Rabeprazole reduces the recurrence risk of peptic ulcers associated with low-dose aspirin in patients with cardiovascular or cerebrovascular disease: a prospective randomized active-controlled trial
Journal of Gastroenterology, 05/01/2012
Sanuki T et al. – Rabeprazole is more effective than gefarnate for reducing the risk of recurrence of peptic ulcer, esophagitis, and gastrointestinal symptoms in low–dose aspirin (LDA) users.Methods
- Patients with a history of peptic ulcers who were receiving LDA for cardiovascular or cerebrovascular disease were randomly assigned to receive rabeprazole at 10 mg daily, rabeprazole at 20 mg daily, or gefarnate (a cytoprotective anti-ulcer agent) at 50 mg twice daily.
- The primary endpoint was the development of gastric and/or duodenal ulcer at 12 weeks.
- The modified Lanza score (MLS) and gastrointestinal symptoms were evaluated at baseline and at 12 weeks.
- The full analysis set comprised 261 patients (rabeprazole 10 mg: n=87, rabeprazole 20 mg: n = 89, gefarnate 100 mg: n=85).
- The cumulative incidences of gastroduodenal ulcers at 12 weeks in the 10 mg rabeprazole group, 20 mg rabeprazole group, and gefarnate group were 7.4, 3.7, and 26.7 %, respectively (rabeprazole group 5.5 % vs. gefarnate group 26.7 %, hazard ratio [HR] 0.179; 95 % confidence interval [CI] 0.082–0.394; p<0.0001).
- The proportions of patients with an MLS of ≥1 and erosive esophagitis were significantly lower in the rabeprazole group than in the gefarnate group at 12 weeks (gastric lesions 33.5 vs. 62.4 %, p<0.0001; duodenal lesions 5.7 vs. 24.7 %, p < 0.0001; erosive esophagitis 5.8 vs. 19.4 %, p<0.0001).
- Rabeprazole was significantly more effective than gefarnate for the resolution and prevention of gastrointestinal symptoms (resolution 53.6 vs. 25.0 %, p=0.017; occurrence 9.2 vs. 28.3 %, p=0.0026).