Efficacy and safety of pantoprazole versus ranitidine in the treatment of patients with symptomatic gastroesophageal reflux disease

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dc.contributor.authorVan Zyl J.
dc.contributor.authorVan Rensburg C.
dc.contributor.authorVieweg W.
dc.contributor.authorFischer R.
dc.date.accessioned2011-05-15T16:16:15Z
dc.date.available2011-05-15T16:16:15Z
dc.date.issued2004
dc.description.abstractBackground/Aim: Gastroesophageal reflux disease (GERD) is a prevalent disease associated with a high symptom burden and a reduced quality of life. This multicenter, randomized, double-blind study compared relief from key GERD symptoms (heartburn, acid eructation, and pain on swallowing) and from other gastrointestinal symptoms (epigastric pain, vomiting, nausea, flatulence, retching, and retrosternal feeling of tightness) and safety profiles of the proton pump inhibitor pantoprazole and the H2 antagonist ranitidine in patients suffering from symptomatic GERD. Methods: The patients [338 intention-to-treat (ITT) population; 284 per-protocol (PP) population] received 20 mg pantoprazole (once daily in the morning) plus ranitidine placebo (once daily in the evening; ITT n = 167, PP n = 136) or pantoprazole placebo (once daily in the morning) plus 300 mg ranitidine (once daily in the evening; ITT n = 171, PP n = 148) for 28 days. The primary efficacy criterion (ITT and PP populations) was relief from key GERD symptoms (heartburn, acid eructation, and pain on swallowing) after 28 days of treatment. Secondary criteria (PP) included relief from key GERD symptoms on day 14, relief from all gastrointestinal symptoms on days 14 and 28, and relief from key GERD symptoms on days 14 and 28. Safety evaluations included adverse events and laboratory assessments. Results: Significantly more pantoprazole-treated patients were free from key GERD symptoms at day 28 (68.3%, n = 114) as compared with ranitidine-treated patients (43.3%, n = 74; 95% confidence interval for odds ratio 1.84-4.51). Pantoprazole was also significantly more efficacious in controlling all gastrointestinal symptoms of GERD. By day 28, 51.5% (n = 70) of the pantoprazole-treated patients were completely symptom free versus 31.1% (n = 46) of the ranitidine-treated patients (95% confidence interval for odds ratio1.45-3.83). Both treatments were well tolerated. Conclusion: Pantoprazole is significantly superior to ranitidine in the treatment of key and associated gastrointestinal symptoms of GERD and is well tolerated. Copyright © 2004 S. Karger AG, Basel.
dc.description.versionArticle
dc.identifier.citationDigestion
dc.identifier.citation70
dc.identifier.citation1
dc.identifier.issn00122823
dc.identifier.other10.1159/000080130
dc.identifier.urihttp://hdl.handle.net/10019.1/13699
dc.subjectacetylsalicylic acid
dc.subjectatenolol
dc.subjectconjugated estrogen
dc.subjectdipeptidyl carboxypeptidase inhibitor
dc.subjecthistamine H2 receptor antagonist
dc.subjecthydrochlorothiazide
dc.subjectpantoprazole
dc.subjectperindopril
dc.subjectproton pump inhibitor
dc.subjectranitidine
dc.subjecttheophylline
dc.subjectabdominal pain
dc.subjectadult
dc.subjectaged
dc.subjectarticle
dc.subjectclinical trial
dc.subjectconfidence interval
dc.subjectconstipation
dc.subjectcontrolled clinical trial
dc.subjectcontrolled study
dc.subjectdiarrhea
dc.subjectdouble blind procedure
dc.subjectdrug efficacy
dc.subjectdrug safety
dc.subjectdysphagia
dc.subjectepigastric pain
dc.subjecteructation
dc.subjectfemale
dc.subjectflatulence
dc.subjectgastroesophageal reflux
dc.subjectgastrointestinal symptom
dc.subjectheartburn
dc.subjecthuman
dc.subjectmajor clinical study
dc.subjectmale
dc.subjectmulticenter study
dc.subjectnausea
dc.subjectpain
dc.subjectphase 3 clinical trial
dc.subjectpriority journal
dc.subjectpruritus
dc.subjectrandomized controlled trial
dc.subjecturticaria
dc.subjectvertigo
dc.subjectvomiting
dc.subject2-Pyridinylmethylsulfinylbenzimidazoles
dc.subjectAdministration, Oral
dc.subjectAdult
dc.subjectAged
dc.subjectAnti-Ulcer Agents
dc.subjectBenzimidazoles
dc.subjectDouble-Blind Method
dc.subjectFemale
dc.subjectGastroesophageal Reflux
dc.subjectHumans
dc.subjectMale
dc.subjectMiddle Aged
dc.subjectOdds Ratio
dc.subjectOmeprazole
dc.subjectPlacebos
dc.subjectRanitidine
dc.subjectSeverity of Illness Index
dc.subjectSulfoxides
dc.subjectTreatment Outcome
dc.titleEfficacy and safety of pantoprazole versus ranitidine in the treatment of patients with symptomatic gastroesophageal reflux disease
dc.typeArticle
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