Pharmacopsychiatry 2017; 50(04): 145-151
DOI: 10.1055/s-0037-1601396
Original Article
© Georg Thieme Verlag KG Stuttgart · New York

Paliperidone Long-Acting Plasma Level Monitoring and a New Method of Evaluation of Clinical Stability

Massimo Carlo Mauri
1   Department of Neuroscience and Mental Health, Clinical Psychiatry, Clinical Psychopharmacology Unit, Fondazione IRCCS Ca’ Granda, Ospedale Maggiore Policlinico, Milan, Italy
,
Silvia Paletta
1   Department of Neuroscience and Mental Health, Clinical Psychiatry, Clinical Psychopharmacology Unit, Fondazione IRCCS Ca’ Granda, Ospedale Maggiore Policlinico, Milan, Italy
,
Chiara Di Pace
1   Department of Neuroscience and Mental Health, Clinical Psychiatry, Clinical Psychopharmacology Unit, Fondazione IRCCS Ca’ Granda, Ospedale Maggiore Policlinico, Milan, Italy
,
Alessandra Reggiori
1   Department of Neuroscience and Mental Health, Clinical Psychiatry, Clinical Psychopharmacology Unit, Fondazione IRCCS Ca’ Granda, Ospedale Maggiore Policlinico, Milan, Italy
,
Chiara Rovera
1   Department of Neuroscience and Mental Health, Clinical Psychiatry, Clinical Psychopharmacology Unit, Fondazione IRCCS Ca’ Granda, Ospedale Maggiore Policlinico, Milan, Italy
,
Alessio Fiorentini
1   Department of Neuroscience and Mental Health, Clinical Psychiatry, Clinical Psychopharmacology Unit, Fondazione IRCCS Ca’ Granda, Ospedale Maggiore Policlinico, Milan, Italy
,
Carlo Alfredo Altamura
1   Department of Neuroscience and Mental Health, Clinical Psychiatry, Clinical Psychopharmacology Unit, Fondazione IRCCS Ca’ Granda, Ospedale Maggiore Policlinico, Milan, Italy
› Author Affiliations
Further Information

Publication History

received 30 June 2016
revised 27 September 2016

accepted 13 October 2016

Publication Date:
09 March 2017 (online)

Abstract

Introduction

The second generation long-acting antipsychotics can be a pharmacologic strategy, both in the early phase of illness and in the case of low compliance. The aim of the study was to evaluate the clinical efficacy and tolerability of one monthly injection of paliperidone palmitate (PP1M), paliperidone plasma levels (PLs), and the clinical outcome.

Methods

21 outpatients, affected by Schizophrenia or Schizoaffective Disorder, were recruited. PP1M started with 150 mg on day 1 and 100 mg on day 8. Following patients were given a dosage ranging from 50 mg to 150 mg every 28 days. At baseline, and then monthly, patients were clinically evaluated.

Results

BPRS and PANSS total score showed a statistically significant decrease from T2 (after 2 months) to T12 (after 12 months). The PLs steady-state was approximatively reached after the fifth injection (T4).

Conclusions

All the patients showed a clinical stabilization: BPRS and PANSS scores showed a significant improvement from T2. PLs data seems to suggest the initial possibility of an oral supplementation, although clinical evaluation demonstrated no relapse during the study.

 
  • References

  • 1 Zipursky RB, Reilly TJ, Murray RM. The myth of schizophrenia as a progressive brain disease. Schizophr Bull 2013; 39: 1363-1372
  • 2 Kane JM. Improving patient outcomes in schizophrenia: achieving remission, preventing relapse, and measuring success. J Clin Psychiatry 2013; 74: e18
  • 3 Ravenstijn P, Remmerie B, Savitz A. et al. Pharmacokinetics, safety, and tolerability of paliperidone palmitate 3-month formulation in patients with schizophrenia: A phase-1, single-dose, randomized, open-label study. J Clin Pharmacol 2015; DOI: 10.1002/jcph.597. [Epub ahead of print]
  • 4 Kishimoto T, Nitta M, Borenstein M. et al. Long-acting injectable versus oral antipsychotics in schizophrenia: a systematic review and meta-analysis of mirror image studies. J Clin Psychiatry 2013; 74: 957-965
  • 5 Leucht S, Tardy M, Komossa K. et al. Antipsychotic drugs versus placebo for relapse prevention in schizophrenia: a systematic review and metaanalysis. Lancet 2012; 379: 2063-2071
  • 6 Hargarter L, Cherubin P, Bergmans P. et al. Intramuscular long-acting paliperidone palmitate in acute patients with schizophrenia unsuccessfully treated with oral antipsychotics. Prog Neuropsychopharmacol Biol Psychiatry 2015; 58: 1-7
  • 7 González-Rodríguez A, Catalán R, Penadés R. et al. Profile of paliperidone palmitate once-monthly long-acting injectable in the management of schizophrenia: long-term safety, efficacy, and patient acceptability – a review. Patient Prefer Adherence 2015; 9: 695-706
  • 8 Samtani MN, Nuamah I, Gopal S. et al. Expansion of guidance for the day 8 initiation dose of paliperidone palmitate to avoid a missed dose. Neuropsychiatr Dis Treat 2013; 9: 721-730
  • 9 Alphs L, Bossie CA, Fu DJ. et al. Onset and persistence of efficacy by symptom domain with long-acting injectable paliperidone palmitate in patients with schizophrenia. Expert Opin Pharmacother 2014; 15: 1029-1042
  • 10 Gopal S, Vijapurkar U, Lim P. et al. A 52-week open-label study of the safety and tolerability of paliperidone palmitate in patients with schizophrenia. J Psychopharmacol 2011; 25: 685-697
  • 11 Carter NJ. Extended-release intramuscular paliperidone palmitate: a review of its use in the treatment of schizophrenia. Drugs 2012; 72: 1137-1160
  • 12 Nussbaum AM, Strou TS. Paliperidone palmitate for schizophrenia. Cochrane Database Syst Rev 2012; 6: CD008296
  • 13 Pandina GJ, Lindenmayer JP, Lull J. et al. A randomized, placebo-controlled study to assess the efficacy and safety of 3 doses of paliperidone palmitate in adults with acutely exacerbated schizophrenia. J Clin Psychopharmacol 2010; 30: 235-234
  • 14 Fleischhacker W, Gopal S, Lane R. et al. A randomized trial of paliperidone palmitate and risperidone long-acting injectable in schizophrenia. Int J Neuropsychopharmacol 2015; 107-118
  • 15 Hough D, Gopal S, Vijapurkar U. et al. Paliperidone palmitate maintenance treatment in delaying the time-to-relapse in patients with schizophrenia: a randomized, double-blind, placebo-controlled study. Schizophr Res 2010; 116: 107-117
  • 16 Kozma CM, Slaton T, Dirani R. et al. Changes in schizophrenia-related hospitalization and ER use among patients receiving paliperidone palmitate: results from a clinical trial with a 52-week open-label extension (OLE). Curr Med Res Opin 2011; 27: 1603-1611
  • 17 Hasan A, Falkai P, Wobrock T. et al. Paliperidone palmitate maintenance treatment in delaying the time-to-relapse injectable antipsychotic, in schizophrenia. Neuropsychopharmacology 2013; 35: 2072-2082
  • 18 Boyer L, Millier A, Perthame E. et al. Quality of life is predictive of relapse in schizophrenia. BMC Psychiatry 2013; 13: 15
  • 19 Naber D, Hansen K, Forray C. et al. Qualify: a randomized head-to-head study of aripiprazole once-monthly and paliperidone palmitate in the treatment of schizophrenia. Schizophr Res 2015; 168: 498-504
  • 20 Lindenmayer JP. Long-acting injectable antipsychotics: focus on olanzapine palmoate. Neuropsychiatr Dis Treat 2010; 6: 261-267
  • 21 Lieberman JA, Stroup TS, McEvoy JP. et al. Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. N Engl J Med 2005; 353: 1209-1223
  • 22 Mauri MC, Maffini M, Di Pace C. et al. “Long-acting” olanzapine in maintenance therapy of schizophrenia: A study with plasma levels. Int J Psychiatry Clin Pract 2015; 19: 99-105
  • 23 Sliwa JK, Bossie CA, Fu DJ et al. Onset of efficacy on specific symptoms domains with long-acting injectionable palperidone palmitate in subjects with schizophrenia. Poster presented at 14th International Congress on Schizophrenia Research 2013 Orlando, FL
  • 24 Nasrallah HA, Gopal S, Gassmann-Mayer C. et al. Paliperidone palmitate for schizophrenia. Cochrane Database Syst Rev 2012; 6: CD008296
  • 25 Kramer M, Litman R, Hough D. et al. Paliperidone palmitate, a potential long-acting treatment for patients with schizophrenia. Results of a randomized, double-blind, placebo-controlled efficacy and safety study. Int J Neuropsychopharmacol 2010; 13: 635-647
  • 26 Hough D, Lindenmayer JP, Gopal S. et al. Safety and tolerability of deltoid and gluteal injections of paliperidone palmitate in schizophrenia. Prog Neuropsychopharmacol Biol Psychiatry 2009; 33: 1022-1031
  • 27 Bossie CA, Sliwa JK, Ma YW. et al. Onset of efficacy and tolerability following the initiation dosing of longacting paliperidone palmitate: post-hoc analyses of a randomized, double-blind clinical trial. BMC Psychiatry 2011; 11: 79
  • 28 Di Pace C, Paletta S, Reggiori A. et al. Paliperidone “long-acting” and plasma levels along 1 year of maintenance therapy in schizophrenia and schizoaffective disorder. Poster presented at Eur Neuropsychopharmacol 2015; 25: 525
  • 29 Stieffenhofer V, Saglam H, Schmidtmann I. et al. Clozapine plasma level monitoring for prediction of rehospitalization schizophrenic outpatients. Pharmacopsychiatry 2011; 44: 55-59
  • 30 Taylor M, Ng KY. Should long-acting (depot) antipsychotics be used in early schizophrenia? A systematic review. Aust N Z J Psychiatry 2013; 42: 624-630
  • 31 Heres S, Lambert M, Vauth R. Treatment of early episode in patients with schizophrenia: the role of long acting antipsychotics. Eur Psychiatry 2014; 29: 1409-1413
  • 32 Schreiner A, Aaamsoo K, Altamura AC. et al. Paliperidone palmitate versus oral antipsychotics in recently diagnosed schizophrenia. Schizophr Res 2015; 69: 393-399