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Bismuth Concentrations in Patients Treated in Real-Life Practice with a Bismuth Subcitrate-Metronidazole-Tetracycline Preparation: The SAPHARY Study.
- Source :
-
Drug safety [Drug Saf] 2019 Aug; Vol. 42 (8), pp. 993-1003. - Publication Year :
- 2019
-
Abstract
- Introduction: A fixed-dose association of bismuth subcitrate, metronidazole and tetracycline (BMT) (Pylera <superscript>®</superscript> , 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.<br />Aims: The aim of the study was to measure eventual bismuth accumulation and neurological toxicity in patients prescribed BMT.<br />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 μg/L was considered abnormal. Neurological complaints were assessed at inclusion, at the end of the 10-day treatment course, and 28 days later.<br />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 μg/L (95% confidence interval 15.6-18.3). Concentrations were > 50 μg/L (56.0 μg/L and 50.9 μg/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.<br />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 μg/L. No serious neurological adverse events were observed.<br />Study Registration: EU-PAS register EUPAS3142 at www.encepp.eu ; ENCePP study seal.
- Subjects :
- Aged
Cohort Studies
Drug Combinations
Female
Helicobacter Infections drug therapy
Helicobacter Infections metabolism
Helicobacter Infections microbiology
Helicobacter pylori drug effects
Helicobacter pylori isolation & purification
Humans
Male
Metronidazole pharmacokinetics
Middle Aged
Neurotoxicity Syndromes blood
Neurotoxicity Syndromes etiology
Organometallic Compounds administration & dosage
Organometallic Compounds adverse effects
Organometallic Compounds blood
Tetracycline pharmacokinetics
Treatment Failure
Bismuth blood
Helicobacter Infections blood
Metronidazole administration & dosage
Organometallic Compounds pharmacokinetics
Tetracycline administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1179-1942
- Volume :
- 42
- Issue :
- 8
- Database :
- MEDLINE
- Journal :
- Drug safety
- Publication Type :
- Academic Journal
- Accession number :
- 31069703
- Full Text :
- https://doi.org/10.1007/s40264-019-00821-6