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95 EVALUATION OF CONTINUOUS AND ON-DEMAND MAINTENANCE THERAPY WITH RABEPRAZOLE (RAB) 20 MG IN UNINVESTIGATED GASTROESOPHAGEAL REFLUX DISEASE (GERD) DG Morgan1, MFJ O'Mahony2, WF O'Mahony3, J Roy4, J Dinniwell5, F Camacho6, FA Husein-Bhabha7 This Canadian, multicentre, randomized study compared six months of RAB 20 mg daily continuous therapy (COT) with RAB 20 mg on-demand (ODT) maintenance therapy in patients demonstrating satisfactory heartburn (HB) control during the final week of a four-week treatment period with daily RAB 20 mg (n=268). Assessments included HB occurrence, severity, RAB and rescue antacid usage, HB control, satisfaction and overall treatment evaluation (OTE).
1Division of Gastroenterology, Hamilton Health Sciences Centre, Hamilton, Ontario; 2London Road Diagnostic Clinic, Sarnia, Ontario, 3Medical Research Centre, Corunna, Ontario, 4Clinique Medicale Les Saules, Les Saules, Quebec; 5Clinical Affairs, Janssen-Ortho Inc, Toronto, Ontario; 6Statistics, Damos Inc, Toronto, Ontario
Primary end point: there were significantly more HB-free days with COT (90%) compared with ODT (65%; P<0.0001). Proportion of days with either no/mild HB was greater with COT than ODT (96% and 84%, respectively; P<0.0001). Proportion of weeks where HB rated "satisfactorily" or "completely" controlled was greater for COT (96%) than for ODT (84%; P<0.0001). Mean duration of HB episodes was significantly different between groups (COT=1.4, ODT=4.4 days; P=0.03). When HB did occur in ODT group, the mean duration of treatment episodes was 4.5 days, with a mean interval of 9.7 days between episodes. The ODT group required medication approximately 14 days/month. Mean daily antacid usage was very low overall (COT=0.1, ODT=0.3 tablets; P=0.002). OTE: more patients were "satisfied" or very satisfied" with COT compared with ODT (92% and 79%, respectively; P=0.007); there was no difference between proportions rating effect on HB control "good" or "very good" (COT= 89%, ODT=83%, P=ns). Both treatment regimens were safe and well tolerated.
Based on detailed symptom assessment, COT maintenance therapy is better than ODT at controlling daily HB symptoms. However, evaluating overall treatment effect and symptom control attained with the regimens over the six-month period, ODT and COT therapy can both be considered appropriate treatment options for GERD maintenance in selected patients.
Funded by an unrestricted grant from Janssen-Ortho Inc, Toronto, Ontario