LOS ANGELES — In patients at moderate risk for an ulcer who were on low-dose daily aspirin therapy, concomitant treatment with esomeprazole 20 mg once daily was significantly more effective than was placebo for preventing endoscopically confirmed gastroduodenal ulcers, a randomized, multicenter trial showed.
“Esomeprazole prevents the development of upper GI lesions and also lessens the occurrence of GI symptoms, and is a safe and well-tolerated therapy,” Dr. Angel Lanas said at the annual Digestive Disease Week.
In a study conducted at 80 centers in 11 countries, 991 patients aged 60 and older were randomized to receive either low-dose aspirin once daily plus esomeprazole (Nexium) 20 mg once daily (493 patients) or low-dose aspirin once daily plus placebo (498 patients). Low-dose aspirin was defined as a dose of 75–325 mg/day. Half of the patients were male, with a mean age of 80 years.
Patients were excluded if they had heartburn or other upper gastrointestinal symptoms that required treatment, or if they had erosive esophagitis. Endoscopy was performed at baseline, 2 months, and 6 months. The main study outcome was the incidence of gastroduodenal ulcers over the 6-month period.
At the study's end, 8 patients in the esomeprazole arm (1.6%) developed a gastroduodenal ulcer, compared with 27 patients (5.4%) in the placebo arm, a difference that was statistically significant.
Dr. Lanas of the gastroenterology department at University Hospital Clinic in Zaragoza, Spain, said that these results corresponded to a relative risk reduction of 70% among patients in the esomeprazole arm, compared with their counterparts in the placebo arm. He also noted that the average ulcer sizes in the esomeprazole arm ranged from 5 mm to 8 mm.
When the researchers applied life-table estimates to the data, they determined that 1.8% of patients in the esomeprazole arm had a gastroduodenal ulcer at 6 months vs. 6.2% of patients in the placebo arm, a difference that also was statistically significant.
AstraZenecaPharmaceuticals LP, maker of Nexium, sponsored the trial. Dr. Lanas disclosed that he is a consultant for AstraZeneca and for Merck & Co.