Dose-dependent control of intragastric pH by pantoprazole, 10, 20 or 40 mg, in healthy volunteers.

Overview

BACKGROUND: Proton pump inhibitors have emerged as the most effective class of drugs for the treatment of gastro-oesophageal reflux. Pantoprazole is a proton pump inhibitor that has demonstrated high clinical efficacy. AIM: To evaluate the effect of once-daily doses of pantoprazole, 10, 20 and 40 mg, on gastric acidity in healthy volunteers. METHODS: Thirty-six subjects received pantoprazole in a three-way crossover design study. Ambulatory 24-h intragastric pH and distal oesophageal pH were monitored at baseline and on the last day of each treatment period. The measured endpoints were the median intragastric and oesophageal pH, the percentage of time the intragastric pH < 4 and oesophageal pH < 4 and the area under the curve for gastric acidity over 24 h. Safety was evaluated by incidence and severity of adverse events. RESULTS: Pantoprazole demonstrated a linear dose- dependent suppression of gastric acidity over the dose range 10-40 mg. The dose of 40 mg demonstrated a significantly greater response than the lower doses, particularly at night. All pantoprazole doses were well tolerated. CONCLUSIONS: Pantoprazole demonstrates a dose-related effect in the range 10-40 mg once daily. The once-daily dose of 40 mg provides the highest and most consistent control of gastric pH, especially at night.