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Bismuth Concentrations in Patients Treated in Real-Life Practice with a Bismuth Subcitrate-Metronidazole-Tetracycline Preparation: The SAPHARY Study

dc.rights.licenseopenen_US
dc.contributor.authorGUIARD, E.
dc.contributor.authorLELIEVRE, B.
dc.contributor.authorROUYER, M.
dc.contributor.authorZERBIB, F.
dc.contributor.authorDIQUET, B.
dc.contributor.authorMEGRAUD, F.
dc.contributor.authorTISON, F.
dc.contributor.authorBIGNON, E.
dc.contributor.authorLASSALLE, R.
dc.contributor.authorDROZ-PERROTEAU, C.
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorMOORE, Nicholas
dc.contributor.authorBLIN, Patrick
dc.date.accessioned2020-07-24T09:14:58Z
dc.date.available2020-07-24T09:14:58Z
dc.date.issued2019-08
dc.identifier.issn1179-1942 (Electronic) 0114-5916 (Linking)en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/10673
dc.description.abstractEnINTRODUCTION: A fixed-dose association of bismuth subcitrate, metronidazole and tetracycline (BMT) (Pylera((R)), Allergan, NJ, USA) was made available in France in 2013 for the eradication of Helicobacter pylori. Due to a historical issue of bismuth encephalopathy, the French Health Authorities requested a study of blood and plasma bismuth concentrations with BMT in daily practice. AIMS: The aim of the study was to measure eventual bismuth accumulation and neurological toxicity in patients prescribed BMT. METHODS: Patients initiating BMT for H. pylori between March 2014 and December 2015 were included. A blood sample was taken before first BMT intake and 24 h after the last intake, for assay of bismuth. A concentration > 50 mug/L was considered abnormal. Neurological complaints were assessed at inclusion, at the end of the 10-day treatment course, and 28 days later. RESULTS: 202 patients were included, of whom 190 took at least one dose of BMT, and 167 provided both required blood samples. Mean blood bismuth concentrations after the BMT course were 16.9 mug/L (95% confidence interval 15.6-18.3). Concentrations were > 50 mug/L (56.0 mug/L and 50.9 mug/L) in two elderly patients, one of whom presented mild, transient memory impairment during treatment. Non-serious neurological symptoms occurred in 20% of all patients and treatment failure was documented in 5% of patients. CONCLUSIONS: In this study measuring blood bismuth concentrations in real-life practice, in < 1% of patients the BMT course resulted in blood bismuth concentrations > 50 mug/L. No serious neurological adverse events were observed. STUDY REGISTRATION: EU-PAS register EUPAS3142 at www.encepp.eu ; ENCePP study seal.
dc.language.isoENen_US
dc.subject.enPharmacoEpi-Drugs
dc.title.enBismuth Concentrations in Patients Treated in Real-Life Practice with a Bismuth Subcitrate-Metronidazole-Tetracycline Preparation: The SAPHARY Study
dc.title.alternativeDrug Safen_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1007/s40264-019-00821-6en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed31069703en_US
bordeaux.journalDrug safetyen_US
bordeaux.page993-1003en_US
bordeaux.volume42en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.issue8en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
hal.exportfalse
bordeaux.COinSctx_ver=Z39.88-2004&amp;rft_val_fmt=info:ofi/fmt:kev:mtx:journal&amp;rft.jtitle=Drug%20safety&amp;rft.date=2019-08&amp;rft.volume=42&amp;rft.issue=8&amp;rft.spage=993-1003&amp;rft.epage=993-1003&amp;rft.eissn=1179-1942%20(Electronic)%200114-5916%20(Linking)&amp;rft.issn=1179-1942%20(Electronic)%200114-5916%20(Linking)&amp;rft.au=GUIARD,%20E.&amp;LELIEVRE,%20B.&amp;ROUYER,%20M.&amp;ZERBIB,%20F.&amp;DIQUET,%20B.&amp;rft.genre=article


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