It Is Time for a Paradigm Shift in Design, Execution, and Publishing of Comparative Helicobacter pylori Treatment Trials

Graham, David Y.

doi:10.14309/ajg.0000000000002298

Cited by 4 publications

(1 citation statement)

References 14 publications

(17 reference statements)

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“…It has been reported that the overall prevalence of primary antibiotic resistance of H. pylori in the Asia-Pacific region between 1990 and 2022 was 22% (95% CI 20% to 23%) for clarithromycin, 52% (95% CI 49% to 55%) for metronidazole, 26% (95% CI 24% to 29%) for levofloxacin, 4% (95% CI 3% to 5%) for tetracycline and 4% (95% CI 3% to 5%) for amoxicillin. 7 Given that infectious disease studies are often susceptibility-based, 8 tetracycline and amoxicillin emerge as primary option for antibiotic candidates. Amoxicillin, characterised by its low resistance rate, high efficacy, safety and availability, is an essential component of H. pylori eradication regimens.…”

Section: Discussionmentioning

confidence: 99%

SimplifiedHelicobacter pyloritherapy for patients with penicillin allergy: a randomised controlled trial of vonoprazan-tetracycline dual therapy

Gao,

Liu,

Wang

et al. 2024

Gut

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Background and aimsThis study aimed to evaluate the efficacy and safety of vonoprazan and tetracycline (VT) dual therapy as first-line treatment forHelicobacter pyloriinfection in patients with penicillin allergy.MethodsIn this randomised controlled trial, treatment-naïve adults withH. pyloriinfection and penicillin allergy were randomised 1:1 to receive either open-label VT dual therapy (vonoprazan 20 mg two times per day+tetracycline 500 mg three times a day) or bismuth quadruple therapy (BQT; lansoprazole 30 mg two times per day+colloidal bismuth 150 mg three times a day+tetracycline 500 mg three times a day+metronidazole 400 mg three times a day) for 14 days. The primary outcome was non-inferiority in eradication rates in the VT dual group compared with the BQT group. Secondary outcomes included assessing adverse effects.Results300 patients were randomised. The eradication rates in the VT group and the BQT group were: 92.0% (138/150, 95% CI 86.1% to 95.6%) and 89.3% (134/150, 95% CI 83.0% to 93.6%) in intention-to-treat analysis (difference 2.7%; 95% CI −4.6% to 10.0%; non-inferiority p=0.000); 94.5% (138/146, 95% CI 89.1% to 97.4%) and 93.1% (134/144, 95% CI 87.3% to 96.4%) in modiﬁed intention-to-treat analysis (difference 1.5%; 95% CI −4.9% to 8.0%; non-inferiority p=0.001); 95.1% (135/142, 95% CI 89.7% to 97.8%) and 97.7% (128/131, 95% CI 92.9% to 99.4%) in per-protocol analysis (difference 2.6%; 95% CI −2.9% to 8.3%; non-inferiority p=0.000). The treatment-emergent adverse events (TEAEs) were significantly lower in the VT group (14.0% vs 48.0%, p=0.000), with fewer treatment discontinuations due to TEAEs (2.0% vs 8.7%, p=0.010).ConclusionsVT dual therapy demonstrated efficacy and safety as a first-line treatment forH. pyloriinfection in the penicillin-allergic population, with comparable efficacy and a lower incidence of TEAEs compared with traditional BQT.Trial registration numberChiCTR2300074693.

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Section: Discussionmentioning

confidence: 99%

SimplifiedHelicobacter pyloritherapy for patients with penicillin allergy: a randomised controlled trial of vonoprazan-tetracycline dual therapy

Gao,

Liu,

Wang

et al. 2024

Gut

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Bismuth-Containing Quadruple Therapy for Helicobacter pylori Eradication: A Randomized Clinical Trial of 10 and 14 Days

Ding,

Duan,

Han

et al. 2024

Dig Dis Sci

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Vonoprazan Dual or Triple Therapy Versus Bismuth‐Quadruple Therapy as First‐Line Therapy for Helicobacter pylori Infection: A Three‐Arm, Randomized Clinical Trial

Cheung,

Lyu,

Deng

et al. 2024

Helicobacter

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BackgroundWe compared efficacy of vonoprazan‐dual or triple therapies and bismuth‐quadruple therapy for treatment‐naive Helicobacter pylori (HP) infection in Southern China, where primary resistance rates of clarithromycin and levofloxacin are >30%.MethodsThis was an investigator‐initiated, three‐arm, randomized clinical trial in Southern China. Between March 2022 and August 2023, treatment‐naïve HP‐infected adults were randomly assigned to receive one of three 14‐day regimens (1:1:1 ratio): vonoprazan‐dual (VA‐dual; vonoprazan 20 mg twice daily and amoxicillin 1 g thrice daily), vonoprazan‐triple (VAC‐triple; vonoprazan 20 mg/amoxicillin 1 g/clarithromycin 500 mg twice daily), or bismuth‐quadruple therapy containing bismuth, esomeprazole, tetracycline, and metronidazole. Primary outcome was noninferiority in HP eradication, evaluated by UBT 4–6 weeks post‐treatment by intention‐to‐treat (ITT) and per‐protocol (PP) analysis (based on subjects who completed 14‐day treatment and rechecked UBT). Bonferroni‐adjusted p‐value of <0.017 was used to determine statistical significance.ResultsA total of 298 subjects (mean age: 35.7 ± 8.4 years; male: 134 [45.0%]; VC‐dual: 100, VAC‐triple: 98, bismuth‐quadruple: 100) were enrolled, and 292 (98.0%) had UBT rechecked. ITT analysis showed that both VA‐dual (eradication rate of 96.0%) and VAC‐triple therapies (95.9%) were noninferior to bismuth‐quadruple therapy (92.0%) (difference: 4.0%, 95% CI: −2.9% to 11.5%, p < 0.001; and 3.9%, 95% CI: −3.1% to 11.5%, p < 0.001, respectively). PP analysis also revealed noninferiority (96.7% or 96.7% vs. 97.4%, with difference: −2.9% and −2.9%, p = 0.009 and 0.010, respectively). The frequency of adverse events was 39.0%, 56.1%, and 71.0% in VA‐dual, VAC‐triple, and bismuth‐quadruple therapies, respectively.ConclusionsVA‐dual and VA‐triple therapies are highly effective and noninferior to bismuth‐quadruple therapy in Southern China. Given the lower adverse effects and fewer antibiotic use, VA‐dual therapy is the preferred first‐line treatment for HP infection.Trial RegistrationChinese Clinical Trial Registry (No. ChiCTR2200056375). Registered on February 4, 2022, https://www.chictr.org.cn/showproj.aspx?proj=14131.

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It Is Time for a Paradigm Shift in Design, Execution, and Publishing of Comparative Helicobacter pylori Treatment Trials

Cited by 4 publications

References 14 publications

SimplifiedHelicobacter pyloritherapy for patients with penicillin allergy: a randomised controlled trial of vonoprazan-tetracycline dual therapy

SimplifiedHelicobacter pyloritherapy for patients with penicillin allergy: a randomised controlled trial of vonoprazan-tetracycline dual therapy

Bismuth-Containing Quadruple Therapy for Helicobacter pylori Eradication: A Randomized Clinical Trial of 10 and 14 Days

Vonoprazan Dual or Triple Therapy Versus Bismuth‐Quadruple Therapy as First‐Line Therapy for Helicobacter pylori Infection: A Three‐Arm, Randomized Clinical Trial

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