INTRAVENOUS (IV) PANTOPRAZOLE DECREASES HEARTBURN AND ANTACID USE IN PATIENTS WITH GASTROESOPHAGEAL REFLUX DISEASE (GERD)

Purpose: To assess the effect of IV pantoprazole on GERD symptoms and antacid usage in patients with GERD who are not currently on acid suppres-sive therapy. Methods: In a multicenter, randomized, double blind, placebo-controlled, double dummy study, eligible patients were randomized to receive either IV pantoprazole 40 mg, oral pantoprazole tablets 40 mg, or placebo once daily for 7 days. Patients had to have a history of erosive esophagitis and recent symptoms of GERD and must have discontinued all acid suppressing medications (PPIs or H2RAs) for 10 days prior to the first day of dosing. Frequency and severity of heartburn and Gelusil usage were assessed twice daily by a telephone entry system. Severity was scored as none = 0, mild = 1, moderate = 2, or severe = 3. The mean values for the last 3 days before treatment (baseline) were compared with the mean for the last 3 days on treatment. As these were secondary endpoints in an acid output study no hypothesis testing was done and only descriptive statistics were conducted. Results: 74 patients were included in the intent-to-treat analysis for symptoms. Patients reported a mean of 3 episodes of heartburn per 24-hour period at baseline. The mean (± SE) change in heartburn and antacid use are shown in table 1.TableIn this study, IV pantoprazole was well tolerated with a safety profile comparable to those of oral pantoprazole and placebo. Conclusions: When used as initial therapy, IV pantoprazole, as well as oral pantoprazole reduced the frequency and severity of heartburn and antacid use. This study suggests that patients with a history of erosive GERD can be treated with IV pantoprazole to reduce GERD symptoms when the use of oral pantoprazole is not indicated.