A systematic review and combined analysis of therapeutic drug monitoring studies for long-acting paliperidone

Georgios Schoretsanitis, Edoardo Spina, Christoph Hiemke, Jose de Leon

Research output: Contribution to journalReview articlepeer-review

48 Scopus citations

Abstract

Introduction: This is a combined analysis of therapeutic drug monitoring (TDM) studies of long-acting injectable paliperidone formulations: monthly (PP1M) and three-month (PP3M) injections. Areas covered: Fourteen PP1M articles and one PP3M article were identified. Using the paliperidone concentration/dose (C/D) ratio as a measure of clearance provided a weighted mean of 7.7 ng/ml per mg/day among 69 patients from three steady-state PP1M studies (twice as high as oral paliperidone). C/D ratios were: 1) higher by a factor of 1.26 in 12 geriatric patients, 2) lower in obese patients, and 3) 50% lower in three patients taking carbamazepine. No clinically meaningful PP3M pharmacokinetic data have been published. Expert commentary: Half-life studies and more TDM PP1M studies using steady state are urgently needed. Early TDM studies may help orient PP1M dosing but steady state may not be reached until after the ninth injection (8 months). PP3M may take > 1 year to reach steady state. Any clinician considering switching patients to PP1M: 1) should switch from oral risperidone to PP1M rather than from oral paliperidone to PP1M, and 2) become proficient in paliperidone TDM to use during switches. TDM is highly recommended for patients with abnormal clearance (from obesity, geriatric age, or potent inducers).

Original languageEnglish
Pages (from-to)1237-1253
Number of pages17
JournalExpert Review of Clinical Pharmacology
Volume11
Issue number12
DOIs
StatePublished - Dec 2 2018

Bibliographical note

Publisher Copyright:
© 2018, © 2018 Informa UK Limited, trading as Taylor & Francis Group.

Keywords

  • Antipsychotic agents/administration & dosage
  • antipsychotic agents/pharmacology
  • delayed-action preparations
  • drug monitoring
  • injections
  • paliperidone palmitate
  • risperidone/administration & dosage
  • risperidone/blood
  • risperidone/metabolism
  • risperidone/pharmacokinetics
  • schizoaffective disorder/drug therapy
  • schizophrenia/drug therapy

ASJC Scopus subject areas

  • General Pharmacology, Toxicology and Pharmaceutics
  • Pharmacology (medical)

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