Esomeprazole administered by itself may heal peptic ulcers at a comparable rate to esomeprazole taken with aspirin, according to recent results.
Among 178 study participants, 89 received 40 mg esomeprazole alone and 89 received 40 mg esomeprazole with 100 mg aspirin daily for 8 weeks. Follow-up endoscopies were conducted at the end of the regimen to determine how well patients’ peptic ulcers had healed in both groups.
A modified intention-to-treat analysis of evaluable patients (n=80 in the esomeprazole group; n=81 in the esomeprazole/aspirin group) indicated a healing rate of 82.5% for the esomeprazole group (95% CI, 74.2%-90.8%) and 81.5% for the group receiving esomeprazole/aspirin (95% CI, 73.0%-90.0%). A per-protocol analysis revealed healing rates of 83.1% in the nonaspirin group and 83.8% in the aspirin group (difference 0.7%, 95% CI, –11.2% to 12.6%).
No patients in either group experienced ulcer bleeding or perforation, and no significant difference was observed in dyspepsia symptoms between groups. Patients with Helicobacter pylori infection were cured in 36 of 38 (94.7%) cases in the nonaspirin group and in 27 of 29 cases (93.1%) in the aspirin group.
Investigators found steroid usage during treatment (P=.006) and ulcers of 1 cm or larger (P=.034) to be significantly associated with reduced healing rates. Factors including age, gender, hypertension, previous bleeding ulcers and H. pylori infection were not associated with healing. A multivariate analysis indicated that only steroid use was an independent risk factor for failed healing (OR=5.6, 95% CI, 1.1%-27.7%).
“In this study, we conducted the first randomized, controlled trial to assess the efficacies of esomeprazole alone and esomeprazole plus aspirin in the treatment of aspirin-related peptic ulcers,” the researchers wrote. “The data demonstrated that the observed healing rates were comparable in the two treatment groups … but the wide CIs in this study do not rule out clinically meaningful differences of more than 10%.”