BACKGROUND: After a course of IV proton pump inhibitor therapy, patients might require continued oral antisecretory therapy. A direct comparison of therapeutic alternatives could assist physicians in decisions regarding optimal acid-suppressive therapy. Oral esomeprazole might control intragastric acidity more effectively compared with other acid-suppressive agents after IV therapy. OBJECTIVE: The aim of this study was to compare intragastric acid control on day 5 of administration of esomeprazole magnesium versus pantoprazole 40 mg PO QD after switching from 5 days of treatment with pantoprazole 40 mg IV in healthy volunteers. METHODS: This randomized, open-label, comparative, 2-way crossover study was conducted at the Oklahoma Foundation for Digestive Research, Oklahoma City, Oklahoma, between October and December 2004. Healthy, Helicobacter pylori-negative adults were randomly assigned to 1 of 2 dosing sequences: pantoprazole IV followed by esomeprazole PO or pantoprazole IV followed by pantoprazole PO. All study medications were administered for 5 days at a dose of 40 mg QD. IV pantoprazole was administered over 2 minutes; all medications were administered 30 minutes before breakfast. There was a 10- to 21-day washout period between each 10-day dosing period. All doses were administered at the study site. Before oral study drug administration on days 1 and 5, 24-hour pH monitoring was performed using a pH catheter positioned 10 cm distal to the lower esophageal sphincter in the stomach. The primary end point was percentage of time with pH >4 (%t pH >4) during the 24-hour pH-monitoring period. Tolerability was assessed using spontaneous reporting, laboratory analysis, and vital-sign measurement. RESULTS: Of 42 subjects randomized to treatment sequences, 4 were withdrawn during the study because of invalid pH data; 38 subjects (24 men, 14 women; mean [SD] age, 25.2 [8.1] years) had assessable data. Day-5 %t pH >4 was 68.5% with esomeprazole and 53.3% with pantoprazole (P < 0.001). Day-1 %t pH >4 was 62.5% with esomeprazole and 51.0% with pantoprazole (P < 0.001). The most common adverse events were rhinitis (2 subjects each with pantoprazole IV and PO; 1 subject with esomeprazole) and headache (2 subjects with esomeprazole; 1 subject with pantoprazole IV). CONCLUSIONS: The results of this study in healthy adult volunteers suggest that switching from pantoprazole 40 mg IV to esomeprazole 40 mg PO QD more effectively suppresses intragastric acid compared with switching from pantoprazole 40 mg IV to pantoprazole 40 mg PO QD. All 3 treatments were well tolerated.
RCT Entities:
BACKGROUND: After a course of IV proton pump inhibitor therapy, patients might require continued oral antisecretory therapy. A direct comparison of therapeutic alternatives could assist physicians in decisions regarding optimal acid-suppressive therapy. Oral esomeprazole might control intragastric acidity more effectively compared with other acid-suppressive agents after IV therapy. OBJECTIVE: The aim of this study was to compare intragastric acid control on day 5 of administration of esomeprazole magnesium versus pantoprazole 40 mg PO QD after switching from 5 days of treatment with pantoprazole 40 mg IV in healthy volunteers. METHODS: This randomized, open-label, comparative, 2-way crossover study was conducted at the Oklahoma Foundation for Digestive Research, Oklahoma City, Oklahoma, between October and December 2004. Healthy, Helicobacter pylori-negative adults were randomly assigned to 1 of 2 dosing sequences: pantoprazole IV followed by esomeprazole PO or pantoprazole IV followed by pantoprazole PO. All study medications were administered for 5 days at a dose of 40 mg QD. IV pantoprazole was administered over 2 minutes; all medications were administered 30 minutes before breakfast. There was a 10- to 21-day washout period between each 10-day dosing period. All doses were administered at the study site. Before oral study drug administration on days 1 and 5, 24-hour pH monitoring was performed using a pH catheter positioned 10 cm distal to the lower esophageal sphincter in the stomach. The primary end point was percentage of time with pH >4 (%t pH >4) during the 24-hour pH-monitoring period. Tolerability was assessed using spontaneous reporting, laboratory analysis, and vital-sign measurement. RESULTS: Of 42 subjects randomized to treatment sequences, 4 were withdrawn during the study because of invalid pH data; 38 subjects (24 men, 14 women; mean [SD] age, 25.2 [8.1] years) had assessable data. Day-5 %t pH >4 was 68.5% with esomeprazole and 53.3% with pantoprazole (P < 0.001). Day-1 %t pH >4 was 62.5% with esomeprazole and 51.0% with pantoprazole (P < 0.001). The most common adverse events were rhinitis (2 subjects each with pantoprazole IV and PO; 1 subject with esomeprazole) and headache (2 subjects with esomeprazole; 1 subject with pantoprazole IV). CONCLUSIONS: The results of this study in healthy adult volunteers suggest that switching from pantoprazole 40 mg IV to esomeprazole 40 mg PO QD more effectively suppresses intragastric acid compared with switching from pantoprazole 40 mg IV to pantoprazole 40 mg PO QD. All 3 treatments were well tolerated.