Pantoprazole sodium is used orally for the short-term (up to 8 weeks) treatment and symptomatic relief of erosive esophagitis in patients with gastroesophageal reflux disease (GERD). Pantoprazole sodium also is used orally as maintenance therapy following healing of erosive esophagitis to reduce recurrence of the disease. Pantoprazole sodium is used IV for up to 7-10 days in the treatment of GERD in patients with a history of erosive esophagitis. IV pantoprazole should be discontinued as soon as the patient is able to initiate or resume treatment with oral pantoprazole. Potential benefits in gastroesophageal reflux and esophagitis result principally from reduced acidity of gastric contents induced by the drug and resultant reduced irritation of esophageal mucosa; the drug can effectively relieve symptoms of esophagitis (e.g., heartburn, regurgitation) and promote healing of ulcerative and erosive lesions.
Suppression of gastric acid secretion is considered by the American College of Gastroenterology (ACG) to be the mainstay of treatment for GERD, and a proton-pump inhibitor or histamine H2-receptor antagonist is used to achieve acid suppression, control symptoms, and prevent complications of the disease. Because GERD is considered to be a chronic disease, the ACG states that many patients with GERD require long-term, even lifelong, treatment. The ACG states that proton-pump inhibitors are more effective (i.e., provide more frequent and more rapid symptomatic relief and healing of esophagitis) than histamine H2-receptor antagonists in the treatment of GERD, and are effective and appropriate as maintenance therapy in many patients with the disease. Proton-pump inhibitors also provide greater control of acid reflux than do prokinetic agents (e.g., cisapride [no longer commercially available in the US], metoclopramide) without the risk of severe adverse effects associated with these agents.
Safety and efficacy of oral pantoprazole for treating GERD and erosive esophagitis (grade 2 or greater on the Hetzel-Dent scale) were established in 2 short-term (up to 8 weeks), controlled studies in adults; pantoprazole was more effective than placebo or nizatidine in healing lesions and providing symptomatic relief. In other studies, pantoprazole was more effective than famotidine or ranitidine and at least as effective as omeprazole.
Safety and efficacy of oral pantoprazole as maintenance therapy following healing of erosive esophagitis were established in two 12-month controlled studies in adults. Pantoprazole (40 mg daily) was more effective than ranitidine (150 mg twice daily) in maintaining healing and decreasing the number of daytime and nocturnal heartburn episodes.
Safety and efficacy of IV pantoprazole for short-term (up to 7-10 days) use in the treatment of GERD in patients with a history of erosive esophagitis have been established in several studies. In a controlled study in adults receiving oral pantoprazole prior to study entry, the degree of inhibition of gastric acid secretion following substitution of IV pantoprazole (40 mg once daily for 7 days) was similar to that achieved following oral administration of the drug at the same daily dosage. In 2 controlled studies evaluating short-term (up to 7 days) use of IV pantoprazole as initial treatment for GERD in adults, the degree of inhibition of gastric acid secretion following IV administration of pantoprazole 40 mg once daily was similar to that achieved following oral administration of pantoprazole at the same daily dosage. In addition, relief of GERD symptoms and healing of esophageal lesions were comparable for IV and oral administration of pantoprazole.
Safety and efficacy of IV pantoprazole use for more than 10 days have not been established.
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Pathologic GI Hypersecretory Conditions
Pantoprazole sodium is used orally or IV for the treatment of pathologic GI hypersecretory conditions associated with Zollinger-Ellison syndrome or other neoplastic conditions. The drug reduces the volume of gastric acid output and hydrogen ion concentration of gastric secretions in patients with these conditions.
In an uncontrolled study in a limited number of patients with pathologic GI hypersecretory conditions (e.g., Zollinger-Ellison syndrome with or without multiple endocrine neoplasia type I), oral administration of pantoprazole at dosages of 80-240 mg daily maintained gastric acid secretion below 5 or 10 mEq/hour in patients who had or had not undergone gastric acid-reducing surgery, respectively. The drug was well tolerated at these dosages for more than 2 years in some patients.
Administration of IV pantoprazole in a limited number of patients with Zollinger-Ellison syndrome (with or without multiple endocrine neoplasia type I) resulted in control of gastric acid secretion to 10 mEq/hour or less with substantial reductions in hydrogen ion concentration and volume of gastric secretions within 45 minutes of drug administration. In another study, control of gastric acid secretion was maintained or improved in a limited number of patients switched from an oral proton-pump inhibitor to IV pantoprazole. In both studies, IV pantoprazole 160 or 240 mg daily in divided doses for up to 6 days maintained basal gastric acid secretion below target levels (10 mEq/hour in patients without or 5 mEq/hour in those with prior gastric acid-reducing surgery) for at least 24 hours in all patients and through the end of treatment (3-7 days) in nearly all patients. Dosage was individualized in both studies, but a regimen of 80 mg every 12 hours controlled gastric acid secretion in more than 80% of patients. There was no evidence of tolerance once acid secretion was controlled.
Crohn's Disease-associated Ulcers
Although evidence currently is limited, proton-pump inhibitors have been used for gastric acid-suppressive therapy as an adjunct in the symptomatic treatment of upper GI Crohn's disease, including esophageal, gastroduodenal, and jejunoileal disease. Most evidence of efficacy to date has been from case studies in patients with Crohn's-associated peptic ulcer disease unresponsive to other therapies (e.g., H2-receptor antagonists, cytoprotective agents, antacids, and/or sucralfate).
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Pantoprazole also has been used orally for treatment of gastric or duodenal ulcers. The recommended dosage of IV pantoprazole does not raise gastric pH sufficiently to contribute to the treatment of some conditions (e.g., life-threatening GI bleeding), and the drug's safety and efficacy in the treatment of conditions other than GERD or pathologic GI hypersecretory conditions associated with Zollinger-Ellison syndrome or other neoplastic conditions have not been established.