Introduction

Treatment response in patients with severe erosive gastroesophageal reflux disease (eGERD) is often inadequate using regular doses of proton pump inhibitors (PPIs), thus necessitating escalation of dosing. High-dose PPIs improve compliance in such patients, leading to better outcomes. However, comparative data on effectiveness of high-dose PPIs is limited.

Aims & Methods

This interim analysis assessed symptomatic improvement of regurgitation in an ongoing, prospective, real-world, observational study to compare the effectiveness of rabeprazole 40mg to pantoprazole 80mg and omeprazole 40mg/esomeprazole 80mg. Adult patients with endoscopically confirmed severe eGERD were enrolled. Patients shifted from low-dose PPIs or started on high-dose PPIs were included; those with complications of GERD were excluded.

Results

A total of 260 patients (rabeprazole, 130; omeprazole/esomeprazole, 65; pantoprazole, 65) from 37 sites in India were analyzed. Although symptomatic improvement of diurnal and nocturnal regurgitation based on patient-reported severity scores was observed among the three arms after 4±1 weeks of treatment, the complete-resolution rate of diurnal regurgitation was significantly higher with rabeprazole (17.97%) compared to omeprazole/esomeprazole (5.08%; p=0.018) and higher than pantoprazole (8.20%; p=0.077). Similarly, complete resolution of nocturnal regurgitation was significantly higher with rabeprazole (14.06%) compared to omeprazole/esomeprazole (1.59%; p=0.007) and higher than pantoprazole (7.94%; p=0.221). Among patients with associated work-related stress (n=132), one-fifth in the rabeprazole arm experienced complete resolution of diurnal regurgitation compared to none in the omeprazole/esomeprazole (p=0.013) or pantoprazole (p=0.030) arms. Patients with lack of regular physical exercise (83.08%) exhibited higher rate of complete resolution of nocturnal regurgitation with rabeprazole (13.73%) compared to the other PPIs. Overall, elderly patients >60 years of age (mean±SD, 68.82±6.54 years) treated with rabeprazole showed significantly higher complete-resolution rates of diurnal regurgitation compared to pantoprazole (36.67% vs. 0%; p=0.003). For complete resolution of nocturnal regurgitation, rabeprazole proved to be significantly better when compared to omeprazole/esomeprazole (31.25% vs. 0%; p=0.015) in elderly patients (Table 1).

Conclusion

The interim results showed that rabeprazole led to significantly higher complete-resolution rates of diurnal and nocturnal regurgitation at 4±1 weeks of treatment than omeprazole/esomeprazole in adults with severe eGERD. In elderly patients, rabeprazole showed significant resolution over pantoprazole.

Disclosure

Study funded by: Dr. Reddy's Laboratories Ltd., Hyderabad, Telangana, India