Oral and intravenous dosage forms of pantoprazole are equivalent in their ability to suppress gastric acid secretion in patients with gastroesophageal reflux disease

OBJECTIVE: The aim of this study was to assess the ability of pantoprazole to maintain gastric acid suppression in patients with gastroesophageal refl ux; disease who are switched from an oral (p.o.) to an intravenous (i.v.) d osage form. METHODS: A total of 65 patients with gastroesophageal reflux disease were a dministered either 40 or 20 mg of p.o. pantoprazole daily for 10 days, then were switched to either a matching dose of i.v. pantoprazole or to placebo for 7 days. Acid output (basal and maximal) was measured at the end of the p.o. treatment period and on the first and last days of i.v. therapy. In t he primary efficacy analysis: the acid output Values at the end of the p.o. pantoprazole treatment were compared with those at the end of the i.v. tre atment. Safety was monitored by periodic vital sign measurements, clinical laboratory evaluations, ophthalmic examinations, electrocardiograms, and re ports of adverse events. The data were tested by an analysis of covariance and by Wilcoxon signed rank and t tests. RESULTS: Maximal acid output (mean +/- SD) in the 40 mg and 20 mg pantopraz ole group after p.o. treatment was 6.5 +/- 5.6 mEq/h and 14.5 +/- 15.5 mEq/ h, respectively; whereas, at the end of the i.v. treatment period, the Valu es were 6.6 +/- 6.3 mEq/h and 11.1 +/- 10.2 mEq/h. respectively. In patient s given i.v. placebo, acid output was significantly (p < 0.05) increased to 29.2 +/- 13.0 mEq/h by day 7. Both p.o. and i.v. pantoprazole dosage forms had similar favorable safety and tolerability profiles. CONCLUSIONS: The p.o. and i.v. formulations of pantoprazole (40 and 20 mg) are equivalent in their ability to suppress gastric acid output. The i.v. f orm of pantoprazole offers an alternative for gastroesophageal reflux disea se patients who are unable to take the p.o. formulation. (Am J Gastroentero l 2000;95:626-633. (C) 2000 by Am. Coll. of Gastroenterology).