PMID- 26850363
OWN - NLM
STAT- MEDLINE
DCOM- 20180117
LR  - 20220317
IS  - 2210-741X (Electronic)
IS  - 2210-7401 (Linking)
VI  - 40
IP  - 4
DP  - 2016 Sep
TI  - Rescue therapy with bismuth-containing quadruple therapy in patients infected 
      with metronidazole-resistant Helicobacter pylori strains.
PG  - 517-24
LID - S2210-7401(16)00003-6 [pii]
LID - 10.1016/j.clinre.2015.12.012 [doi]
AB  - BACKGROUND: The emergence of H. pylori strains that are resistant to 
      clarithromycin, metronidazole and fluoroquinolone requires the evaluation of new 
      and effective salvage therapies. AIMS: To test the efficacy of a new formulation 
      of a bismuth-containing quadruple therapy as a rescue therapy in patients who 
      were infected with a H. pylori strain resistant to metronidazole, clarithromycin 
      and fluoroquinolone or who failed multiple lines of treatment using these three 
      antibiotics. METHODS: A total of 103 patients with confirmed H. pylori infection 
      with a resistance profile described above were treated with Pylera((R)) (3-in-1 
      capsules containing bismuth subcitrate potassium 140mg, metronidazole 125mg and 
      tetracycline 125mg) 3 capsules four times a day plus omeprazole 20mg two times a 
      day for 10 days in a named patient program. Eradication was confirmed using a 
      urea breath test at least 28 days after the end of treatment. Efficacy and safety 
      were studied. RESULTS: A total of 103 patients were prospectively included from 
      June 2010 to October 2011. The eradication rate for the intent-to-treat analysis 
      was 83% (CI95%[75-89%]); an 87% eradication rate (CI95%[80-94%]) was found for 
      the per-protocol analysis and 81% (CI95%[80-82%]) for the intent-to-treat 
      analysis in patients with proven resistance to metronidazole. Nine patients 
      discontinued treatment, all due to adverse events. Two serious adverse events 
      (AEs) were reported (memory disorders of unknown significance). Fifty-six (54%) 
      patients reported at least one AE. CONCLUSION: This bismuth-containing quadruple 
      therapy achieved a remarkable eradication rate as a salvage therapy in patients 
      infected with metronidazole-resistant H. pylori strain, despite the frequent 
      occurrence of mild-to-moderate adverse events.
CI  - Copyright (c) 2016. Published by Elsevier Masson SAS.
FAU - Muller, Nelly
AU  - Muller N
AD  - Department of Gastroenterology, Assistance publique-Hopitaux de Paris (AP-HP), 
      Paris Est Creteil University (UPEC), Henri-Mondor Hospital, 51, avenue du 
      Marechal-de-Lattre-de-Tassigny, 94010 Creteil, France.
FAU - Amiot, Aurelien
AU  - Amiot A
AD  - Department of Gastroenterology, Assistance publique-Hopitaux de Paris (AP-HP), 
      Paris Est Creteil University (UPEC), Henri-Mondor Hospital, 51, avenue du 
      Marechal-de-Lattre-de-Tassigny, 94010 Creteil, France; Laboratory of Clinical 
      Investigation (LIC, EA 4393), Paris Est Creteil University (UPEC), 94010 Creteil, 
      France.
FAU - Le Thuaut, Aurelie
AU  - Le Thuaut A
AD  - Laboratory of Clinical Investigation (LIC, EA 4393), Paris Est Creteil University 
      (UPEC), 94010 Creteil, France; Department of Public Health, Assistance 
      publique-Hopitaux de Paris (AP-HP), Henri-Mondor Hospital, 94010 Creteil, France; 
      Clinical Research Unit (URC Mondor), Assistance publique-Hopitaux de Paris 
      (AP-HP), Henri-Mondor Hospital, Creteil, France.
FAU - Bastuji-Garin, Sylvie
AU  - Bastuji-Garin S
AD  - Laboratory of Clinical Investigation (LIC, EA 4393), Paris Est Creteil University 
      (UPEC), 94010 Creteil, France; Department of Public Health, Assistance 
      publique-Hopitaux de Paris (AP-HP), Henri-Mondor Hospital, 94010 Creteil, France; 
      Clinical Research Unit (URC Mondor), Assistance publique-Hopitaux de Paris 
      (AP-HP), Henri-Mondor Hospital, Creteil, France.
FAU - Deforges, Lionel
AU  - Deforges L
AD  - Laboratory of microbiology Research Unit (URC Mondor), Assistance 
      publique-Hopitaux de Paris (AP-HP), Henri-Mondor Hospital, Creteil, France.
FAU - Delchier, Jean-Charles
AU  - Delchier JC
AD  - Department of Gastroenterology, Assistance publique-Hopitaux de Paris (AP-HP), 
      Paris Est Creteil University (UPEC), Henri-Mondor Hospital, 51, avenue du 
      Marechal-de-Lattre-de-Tassigny, 94010 Creteil, France. Electronic address: 
      jean-charles.delchier@hmn.aphp.fr.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
DEP - 20160202
PL  - France
TA  - Clin Res Hepatol Gastroenterol
JT  - Clinics and research in hepatology and gastroenterology
JID - 101553659
RN  - 0 (Anti-Infective Agents)
RN  - 0 (Drug Combinations)
RN  - 0 (Organometallic Compounds)
RN  - 0 (Proton Pump Inhibitors)
RN  - 140QMO216E (Metronidazole)
RN  - F8VB5M810T (Tetracycline)
RN  - HS813P8QPX (bismuth tripotassium dicitrate)
RN  - KG60484QX9 (Omeprazole)
SB  - IM
MH  - Anti-Infective Agents/*therapeutic use
MH  - Drug Combinations
MH  - *Drug Resistance, Multiple, Bacterial
MH  - Drug Therapy, Combination
MH  - Female
MH  - Helicobacter Infections/*drug therapy
MH  - Helicobacter pylori
MH  - Humans
MH  - Male
MH  - Metronidazole/therapeutic use
MH  - Middle Aged
MH  - Omeprazole/therapeutic use
MH  - Organometallic Compounds/therapeutic use
MH  - Prospective Studies
MH  - Proton Pump Inhibitors/therapeutic use
MH  - Salvage Therapy
MH  - Tetracycline/therapeutic use
EDAT- 2016/02/07 06:00
MHDA- 2018/01/18 06:00
CRDT- 2016/02/07 06:00
PHST- 2015/07/28 00:00 [received]
PHST- 2015/12/11 00:00 [revised]
PHST- 2015/12/25 00:00 [accepted]
PHST- 2016/02/07 06:00 [entrez]
PHST- 2016/02/07 06:00 [pubmed]
PHST- 2018/01/18 06:00 [medline]
AID - S2210-7401(16)00003-6 [pii]
AID - 10.1016/j.clinre.2015.12.012 [doi]
PST - ppublish
SO  - Clin Res Hepatol Gastroenterol. 2016 Sep;40(4):517-24. doi: 
      10.1016/j.clinre.2015.12.012. Epub 2016 Feb 2.