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MAINTENANCE OF HEARTBURN CONTROL AFTER CONVERSION TO RABEPRAZOLE 20 MG FROM PREVIOUS PROTON PUMP INHIBITOR (PPI) THERAPY IN UNINVESTIGATED GASTROESOPHAGEAL REFLUX DISEASE (GERD)

DG Morgan¹, J Dinniwell², F Camacho³, FA Husein-Bhabha^2
1Division of Gastroenterology, Hamilton Health Sciences Centre, Hamilton, Ontario; ²Clinical Affairs, Janssen-Ortho Inc, Toronto, Ontario; ³Statistics, Damos Inc, Toronto, Ontario

As part of a randomized, controlled study investigating on-demand therapy, this initial phase of the study established maintenance of symptom control after four weeks on rabeprazole (RAB) in patients with controlled heartburn (HB) on previous PPIs at entry, before randomization in the second phase to either maintenance on-demand or continuous therapy. In this phase, 331 HB-predominant, uninvestigated GERD patients with adequate HB control (defined as no severe episodes and £ one moderate episode in seven days before enrollment) received RAB 20 mg (2´10 mg) for four weeks. Diary assessments included HB occurrence and severity, RAB and rescue antacid usage (daily), HB control and satisfaction during the past seven days (weekly).
RESULTS: Previous PPI usage at entry: esomeprazole (ESO) 29%, RAB 25%, pantoprazole (PAN) 20%, omeprazole (OME) 17%, lansoprazole (LAN) 9%. There was little change at four weeks from baseline with respect to HB occurrence and severity (proportions reporting no HB: baseline =59%, week 4=53%), and HB control (proportions reporting HB "satisfactorily" or "completely" controlled: baseline =98%, week 4=93%); responses at four weeks did not differ based on previously used PPI. At four weeks, 89% indicated that they were "very satisfied" or "satisfied" with HB control on RAB 20 mg; again, responses did not differ by previous PPI therapy. Daily mean rescue antacid consumption during the four weeks was 0.2 tablets. Medication and diary compliance was excellent (>90%).
CONCLUSIONS: In GERD patients previously responsive to PPI therapy, conversion to continuous therapy with rabeprazole 20 mg for four weeks maintained symptom control with a high level of satisfaction with heartburn control. No differences in symptom control were seen based on the previous PPI used.
This research was funded by an unrestricted grant from Janssen-Ortho Inc, Toronto, Ontario

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