Paliperidone extended-release: Does it have a place in antipsychotic therapy?

Drug Design, Development and Therapy

Volumn , Issue 5, 2011, Pages 125-146

  Gahr, Maximilian ^a   Kölle, Markus A ^a   Schönfeldt Lecuona, Carlos ^a   Lepping, Peter ^b   Freudenmann, Roland W ^a  

^a UNIVERSITY OF ULM   (Germany)

^b GLYNDWR UNIVERSITY   (United Kingdom)

Author keywords

Antipsychotic treatment; Bipolar disorder; Extended release; Paliperidone; Psychopharmacology; Schizophrenia; Second generation antipsychotics

Indexed keywords

AMISULPRIDE; CLOZAPINE; HALOPERIDOL; OLANZAPINE; PALIPERIDONE; PLACEBO; QUETIAPINE; RISPERIDONE; 9 HYDROXY RISPERIDONE; 9-HYDROXY-RISPERIDONE; ISOXAZOLE DERIVATIVE; NEUROLEPTIC AGENT; PYRIMIDINE DERIVATIVE;

ACUTE CORONARY SYNDROME; ADD ON THERAPY; AGITATION; AKATHISIA; AMENORRHEA; ASTHENIA; BIPOLAR DISORDER; BIPOLAR I DISORDER; CARDIOVASCULAR DISEASE; COGNITIVE DEFECT; CONSTIPATION; COST EFFECTIVENESS ANALYSIS; DEPRESSION; DIZZINESS; DOSE RESPONSE; DRUG ABUSE; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG COST; DRUG DEPENDENCE; DRUG DOSAGE FORM COMPARISON; DRUG DOSE ESCALATION; DRUG DOSE INCREASE; DRUG DOSE SEQUENCE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG EXCRETION; DRUG HALF LIFE; DRUG MECHANISM; DRUG POTENCY; DRUG RECEPTOR BINDING; DRUG RELEASE; DRUG SAFETY; DRUG SUBSTITUTION; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSKINESIA; DYSPEPSIA; DYSTONIA; ENDOCRINE DISEASE; EXTENDED DRUG RELEASE; EXTRAPYRAMIDAL SYNDROME; FATIGUE; FOOD; FOOD DRUG INTERACTION; GALACTORRHEA; GASTROINTESTINAL DISEASE; GLUCOSE METABOLISM; GYNECOMASTIA; HEADACHE; HEART ARRHYTHMIA; HEART DISEASE; HEPATITIS; HUMAN; HYPERPROLACTINEMIA; HYPERTENSION; HYPOTENSION; INFECTION; INFESTATION; INSOMNIA; LIVER DISEASE; MANIA; MENSTRUATION DISORDER; METABOLIC DISORDER; MIXED MANIA AND DEPRESSION; MOOD DISORDER; NAUSEA AND VOMITING; NEGATIVE SYNDROME; NEUROLEPTIC MALIGNANT SYNDROME; NEUROLOGIC DISEASE; NONHUMAN; ORTHOSTATIC INTOLERANCE; PARANOID SCHIZOPHRENIA; PARKINSONISM; PATIENT SATISFACTION; PNEUMONIA; POST HOC ANALYSIS; PROLACTIN BLOOD LEVEL; PSYCHOSIS; QT PROLONGATION; QUALITY OF LIFE; RECOMMENDED DRUG DOSE; RECURRENT DISEASE; REVIEW; RHINOPHARYNGITIS; SCHIZOAFFECTIVE PSYCHOSIS; SCHIZOPHRENIA; SEDATION; SEXUAL DYSFUNCTION; SIDE EFFECT; SINGLE DRUG DOSE; SINUS TACHYCARDIA; SOMNOLENCE; SUICIDAL IDEATION; SUICIDE ATTEMPT; SYNCOPE; T WAVE INVERSION; TACHYCARDIA; TARDIVE DYSKINESIA; TREMOR; VASCULAR DISEASE; WEIGHT GAIN; ANIMAL; CLINICAL TRIAL (TOPIC); DELAYED RELEASE FORMULATION;

ANIMALS; ANTIPSYCHOTIC AGENTS; BIPOLAR DISORDER; CLINICAL TRIALS AS TOPIC; DELAYED-ACTION PREPARATIONS; HUMANS; ISOXAZOLES; PYRIMIDINES; SCHIZOPHRENIA;

EID: 79952957564     PISSN: 11778881     EISSN: None     Source Type: Journal    
DOI: 10.2147/DDDT.S17266     Document Type: Review

References (86)

1. Citrome L. Paliperidone: Quo vadis? Int J Clin Pract. 2007;61: 653-662.
2. Nussbaum AM, Stroup TS. Oral paliperidone for schizophrenia. Cochrane Database Syst Rev. 2008;2:CD006369.
3. Dolder C, Nelson M, Deyo Z. Paliperidone for schizophrenia. Am J Health Syst Pharm. 2008;65:403-413.
4. Jones M, Nicholl D, Trakas K. Efficacy and tolerability of paliperidone ER and other oral atypical antipschotics in schizophrenia. Int J Clin Pharmacol Ther. 2010;48:383-399.
5. Birnbaum M, Sharif Z. Medication adherence in schizophrenia: Patient perspectives and the clinical utility of paliperidone ER. Patient Prefer Adherence. 2008;2:233-240.
6. Spina E, Cavallaro R. The pharmacology and safety of paliperidone extended-release in the treatment of schizophrenia. Expert Opin Drug Saf. 2007;6:651-662.
7. Dlugosz H, Nasrallah A. Paliperidone: A new extended-release oral atypical antipsychotic. Expert Opin Pharmacother. 2007;8: 2307-2313.
8. Fowler J, Bettinger T, Argo T. Paliperidone extended-release tabletes for the acute and maintenance treatment of schizophrenia. Clin Ther. 2008;30:231-248.
9. Janicak P, Winans E. Paliperidone ER: A review of the clinical trial data. Neuropsychiatr Dis Treat. 2007;3:869-883.
10. Yang L, Plosker G. Paliperidone extended release. CNS Drugs. 2007;21:417-425.
11. The World Health Report 2001. Mental Health: New Understanding, New Hope. Geneva: World Health Organization; 2001.
12. Lepping P, Delieu J, Mellor R, et al. Antipsychotic medication and oxidative cell stress: A systematic review. J Clin Psychiatry. June 29, 2010. [Epub ahead of print].
13. Swartz M, Stroup T, McEvoy J, et al. What CATIE found: Results from the schizophrenia trial. Psychiatr Serv. 2008;59:500-506.
14. Jones P, Barnes T, Davies L, et al. Randomized controlled trial of the effect on quality of life of second- vs first-generation antipsychotic drugs in schizophrenia: Cost Utility of the Latest Antipsychotic Drugs in Schizophrenia Study (CUTLASS 1). Arch Gen Psychiatry. 2006;63:1079-1087.
15. Leucht S, Corves C, Arbter D, et al. Second-generation versus firstgeneration antipsychotic drugs for schizophrenia: A meta-analysis. Lancet. 2009;373(9657):31-41.
16. Correll C, Schenk E. Tardive dyskinesia and new antipsychotics. Curr Opin Psychiatry. 2008;2:151-156.
17. Lepping P, Sambhi R, Whittington R, et al. A sytematic review of the clinical relevance of findings in trials of antipsychotics. Br J Psychiatry (in press). 2010.
18. Heres S, Reichhart T, Hamann J, et al. Psychiatrists' attitude to antipsychotic depot treatment in patients with first-episode schizophrenia. Eur Psychiatry. June 4, 2010. [Epub ahead of print].
19. Hamann J, Mendel R, Heres S, et al. How much more effective do depot antipsychotics have to be compared to oral antipsychotics before they are prescribed? Eur Neuropsychopharmacol. 2010;20: 276-279.
20. Tungaraza T, Gupta S, Jones J, et al. Polypharmacy and highdose antipsychotic regimes in the community. The Psychiatrist. 2010;34:44-46.
21. Lepping P, Harborne G. Polypharmacy: How bad are we really. The Psychiatrist. 2010;34:208-209.
22. Karlsson P, Dencker E, Nyberg S, et al. Pharmacokinetics and dopamine D2 and serotonin 5-HT2A receptor occupancy of paliperidone in healthy subjects: Two open-label, single-dose studies. Clin Pharmacol Ther. 2006;79:74.
23. Seeman P. An update of fast-off dopamine D2 atypical antipsychotics. Am J Psychiatry. 2005;162:1984-1985.
24. Arakawa R, Ito H, Takano A. Dose-finding study of paliperidone ER based on striatal and extrastriatal dopamine D2 receptor occupancy in patients with schizophrenia. Psychopharmacology (Berl). 2008;197:229-235.
25. Kapur S, Zipursky R, Jones C, Remington G, Houle S. Relationship between dopamine D(2) occupancy, clinical response, and side effects: A double-blind PET study of first-episode schizophrenia. Am J Psychiatry. 2000;157:514-520.
26. Ereshefsky L, Mascarenas C. Comparison of the effects of different routes of antipsychotic administration on pharmacokinetics and pharmacodynamics. J Clin Psychiatry. 2003;64(Suppl 16):18-23.
27. Conley R, Gupta S, Sathyan G. Clinical spectrum of the osmoticcontrolled release oral delivery system (OROS), an advanced oral delivery form. Curr Med Res Opin. 2006;22:1879-1892.
28. Boom S, Talluri K, Janssens L, et al. Single- and multiple-dose pharmacokinetics and dose proportionality of the psychotropic agent paliperidone extended release. J Clin Pharmacol. 2009;49:1318-1330.
29. Keith S. Advances in psychotropic formulations. Prog Neuro Psychopharmacol Biol Psychiatry. 2006;30:1879-1892.
30. Rossenu S, Cleton A, Talluri K. Evaluation of the pharmacokinetics of an extended-release formulation of paliperidone with an immediate-release formulation of risperidone. Clin Pharm Ther. 2007;81(Suppl 1):62.
31. Rossenu S, Cleton A, Rusch S, et al. Extended-release formulation of paliperidone shows dose-proportional pharmacokinetics. AAPS J. 2006;8(Suppl):3123.
32. Rossenu S, Crauwels H, Cleton A. Evaluation of the pharmacokinetics of several formulations of paliperidone. AAPS J. 2006;8(Suppl):1042.
33. European_Medicines_Agency. Invega (paliperidone prolonged-release tablets): Summary of product characteristics. Available at: http://www.emea.europa.eu/humandocs/Humans/EPAR/invega/invega.htm. Accessed February 5, 2011.
34. Ortho-McNeil-Janssen-Pharmaceuticals. Invega (paliperidone) extended-release tablets: US prescribing information. Titusville, NJ: Ortho-McNeil-Janssen-Pharmaceuticals; 2010.
35. Mannens G, Huang M, Meuldermans W, et al. Absorption, metabolism, and excretion of risperidone and its distribution in humans. Drug Metab Dispos. 1993;21:1134-1141.
36. Zhu H, Wang J, Markowitz J, et al. Risperidone and paliperidone inhibit P-glycoprotein activity in vitro. Neuropsychopharmacology. 2007;32:757-764.
37. Berwaerts J, Cleton A, Herben V. The effects of paroxetine on the pharmacokinetics of paliperidone extended-release tablets. Pharmacopsychiatry. 2009;42:158-163.
38. Vermeir M, Naessens I, Remmerie B, et al. Absorption, metabolism, an excretion of paliperidone, a new monoaminergic antagonist, in humans. Drug Metab Dispos. 2008;36:769-779.
39. Boom S, Thyssen A, Crauwels H, et al. The influence of hepatic impairment on the pharmacokinetics of paliperidone. Int J Clin Pharmacol Ther. 2009;47:606-616.
40. Thyssen A, Crauwels H, Cleton A. Effects on renal impairment on the pharmacokinetic profile of paliperidone extended-release. Clin Pharm Ther. 2007;81(Suppl):63.
41. Thyssen A, Cleton A, Talluri K, et al. No pharmacokinetic interaction between paliperidone extended-release tablets and trimethoprim in healthy subjects. Hum Psychopharmacol. 2009;24:532-539.
42. Rossenu S, Cleton A, Boom S, et al. Evaluation of the pharmacokinetics of paliperidone extended-release tablets in healthy elderly subjects. Clin Pharm Ther. 2007;81(Suppl):64.
43. European_Medicines_Agency. Invega (paliperidone prolonged-release tablets): Scientific discussion. Available at: http://www.emea.europa.eu/huandocs/PDFs/EPAR/invega/H-746-en6.pdf. Accessed February 5, 2011.
44. Davidson M, Emsley R, Kramer M, et al. Efficacy, safety and early response of paliperidone extended-release tablets (paliperidone ER): Results of a 6-week, randomized, placebo-controlled study. Schizophr Res. 2007;93:117-130.
45. Kane J, Canas F, Kramer M, et al. Treatment of schizophrenia with paliperidone extended-release tablets: A 6-week placebo-controlled trial. Schizophr Res. 2007;90:147-161.
46. Marder S, Kramer M, Ford L, et al. Efficacy and safety of paliperidone extended-release tablets: Results of a 6-week, randomized, placebocontrolled study. Biol Psychiatry. 2007;62:1363-1370.
47. Kay S, Fiszbein A, Opler L. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13: 261-276.
48. Marder S, Davis J, Chouinard G. The effects of risperidone on the five dimensions of schizophrenia derived by factor analysis: Combined results of the North American trials. J Clin Psychiatry. 1997;58:538-546.
49. Guy W. Clinical global impression. In: Guy W, editor. ECDEU Assessment Manual for Psychopharmacology. Rockville, MD: National Institute of Mental Health; 1976.
50. Morosini P, Magliano L, Brambilla L. Development, reliability and acceptability of a new version of the DSM-IV Social and Occupational Functioning Assesment Scale (SODAS) to assess routine social functioning. Acta Psychiatr Scand. 2000;101:323-329.
51. Patrick D, Burns T, Morosini P, et al. Reliability, validity and ability to detect change of the clinician-rated Personal and Social Performance scale in patients with acute symptoms of schizophrenia. Curr Med Res Opin. 2009;25:325-338.
52. Emsley R, Baerwaerts J, Eerdekens M, et al. Efficacy and safety of oral paliperidone extended-release tablets in the treatment of acute schizophrenia: Pooled data from three 52-week open-label studies. Int Clin Psychopharmacol. 2008;23:343-356.
53. Meltzer H, William V, Isaac F, et al. Efficacy and tolerability of oral paliperidone extended-release tablets in the treatment of acute schizophrenia: Pooled data from three 6-week, placebo-controlled studies. J Clin Psychiatry. 2008;69:817-829.
54. Canuso C, Bossie C, Amatniek J, et al. Paliperidone extended-release tablets in patients with recently diagnosed schizophrenia. Early Interv Psych. 2010;4:64-78.
55. Milev P, Ho BC, Arndt S, Andreasen NC. Predictive values of neurocognition and negative symptoms on functional outcome in schizophrenia: A longitudinal first-episode study with 7-year-follow-up. Am J Psychiatry. 2005;162:495-506.
56. Turkoz I, Bossie C, Dirks B, Canuso CM. Direct and indirect effects of paliperidone extended-release tablets on negative symptoms of schizophrenia. Neuropsychiatr Dis Treat. 2008;4:949-958.
57. Canuso C, Turkoz I, Sheehan J, et al. Efficacy and safety of paliperidone extended-release in schizophrenia patients with prominent affective symptoms. J Affect Disord. 2010;120:193-199.
58. Canuso C, Youssef E, Bossie C, et al. Paliperidone extended-release tablets in schizophrenia patients previously treated with risperidone. Int Clin Psychopharmacol. 2008;23:209-215.
59. Tzimos A, Samokhvalov V, Kramer M, et al. Safety and tolerability of oral paliperidone extended-release tablets in elderly patients with schizophrenia. Am J Geriatr Psychiatry. 2008;16:31-43.
60. Wilkinson G, Hesdon B, Wild D, et al. Self-report quality of life measure for people with schizophrenia: The SQLS. Br J Psychiatry. 2000;177:42-46.
61. Kramer M, Simpson G, Maciulis V, et al. Paliperidone extendedrelease tablets for prevention of symptom recurrence in patients with schizophrenia. J Clin Psychopharmacol. 2007;27:6-14.
62. Luthringer R, Staner L, Noel N, et al. A double-blind, placebo-controlled, randomized study evaluating the effect of paliperidone ER tablets on sleep architexture in patients with schizophrenia. Int Clin Psychopharmacol. 2007;22:299-308.
63. Parrott A, Hindmarch I. The Leeds Sleep Evaluation Questionnaire in psychopharmacological investigations: A review. Psychopharmacology (Berl). 1980;71:173-179.
64. Canuso C, Dirks B, Carothers J, et al. Randomized, double-blind, placebo-controlled study of paliperidone extended-release and quetiapine in inpatients with recently exacerbated schizophrenia. Am J Psychiatry. 2009;166:691-701.
65. Canuso C, Lindenmayer J, Kosik-Gonzalez C, et al. A randomized, double-blind, placebo-controlled study of 2 dose ranges of paliperidone extended-release in the treatment of subjects with schizoaffective disorder. J Clin Psychiatry. 2010;71:587-598.
66. Berwaerts J, Xu H, Nuamah I, et al. Evaluation of the efficacy and safety of paliperidone extended-release in the treatment of acute mania: A randomized, double-blind, dose-response study. J Affect Disord. July 10, 2010. [Epub ahead of print].
67. Young R, Biggs J, Ziegler V, et al. A rating scale for mania: Reliability, validity and sensitivity. Br J Psychiatry. 1978;133:429-435.
68. Vieta E, Nuamah I, Lim P, et al. A randomized, placebo- and activecontrolled study of paliperidone extended release for the treatment of acute manic and mixed episodes of bipolar I disorder. Bipolar Disord. 2010;12:230-243.
69. Spearing M, Post R, Leverich G, et al. Modification of the Clinical Global Impression (CGI) Scale for use in bipolar illness (BP). Psychiatry Res. 1997;73:159-171.
70. Dremencov E, El Mansari M, Blier P. Distinct electrophysiological effects of paliperidone and risperidone on the firing activity of rat serotonin and norepinephrine neurons. Psychopharmacology (Berl). 2007;194:63-72.
71. Corena-McLeod MP, Oliveros A, Charlesworth C, et al. Paliperidone as a mood stabilizer: A pre-frontal cortex synaptoneurosomal proteomics comparison with lithium and valproic acid after chronic treatment reveals similarities in protein expression. Brain Res. 2008;1233:8-19.
72. Sun F, Su Z, Sui C, et al. Studies on the acute toxicity, pharmacokinetics and pharmacodynamics of paliperidone derivatives - comparison to paliperidone and risperidone in mice and rats. Basic Clin Pharmacol Toxicol. 2010;107:656-662.
73. Knegtering R, Baselmans P, Kastelin C. Predominant role of the 9-hydroxy-metabolite of risperidone in elevating blood prolactin-levels. Am J Psychiatry. 2005;162:1010-1012.
74. Doggal H. Possible malignant neuroleptic syndrome associated with paliperidone. J Neuropsychiatry Clin Neurosci. 2007;19:477-478.
75. Mantas C, Kalabokis G, Goulia P, et al. Possible malignant neuroleptic syndrome during paliperidone administration. J Clin Psychopharmacol. 2010;30:89-91.
76. Hsieh C, Liou Y. Manic symptoms induced by paliperidone. J Clin Psychopharmacol. 2010;30:202-204.
77. Paulzen M, Orphanos S, Gründer G. Remission of drug induced hepatitis after switching from risperidone to paliperidone. Am J Psychiatry. 2010; 167:351-352.
78. Gray R, Rofail D, Allen J, et al. A survey of patient satisfaction with and subjective experiences of treatment with antipsychotic medication. J Adv Nurs. 2005;52:31-37.
79. Mohamed S, Rosenheck R, McEvoy J, et al. Cross-sectional and longitudinal relationships between insight and attitudes toward medication and clinical outcomes in chronic schizophrenia. Schizophr Bull. 2009;35:336-346.
80. Canuso C, Grinspan A, Kalali A, et al. Medication satisfaction in schizophrenia: A blinded-initiation study of paliperidone extended release in patients suboptimally responsive to risperidone. Int Clin Psychopharmacol. 2010;25:155-164.
81. Atkinson M, Sinha A, Hass S, et al. Validation of a general measure of treatment satisfaction, the treatment satisfaction questionnaire for medication (TSQM), using a national panel study of chronic diseases. Health Qual Life Outcomes. 2004;2:12.
82. Kalali A. Evaluating patient satisfaction: A practical approach. Clear Perspectives. 1999;2:18-21.
83. Sokal J, Messias E, Dickerson F, et al. Comorbidity of medical illness among adults with serious mental illness who are receiving community psychiatric services. J Nerv Ment Dis. 2004;192:421-427.
84. Geitona M, Kousoulakou H, Ollandezoss M, et al. Costs and effects of paliperidone extended release compared with alternative oral antipsychotic agents in patients with schizophrenia in Greece: A cost effectiveness study. Ann Gen Psychiatry. 2008;7:16.
85. Edwards N, Pesa J, Meletiche D. One-year clinical and economic consequences of oral typical antipsychotics in the treatment of schizophrenia. Curr Med Res Opin. 2008;24:3341-3355.
86. Berto P, Negrini C, Ferrannini L. Analisi costo-efficacia di paliperidone ER nel trattamento delle ricadute della schizofrenia, nella prospettiva del Sistema Sanitario Nazionale italiano. Farmeconomia e Percorsi Terapeutici. 2008;9:95-108.