Abstract
We sought to evaluate safety and efficacy of IV pantoprazole when used as initial therapy in patients with gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) in a double-blind, placebo-controlled, randomized, parallel-group study. Patients were randomized to 7 days of once-daily IV or oral pantoprazole (40 mg) or placebo. Efficacy variables included maximal acid output, basal acid output, and changes from baseline in frequency/severity of GERD symptoms, and frequency of antacid usage. Seventy-eight patients were randomized (n=26/27/25 [IV/oral/placebo]). Mean maximal acid output was 8.4, 6.3, and 20.9 mEq/h for IV or oral pantoprazole, and placebo, respectively. For pantoprazole versus placebo, maximal and basal acid output were significantly lower (P<.001) and there was a numerical trend toward improved GERD and antacid usage. Both treatments were well tolerated. In conclusion, IV/oral pantoprazole were similarly effective in suppressing basal and pentagastrin-stimulated gastric acid secretion in GERD patients with a history of EE.
Publication types
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Comparative Study
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Multicenter Study
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Randomized Controlled Trial
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Research Support, Non-U.S. Gov't
MeSH terms
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2-Pyridinylmethylsulfinylbenzimidazoles
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Administration, Oral
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Adult
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Aluminum Hydroxide / therapeutic use
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Analysis of Variance
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Anti-Ulcer Agents / administration & dosage*
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Anti-Ulcer Agents / adverse effects
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Benzimidazoles / administration & dosage*
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Benzimidazoles / adverse effects
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Body Weights and Measures
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Double-Blind Method
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Drug Combinations
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Esophagitis, Peptic / drug therapy*
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Esophagitis, Peptic / etiology
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Female
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Gastric Acid / physiology
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Gastric Acidity Determination
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Gastroesophageal Reflux / complications
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Gastroesophageal Reflux / drug therapy*
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Humans
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Infusions, Intravenous
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Magnesium Hydroxide / therapeutic use
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Male
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Middle Aged
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Omeprazole / administration & dosage
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Omeprazole / adverse effects
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Omeprazole / analogs & derivatives*
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Pantoprazole
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Placebo Effect
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Severity of Illness Index
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Silicic Acid / therapeutic use
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Sulfoxides / administration & dosage*
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Sulfoxides / adverse effects
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Treatment Outcome
Substances
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2-Pyridinylmethylsulfinylbenzimidazoles
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Anti-Ulcer Agents
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Benzimidazoles
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Drug Combinations
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Sulfoxides
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Silicic Acid
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Aluminum Hydroxide
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Gelusil
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Pantoprazole
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Omeprazole
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Magnesium Hydroxide