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

Abstract

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.

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

“…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].…”

“…However, our study differs significantly from those experiences. In particular, Di Ciaula et al [18] enrolled both symptomatic and asymptomatic subjects, while the study by Gómez Rodríguez et al [19] was small, enrolling less than 60 subjects. Therefore, our large study population reached more real results, similar to those reached by pivotal studies [13, 14].…”

Rescue therapy with bismuth quadruple regimen in patients with Helicobacter pylori ‐resistant strains

“…Finally, we administered the therapy for 10 days, and a longer 14‐day regimen should be tested. However, high eradication rates were achieved in using the same 10‐day regimen in three recent Italian studies, and in multicenter, European study …”

First-line therapies for Helicobacter pylori eradication: a critical reappraisal of updated guidelines

“…However, in the last decade, an eradication rate of >90% has repeatedly been found in all multicenter Italian trials involving thousands of patients [35,36], apart from one study published in 2010 where the infection was cured in 83% of 122 patients [37]. When considering only data from studies published in the last 5 years, the cure rate following sequential therapy was still 90-92.6% in 5 Italian studies with more than 1000 patients [26,38-41], and 73% in another study with 100 cases [42]. A similarly high success rate of sequential therapy has been observed in studies recently performed in Slovenia (94.2%) [43], Portugal (90%) [44], Belgium (90%) [3], Israel (95.9%) [45], Thailand (94%) [46], Taiwan (91.9%) [47], Singapore (90.3%) [48], and the United Arab Emirates (88.6%) [49], suggesting that this therapy is still effective in several countries.…”

“…The bismuth-based quadruple therapy is included among the recommended first-line therapies in the current European, US, Canadian and Chinese guidelines [8,9,15,19]. Surprisingly, such a therapy was also suggested as an alternative first-line therapy in the Italian guidelines published in 2015, which was before the marketing of these tablets (2016 in Italy) and without any data from Italian trials, the first studies only now being available [41,63]. …”