Trial reportClinical pharmacology and therapeutics2018
Ribociclib Bioavailability Is Not Affected by Gastric pH Changes or Food Intake: In Silico and Clinical Evaluations.
Trial report in Clinical pharmacology and therapeutics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers, 3 of them syntheses that pooled 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.
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
40 citing papers in PubMed, 3 syntheses or guidelines pooled it, 78 citations in OpenAlex.
- Pharmacokinetic interactions and clinical implications of PPIs and CDKIs in breast cancer: a systematic review and meta-analysis.Systematic reviews · 2025Pooled it
- Efficacy of cyclin-dependent kinase inhibitors with concurrent proton pump inhibitors in patients with breast cancer: a systematic review and meta-analysis.The oncologist · 2025Pooled it
- Do proton pump inhibitors affect the effectiveness of cyclin-dependent kinase 4/6 inhibitors in advanced HR positive, HER2 negative breast cancer? A meta-analysis.Frontiers in pharmacology · 2024Pooled it
- Response to: "Proton-pump inhibitor use in combination with a CDK4/6 inhibitor: is formulation the issue?"The oncologist · 2026Article
- Ribociclib is not a substrate or inhibitor of Oatp1b-mediated uptake in vivo.Cancer chemotherapy and pharmacology · 2026Article
- Optimizing ribociclib dosing in breast cancer with brain metastasis patients using a physiologically based pharmacokinetic model.BMC cancer · 2026Article
- The administration of proton pump inhibitors with the CDK4/6 inhibitor abemaciclib does not affect the clinical outcome of metastatic breast cancer patients.Therapeutic advances in drug safety · 2026Article
- Real-world evaluation of CDK4/6 inhibitors in hormone receptor-positive metastatic breast cancer: prognostic effect of proton pump inhibitor use.The oncologist · 2025Article
- Temperature-dependent solubilization and thermodynamic characteristics of ribociclib in varied {PEG 400 + water} combinations.BMC chemistry · 2025Article
- Advancements in breast cancer management: a comprehensive review of ribociclib combined with endocrine therapy.Annals of medicine and surgery (2012) · 2024Review
- Advancements in Virtual Bioequivalence: A Systematic Review of Computational Methods and Regulatory Perspectives in the Pharmaceutical Industry.Pharmaceutics · 2024Review
- The Effect of Concomitant Administration of Proton Pump Inhibitors on the Pharmacokinetics of CDK4/6 Inhibitors in Rats: Implications for the Evaluation of Hepatic and Transporter-Mediated Drug-Drug Interactions.European journal of drug metabolism and pharmacokinetics · 2024Article
- Identification of neutrophil extracellular trap-driven gastric cancer heterogeneity and C5AR1 as a therapeutic target.Acta biochimica et biophysica Sinica · 2024Article
- Use of Pharmacokinetic and Pharmacodynamic Data to Develop the CDK4/6 Inhibitor Ribociclib for Patients with Advanced Breast Cancer.Clinical pharmacokinetics · 2024Review
- Estimation of CDK inhibitors by RP-HPLC: application for pharmacokinetic interactions studies with PPIs.Bioanalysis · 2024Article
- Review
- Optimisation of Solid-Phase Extraction and LC-MS/MS Analysis of Six Breast Cancer Drugs in Patient Plasma Samples.Pharmaceuticals (Basel, Switzerland) · 2023Article
- Ribociclib Hybrid Lipid-Polymer Nanoparticle Preparation and Characterization for Cancer Treatment.Polymers · 2023Article
- Does Proton Pump Inhibitors Decrease the Efficacy of Palbociclib and Ribociclib in Patients with Metastatic Breast Cancer?Medicina (Kaunas, Lithuania) · 2023Article
- Drug-drug interactions with proton pump inhibitors in cancer patients: an underrecognized cause of treatment failure.ESMO open · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Ribociclib (KISQALI), a cyclin-dependent kinase 4/6 inhibitor approved for the first-line treatment of HR+/HER2- advanced breast cancer with an aromatase inhibitor, is administered with no restrictions on concomitant gastric pH-elevating agents or food intake. The influence of proton pump inhibitors (PPIs) on ribociclib bioavailability was assessed using 1) biorelevant media solubility, 2) physiologically based pharmacokinetic (PBPK) modeling, 3) noncompartmental analysis (NCA) of clinical trial data, and 4) population PK (PopPK) analysis. This multipronged approach indicated no effect of gastric pH changes on ribociclib PK and served as a platform for supporting ribociclib labeling language, stating no impact of gastric pH-altering agents on the absorption of ribociclib, without a dedicated drug-drug interaction trial. The bioequivalence of ribociclib exposure with or without a high-fat meal was demonstrated in a clinical trial. Lack of restrictions on ribociclib dosing may facilitate better patient compliance and therefore clinical benefit.
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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.