Trial reportJournal of pharmacokinetics and pharmacodynamics2018
Population pharmacokinetics-pharmacodynamics of oral everolimus in patients with seizures associated with tuberous sclerosis complex.
Trial report in Journal of pharmacokinetics and pharmacodynamics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis 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
11 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Systematic review of mTOR inhibitor treatment, biomarkers and prophylaxis for tuberous sclerosis complex-associated seizures.Clinical medicine (London, England) · 2022Pooled it
- Pharmacokinetics and safety of the antitumor drug everolimus in healthy Chinese subjects: a single-dose, open-label, randomized, two-sequence, two-period crossover, phase I bioequivalence study.Frontiers in pharmacology · 2025Trial
- Impact of Administration Time Errors on Clearance Estimation in Pharmacokinetic Analyses.Clinical and translational science · 2025Article
- Application of population pharmacokinetic modeling of SVG-101 to evaluate proper dose selection.Translational and clinical pharmacology · 2025Article
- Automated Poisson regression exposure-response analysis for binary outcomes with PoissonERM.CPT: pharmacometrics & systems pharmacology · 2024Article
- Population pharmacokinetics of everolimus in patients with seizures associated with focal cortical dysplasia.Frontiers in pharmacology · 2023Article
- Everolimus pharmacokinetics and exposure-response relationship in Japanese patients with advanced breast cancer.Frontiers in pharmacology · 2022Article
- Therapeutic drug monitoring of oral targeted antineoplastic drugs.European journal of clinical pharmacology · 2021Review
- Model-Informed Precision Dosing of Everolimus: External Validation in Adult Renal Transplant Recipients.Clinical pharmacokinetics · 2021Article
- Model-Informed Drug Development for Everolimus Dosing Selection in Pediatric Infant Patients.CPT: pharmacometrics & systems pharmacology · 2020Article
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Everolimus is approved in Europe and in the USA for the adjunctive treatment of patients aged 2 years and older whose refractory partial-onset seizures, with or without secondary generalization, are associated with tuberous sclerosis complex. The objective of this analysis was to establish a population pharmacokinetic (PK)/pharmacodynamic model describing the relationship between seizure frequency and everolimus exposure to confirm the recommended target concentration range of 5-15 ng/mL. The PK model was a two-compartment model with first order absorption and clearance. CYP3A and P-gp inducers and body-surface area were shown to impact everolimus exposure, justifying dose adjustments. A Poisson distribution was found to adequately describe the random nature of daily seizure counts during the screening phase. A placebo effect on the Poisson seizure mean was implemented as an asymptotic exponential function of time leading to a new steady-state seizure mean. The everolimus effect was implemented as an inhibitory E
Indexed as
Identifiers
29992479What OpenQuestion holds
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.