Long-term treatment of gastro-oesophageal reflux disease patients with frequent symptomatic relapses using rabeprazole: on-demand treatment compared with continuous treatment.

BACKGROUND: On-demand treatment may be an alternative in the long-term treatment of non-severe gastro-oesophageal reflux disease in patients with frequent symptomatic relapses. AIM: To compare the efficacy of on-demand treatment with rabeprazole 10 mg versus continuous treatment in the long-term treatment of patients with frequent symptomatic relapses of mild to moderate gastro-oesophageal reflux disease. METHODS: This randomized, open-label study enrolled patients diagnosed with non-erosive reflux disease or oesophagitis grade 1 or 2 (Savary-Miller classification) reporting frequent symptomatic relapses (requiring > or =2 courses of antisecretory therapy during the previous year), whose intensity is rated at least moderate (>2 on a 5-point Likert scale). After a 4-week selection phase with rabeprazole 10 mg once daily, patients reporting symptom relief (Likert score < or =2) were randomized to receive either rabeprazole 10 mg continuous treatment or on-demand treatment for 6 months. The main evaluation criterion was the rate of symptom relief (scored on the Likert scale) after 6 months. RESULTS: One hundred and seventy-six patients were enrolled in the 4-week selection phase (men, 53%; mean age, 49 years; non-erosive reflux disease, 36.4%; gastro-oesophageal reflux disease 1, 53.4%; gastro-oesophageal reflux disease 2, 10.2%). Rabeprazole relieved symptoms in 88.6% of patients. Of this group, 152 were randomized to the comparative phase to receive rabeprazole 10 mg continuous treatment (once daily) or on-demand treatment (continuous treatment, n = 81; on-demand treatment, n = 71). At month 6 (end point), the symptom relief rate was slightly higher for patients in the continuous treatment group compared with those in the on-demand treatment group: 86.4% versus 74.6%, respectively. This difference was not statistically significant (P = 0.065). For the overall quality of life score, there was no difference between the continuous treatment and on-demand treatment groups (86.25 and 84.94). Mean daily consumption of rabeprazole was significantly lower in the on-demand treatment group versus the continuous treatment group (0.31 tablets versus 0.96 tablets; P < 0.0001). CONCLUSION: On-demand therapy with rabeprazole 10 mg provides an alternative to continuous therapy in patients with mild to moderate gastro-oesophageal reflux disease suffering from frequent symptomatic relapses.

Effect of low-dose rabeprazole and omeprazole on gastric acidity: results of a double blind, randomized, placebo-controlled, three-way crossover study in healthy subjects.

BACKGROUND: The treatment of acid-related symptoms requires rapid and consistent acid suppression, especially with on-demand regimens. AIM: To compare the antisecretory activity of low-dose rabeprazole and omeprazole in healthy, Helicobacter pylori-negative subjects. METHODS: In this randomized, double-blind, placebo-controlled, three-way crossover study, 27 volunteers were given rabeprazole 10 mg, omeprazole 10 mg, or placebo once daily for 7 days with a 10-14-day washout between treatments. Intragastric pH was monitored for 24-h on days 1 and 7 of each treatment. RESULTS: Median gastric pH was significantly higher with rabeprazole than with omeprazole or placebo: day 1: 2.3, 1.4 and 1.3, respectively (P = 0.0056, rabeprazole vs. omeprazole; P < 0.0001, rabeprazole vs. placebo); day 7: 3.7, 2.2 and 1.3, respectively (P = 0.0016 rabeprazole vs. omeprazole; P < 0.0001, rabeprazole vs. placebo). Time with gastric pH above 4 was significantly higher with rabeprazole than with omeprazole: day 1, 5.8 h vs. 3.7 h, respectively (P < 0.02); day 7, 10.5 h vs. 4.6 h, respectively (P = 0.0008). CONCLUSIONS: Rabeprazole 10 mg provides more rapid acid inhibition compared with omeprazole 10 mg. After 7 days, the time with pH above 4 is more than doubled with rabeprazole 10 mg vs. omeprazole 10 mg.