Safety and efficacy of pantoprazole 40 mg daily as relapse prophylaxis in patients with healed reflux oesophagitis - A 2-year follow-up

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dc.contributor.authorVan Rensburg C.J.
dc.contributor.authorHoniball P.J.
dc.contributor.authorVan Zyl J.H.
dc.contributor.authorDe Grundling H.K.
dc.contributor.authorEloff F.P.
dc.contributor.authorSpies S.K.
dc.contributor.authorSimjee A.E.
dc.contributor.authorTheron I.
dc.contributor.authorFischer R.
dc.contributor.authorLouw J.A.
dc.date.accessioned2011-05-15T16:15:18Z
dc.date.available2011-05-15T16:15:18Z
dc.date.issued1999
dc.description.abstractBackground: Pantoprazole is a benzimidazole derivative which selectively inhibits the proton pump H+, K+-ATPase, necessary for the final step in gastric acid secretion. Aim: To assess safety and efficacy of oral pantoprazole (40 mg o.d.) used as a prophylaxis against relapse in patients with healed reflux oesophagitis during an open-label, 2-year study. Methods: Outpatients (n = 157) with healed stage II or III reflux oesophagitis (Savary-Miller classification) were enrolled into a long-term, multicentre maintenance study. Endoscopy was performed at entry into the study, after 12 and 24 months, or when disease-specific symptoms occurred on more than three consecutive days. Symptoms were assessed at 3-monthly intervals. Endoscopically confirmed relapses (at least stage I) were evaluated as treatment failures. Results: Of the 178 adverse events, experienced by 88 (56%) patients (intention-to-treat population), 12 (7%) were assessed by the investigators as possibly related to the study medication. Median serum gastrin levels increased from a baseline of 46 ng/L to 90 ng/L, reaching a plateau after 9 months. For the intention-to-treat population the endoscopic remission rates after 12 and 24 months were 87% and 76%, respectively (Life-Table survival analysis, Kaplan-Meier). Conclusion: Pantoprazole 40 mg proved to be safe and efficacious during a 2-year prophylaxis treatment in patients with healed reflux oesophagitis.
dc.description.versionArticle
dc.identifier.citationAlimentary Pharmacology and Therapeutics
dc.identifier.citation13
dc.identifier.citation8
dc.identifier.issn02692813
dc.identifier.other10.1046/j.1365-2036.1999.00573.x
dc.identifier.urihttp://hdl.handle.net/10019.1/13275
dc.subjectgastrin
dc.subjectpantoprazole
dc.subjectadult
dc.subjectaged
dc.subjectarticle
dc.subjectclinical trial
dc.subjectdiarrhea
dc.subjectdrug efficacy
dc.subjectdrug safety
dc.subjectfemale
dc.subjectfollow up
dc.subjectgastrin blood level
dc.subjectgastrointestinal endoscopy
dc.subjecthuman
dc.subjectinfluenza
dc.subjectmajor clinical study
dc.subjectmale
dc.subjectmulticenter study
dc.subjectoral drug administration
dc.subjectpriority journal
dc.subjectreflux esophagitis
dc.subjectrelapse
dc.subjectremission
dc.subjectstomach acid secretion
dc.subjectsymptom
dc.subjectupper respiratory tract infection
dc.subject2-Pyridinylmethylsulfinylbenzimidazoles
dc.subjectAdolescent
dc.subjectAdult
dc.subjectAged
dc.subjectAged, 80 and over
dc.subjectAnti-Ulcer Agents
dc.subjectBenzimidazoles
dc.subjectEnzyme Inhibitors
dc.subjectEsophagitis, Peptic
dc.subjectFemale
dc.subjectFollow-Up Studies
dc.subjectH(+)-K(+)-Exchanging ATPase
dc.subjectHumans
dc.subjectLife Tables
dc.subjectMale
dc.subjectMiddle Aged
dc.subjectOmeprazole
dc.subjectRecurrence
dc.subjectSulfoxides
dc.subjectTime Factors
dc.titleSafety and efficacy of pantoprazole 40 mg daily as relapse prophylaxis in patients with healed reflux oesophagitis - A 2-year follow-up
dc.typeArticle
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