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Title: Oral Rabeprazole Has Better Control of Intragastric pH Than IV Pantoprazole in Healthy Subjects: Presented at UEGW

"Oral Rabeprazole Has Better Control of Intragastric pH Than IV Pantoprazole in Healthy Subjects: Presented at UEGW"

By Chris Berrie BERLIN, GERMANY -- October 27, 2006 -- Oral rabeprazole provides greater acid suppression than IV pantoprazole in the early phases of administration in healthy Helicobacter-pylori-negative, subjects, according to a single centre, randomised, controlled, double-blind, crossover study presented here at the United European Gastroenterology Week (UEGW) 2006. In the hospital setting, IV proton-pump inhibitors (PPIs) are indicated in patients who cannot take oral medications or in those who require rapid, prolonged acid suppression. Despite the advantages of oral administration, there appears to have been an increase in the inappropriate use of IV PPIs, possibly due in part to clinicians' concerns that oral therapy might be less effective than IV therapy, said principal investigator David Armstrong, MA, MB, BChir, service chief, division of gastroenterology, Hamilton Health Sciences, and associate professor, department of gastroenterology, McMaster University, Hamilton, Canada. This study, presented on October 25[^th, was carried out with the primary objective of demonstrating that oral rabeprazole produces equivalent acid suppression to IV pantoprazole in healthy H.-pylori-free subjects.

Exclusion criteria included no significant concurrent disease or clinical illness within 14 days of screening, with various ineligibility criteria also applied to the use of other medications.

The study design provided 14 days of initial screening, with randomisation and monitoring of baseline pH at day 0. The initial 3-day treatment period with pH monitoring and dosing with oral rabeprazole 20 mg plus IV placebo or placebo plus IV pantoprazole 40 mg. A 14-day washout period followed, then further pH monitoring with patient treatment crossover for treatment period 2.

The primary efficacy variable was mean percentage of time with an intragastric pH >4 on day 1 (of both treatment periods). There were also a range of secondary efficacy variables related to the median 24-hour pH level, percentages of pH >4 and >3 on treatment days 1 and 3, and proportion of subjects with various intragastric pH values on treatment days 1 and 3.

A total of 38 subjects were randomised, with a mean age of 29 years (male, 63%; Caucasian, 95%; mean body mass index (BMI), 25.4 kg/m²). Thirty-three of these subjects were available for efficacy evaluations.

For the primary efficacy variable, oral rabeprazole showed a significantly greater percentage time at pH >4 on day 1 than IV pantoprazole (37.7% vs 23.9%, respectively; 95% confidence intervals [CIs], 30.6-44.8, 20.0-27.8, respectively). This was paralleled by the data for the secondary efficacy variables relating to pH >4 and pH >3 on both days 1 and 3, and reflected in the data for pH >3, >5 and >6, again across both days 1 and 3.

Of note, the effect of study period or treatment sequence was not statistically significant in any of the analyses, indicating that there was no carryover effect between periods.

Although there were no significant differences between the treatment groups for adverse events (AEs), with none experienced by 70.3% of the rabeprazole group and 73.0% of the IV pantoprazole group, there was a trend for increased moderate or serious AEs (both treatment unrelated and treatment related) with oral rabeprazole treatment (unrelated, 24.3% vs 8.1%; P = .066; related, 16.2% vs 5.4%; P = .125).

"The main message is that an oral PPI -- rabeprazole in this case -- is actually more effective in reducing acid secretion than intravenous pantoprazole, in terms of duration and in terms of the absolute magnitude of acid suppression," Armstrong concluded.

This study was funded by an unrestricted grant from Janssen-Ortho Inc., Canada.

[Presentation title: Oral Rabeprazole Versus Intravenous Pantoprazole: A Comparison of the Effect on Intragastric pH in Healthy Subjects. Abstract Wed-G-145]

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