Effects of 3-day IV pantoprazole versus omeprazole on 24-hour intragastric acidity at 3 days in Chinese patients with duodenal ulcer: A single-center, prospective, randomized, comparative, pilot trial

Background: Pantoprazole and omeprazole are irreversible proton pump inhibitors that have been found to significantly reduce intragastric acidity in patients with peptic ulcer and/or esophagitis. It has been reported that gastric acid secretion is lower in the Chinese patients compared with the Western population. Based on a MEDLINE search, no studies of the treatment of intragastric acidity with IV pantoprazole have been conducted in the Chinese population to date. Objective: This trial was performed to compare the effects of IV pantoprazole versus omeprazole on 24-hour intragastric acidity in Chinese patients with endoscopically confirmed duodenal ulcer. Methods: This single-center, randomized, pilot study was conducted at the Division of Gastroenterology, Department of Medicine, Veterans General Hospital, Taipei, Taiwan. Chinese patients aged 18 to 80 years with encloscopically confirmed duodenal ulcer were randomly assigned to receive a continuous IV infusion of pantoprazole or omeprazole 160 mg/d for 3 days. On days 4 to 14, patients received pantoprazole 40 mg/d or omeprazole 20 mg/d orally. During endoscopic examination at enrollment, an antral biopsy specimen was obtained for rapid urease test, with each patient's agreement, by a blinded investigator. The primary end point was 24-hour intragastric pH on day 3. Secondary end points were percentage of the total time during the 24-hour period (%t) pH < 3 and < 4 and proportions of patients with healed ulcers on day-14 endoscopy. Endoscopic examination for monitoring of adverse effects of both drugs was repeated 8 weeks after study completion. Results: A total of 40 patients were enrolled (35 men, 5 women; mean age, 63.3 years; 20 per treatment group). Twenty-four-hour intragastric pH was not significantly different between the omeprazole and pantoprazole groups (mean [SD], 6.61 [1.27] vs 6.84 [0.78]). The %t pH < 3 (mean [SD], 8.01% [19.60%] vs 2.70% [7.18%]) and pH < 4 (mean [SD], 9.28% [21.41%] vs 3.87% [9.79%]) were not significantly different between the omeprazole and pantoprazole groups. On day-14 endoscopy, ulcers were found to be healed in 3 (15%) patients in each group. In the omeprazole group, 1 (5%) patient experienced mild diarrhea, and 1 (5%) experienced mild abdominal fullness. These adverse effects were considered treatment related. No adverse effects were reported in either treatment group at 8 weeks after the study. Conclusions: The results of this pilot study of 3-day treatment with a continuous IV infusion of pantoprazole or omeprazole 160 mg/d found that these 2 treatments had similar effects on 24-hour intragastric pH in this small population of Chinese patients with duodenal ulcer. Both treatments were well tolerated. (Clin Ther. 2006;28:1303-1307) Copyright (c) 2006 Excerpta Medica, Inc.