Efficacy and safety of pantoprazole in patients with gastroesophageal reflux disease using an intravenous-oral regimen

BACKGROUND/AIMS: To investigate the efficacy and safety of an intravenous-o ral regimen using the gastric proton pump inhibitor pantoprazole. METHODOLOGY: Outpatients, with endoscopically diagnosed moderate or severe gastro-esophageal reflux disease (GERD stage II and III, respectively, Sava ry-Miller classification), were recruited from ten hospitals or private pra ctice centers and enrolled into an open-labeled study (intention-to-treat p opulation n = 110, age 20-88 years; per-protocol population n = 98). Patien ts were treated once daily with 40mg pantoprazole which was administered as an intravenous injection for the initial 5-7 consecutive days, then as a t ablet, for up to 8 weeks. The efficacy parameters were complete healing of lesions evaluated endoscopically after week 4 and 8, and relief from sympto ms assessed after week 2 and 4. RESULTS: Complete healing was achieved in 85/98 (87%) and 93/98 (95%) per-p rotocol patients, after 4 and 8 weeks, respectively. The corresponding resu lts for the intention-to-treat population were 85/110 (77%) and 93/110 (85% ), respectively. After 2 weeks of treatment, heartburn, acid regurgitation, and pain on swallowing resolved in 97%, 98%, and 100% of the per-protocol patients, respectively. Faster healing was observed in non-smokers, those i nfected with Helicobacter pylori, and those with initial GERD stage II. The intravenous and oral administration phases were well tolerated. CONCLUSIONS: Pantoprazole (40mg), applied as an intravenous-oral regimen to patients with GERD led to fast resolution of symptoms and high healing rat es. For patients, temporarily unable to take oral medications, this regimen offers safe and reliable gastric acid suppression and allows the possibili ty of changing between the oral and intravenous administration without the need for dose adjustment.