifier: NCT01138969).
We screened for eligible
Patients
From August 2008 to January 2010, we screened 253 consecutive patients who had a past history of gastroduodenal ulcer and underwent endoscopy with dyspeptic symptoms while receiving clopidogrel 75 or 37.5 mg/day, and a total of 165 of these patients were enrolled. Eighty-eight patients were excluded. Supplementary Figure 1 shows the trial profile.
All 165 randomized patients received at least one dose and were included in the ITT analysis (esomeprazole plus clopidogrel, n = 83; clopidogrel, n =
Discussion
The current study showed 11.0% of the patients with a peptic ulcer history who took clopidogrel for the prevention of ischemic events had recurrent peptic ulcer during a 6-month follow-up period.
The data indicate that a significant number of atherosclerotic patients who have a past history of peptic ulcers develop recurrent peptic ulcers during clopidogrel use. Two prospective randomized trials showed that the cumulative incidence of recurrent bleeding or ulcer complications during a 12-month
Acknowledgments
The authors are indebted to Drs F. W. Tsay, H. M. Wang, C. C. Lee, K. M. Wang, S. N. Chang, and J. L. Ou for recruiting the patients and performing the endoscopies; to the study nurses at the Kaohsiung Veterans General Hospital; to Professor L. P. Ger for statistical calculations; and to Professor D. Y. Graham for his review.
The registration number for this study is NCT01138969.
The statistical analysis of the entire data sets pertaining to efficacy (specifically primary and major secondary
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Conflicts of interest The authors disclose no conflicts.
Funding This study was funded by research grant VGHKS99-020 from the Research Fund of the Kaohsiung Veterans General Hospital.