A Potassium-Competitive Acid Blocker-Based Regimen as Second-Line Therapy Improves Helicobacter pylori Eradication

Nabeta, Haruaki; Shinozaki, Satoshi; Abe, Yasuhiro; Koyanagi, Ryota; Nakamichi, Taro; Kobayashi, Yasutoshi; Lefor, Alan Kawarai; Hirashima, Hayato

doi:10.1159/000499857

Cited by 13 publications

(15 citation statements)

References 27 publications

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“…61 The VPZ and AMPC doses were the same as those of the first-and second-line regimens; the STFX dose was 100 mg bid (200 mg/day). The eradication rates were 75.8% (95% CI, 57.7 to 88.9) for VPZ therapy versus 53…”

Section: Vpz-versus Ppi-based Triple Therapies Consisting Of Ampc and Stfx For Third-line Eradicationmentioning

confidence: 97%

“…Another MA excluded most studies, considered "low-quality studies with poorly defined populations. " 12 In the MA, two propensity score-matched analyses 52,53 were included. However, both works lacked antibiotic-resistance data, and this was not remedied by propensity score matching.…”

Section: Vpz-compared With Ppi-based Second-line Triple Therapy Consisting Of Ampc and Mnzmentioning

confidence: 99%

“…In the PP analysis, the eradication rates were 91.1% (95% CI, 89.8 to 92.2) for VPZ-based therapy compared with 88.2% (95% CI, 87.2 to 89.2) for PPI-based therapy (p<0.001). Sixteen studies 24 , 32 , 36 , 37 , 41 , 43 , 48 , 50 , 53 - 60 were evaluated. 52 Heterogeneity was very low (I 2 =0%), suggesting that the MA was very reliable.…”

Section: Vpz-compared With Ppi-based Second-line Triple Therapy Consisting Of Ampc and Mnzmentioning

confidence: 99%

“…Also, most retrospective studies are at high risk of bias, lack pre-planned analyses, and used arbitrary numbers in the PPI-based arm that serve as historical controls. Another MA excluded most studies, considered “low-quality studies with poorly defined populations.” 12 In the MA, two propensity score-matched analyses 52 , 53 were included. However, both works lacked antibiotic-resistance data, and this was not remedied by propensity score matching.…”

Section: Vpz-compared With Ppi-based Second-line Triple Therapy Consisting Of Ampc and Mnzmentioning

confidence: 99%

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Is a Potassium-Competitive Acid Blocker Truly Superior to Proton Pump Inhibitors in Terms of Helicobacter pylori Eradication?

Sue

Maeda

2021

Gut and Liver

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Vonoprazan (VPZ), a new potassium-competitive acid blocker, has been approved and used for Helicobacter pylori eradication in Japan. To date, many studies, as well as several systematic reviews and meta-analyses (MAs), have compared VPZ-based 7-day triple therapy with proton pump inhibitor (PPI)-based therapy. An MA of randomized controlled trials (RCTs) comparing first-line VPZ-with PPI-based triple therapy, the latter featuring amoxicillin (AMPC) and clarithromycin (CAM), found that approximately 30% of patients hosted CAM-resistant H. pylori; however, the reliability was poor because of high heterogeneity and a risk of selection bias. VPZ-based triple therapy is superior to PPI-based triple therapy for patients with CAM-resistant H. pylori, but not for those with CAM-susceptible H. pylori. An MA of non-RCTs found that second-line VPZbased triple therapies were slightly (~2.6%) better than PPI-based triple therapies (with AMPC and metronidazole). However, the reliability of that MA was also low because of selection bias, confounding variables and a risk of publication bias; in addition, it is difficult to generalize the results because of a lack of data on antibiotic resistance. VPZ-based triple therapy (involving AMPC and sitafloxacin) was more effective than PPI-based triple therapy in a third-line setting, but a confirmatory RCT is needed. Non-RCT studies indicated that VPZ-based triple therapy involving CAM and metronidazole may be promising. Any further RCTs must explore the antibiotic-resistance status when evaluating the possible superiority of a potassium-competitive acid blocker.

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Section: Vpz-versus Ppi-based Triple Therapies Consisting Of Ampc and Stfx For Third-line Eradicationmentioning

confidence: 97%

Section: Vpz-compared With Ppi-based Second-line Triple Therapy Consisting Of Ampc and Mnzmentioning

confidence: 99%

Section: Vpz-compared With Ppi-based Second-line Triple Therapy Consisting Of Ampc and Mnzmentioning

confidence: 99%

Section: Vpz-compared With Ppi-based Second-line Triple Therapy Consisting Of Ampc and Mnzmentioning

confidence: 99%

See 2 more Smart Citations

Is a Potassium-Competitive Acid Blocker Truly Superior to Proton Pump Inhibitors in Terms of Helicobacter pylori Eradication?

Sue

Maeda

2021

Gut and Liver

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“… 5 In addition, P‐CABs inhibit the secretion of gastric acid faster than PPI and raise intragastric pH for a longer period of time. 3 , 6 , 7 …”

Section: Introductionmentioning

confidence: 99%

A population PK–PD model of YH4808, a novel P‐CAB, and intragastric pH that incorporated negative feedback by increased intragastric pH onto the systemic exposure to YH4808

Chung

Lee

et al. 2022

CPT Pharmacom & Syst Pharma

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YH4808 is a novel potassium-competitive acid blocker that is under clinical development to treat patients with gastroesophageal reflux disease and peptic ulcer diseases. In this study, the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of YH4808 were modeled in healthy male volunteers who received a single oral dose of YH4808 at 30, 50, 100, 200, 400, 600, and 800 mg or matching placebo and multiple once-daily oral doses of YH4808 at 100, 200, and 400 mg or matching placebo for 7 days. A population PK-PD model adequately described the time-concentration-effect profiles of YH4808. The maximum increasing effect of YH4808 on intragastric pH was 4.38, which was higher than the observed maximum increase in intragastric pH after omeprazole at 40 mg (2.2 in pH). The maximum inhibitory effect by the increased intragastric pH on the exposure to repeated YH4808 was 58% from baseline. Monte-Carlo simulation experiments based on the final model showed that YH4808 at 200 mg will produce a higher percentage of time at pH > 4 over 24 h on day 1 than observed value of esomeprazole at 40 mg once-daily, an active comparator (84.7% time vs. 58.3% time, respectively). Because YH4808 at ≥200 mg resulted in a higher percentage of time at intragastric pH > 4 than seen after once-daily esomeprazole at 40 mg and YH4808showed acceptable tolerability at a single-dose of 30-800 mg, we suggest to test the 200 mg once daily dosage regimen in further clinical trials of YH4808. Study HighlightsWHAT IS THE CURRENT KNOWLEDGE ON THE TOPIC? YH4808, a novel potassium-competitive acid blocker, showed a reduced systemic exposure after multiple oral administrations, particularly at higher doses (i.e., 200 and 400 mg). Because the solubility of YH4808 is pH-dependent, the reduced

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Helicobacter pylori Eradication Treatment in Older Patients

Jonaitis,

Kupcinskas,

Gisbert

et al. 2024

Drugs Aging

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A Potassium-Competitive Acid Blocker-Based Regimen as Second-Line Therapy Improves Helicobacter pylori Eradication

Cited by 13 publications

References 27 publications

Is a Potassium-Competitive Acid Blocker Truly Superior to Proton Pump Inhibitors in Terms of Helicobacter pylori Eradication?

Is a Potassium-Competitive Acid Blocker Truly Superior to Proton Pump Inhibitors in Terms of Helicobacter pylori Eradication?

A population PK–PD model of YH4808, a novel P‐CAB, and intragastric pH that incorporated negative feedback by increased intragastric pH onto the systemic exposure to YH4808

Helicobacter pylori Eradication Treatment in Older Patients

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