ABSTRACT
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.
Subject(s)
2-Pyridinylmethylsulfinylbenzimidazoles/administration & dosage , Enzyme Inhibitors/administration & dosage , Gastroesophageal Reflux/drug therapy , Administration, Oral , Adult , Aged , Dose-Response Relationship, Drug , Female , Follow-Up Studies , Gastroesophageal Reflux/complications , Heartburn/drug therapy , Heartburn/etiology , Humans , Male , Middle Aged , Proton-Translocating ATPases/antagonists & inhibitors , Rabeprazole , Retrospective Studies , Severity of Illness Index , Treatment OutcomeABSTRACT
BACKGROUND: Intravenous pantoprazole is often administered inappropriately to hospitalized patients who can take oral medications. AIM: To compare the antisecretory effects of oral rabeprazole and intravenous pantoprazole in healthy subjects. METHODS: In a double-blind, double-dummy, two-way crossover study, 38 Helicobacter pylori-negative volunteers were randomized to oral rabeprazole 20 mg or intravenous pantoprazole 40 mg daily for 3 days followed, after a 14-day washout period by the comparator treatment. Intragastric pH was recorded continuously for 24 h at baseline and on days 1 and 3 of each treatment period. RESULTS: The mean (95% CI) percentage of the 24-h recording with gastric pH >4 was higher with rabeprazole than with pantoprazole on day 1: 37.7% (30.6-44.8%) vs. 23.9% (20.0-27.8). The mean percentage times with pH >3 and >4 for all intervals assessed were greater and the median 24-h intragastric pH values were higher with rabeprazole than with pantoprazole on days 1 and 3. The mean acidity index was lower with rabeprazole on days 1 and 3. CONCLUSIONS: Oral rabeprazole 20 mg produced greater acid suppression than intravenous pantoprazole 40 mg. Therefore, it may be an appropriate and effective alternative in patients who can take oral medication.
