ArticleJournal of clinical pharmacology2022
A Population Pharmacokinetic Model of Vonoprazan: Evaluating the Effects of Race, Disease Status, and Other Covariates on Exposure.
Article in 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 18 papers.
What it found
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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.
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.
Who cites it
18 citing papers in PubMed, 22 citations in OpenAlex.
- Bioequivalence study of vonoprazan fumarate tablets in healthy Chinese subjects: a randomized, open-label, two-period crossover trial.Frontiers in pharmacology · 2026Trial
- Vonoprazan pharmacokinetics and effects on gastric pH following administration to fed and fasted horses.Equine veterinary journal · 2026Article
- Development and Use of a Population Pharmacokinetic Model for Characterizing the Pharmacokinetics of Vonoprazan in Pediatric Patients.CPT: pharmacometrics & systems pharmacology · 2026Article
- Gatherings in Esophagology: Innovations and Future Directions in the Diagnosis and Management of Reflux Disease.Annals of the New York Academy of Sciences · 2026Article
- Vonoprazan: A Review in Erosive Esophagitis and Non-Erosive Gastro-Esophageal Reflux Disease.Drugs · 2025Review
- Vonoprazan-related adverse events: a pharmacovigilance study based on the FDA adverse event reporting system.Frontiers in medicine · 2025Article
- Generation of realistic virtual adult populations using a model-based copula approach.Journal of pharmacokinetics and pharmacodynamics · 2024Article
- Population pharmacokinetic analysis of zastaprazan (JP-1366), a novel potassium-competitive acid blocker, in patients and healthy volunteers.CPT: pharmacometrics & systems pharmacology · 2024Article
- Potassium-competitive Acid Blockers: Current Clinical Use and Future Developments.Current gastroenterology reports · 2024Review
- A Comprehensive Review on the Efficacy and Safety of Vonoprazan in the Management of Gastric Acid-Related Diseases.Cureus · 2024Review
- Review
- Why the Vonoprazan Helicobacter pylori Therapies in the US-European Trial Produced Unacceptable Cure Rates.Digestive diseases and sciences · 2023Review
- Incidence and type of adverse events in patients taking vonoprazan: A systematic review and meta-analysis.Therapeutic advances in gastroenterology · 2023Article
- Potassium-Competitive Acid Blockers: Present and Potential Utility in the Armamentarium for Acid Peptic Disorders.Gastroenterology & hepatology · 2022Article
- 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.CPT: pharmacometrics & systems pharmacology · 2022Article
- Scope and Limitations of Current Antibiotic Therapies againstPharmaceutics · 2022Review
- Potassium-Competitive Acid Blocker and Proton Pump Inhibitor-Based Regimens for First-LineGastro hep advances · 2022Article
- The role of vonoprazan in patients with erosive esophagitis.Therapeutic advances in gastroenterology · 2022Review
Corrections and comments
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Authors and funding
7 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Vonoprazan, a potassium-competitive acid blocker, is under investigation in the United States and Europe for the treatment of erosive esophagitis and Helicobacter pylori infection. Population pharmacokinetic (popPK) analysis allows the identification of factors that could affect drug exposure in population subgroups. Here, we report a popPK model based on pooled data sets of available pharmacokinetic (PK) studies in healthy volunteers and patients with gastroesophageal reflux disease, including erosive esophagitis, from Asia and Europe. This model was used to evaluate the impact of different covariates, including race and disease status, on vonoprazan exposure. We analyzed PK data from 746 patients and 410 healthy volunteers from 15 clinical trials using a nonlinear mixed-effects approach to develop the popPK model. Model development focused on characterizing and quantifying the effects of clinical covariates of race (Asian vs non-Asian) and disease status (gastroesophageal reflux disease vs healthy volunteers) on vonoprazan exposure. Identified clinical covariates included fed/fasting status, race, sex, disease status, weight, serum creatinine, and age. The impact of variations in these clinical covariates on exposure to vonoprazan was smaller than the effect of halving or doubling the dose. PK parameters were similar in Asian and non-Asian populations. Variations in weight, age, and race are not predicted to have a clinically relevant impact on vonoprazan exposure or safety and require no changes in vonoprazan dosing. The limited impact of race on exposure suggests that efficacy and safety data for vonoprazan in Asian populations are translatable to non-Asian populations.
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Registered trials
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 OpenQuestion graph.