GERD and Rabeprazole
Abstract & Commentary
By Malcolm Robinson MD, FACP, FACG, Emeritus Clinical Professor of Medicine, University of Oklahoma College of Medicine, Oklahoma City. Dr. Robinson serves as a consultant for TAP, Pfizer, Janssen, Eisai, J&J-Merck, and Procter & Gamble, is on the speaker's bureau of Janssen, Eli Lilly, Solvay, TAP, and Aventis, and does research for Forest Labs, Wyeth-Ayerst, AstraZeneca, and Centocor.
Synopsis: In contrast to the findings from a recent esomeprazole study, these authors show that on-demand therapy with rabeprazole is a good alternative to continuous treatment.
Source: Bour B, et al. Long-term treatment of gastro-oesophageal reflux disease patients with frequent symptomatic relapses using rabeprazole: on-demand treatment compared with continuous treatment. Aliment Pharmacol Ther. 2005;21:805-812.
Since most patients with gastroesophageal reflux disease (GERD) suffer intermittent rather than continuous symptoms, and since most patients don't have severe erosive esophagitis, the goal of GERD therapy is mainly to relieve symptoms. This study was done in patients with either nonerosive GERD or mild esophagitis (including grade 2 erosions). This segment of the GERD population probably includes more than 80% of all patients. The study began with a 4-week selection phase with 176 patients. Approximately 89% of these patients with mild-to-moderate GERD had relief of their symptoms in this study phase. Patients who immediately relapsed in the period during which treatment was interrupted were excluded from the study since they were felt to be "PPI-addicted" and thus not really suitable for an on-demand form of therapy. However, it appears that few patients were so excluded. 152 patients were randomized to either 10 mg of rabeprazole daily 9 (n = 81) or to on-demand treatment (n = 71). The on-demand group was told to take the rabeprazole for symptoms interfering with their quality of life and was urged to discontinue therapy after 48 hours without symptoms. Symptom relief slightly favored the continuous treatment with 86.4% symptom relief vs 74.6% for the on-demand group (NS). However, quality-of-life scores were similar for both groups, and the mean consumption of rabeprazole by the on-demand group was only 0.31 tablets daily.
In Europe, 10 mg of rabeprazole is approved for GERD maintenance therapy. Although less potent than the usual US dose of 20 mg, the 10 mg dose has been proven to be clinically effective. Unlike the recent study of esomeprazole in erosive esophagitis, this rabeprazole study did not follow these maintenance therapy patients with endoscopy. However, the likelihood of significant disease worsening in such a setting is generally accepted to be extremely low. Patients in this study had chronic illness, impaired quality of life, and almost all experienced numerous past symptomatic relapses. Almost half (45%) of the on-demand rabeprazole recipients took between one and three tablets per week during the study. Unlike other studies of PPIs for maintenance therapy, this one did not provide 'rescue' antacids. In general, the proportional results of this study with low-dose rabeprazole parallel those of other PPIs studied in on-demand settings where antacids were provided (thereby potentially lowering the likelihood of PPI consumption). It is recognized by most physicians that their patients often opt for on-demand therapy even when daily therapy is prescribed. This study is encouraging in its support for this approach to treating a very substantial proportion of our GERD patients.