Evidence map›Paper›PMID 37631333›Full record

ArticlePharmaceutics2023

Real-World Evidence of Factors Affecting Cannabidiol Exposure in Children with Drug-Resistant Developmental and Epileptic Encephalopathies.

Lucas Brstilo, Gabriela Reyes Valenzuela, Roberto Caraballo, Carlos Pérez Montilla, Facundo García Bournissen, Paulo Cáceres Guido, Paula Schaiquevich

Abstract read
In one paragraph

Article in Pharmaceutics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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

2 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
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

7 authors.

Lucas BrstiloUnit of Innovative Treatments, Hospital de Pediatría Prof. Dr. JP Garrahan, Buenos Aires C1245AAM, Argentina.
Gabriela Reyes ValenzuelaNeurology Service, Hospital de Pediatría Prof. Dr. JP Garrahan, Buenos Aires C1245AAM, Argentina.
Roberto CaraballoNeurology Service, Hospital de Pediatría Prof. Dr. JP Garrahan, Buenos Aires C1245AAM, Argentina.
Carlos Pérez MontillaMultidisciplinary Institute for Research on Pediatric Diseases, Parasitology and Chagas Service, Buenos Aires Children's Hospital Ricardo Gutierrez, Buenos Aires C1425EFD, Argentina.ORCID 0000-0002-3939-6490
Facundo García BournissenDivision of Pediatric Clinical Pharmacology, Department of Pediatrics, Schulich School of Medicine & Dentistry, University of Western Ontario, London, ON N6A 3K7, Canada.ORCID 0000-0002-8732-247X
Paulo Cáceres GuidoPharmacokinetics and Research in Clinical Pharmacology Unit, Hospital de Pediatría Prof. Dr. JP Garrahan, Buenos Aires C1245AAM, Argentina.ORCID 0000-0002-9747-4960
Paula SchaiquevichUnit of Innovative Treatments, Hospital de Pediatría Prof. Dr. JP Garrahan, Buenos Aires C1245AAM, Argentina.ORCID 0000-0002-2568-4731

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The identification of factors that affect cannabidiol (CBD) systemic exposure may aid in optimizing treatment efficacy and safety in clinical practice. In this study, we aimed to correlate CBD plasma concentrations at a steady state to demographic, clinical, and pharmacological characteristics as well as seizure frequency after the administration of a purified CBD oil solution in a real-world setting of children with drug-resistant developmental and epileptic encephalopathies (DEEs). Patients receiving oral CBD pharmaceutical products at maintenance were enrolled. Venous blood samples were drawn before the CBD morning dose, 12 h apart from the last evening dose (C0 or CBD trough concentration). A linear mixed-effect analysis was implemented to assess the correlation between C0 and clinical, laboratory, pharmacological, and lifestyle factors. Fifteen females and seven males with a median age of 12.8 years (ranging between 4.7 and 17.2) were included. The median CBD dose was 8.8 mg/kg/day (ranging between 2.6 and 22.5), and the CBD C0 median (range) was 48.2 ng/mL (3.5-366.3). The multivariate model showed a 109.6% increase in CBD C0 in patients with concomitant levothyroxine (β = 0.74 ± 0.1649,

Indexed as

cannabidioldrug-resistant developmental and epileptic encephalopathiesfood effectketogenic dietlevothyroxine

Identifiers

PMID37631333
PMCPMC10459683

What OpenQuestion holds

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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 OpenQuestion graph.