Paliperidone

A review of clinical trial data and clinical implications

Sheng Min Wang, Changsu Han, Soo Jung Lee, Ashwin A. Patkar, Chi Un Pae, W. Wolfgang Fleischhacker

Research output: Contribution to journalReview article

14 Citations (Scopus)

Abstract

Paliperidone, 9-hydroxy-risperidone, is the major metabolite of the atypical antipsychotic risperidone and is available in an oral extended-release (ER) formulation. Paliperidone ER was approved for treating schizophrenia in 2006, and in 2009 it became the first atypical antipsychotic licensed for treating schizoaffective disorder.The short-term efficacy, safety and tolerability of paliperidone ER for patients with schizophrenia were demonstrated in three pivotal 6-week, randomized, double-blind, placebo-controlled studies. Data from the long-term trial showed that paliperidone ER is also effective in preventing relapse of schizophrenia. Two randomized, placebo-controlled, short-term studies have documented the efficacy and tolerability of paliperidone ER in the treatment of schizoaffective disorder, but no long-term or maintenance study has been conducted in patients with schizoaffective disorder. Two 3-week, randomized, double-blind, placebo-controlled studies showed that paliperidone ER is significantly superior to placebo for treating patients with bipolar disorder, but the results were driven by certain subpopulations. Limited evidence suggests that paliperidone ER can potentially be superior to quetiapine and risperidone. However, few direct head-to-head comparisons between paliperidone ER and other antipsychotics have been conducted to confirm these results.The distinctive pharmacological characteristics of paliperidone ER, including smooth fluctuations in plasma drug concentrations, predominantly renal excretion, low risk of causing hepatic impairment and low drug-drug interaction, might provide important clinical advantages compared with risperidone. However, certain side effects require clinical attention. The rate of extrapyramidal side effects was considerably higher than that of a placebo at doses ≥9mgday. The risks for orthostatic hypotension, prolongation of the corrected QT interval and hyperprolactinaemia are also concerns.This review summarizes the currently published data on paliperidone ER for treating patients with schizophrenia, schizoaffective disorder and bipolar disorder, and suggests its appropriate use in clinical practice.

Original languageEnglish
Pages (from-to)497-512
Number of pages16
JournalClinical Drug Investigation
Volume32
Issue number8
DOIs
Publication statusPublished - 2012 Jul 12
Externally publishedYes

Fingerprint

Clinical Trials
Psychotic Disorders
Placebos
Risperidone
Schizophrenia
Antipsychotic Agents
Bipolar Disorder
Paliperidone Palmitate
Orthostatic Hypotension
Hyperprolactinemia
Drug Interactions
Pharmaceutical Preparations
Maintenance
Pharmacology
Safety
Recurrence
Liver

Keywords

  • Bipolar-disorders
  • Controlled-release-drugs
  • Paliperidone
  • Schizoaffective-disorder
  • Schizophrenia

ASJC Scopus subject areas

  • Pharmacology (medical)

Cite this

Wang, S. M., Han, C., Lee, S. J., Patkar, A. A., Pae, C. U., & Fleischhacker, W. W. (2012). Paliperidone: A review of clinical trial data and clinical implications. Clinical Drug Investigation, 32(8), 497-512. https://doi.org/10.2165/11634440

Paliperidone : A review of clinical trial data and clinical implications. / Wang, Sheng Min; Han, Changsu; Lee, Soo Jung; Patkar, Ashwin A.; Pae, Chi Un; Fleischhacker, W. Wolfgang.

In: Clinical Drug Investigation, Vol. 32, No. 8, 12.07.2012, p. 497-512.

Research output: Contribution to journalReview article

Wang, SM, Han, C, Lee, SJ, Patkar, AA, Pae, CU & Fleischhacker, WW 2012, 'Paliperidone: A review of clinical trial data and clinical implications', Clinical Drug Investigation, vol. 32, no. 8, pp. 497-512. https://doi.org/10.2165/11634440
Wang, Sheng Min ; Han, Changsu ; Lee, Soo Jung ; Patkar, Ashwin A. ; Pae, Chi Un ; Fleischhacker, W. Wolfgang. / Paliperidone : A review of clinical trial data and clinical implications. In: Clinical Drug Investigation. 2012 ; Vol. 32, No. 8. pp. 497-512.
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