Evidence map›Paper›PMID 29943125›Full record

ArticleEuropean journal of drug metabolism and pharmacokinetics2018

Population Pharmacokinetic Analysis and Model-Based Simulations of Aripiprazole for a 1-Day Initiation Regimen for the Long-Acting Antipsychotic Aripiprazole Lauroxil.

Marjie L Hard, Angela Y Wehr, Brian M Sadler, Richard J Mills, Lisa von Moltke

Open access · hybridAbstract read
In one paragraph

Article in European journal of drug metabolism and pharmacokinetics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 2 pooled it
3.4field-weighted citation impact, top 7% 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

17 citing papers in PubMed, 2 syntheses or guidelines pooled it, 31 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Article
  6. Review
  7. Article
  8. How drug onset rate and duration of action affect drug forgiveness.Journal of pharmacokinetics and pharmacodynamics · 2024
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  9. Should patients skip late doses of medication? A pharmacokinetic perspective.Journal of pharmacokinetics and pharmacodynamics · 2022
    Article
  10. A pharmacokinetic and pharmacodynamic analysis of drug forgiveness.Journal of pharmacokinetics and pharmacodynamics · 2022
    Article
  11. What should patients do if they miss a dose of medication? A theoretical approach.Journal of pharmacokinetics and pharmacodynamics · 2021
    Article
  12. Consideration of Long-Acting Injectable Antipsychotics for Polypharmacy Regimen in the Treatment of Schizophrenia: Put It on the Table or Not?Clinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology · 2021
    Review
  13. Review
  14. Review
  15. How to Handle Delayed or Missed Doses: A Population Pharmacokinetic Perspective.European journal of drug metabolism and pharmacokinetics · 2020
    Review
  16. Article
  17. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors at 3 institutions in 2 countries.

Marjie L HardAlkermes, Inc., 852 Winter Street, Waltham, MA, 02451, USA.
Angela Y WehrAlkermes, Inc., 852 Winter Street, Waltham, MA, 02451, USA.
Brian M SadlerICON, Gaithersburg, MD, USA.
Richard J MillsICON, Marlow, UK.
Lisa von MoltkeAlkermes, Inc., 852 Winter Street, Waltham, MA, 02451, USA. Lisa.vonMoltke@alkermes.com.
Alkermes (United States) · USIcon (United Kingdom) · GBIcon (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesAripiprazole lauroxil (AL), a long-acting injectable antipsychotic for the treatment of schizophrenia, requires 21 days of oral aripiprazole supplementation upon initiation (21-day initiation regimen). An alternative 1-day initiation regimen utilizing a nano-crystalline milled dispersion of AL (AL

methodsIn total, 12,768 plasma aripiprazole concentrations from 343 patients (from 4 clinical studies) were included in the PopPK analysis and used to construct the model.

resultsConcomitant administration of the 1-day initiation regimen with all approved AL dosing regimens (441, 662, or 882 mg monthly, 882 mg every 6 weeks, or 1064 mg every 2 months) is predicted to achieve aripiprazole concentrations associated with therapeutic doses of AL using the 21-day initiation regimen within 4 days, maintaining these concentrations until the next AL dose. Administration of the first AL injection 10 days after the 1-day initiation regimen resulted in median aripiprazole concentrations just before the second dose of AL ≥ 77% of that when coadministered on the same day. Coadministration of AL with a single AL

conclusionsModel-based simulations demonstrate that the 1-day initiation regimen is suitable for starting treatment with all AL doses, allowing a window of ≤ 10 days between initiation and AL administration. AL

Indexed as

Computer SimulationModels, BiologicalAdministration, OralAntipsychotic AgentsAripiprazoleDelayed-Action PreparationsDrug Administration ScheduleHumansInjections, IntramuscularNanoparticlesAntipsychotic AgentsAripiprazolearipiprazole lauroxilDelayed-Action Preparations

Identifiers

PMID29943125
PMCPMC6060990
OpenAlexW2808426025

What OpenQuestion holds

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LicenceCC BY-NC
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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.