Evidence map›Paper›PMID 34080718›Full record

Trial reportBritish journal of clinical pharmacology2022

Evaluation of safety and pharmacokinetics of bismuth-containing quadruple therapy with either vonoprazan or lansoprazole for Helicobacter pylori eradication.

Ki Young Huh, Hyewon Chung, Yu Kyong Kim, SeungHwan Lee, Siddharth Bhatia, Yohei Takanami, Ryou Nakaya, Kyung-Sang Yu

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in British journal of clinical pharmacology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 5 pooled it
6.1field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 5 syntheses or guidelines pooled it, 42 citations in OpenAlex.

  1. Pooled it
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  5. Pooled it
  6. Trial
  7. Trial
  8. Review
  9. Article
  10. Article
  11. Review
  12. Review
  13. Review
  14. Vonoprazan and proton pump inhibitors: Which is superior forWorld journal of gastroenterology · 2025
    Article
  15. The efficacy and safety of Vonoprazan and Tegoprazan inTherapeutic advances in gastroenterology · 2025
    Article
  16. Observational
  17. Article
  18. Article
  19. Article
  20. P-CABTherapeutic advances in gastroenterology · 2024
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 5 institutions in 3 countries.

Ki Young HuhDepartment of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.
Hyewon ChungDepartment of Clinical Pharmacology and Toxicology, Korea University Guro Hospital, Seoul, Republic of Korea.
Yu Kyong KimDepartment of Clinical Pharmacology and Therapeutics, Chungbuk National University Hospital, Chungcheongbuk-do, Republic of Korea.
SeungHwan LeeDepartment of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.
Siddharth BhatiaTakeda Pharmaceuticals International Co., Cambridge, MA, USA.
Yohei TakanamiTakeda Pharmaceutical Company Limited, Osaka, Japan.
Ryou NakayaTakeda Pharmaceutical Company Limited, Osaka, Japan.
Kyung-Sang YuDepartment of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.ORCID 0000-0003-0921-7225
Seoul National University Hospital · KRTakeda (Japan) · JPChungbuk National University Hospital · KRKorea University Medical Center · KRTakeda (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsHelicobacter pylori (Hp) eradication plays a key role in the treatment and prevention of peptic ulcer diseases. Increasing clarithromycin resistance in Hp necessitates more effective treatments for eradication, such as bismuth-containing quadruple therapy. We aimed to compare the safety and pharmacokinetics (PK) of bismuth between vonoprazan- and lansoprazole-containing quadruple therapy in Hp-positive subjects.

methodsIn this randomised, double-blind, parallel-group study, Hp-positive subjects were randomised to receive vonoprazan- or lansoprazole-containing quadruple therapy. Each subject received vonoprazan 20 mg or lansoprazole 30 mg combined with bismuth 220 mg, clarithromycin 500 mg and amoxicillin 1000 mg twice daily for 14 days. Blood sampling and urine collection for bismuth PK were conducted predose and up to 12 hours postdose at steady-state. The PK parameters of bismuth were derived using a noncompartmental method and compared between treatments. An exploratory breath test for Hp was conducted at screening and at the follow-up visit on day 42. Safety was assessed by adverse event monitoring, physical examinations, vital signs, 12-lead electrocardiograms and clinical laboratory tests.

resultsA total of 30 subjects were randomised and 26 subjects completed the study (12 in the vonoprazan group and 14 in the lansoprazole group). The systemic exposure of bismuth in the 2 treatments was comparable (~5% difference). All subjects turned negative for Hp at the follow-up visit. No significant difference in safety profiles was noted between the 2 treatments.

conclusionThe systemic exposure of bismuth was similar between vonoprazan- and lansoprazole-containing quadruple therapy. Vonoprazan-containing quadruple therapy was safe and well tolerated.

Indexed as

Helicobacter InfectionsHelicobacter pyloriAmoxicillinAnti-Bacterial AgentsBismuthClarithromycinDrug Therapy, CombinationHumansLansoprazolePyrrolesSulfonamidesTreatment Outcome1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamineAmoxicillinAnti-Bacterial AgentsBismuthClarithromycinLansoprazolePyrrolesSulfonamidesbismuth, drug interaction, Helicobacter pylori, quadruple therapy, vonoprazan

Identifiers

PMID34080718
PMCPMC9291775
OpenAlexW3165355806

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.