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Efficacy and safety of pantoprazole 20 mg once daily treatment in patients with ulcer-like functional dyspepsia.

Abstract：

OBJECTIVE:To investigate the efficacy of pantoprazole 20 mg once daily (o.d.) in relieving epigastric pain associated with ulcer-like functional dyspepsia. RESEARCH DESIGN AND METHODS:In this double-blind, placebo-controlled, multicentre study, patients experiencing ulcer-like functional dyspepsia, with epigastric pain as the predominant symptom, were randomised to receive pantoprazole 20 mg or placebo o.d. for 28 days. Primary endpoint was the complete relief (i.e. absence) from epigastric pain after 28 days' treatment. The odds ratio (OR) for pantoprazole/placebo and its 95% confidence intervals (CIs) were determined. Significant superiority of pantoprazole was concluded if the value 1.0 was above this interval. RESULTS:Of 419 patients (intention-to-treat [ITT]) randomised to treatment, 207 received pantoprazole and 212 received placebo. Epigastric pain relief was achieved after 28 days' treatment in 55% of pantoprazole recipients and 45% of placebo recipients (per-protocol [PP]: 58% and 47%, respectively). Pantoprazole demonstrated statistically significant superiority compared with placebo in the ITT (OR: 0.68; 95% CI: 0.46-0.99) and PP populations (OR: 0.64; 95% CI: 0.42-0.98). Pantoprazole was more efficacious than placebo in relieving heartburn and acid regurgitation after 7, 14 and 28 days of treatment. The sum score of gastrointestinal symptoms after 28 days was statistically significantly lower in the pantoprazole than placebo group. Fewer patients receiving concomitant psychotropic medication experienced relief from epigastric pain than those not receiving such medication. Adverse events did not significantly differ between pantoprazole and placebo. CONCLUSIONS:Results of this study suggest that pantoprazole 20 mg is more efficacious than placebo, and is a well-tolerated treatment for relieving epigastric pain in patients with ulcer-like functional dyspepsia. Further research is needed to confirm these findings.

journal_name

Curr Med Res Opin

journal_title

Current medical research and opinion

authors

van Rensburg C,Berghöfer P,Enns R,Dattani ID,Maritz JF,Gonzalez Carro P,Fischer R,Schwan T

doi

10.1185/03007990802184545

subject

Has Abstract

pub_date

2008-07-01 00:00:00

pages

2009-18

issue

eissn

0300-7995

issn

1473-4877

pii

4456

journal_volume

pub_type

杂志文章,多中心研究,随机对照试验

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Efficacy and safety of pantoprazole 20 mg once daily treatment in patients with ulcer-like functional dyspepsia.