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

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dc.contributor.authorVan Rensburg C.
dc.contributor.authorBerghofer P.
dc.contributor.authorEnns R.
dc.contributor.authorDattani I.D.
dc.contributor.authorMaritz J.F.
dc.contributor.authorCarro P.G.
dc.contributor.authorFischer R.
dc.contributor.authorSchwan T.
dc.date.accessioned2011-05-15T16:16:11Z
dc.date.available2011-05-15T16:16:11Z
dc.date.issued2008
dc.description.abstractObjective: 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. © 2008 Informa UK Ltd.
dc.description.versionConference Paper
dc.identifier.citationCurrent Medical Research and Opinion
dc.identifier.citation24
dc.identifier.citation7
dc.identifier.issn03007995
dc.identifier.other10.1185/03007990802184545
dc.identifier.urihttp://hdl.handle.net/10019.1/13668
dc.subjectpantoprazole
dc.subjectplacebo
dc.subjectpsychotropic agent
dc.subjectadult
dc.subjectaged
dc.subjectanalgesia
dc.subjectarthralgia
dc.subjectclinical protocol
dc.subjectclinical trial
dc.subjectconference paper
dc.subjectconfidence interval
dc.subjectconstipation
dc.subjectcontrolled clinical trial
dc.subjectcontrolled study
dc.subjectdefecation habit
dc.subjectdiarrhea
dc.subjectdisease association
dc.subjectdouble blind procedure
dc.subjectdrug efficacy
dc.subjectdrug safety
dc.subjectdrug tolerability
dc.subjectdrug withdrawal
dc.subjectdysmenorrhea
dc.subjectdyspepsia
dc.subjectepigastric pain
dc.subjectfemale
dc.subjectflatulence
dc.subjectflu like syndrome
dc.subjectheadache
dc.subjectheartburn
dc.subjecthuman
dc.subjecthypertriglyceridemia
dc.subjectmajor clinical study
dc.subjectmale
dc.subjectmigraine
dc.subjectmulticenter study
dc.subjectrandomized controlled trial
dc.subjectscoring system
dc.subjectside effect
dc.subjectsomnolence
dc.subjectstatistical significance
dc.subjectstomach ulcer
dc.subjecttreatment duration
dc.subjecturinary tract infection
dc.subjectvertigo
dc.subject2-Pyridinylmethylsulfinylbenzimidazoles
dc.subjectAbdominal pain
dc.subjectAdolescent
dc.subjectAdult
dc.subjectAged
dc.subjectAnti-ulcer agents
dc.subjectDouble-blind method
dc.subjectDyspepsia
dc.subjectFemale
dc.subjectHumans
dc.subjectMale
dc.subjectMiddle aged
dc.subjectPlacebos
dc.subjectTreatment outcome
dc.titleEfficacy and safety of pantoprazole 20 mg once daily treatment in patients with ulcer-like functional dyspepsia
dc.typeConference Paper
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