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Intra-oesophageal pH profiles and pharmacokinetics of pantoprazole and esomeprazole: a crossover study in patients with gastro-oesophageal reflux disease.

Abstract：

AIM:To compare the effect of pantoprazole and esomeprazole on intra-oesophageal pH and investigate their pharmacokinetics in patients with symptomatic gastro-oesophageal reflux disease (GORD). METHODS:Double-blind, randomized, two-period crossover study. Caucasian men with symptomatic GORD (n=48) were selected on the basis of clinical records of typical GORD symptoms, confirmed by a pathological reflux time (oesophageal pH<4 for > or =6% of the time). They received oral pantoprazole 40 mg once daily (od) or esomeprazole 40 mg od for seven days. Continuous 24 h oesophageal pH-metry was performed at baseline and day 7. Evaluations included: pre- and post-treatment differences in the percentage of time with pH<4.0 and <3.0 between baseline and day 7; area under the curve (AUC), Cmax, and T(1/2); point estimates and 90% confidence intervals (CI) on days 1 and 7, calculated for ratios of the AUC and Cmax. RESULTS:Both drugs decreased the mean total number of reflux episodes and reduced the percentage of reflux time within 24 h to <3%. No pathological reflux was detectable after repeated administration of either drug. The 90% CI were within the predefined range at all time points; thus, equivalence of pantoprazole and esomeprazole was concluded. For pantoprazole, Cmax and AUC were unchanged on day 7 vs day 1, confirming its high and constant bioavailability. For esomeprazole, Cmax and AUC were increased on day 7 vs day 1 by 80% and 50%, respectively, indicating low initial bioavailability. No clinically relevant side effects were seen for either drug. CONCLUSION:Pantoprazole and esomeprazole have equivalent effect on oesophageal pH, since no pathological reflux was detected after treatment with either drug. For esomeprazole, the Cmax and AUC increased after multiple dosing; for pantoprazole the pharmacokinetics were predictable and independent of the number of administered doses.

journal_name

Eur J Gastroenterol Hepatol

journal_title

European journal of gastroenterology & hepatology

authors

Simon B,Müller P,Pascu O,Gatz G,Sander P,Huber R,Mascher H

doi

10.1097/01.meg.0000059157.46867.42

subject

Has Abstract

pub_date

2003-07-01 00:00:00

pages

791-9

issue

eissn

0954-691X

issn

1473-5687

journal_volume

pub_type

临床试验,杂志文章,随机对照试验

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Intra-oesophageal pH profiles and pharmacokinetics of pantoprazole and esomeprazole: a crossover study in patients with gastro-oesophageal reflux disease.