Effectiveness and Tolerability of Rabeprazole 20mg as Once-Daily Monotherapy in Treatment of Erosive or Ulcerative Gastro-Oesophageal Reflux Disease

Abstract

Rabeprazole, a new proton pump (H+, K+-ATPase) inhibitor, is a consistently effective treatment for patients with gastro-oesophageal reflux disease (GORD). Most of the data, however, has been obtained from controlled trials. The present study was carried out to assess the effectiveness and tolerability of rabeprazole in actual conditions of use in everyday clinical practice. This was a multicentre, observational, noncomparative, open-label, short-term study conducted in the outpatient clinics of 11 hospitals from a single country (Brazil). Male and female patients over 18 years of age with endoscopically confirmed erosive/ulcerative oesophagitis (Savary-Miller classification) and moderate to severe heartburn as the predominant symptom were eligible. Patients received rabeprazole 20mg once daily in the morning for 4 or 8 weeks. Patients with endoscopically documented healing at week 4 exited the study at that point. 92 patients were included in the intention-to-treat (ITT) group and 68 in the per-protocol (PP) group. At the end of the 4-week treatment period, daytime heartburn was present in 16.2% of patients, as compared with 97.1% at baseline (p < 0.001) and night-time heartburn in 10.3%, as compared with 77.9% at baseline (p < 0.001). All other symptoms of GORD (acid regurgitation, dysphagia, eructation, fullness, nausea, vomiting, epigastric pain) improved significantly after 4 weeks of rabeprazole treatment. The healing rate of erosive/ulcerative oesophagitis was 70.6% in the PP analysis and 69.6% in the ITT analysis after 4 weeks of treatment. At 4 or 8 weeks, the healing rate in the PP group was 78.3% for grade I oesophagitis, 91.7% for grade II, 60% for grade III, and 40% for grade IV. According to diary card information, most patients obtained marked relief of heartburn within the first 3 days of treatment and reduction in the need for supplemental antacids within the first 5 days. A total of 18 adverse events occurred in 17 (18.5%) patients, with a ‘possible’ relationship to the use of rabeprazole in only four cases. Withdrawal of the medication because of adverse events was not necessary. In this non-comparative, open-label, short-term study, rabeprazole 20mg once daily has shown clinical effectiveness in healing oesophageal lesions and in reducing the frequency and intensity of heartburn associated with erosive/ ulcerative oesophagitis in patients with GORD. Rabeprazole was also well tolerated.