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AN EXPLORATORY STUDY OF ONCE DAILY MORNING, EVENING OR TWICE DAILY RABEPRAZOLE (RAB) REGIMENS FOR CONTROL OF NOCTURNAL HEARTBURN (NT HB) SYMPTOMS IN UNINVESTIGATED SYMPTOMATIC GASTROESOPHAGEAL REFLUX DISEASE (S-GERD)

DG Morgan¹, SC Ganguli², MFJ O'Mahony³, J Roy⁴, F Camacho⁵, B Teixeira⁶, FA Husein-Bhabha^6
1Division of Gastroenterology, Hamilton Health Sciences Centre, Hamilton, Ontario; ²Department of Gastroenterology, St Joseph's Healthcare, Hamilton, Ontario; ³London Road Diagnostic Clinic, Sarnia, Ontario; ⁴Clinique Medicale Les Saules, Les Saules, Ontario; ⁵Statistics, DAMOS Inc, Toronto, Ontario; ⁶Clinical Affairs, Janssen-Ortho Inc, Toronto, Ontario

This exploratory study evaluated three RAB regimens in controlling NT HB symptoms in S-GERD patients with bothersome NT HB, and no more than mild, infrequent daytime (DT) HB symptoms on standard proton pump inhibitor or histamine-2 receptor antagonist therapy. This was determined by NT and DT scores during the 14-day run-in period (where score = summation of frequency ´ severity of episodes for the defined period). Randomized patients (n=48) received either RAB 20 mg taken once daily before breakfast (QAM), or RAB 20 mg taken once daily before dinner (QPM), or RAB 10 mg taken twice daily in morning and evening before meals (BID) for eight weeks. Diary assessments included heartburn occurrence and severity, RAB and rescue antacid usage (daily), and ratings of heartburn control and satisfaction (weekly).
RESULTS: Mean (±SD) NT HB scores estimates at four weeks were QPM: 6.9±8.0, QAM: 8.1±10.4 and BID 12±12.6 (P=0.2330). There were changes at 4- and 8-weeks from baseline for all regimens with respect to mean NT HB score and antacid usage; changes were consistently larger for QAM and QPM regimens than for the BID regimen. The majority of patients in all regimens rated heartburn control "satisfactorily" or "completely controlled" at 4- and 8-weeks, as well as rated satisfaction with HB control as "satisfied" or "very satisfied" at these time points. Compliance with each regimen was excellent (³94%). All RAB regimens were safe and well tolerated.
CONCLUSIONS: In many patients with NT HB, QAM or QPM regimens may provide better NT symptom control; however, further study is required to identify the best regimen.
This research was funded by an unrestricted grant from Janssen-Ortho Inc, Toronto, Ontario

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