当前位置： SCI文献检索 > ALIMENTARY PHARMACOLOGY & THERAPEUTICS期刊下所有文献 > Oral pantoprazole in the form of granules or tablets are pharmacodynamically equivalent in suppressing acid output in patients with gastro-oesophageal reflux disease and a history of erosive oesophagitis.

Oral pantoprazole in the form of granules or tablets are pharmacodynamically equivalent in suppressing acid output in patients with gastro-oesophageal reflux disease and a history of erosive oesophagitis.

Abstract：

AIM:To demonstrate the pharmacodynamic comparability between oral 40 mg pantoprazole delayed-release granules and tablets. METHODS:This was a multicentre, randomized, open-label, 2-period, 2-sequence, 9-week crossover study in patients aged 18-65 years with gastro-oesophageal reflux disease and documented erosive oesophagitis. The primary endpoint was a comparison of the inhibition of pentagastrin-stimulated maximum acid output (MAO) at steady state after once daily dosing for 1 week and 23 h after the last dose of pantoprazole granules and tablets. Basal acid output was measured prior to MAO. Standard safety evaluations were performed. The one-sided t-test was used to test the null hypothesis that granules - 1.2 x tablet >/= 0 against the alternative hypothesis that this difference was <0 for both MAO and basal acid output values. RESULTS:Sixty patients completed the study. The mean MAO values were 7.11 +/- 4.98 and 7.29 +/- 4.77 mmol/h, while the mean basal acid output values were 0.74 +/- 0.91 and 0.58 +/- 0.63 mmol/h for the granules and tablets, respectively. The two formulations were shown statistically to be pharmacodynamically equivalent in suppressing MAO (P = 0.006), safe and well tolerated. CONCLUSION:Patients with gastro-oesophageal reflux disease who are unable to swallow the tablet may safely be prescribed the pantoprazole sodium granules.

journal_name

Aliment Pharmacol Ther

journal_title

Alimentary pharmacology & therapeutics

authors

Hogan D,Pratha V,Riff D,Ducker S,Schwartz H,Soffer E,Wang W,Rath N,Comer GM

doi

10.1111/j.1365-2036.2007.03375.x

subject

Has Abstract

pub_date

2007-07-15 00:00:00

pages

249-56

issue

2

eissn

0269-2813

issn

1365-2036

pii

APT3375

journal_volume

26

pub_type

杂志文章,多中心研究,随机对照试验

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