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Canadian Journal of Gastroenterology
Volume 21, Issue 12, Pages 820-826
Original Article

Maintenance Treatment of Gastroesophageal Reflux Disease: An Evaluation of Continuous and On-Demand Therapy with Rabeprazole 20 mg

David G Morgan,1 Michael FJ O’Mahony,2 William F O’Mahony,3 Jean Roy,4 Fernando Camacho,5 Julie Dinniwell,6 GLA Horbay,6 Farah A Husein-Bhabha,6 and for the RAB-GRD-3002 Study Group1

1Division of Gastroenterology, St Joseph’s Healthcare, Hamilton, Canada
2London Road Diagnostic Clinic, Sarnia, canada
3Medical Research Centre, Corunna, Ontario, Canada
4Clinique Medicale Les Saules, Les Saules, Quebec, Canada
5DAMOS Inc, Toronto, Ontario, Canada
6Clinical Affairs, Janssen-Ortho Inc, Toronto, Ontario, Canada

Received 21 December 2006; Accepted 27 March 2007

Copyright © 2007 Hindawi Publishing Corporation. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


OBJECTIVE: To evaluate continuous therapy (COT) and on-demand therapy (ODT) with rabeprazole 20 mg for maintenance in uninvestigated gastroesophageal reflux disease (GERD).

METHODS: This randomized, open-label study enrolled 331 GERD (heartburn-predominant) patients with a pre-existing proton pump inhibitor history of one month or longer, to an acute four-week trial with 20 mg rabeprazole daily for heartburn management. Patients who achieved satisfactory heartburn control during the acute phase (three days or less of heartburn, with no more than one episode rated as moderate, and heartburn rated satisfactorily or completely controlled with minimal rescue antacid use in the seven days preceding randomization) were randomly assigned to six months of rabeprazole 20 mg given as either daily COT or daily ODT, which was initiated upon symptom recurrence and stopped upon symptom resolution. Rescue antacid usage was permitted and tracked. Primary efficacy was measured as the proportion of heartburn-free days over six months.

RESULTS: For the 268 patients, the mean percentage of heartburn-free days for the COT group and for the ODT group were 90.3%±14.8% and 64.8%±22.3%, respectively (P<0.0001). COT was associated with an increased number of medication intake days (154±40.2) versus ODT (68±46.1), with less heartburn episodes observed with COT versus ODT, respectively (n=7, n=26, P<0.0001). Ninety-two per cent of COT patients and 79% of ODT patients were either ‘satisfied’ or ‘very satisfied’ with treatment. The mean usage of antacids was low and similar in both groups. COT and ODT regimens were safe and well-tolerated, with a similar incidence of adverse events.

CONCLUSION: Results based on symptom assessments favour COT with rabeprazole 20 mg for maintenance therapy in patients with uninvestigated GERD; however, both therapy types are safe and acceptable treatment options for selected patients.