Gastroduodenal and Esophageal Ulceration
The ASTERIX study showed that both gastroduodenal ulcers and esophageal ulcers occur less often in at-risk patients who add esomeprazole (AstraZeneca) to low-dose aspirin than in those who add placebo. Low-dose aspirin reduces recurrent events in patients with cardiovascular or cerebrovascular disease, but it is also associated with an 11% prevalence of gastroduodenal ulcer, said Angel Lanas, MD, from Clinical University Hospital in Zaragoza, Spain.
The aim of ASTERIX was to compare the incidence of gastroduodenal ulcers among patients taking low-dose, enteric-coated aspirin (75-325 mg/daily) plus either 20 mg daily of esomeprazole or placebo for six months. The double-blind, randomized, parallel-group study was conducted in 80 centers in 11 countries.
Endoscopy was performed at the baseline evaluation, at two months, and at six months. To be enrolled, the patients:
The main study endpoint was the incidence of gastroduodenal ulcer.
At six months, an analysis among 991 patients (with a mean age of 70) revealed an ulcer-free rate of 98.2% in canadian esomeprazole patients and a 93.8% rate with placebo patients (P < .007). Among patients who did develop ulcers (nine with eso-meprazole, 31 with placebo), the size of the ulcer was generally smaller in the esomeprazole group. Furthermore, more esomeprazole patients were free of esophageal lesions at six months (95.6%), compared with those receiving placebo (81.7%) (P < .0001). The esomeprazole patients were significantly less likely to have GI symptoms of epigastric burning, epigastric discomfort, or heartburn.
Well tolerated in these older patients, and discontinuation of therapy by ulcer-free patients was more frequent in the placebo group (13.6% vs. 18.9%).
Dr. Lanas concluded that in this at-risk population, esomeprazole was more effective than placebo in preventing gastroduodenal ulcers, esophageal lesions, and GI symptoms. He also noted that age was the most significant risk factor for GI complications.