CHICAGO – Continued use of aspirin does not impair the healing of aspirin-related peptic ulcers under powerful proton pump inhibitor therapy, a randomized study in 160 patients suggests.
The ulcer healing rate, according to an intention-to-treat analysis, was 85.2% for patients receiving esomeprazole (Nexium) alone and 84.8% for those receiving esomeprazole plus aspirin. The per-protocol analysis showed nearly identical healing rates at 83.1% and 82.1%, Dr. Ping-I Hsu reported at the annual Digestive Disease Week.
Dr. Ping-I Hsu
The findings are noteworthy because patients are sometimes switched from aspirin to clopidogrel (Plavix) as an alternative treatment for aspirin-related peptic ulcers. There are no specific guidelines for the use of gastroprotective agents like proton pump inhibitors (PPIs) and clopidogrel. However, in a highly controversial move, the Food and Drug Administration discouraged concomitant use of clopidogrel and PPIs, especially omeprazole (Prilosec), because of a potential drug interaction.
Dr. Hsu pointed out that clopidogrel is far more expensive than aspirin, and that an earlier study showed that clopidogrel plus omeprazole had a similar ulcer healing rate as aspirin plus omeprazole (Aliment. Pharmacol. Ther. 2004;19:359-65).
"We therefore suggest that continuing aspirin use plus a powerful PPI is the best initial treatment of aspirin-related peptic ulcers," said Dr. Hsu, with the division of gastroenterology, Kaohsiung Veterans General Hospital and National Yang-Ming University, Kaohsiung, Taiwan.
The trial randomized 160 patients who were on low-dose aspirin and had a 3 mm or more peptic ulcer to esomeprazole 40 mg/day alone or with aspirin 100 mg/day for 8 weeks. Patients with Helicobacter pylori infection were treated with 10-day, standard triple therapy.
Exclusion criteria included serious medical illness or acute gastrointestinal bleeding, cardiovascular events within 6 months, history of partial gastrectomy, concomitant use of clopidogrel or anticoagulant and long-term use of NSAIDs.
Ten patients in the esomeprazole group and 12 in the combination group were excluded because of poor compliance or refusal of follow-up endoscopy, leaving 71 esomeprazole and 67 combination patients in the per-protocol analysis.
At baseline, the 81 esomeprazole patients and 79 esomeprazole plus aspirin patients were similar with respect to NSAID use (17% vs. 11%), prior peptic ulcer bleeding (12% vs. 14%), H. pylori infection (47% vs. 37%), and rates of underlying diseases such as diabetes mellitus (27% vs. 33%), hypertension (67% vs. 58%), coronary artery disease (52% vs. 57%), and cerebrovascular accident (10% vs. 15%). Their mean age was 69 years.
At week 8, Lanza scores decreased from 4 at baseline to 1.27 in each group, Dr. Hsu said.
Dyspepsia symptom scores decreased in the esomeprazole group from 1.78 to 0.50 and from 1.59 to 0.5 in the combination group. No patient in either group experienced ulcer bleeding or perforation.
Cardiovascular outcomes also were similar with or without continuous aspirin use. Only one case of unstable angina occurred in the combination group, and no patients experienced an acute MI, ischemic stroke or died, he said.
Independent risk factors predicting ulcer healing failure were diabetes mellitus (odds ratio, 3.2), use of steroids (OR, 12.1) and persistent H. pylori infection (OR, 20.2), Dr. Hsu said. The healing rate of ulcers with H. pylori infection was 25% vs. 84% without infection.
"Eradicating H. pylori is important for the healing of aspirin-related peptic ulcers," he said.
Dr. Hsu disclosed no conflicts of interest.