Empiric “Three-in-One” Bismuth Quadruple Therapy for Second-Line Helicobacter pylori Eradication: An Intervention Study in Southern Italy

Abstract

The eradication of Helicobacter pylori (H. pylori) may be difficult due to antibiotic resistance. Indeed, after one failure, a second-line therapy is needed and a bismuth containing quadruple therapy (BQT) with a three-in-one capsule formulation is becoming very popular. Therefore, we aimed to evaluate effectiveness and safety of BQT as a second-line therapy. We recruited consecutive patients with one therapy failure. For ten days patients received the three-in-one BQT Pylera® therapy, in combination with a proton-pump inhibitor (PPI), decided at the choice of the investigator, at full dose bid. The eradication rate was calculated by intention-to-treat (ITT) and per-protocol (PP)analyses and 95% confidence intervals (CI) were calculated. Seventy-three patients were recruited, 41 females and 32 males (mean age 53.0±13.1 years). Fifty-five patients failed triple therapy with amoxicillin and clarithromycin and the remaining 18 received sequential therapy. Seventy-two patients consumed at least 90% of the capsules, while only one did not complete the therapy due to adverse events (nausea and diarrhea). By ITT analysis, BQT was successful in 62 subjects (eradication rate 84.9%, 95%CI 76.7–93.1%). By PP analysis, the eradication rate was 86.1% (95%CI 78.1–94.1%).Adverse events were observed in 14 subjects (20.5%).In conclusion, our report confirmed that BQT is effective as an empiric second-line regimen.

Clinical Implications of Helicobacter pylori Antibiotic Resistance in Italy: A Review of the Literature

“…Adverse events did not affect eradication outcomes ( p = 0.39). This report confirms that BQT is an effective second-line treatment [ 122 ].…”

Concomitant and Bismuth Quadruple Therapy for Helicobacter pylori Eradication in Southern Italy: Preliminary Data from a Randomized Clinical Trial

“…For this reason, clarithromicin-free therapeutic regimens such as bismuth quadruple therapy (BQT), which is not influenced by single clarithromycin or dual clarithromycin and metronidazole resistance, are becoming fundamental not only when used as secondline [22] but also as first-line treatment in geographical areas, including southern Italy, where clarithromycin resistance exceeds 15% [12,13]. Another treatment option to overcome the issue of antibiotic resistance when used as a first-line treatment is concomitant therapy, even if the first option (BQT) tends to be preferred in populations with elevated dual clarithromycin and metronidazole resistance profiles [18,23].…”

Treatment of refractory Helicobacter pylori infection: A new challenge for clinicians

“…In clinical trials, 20 mg (low dose) and 40 mg (high dose) are usually used for comparison ( Graham et al, 2019 ). High doses of PPI significantly improved the outcome of standard triple therapy ( Katelaris and Katelaris, 2017 ; Ierardi et al, 2019 ; Losurdo et al, 2022b ). Therefore, a double dose of PPIs is recommended for rescue therapy.…”