This study demonstrated that, after 10 days of repeated oral administration followed by 7 days of intravenous administration, the oral and intravenous dosage forms of PROTONIX 40 mg are similar in their ability to suppress MAO and BAO in patients with GERD and a history of erosive esophagitis (see table below). Also, patients on oral PROTONIX who were switched to intravenous placebo experienced a significant increase in acid output within 48 hours of their last oral dose. However, at 48 hours after their last oral dose, patients treated with PROTONIX I.V. for Injection had a significantly lower mean basal acid output than those treated with placebo.

ANTISECRETORY EFFECTS (mEq/h) OF 40 mg PROTONIX I.V. for INJECTION AND 40 mg ORAL PROTONIX IN GERD PATIENTS WITH A HISTORY OF EROSIVE ESOPHAGITIS

To evaluate the effectiveness of PROTONIX I.V. (pantoprazole sodium) for Injection as an initial treatment to suppress gastric acid secretion, two studies were conducted.

Study 1 was a multicenter, double-blind, placebo controlled, study of the pharmacodynamic effects of PROTONIX I.V. for Injection and oral PROTONIX. Patients with GERD and a history of erosive esophagitis (n=78, 20-67 years; 39 females; 7 black, 19 Hispanic, 52 white) were randomized to receive either 40 mg intravenous pantoprazole, 40 mg oral pantoprazole, or placebo once daily for 7 days. Following an overnight fast, test medication was administered and patients were given a light meal within 15 minutes. MAO and BAO were determined 24 hours following the last day of study medication. MAO was estimated from a 1 hour continuous collection of gastric contents following subcutaneous injection of 6.0 µg/kg of pentagastrin to stimulate acid secretion. This study demonstrated that, after treatment for 7 days, patients treated with PROTONIX I.V. for Injection had a significantly lower MAO and BAO than those treated with placebo (p < 0.001), and results were comparable to those of patients treated with oral PROTONIX (see table below).

ANTISECRETORY EFFECTS (mEq/h) OF INITIAL TREATMENT WITH 40 mg PROTONIX I.V. for INJECTION AND 40 mg ORAL PROTONIX IN GERD PATIENTS WITH A HISTORY OF EROSIVE ESOPHAGITIS

ANTISECRETORY EFFECTS (mEq/h) OF INITIAL TREATMENT WITH 40 mg PROTONIX I.V. for INJECTION AND 40 mg ORAL PROTONIX IN GERD PATIENTS WITH A HISTORY OF EROSIVE ESOPHAGITIS

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