Rescue therapy with bismuth-containing quadruple therapy in patients infected with metronidazole-resistant Helicobacter pylori strains

Muller, Nelly; Amiot, Aurélien; Thuaut, Aurélie Le; Bastuji‐Garin, Sylvie; Deforges, Lionel; Delchier, Jean‐Charles

doi:10.1016/j.clinre.2015.12.012

Cited by 44 publications

(43 citation statements)

References 22 publications

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“…The eradication rate (96.9%, ITT analysis) obtained by treatment with Pylera® in the present series of patients from Southern Italy was higher than that reported by previous international studies [12,51,55], but similar to that reported by another recent Italian study both in patients on first treatment and in rescue therapy [56], confirming the elevated therapeutic efficacy of regimen with bismuth subcitrate potassium in this specific geographical area.…”

Section: Discussionsupporting

confidence: 85%

Eradication Rates in Italian Subjects Heterogeneously Managed for Helicobacter pylori Infection. Time to Abandon Empiric Treatments in Southern Europe

Ciaula

Scaccianoce

Venerito

et al. 2017

JGLD

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Background & Aims: H. pylori eradication is strongly affected by various factors, including the ongoing antibiotic resistance. We describe a “real life” scenario in patients managed for H. pylori-related conditions, living in a southern Italian region (Apulia), an area with clarithromycin resistance >15%.Methods: 2,224 subjects were studied in two tertiary referral centers in Apulia. Analyses included: reason for referral, H. pylori infection rates (13C-urea breath test – UBT or upper endoscopy), and eradication rates following distinct regimens previously prescribed or prospectively prescribed (such as the bismuth-based quadruple therapy Pylera®, recently marketed in Italy).Results. Over 80% of the patients were referred by family physicians (60% naïve subjects). The overall infection rate was 32.5% and it was similar in asymptomatic patients (31.1%) or with H. pylori-related symptoms/clinical conditions (34.3%). In the 987 H. pylori+ve patients receiving therapy, the overall eradication rate was 80.2% (ITT). Observed eradication rate varied greatly across different regimens: 57.1% (2nd line levofloxacin), 59.6% (unconventional), 70.7% (7-day triple), 73.2% (7-day undefined), 89% (10-day sequential) and 96.9% (ITT, 10 day Pylera®, 1st to 5th line regimens given to 227 patients).Conclusions. A heterogeneous “real life” scenario in Southern Europe shows that H. pylori+ve patients are put at risk of poor outcomes and points to the need of a susceptibility-based therapy according to guidelines and local microbial resistance. In the present setting (i.e. high clarithromycin resistance), despite the high observed eradication rate, sequential therapy should not be recommended (absent in guidelines, unneeded antibiotic). Bismuth-based quadruple treatment (1st, 2nd or subsequent lines) yields the highest eradication rates.Abbreviations: ALT: Altamura; BA: Bari; EGDS: esophagogastroduodenoscopy; GERD: gastro-esophageal reflux disease; H. pylori: Helicobacter pylori; ITT: intention-to-treat; PP: per-protocol; PPI: proton pump inhibitor; UBT: urea breath test.

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Section: Discussionsupporting

confidence: 85%

Eradication Rates in Italian Subjects Heterogeneously Managed for Helicobacter pylori Infection. Time to Abandon Empiric Treatments in Southern Europe

Ciaula

Scaccianoce

Venerito

et al. 2017

JGLD

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“…We found that TEAEs occurred in about 16% of treated people, and that in only a minority of cases they caused discontinuation of treatment. This TEAE rate was significantly lower than the others reported by the literature, considering both pivotal studies [13, 14] as well as real life ones [16, 19], except for the study of Di Ciaula et al [18]. In our experience, this anti- H. pylori regimen shows a TEAE rate similar to that of standard triple therapy [3].…”

Section: Discussioncontrasting

confidence: 51%

“…Two pivotal studies [13, 14] found this formulation significantly better than standard triple therapy in eradicating H. pylori . The same effectiveness has been recently found with respect to rescue therapy in patients failing eradication [15, 16]. …”

Section: Introductionsupporting

confidence: 51%

Effectiveness and Safety of Pylera® in Patients Infected by <b><i>Helicobacter Pylori</i></b>: A Multicenter, Retrospective, Real Life Study

Tursi

Franceschi²,

Allegretta³

et al. 2018

Dig Dis

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Background: Our aims were to assess the real life effectiveness and safety of the new bismuth-containing quadruple therapy in a large population of patients infected by Helicobacter pylori. Methods: Consecutive dyspeptic H. pylori-positive patients were enrolled, both naïve for treatment and already unsuccessfully treated. Patients were treated with Pylera® 3 capsules 4 times/daily plus omeprazole 20 mg or esomeprazole 40 mg 2 times/daily for 10 days. Eradication was confirmed using a urea-breath test (at least 30 days after the end of the treatment). Efficacy and safety were assessed. Results: A total of 349 patients were treated. H. pylori eradication was achieved in 316 (90.5%, 95% CIs 80.8–1.0) patients in the intention-to-treat population, and in 93.5% (95% CIs 83.5–1.0) in the per-protocol population. No difference in the eradication rate was found between naïve and previously treated patients (91.3 vs. 90.0%, p = 0.901). Adverse events occurred in 55 patients (15.8%, 95% CIs 11.9–20.1). Five patients discontinued treatment: 2 patients suffered from severe abdominal pain, one patient from headache, one patient from diarrhea, and one patient from diffuse urticarial rush. Conclusions: Pylera® achieved a remarkable eradication rate in real life both as first treatment and as a rescue therapy, with a good safety profile.

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“…Use of Pylera ® resulted in eradication rates of 80-93% in a series of studies conducted in populations who were either treatment naïve or had failed 1 treatment course [79-82]. A more recent study looked at effectiveness of this regimen in patients with known resistance to metronidazole, clarithromycin, and levofloxacin or who had failed multiple prior treatment courses, and found eradication rates of 83% (intention to treat) and 87% (per-protocol) [83]. These numbers are encouraging especially in the setting of known metronidazole resistance and in a difficult to treat population.…”

Section: Introductionmentioning

confidence: 99%

Eradication of Helicobacter pylori Infection

Marcus

Sachs

Scott

2016

Curr Gastroenterol Rep

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Helicobacter pylori infects about 50% of the world’s population, causing at a minimum chronic gastritis. A subset of infected patients will ultimately develop gastric or duodenal ulcer disease, gastric adenocarcinoma, or MALT (mucosa-associated lymphoid tissue) lymphoma. Eradication of H. pylori requires complex regimens that include acid suppression and multiple antibiotics. The efficacy of treatment using what were once considered standard regimens have declined in recent years, mainly due to widespread development of antibiotic resistance. Addition of bismuth to standard triple therapy regimens, use of alternate antibiotics, or development of alternative regimens using known therapies in novel combinations, have improved treatment efficacy in specific populations, but overall success of eradication remains less than ideal. Novel regimens under investigation either in vivo or in vitro, involving increased acid suppression ideally with fewer antibiotics or development of non-antibiotic treatment targets show promise for future therapy.

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Rescue therapy with bismuth-containing quadruple therapy in patients infected with metronidazole-resistant Helicobacter pylori strains

Cited by 44 publications

References 22 publications

Eradication Rates in Italian Subjects Heterogeneously Managed for Helicobacter pylori Infection. Time to Abandon Empiric Treatments in Southern Europe

Eradication Rates in Italian Subjects Heterogeneously Managed for Helicobacter pylori Infection. Time to Abandon Empiric Treatments in Southern Europe

Effectiveness and Safety of Pylera® in Patients Infected by <b><i>Helicobacter Pylori</i></b>: A Multicenter, Retrospective, Real Life Study

Eradication of Helicobacter pylori Infection

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