A randomized, double-blind, comparative study of standard-dose rabeprazole and high-dose omeprazole in gastro-oesophageal re¯ux disease G. HOLTMANN*, P. BYTZER  , M. METZ à , V. LOEFFLER à & A. L. BLUM§ *Department of Gastroenterology and Hepatology, University of Essen, Essen, Germany;  Department of Medical Gastroenterology, Glostrup University Hospital, Denmark; àEisai GmbH, Frankfurt, Germany; §CHUV, Lausanne, Switzerland Accepted for publication 29 October 2001 INTRODUCTION Gastro-oesophageal re¯ux disease (GERD) is a common and chronic disorder. Its most common symptom is heartburn, which affects about one-quarter of all adults on a regular basis in Western countries. 1, 2 The disease is not self-limiting, and pathological re¯ux in patients with GERD typically persists for years or even decades. 3 Various treatments are available for GERD. Some patients with mild disease may obtain relief of symptoms from lifestyle changes alone, such as elevation of the head of the bed or the avoidance of large meals late at night, while, at the other end of the spectrum, patients with severe disease may require surgery. However, most SUMMARY Background: Rabeprazole has a faster onset of antise- cretory action than omeprazole, and it is of interest to determine whether this translates into faster symptom relief in patients with gastro-oesophageal re¯ux disease. Aims: To assess the relief from heartburn after 3 days of treatment with standard-dose rabeprazole or high-dose omeprazole (primary end-point). Secondary end-points included the decrease in score for other symptoms of gastro-oesophageal re¯ux disease, healing rates and quanti®cation of antacid use. Methods: Patients with endoscopically con®rmed ero- sive oesophagitis were randomized to receive 4 weeks of double-blind treatment with rabeprazole (20 mg) or omeprazole (40 mg). Patients who were not healed after 4 weeks received a further 4 weeks of treatment. Results: Two hundred and seventy-four patients were screened, 251 patients were randomized and 230 patients completed the trial. The numbers of patients with relief from heartburn on day 4 were similar in the two groups (84% for rabeprazole; 95% con®dence interval, 76±90%; 83% for omeprazole; 95% con®dence interval, 75±89%). There were no signi®cant differences between the treatments in the relief from other gastro- oesophageal re¯ux disease symptoms or in healing rates. The number of reports of severe heartburn during the ®rst 3 days was higher in the omeprazole group (daytime heartburn: 4.7% for rabeprazole vs. 10.3% for omeprazole, P  0.005; night-time heartburn: 4.7% for rabeprazole vs. 9.8% for omeprazole, P  0.01; statis- tical comparisons de®ned post hoc). Conclusions: Standard-dose rabeprazole was as effective as high-dose omeprazole in relieving symptoms by day 4 of treatment and in healing oesophageal lesions, but had a faster onset of action in patients with severe heartburn. This suggests that the improved pharmaco- logical properties of rabeprazole translate into a clinic- ally relevant advantage. Correspondence to: Professor G. Holtmann, University of Essen, Depart- ment of Gastroenterology and Hepatology, Hufelandstraûe 55, 45122 Essen, Germany. E-mail: g.holtmann@uni-essen.de Aliment Pharmacol Ther 2002; 16: 479±485. Ó 2002 Blackwell Science Ltd 479