Rabeprazole versus omeprazole in preventing relapse of erosive or ulcerative gastroesophageal reflux disease - A double-blind, multicenter, European trial

Gastroesophageal reflux disease (GERD) is a chronic condition, with 50-80% of patients experiencing recurrence within one year of completing initial t reatment. In patients with erosive GERD, proton-pump inhibitors (PPI) provi de faster healing and symptom relief than do H-2-receptor antagonists and h ave become the treatment of choice. Rabeprazole is a new PPI with demonstra ted efficacy in both the acute and maintenance treatment of erosive GERD. T he primary objective was to compare efficacy and tolerability of rabeprazol e and omeprazole in preventing relapse of healed erosive GERD. Secondary ob jectives included comparison of efficacy in preventing GERD relapse symptom s and in maintaining quality of life. Tn this multicenter, double-blind, pa rallel-group study, 243 patients with healed erosive GERD were randomised t o receive rabeprazole 10 mg once daily in the morning (QAM) (N = 82); rabep razole 20 mg QAM (N = 78); or omeprazole 20 mg QAM (N = 83). Endoscopies we re per-formed at weeks 13, 26, 39 (if clinically indicated), and 52, or whe n symptoms suggested recurrence. Corpus biopsies were performed at each end oscopy, and antral biopsies were performed at study entry and exit. Rabepra zole 10 mg and 20 mg QAM were equivalent to omeprazole 20 mg QAM for all ef ficacy parameters. At week 52, relapse rates in the intent-to-treat populat ions were 5%, 4%, and 5% for rabeprazole 10 mg and 20 mg and omeprazole 20 mg, respectively. All treatments were well tolerated. In conclusion, both r abeprazole 10 mg and 20 mg QAM are equivalent to omeprazole 20 mg QAM in pr eventing recurrence of erosive GERD.