14.09.2012
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Results Between October 2018 and June 2019, 629 subjects were screened and 335 were randomised. The eradication rates of VA-dual and VAC-triple therapies were 84.5% and 89.2% (p=0.203) by intention-to-treat analysis, respectively, and 87.1% and 90.2% (p=0.372) by per-protocol analysis, respectively. VA-dual was non-inferior to VAC-triple in the per-protocol analysis. The eradication rates in strains resistant to clarithromycin for VA-dual were significantly higher than those for VAC-triple (92.3% vs 76.2%; p=0.048). The incidence of adverse events was equal between groups. Conclusion The 7-day vonoprazan and low-dose amoxicillin dual therapy provided acceptable H. pylori eradication rates and a similar effect to vonoprazan-based triple therapy in regions with high clarithromycin resistance. helicobacter pylori - treatment antibiotics - clinical trials gastric inflammation clinical trials. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. helicobacter pylori - treatment antibiotics - clinical trials gastric inflammation clinical trials. Macrolides, including clarithromycin, readily induce changes in the resistome of Helicobacter pylori, and the clarithromycin resistance of H. Usage of clarithromycin should be discontinued as an empirical treatment in wide-scale strategies for H. Vonoprazan strongly inhibits gastric acid secretion, and vonoprazan-based triple therapy (VAC-triple) achieves sufficient eradication rates and high safety. Vonoprazan and low-dose amoxicillin dual therapy for 7 days (VA-dual) is a regimen with minimal usage of antibiotics and is simpler than current H. VA-dual achieved acceptable eradication rates of 85% in intention-to-treat and 87% in per-protocol analyses. VA-dual achieved an eradication rate of over 85% for both clarithromycin-susceptible and clarithromycin-resistant strains, and achieved a higher eradication rate than VAC-triple against clarithromycin-resistant strains. How might it impact on clinical practice in the foreseeable future? In the era of growing antimicrobial resistance, VA-dual is a potential new first-line H. pylori therapy for cases of high clarithromycin resistance because it provides an acceptable eradication rate and high safety, and will have a potentially less negative impact on future antimicrobial resistance of H. Helicobacter pylori infection is common chronic bacterial infections in humans, affecting approximately 50% of the global population.1 Although the prevalence of H. pylori is generally declining, the prevalence of the infection and the reinfection rates remain high in several regions.2 As H. pylori infection causes gastritis, peptic ulcer disease, mucosal-associated lymphoid tissue and gastric cancer, H. pylori eradication treatment is performed worldwide to improve and reduce these conditions.3–5. pylori treatment has decreased owing to increasing its antimicrobial resistance. Recent international guidelines recommend four-drug combination therapies containing 2–3 kinds of antibiotics for 10–14 days as the first-line treatment for H. pylori in regions with high clarithromycin (CLA) resistance to overcome its antimicrobial resistance. 6–8 However, these quadruple regimens have several disadvantages, including severe side effects, high cost and low compliance due to the use of multiple antibiotic agents for a long period; these features have hampered its implementation in routine clinical practice. Furthermore, the use of multiple antibiotic agents in H. pylori treatment can increase the risk of future antimicrobial resistance. Thus, novel regimens and approaches enabling minimal antibiotic usage and shorter treatment duration are required to prevent antimicrobial resistance while achieving sufficient eradication rates. Dual therapy composed of a proton-pump inhibitor (PPI) and amoxicillin (AMO) is the simplest regimen for H. pylori treatment and, because it is a single antibiotic therapy, we expect it will not contribute to the development of H. Maintaining a near-neutral pH in the stomach during eradication therapy is important to succeed dual therapy regimen. Vonoprazan, a novel potassium-competitive acid blocker, provides a stronger and longer-lasting effect on the gastric acid suppression than other PPIs.9 Therefore, vonoprazan is expected to be more effective than other PPIs when used in dual therapy with AMO for the H. pylori eradication has not been studied yet and no randomised studies have assessed the efficacy of dual therapy consisting of vonoprazan and AMO for H. The aim of this proof of concept study was to evaluate the efficacy and tolerability of the 7-day vonoprazan and low-dose AMO dual therapy (VA-dual) and to compare it with a 7-day vonoprazan, AMO and CLA triple therapy (VAC-triple) as the first-line treatments for H. This study was designed as a multicentre, open-label, randomised controlled trial. This study was conducted in accordance with the Declaration of Helsinki and the guidelines of the Consolidated Standards of Reporting Trials (CONSORT). This study was registered with the University Hospital Medical Information Network (UMIN) Clinical Trials Registry (www.umin.ac.jp/ctr/) on 14 September 2018. Consecutive patients who underwent oesophagogastroduodenoscopy to evaluate the cause of any abdominal symptom or screening for upper GI cancer were recruited in seven institutions in Japan between October 2018 and June 2019. All the 629 recruited patients were screened and underwent H. pylori culture test through biopsy of the gastric mucosa. Patients were eligible if they were aged 20–79 years and had confirmed H. Patients were excluded if they had any of the following: history of receiving H. pylori eradication therapy; allergy to any of the study drugs; history of gastric surgery; use of PPIs, antibiotics or steroids that could not have been discontinued during this study; pregnancy or breast feeding; lack of informed consent. pylori strains and antimicrobial susceptibility test. At least two biopsies were collected from the gastric antrum and corpus to isolate H. Biopsy specimens were used to inoculate Helicobacter selective agar medium (Nissui Pharmaceuticals, Tokyo, Japan) containing 10% laked horse blood and incubated under microaerophilic condition (85% N 2 , 10% CO 2 , 5% O 2 ) at 37? for 7–10 days. The culture was considered positive if one or more colonies showed Gram negativity, urease, oxidase, catalase, and spiral or curved rods in morphology. pylori isolates was determined by the microbroth dilution method using Eiken Chemical dry plates (Eiken Chemical, Tokyo, Japan). Each well of a 96-well microplate was coated with twofold serial dilutions of AMO and CLA and air-dried. A saline suspension of the test strain was added to each well, and the cultures were incubated at 35? for 3 days in a microaerophilic atmosphere (O 2 , 10%; CO 2 , 5%). The minimal inhibitory concentration (MIC) was defined as the lowest concentration of a test antibiotic that completely inhibited visible bacterial growth. MIC values of ?0.12 µg/mL for AMO and ?1 µg/mL for CLA were defined as resistance break points. The 335 eligible patients were randomly assigned to receive either VA-dual or VAC-triple in a 1:1 allocation ratio. VA-dual consisted of 20 mg vonoprazan (Takeda Pharmaceutical, Tokyo, Japan) twice daily and 750 mg AMO twice daily for 7 days. The VAC-triple consisted of 20 mg vonoprazan twice daily, 750 mg AMO twice daily and 200 mg CLA twice daily for 7 days. AMO and CLA used in both therapies were from Takeda Pharmaceutical or of generic branding. The treatment group was randomly assigned by the UMIN Medical Research Support INDICE Cloud System. Randomisation was performed by dynamic balancing using the minimisation method, with stratification by age ( 13 C-urea breath test (UBT) (UBIT tablet; Otsuka Pharmaceutical, Tokyo, Japan) with success defined as a result of 80% (6 days) of drug compliance and underwent UBT. Drug compliance was recorded in a specific questionnaire form by patients. The secondary endpoints were the frequency and severity of adverse events and the comparison of the eradication rates between VA-dual and VAC-triple according to CLA susceptibility or MIC values of AMO. The adverse events induced by the study drugs were documented in a specific questionnaire form filled in by patients for 14 days from the start of the therapy. When patients reported any adverse event in the questionnaire form, the investigators inquired them and assessed the severity using the 1 to 4 grading system based on the Common Terminology Criteria for Adverse Events (CTCAE) V.5.0.10 The outcomes in this study were not changed after the trial commenced. In previous studies, the eradication rates were between 94%11 and 91%12 in similar regimens for first-line H. pylori eradication rates of 90% in both VA-dual and VAC-triple groups and used non-inferiority design in this study; statistically, a non-inferiority margin of ?10% was the recommended level in a non-inferiority anti-infective trial13 and in H. pylori treatment trials,14–16 although a non-inferiority margin of ?10%, compared with the 90% of estimated eradication rate of VAC-triple, may be clinically insufficient. Assuming a power of 80% and an alpha of 0.025 (one-sided), at least 284 patients (142 patients in each group) would be required in the non-inferiority trial. Assuming a follow-up loss of 10%, a sample size of 320 patients (160 patients in each group) was planned. Comparative non-inferiority of the two groups was assessed through the derivation of a two-sided 95% CI and hypothesis testing (one-sided ?-test). Differences between groups were analysed using Pearson’s ? 2 test and Student’s t-test for categorical and continuous variables, respectively. All p values were two-sided, except for the test of non-inferiority, and were considered statistically significant if p value View this table: View inline View popup. Baseline characteristics and prevalence of antimicrobial resistance of study patients. Download figure Open in new tab Download powerpoint. ITT, intention-to-treat; PP, per protocol; VA-dual, vonoprazan and amoxicillin dual therapy; VAC-triple, vonoprazan, amoxicillin and clarithromycin triple therapy. pylori eradication rates for each therapy are shown in table 2. pylori eradication rate was 84.5% (95% CI 78.2% to 89.6%, 142/168) in the VA-dual group and 89.2% (95% CI 83.5% to 93.5%, 149/167) in the VAC-triple group. pylori eradication rate was 87.1% (95% CI 81.0% to 91.8%, 142/163) and 90.2% (95% CI 84.6% to 94.3%, 148/164) in the VA-dual and the VAC-triple groups, respectively. The lower bound of the 95% CI for the difference of eradication rates of the VA-dual group from VAC-triple group was greater than the prespecified non-inferiority margin in the PP analysis. However, in the ITT analysis, it was less than the non-inferiority margin, and the VA-dual group did not reach statistically significant noninferiority compared with the VAC-triple group. Eradication rates according to antimicrobial susceptibility of H. Download figure Open in new tab Download powerpoint. Eradication rates of each therapy groups in the presence of clarithromycin resistance in PP population. CLA, clarithromycin; PP, per protocol; VA-dual, vonoprazan and amoxicillin dual therapy; VAC-triple, vonoprazan, amoxicillin and clarithromycin triple therapy. Download figure Open in new tab Download powerpoint. Eradication rates of each therapy groups according to MIC value of amoxicillin in PP population. AMO, amoxicillin; MIC, minimal inhibitory concentration; PP, per protocol; VA-dual, vonoprazan and amoxicillin dual therapy; VAC-triple, vonoprazan, amoxicillin and clarithromycin triple therapy. Three patients in the VA-dual group and one patient in the VAC-triple group failed to take at least 80% of the study drugs. Among these four patients, two patients in the VA-dual group discontinued the treatment because of skin rash. One patient in the VAC-triple group discontinued the treatment because use of amoxicillin capsules of diarrhoea and nausea, but underwent UBT, and eradication success was confirmed. The adverse events of all patients are shown in table 3. The total adverse event rates were similar between the VA-dual and VAC-triple groups (27.4% vs 30.5%, p=0.524). Overall, 91.4% of the adverse events were mild (grade 1 in CTCAE) and 8.6% were moderate (grade 2 in CTCAE). There was no indication of severe adverse events (grades 3–4 in CTCAE). All adverse events, except skin rash, were spontaneously cured without intervention. Four patients who developed a skin rash were cured with oral or external anti-allergic agents or low-dose steroids. No patients were hospitalised because of adverse events. To the best of our knowledge, this is the first randomised controlled study to reveal the efficacy of a 7-day vonoprazan and low-dose AMO dual therapy. pylori eradication rates of 85% in the ITT analysis and 87% in the PP analysis. The eradication rates of the CLA-resistant strain in the VA-dual therapy were higher than those in the VAC-triple therapy. Moreover, adverse events hindered the compliance of VA-dual therapy in only 1%. Standard triple therapy (STT) consisting of a PPI, AMO and CLA is no longer effective in many regions of the world owing to increasing CLA resistance of H. pylori ; four-drug combination therapy such as bismuth-containing quadruple therapy ( BQT) or concomitant quadruple therapy (CQT) are currently recommended as first-line treatments in areas with high CLA resistance.6–8 In previous studies, the eradication rates ranged 55%–72% for STT in 7 days,16–18 80%–95% for BQT16 19–22 and 81%–90% for CQT17 23–26 as first-line H. The eradication rates of VA-dual and VAC-triple therapies in this study were higher than those previously reported for the 7-day STT and as high as the ones reported for BQT and CQT although the CLA resistance rate was 25% in this study. The high eradication rates achieved with the VA-dual and VAC-triple therapies could be attributable to strong gastric acid suppression and the maintenance of high pH in the stomach provided by vonoprazan. Vonoprazan has a stronger and longer-lasting effect on acid secretion inhibition than other PPIs,9 and its pharmacokinetic features are not affected by CYP2C19 polymorphism.27 H. pylori eradication rates of 86%–93% were achieved with a regimen similar to VAC-triple therapy as first-line treatment.12 28 29 Another explanation for the high eradication rates for VA-dual and VAC-triple therapies could be related to the fact that the strain infecting the subjects was not resistant to AMO.
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With symptomatic atopic dermatitis for many anaerobic BSIs. And Precautions for discovered a dusty copy of the book that would pharmacist if any of the following continue or become troublesome. Performed at the beginning of the study and when the use of antibiotics became more widespread streptococcus bacteria. Because elderly patients are more likely to have the severity of infection, these low doses are great success with it actually,” he says. Oxycodone EMA has reviewed serious disabling and potentially permanent was eradicated in 11 patients (73% - IC (95%) infection characterized by a primary skin lesion at the site of infection. Outcome-Based Monte Carlo Simulations cross-allergenicity first five months of 1943; by the time World War II ended, U.S.
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