Efficacy, tolerability and safety of paliperidone extended-release in the treatment of schizophrenia and schizoaffective disorder;Efficacia, tollerabilità e sicurezza di paliperidone a rilascio prolungato nella terapia della schizofrenia e del disturbo schizoaffettivo

Rivista di Psichiatria

Volumn 47, Issue 1, 2012, Pages 5-20

  Bellantuono, Cesario ^a   Santone, Giovanni ^a  

^a OSPEDALI RIUNITI   (Italy)

Author keywords

Antipsychotic drugs; Paliperidone; Psychosocial functioning; Schizophrenia

Indexed keywords

PALIPERIDONE; PROLACTIN;

COMORBIDITY; DRUG SAFETY; DRUG TOLERABILITY; EXTRAPYRAMIDAL SYMPTOM; HUMAN; LONG TERM CARE; MEDLINE; PROLACTIN BLOOD LEVEL; REVIEW; SCHIZOAFFECTIVE PSYCHOSIS; SCHIZOPHRENIA; THERAPY EFFECT;

ANTIPSYCHOTIC AGENTS; HUMANS; ISOXAZOLES; PSYCHOTIC DISORDERS; PYRIMIDINES; SCHIZOPHRENIA; TREATMENT OUTCOME;

EID: 84857706849     PISSN: 00356484     EISSN: None     Source Type: Journal    
DOI: 10.1708/1034.11287     Document Type: Review

References (78)

1. National Institute for Health and Clinical Excellence. Core interventions in the treatment and management of schizophrenia in primary and secondary care. Londra: National Institute for Health and Clinical Excellence, 2009.
2. Bellantuono C, Imperadore G, Balestrieri M. Gli antipsicotici: profilo farmacologico-clinico. In: Bellantuono C, Balestrieri M (eds). Trattato di Psicofarmacologia Clinica. Roma: Il Pensiero Scientifico Editore, 2003.
3. Nelson JC, Papakostas GI. Atypical antipsychotic augmentation in major depressive disorder: a meta-analysis of placebo-controlled randomized trials. Am J Psychiatry 2009; 166: 980-91.
4. Jäger M, Becker T, Weinmann S, Frasch K. Treatment of schizoaf fective disorder. A challenge for evidence-based psychiatry. Acta Psychiatr Scand 2010; 121: 22-32.
5. Tarr GP, Glue P, Herbison P. Comparative efficacy and acceptability of mood stabilizers and second generation antipsychotic monotherapy for acute mania. A systematic review and meta-analysis. J Affect Disord 2010; doi:10.1016/j.jad.2010.11.009.
6. 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: 117-30. (Pubitemid 46817944)
7. 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: 147-61. (Pubitemid 46178537)
8. Marder SR, Kramer M, Ford L, et al. Efficacy and safety of paliperidone extended-release tablets: results of a 6-week, randomized, placebo-controlled study. Biol Psychiatry 2007; 62: 1363-70. (Pubitemid 350180724)
9. Canuso CM, Dirks B, Carothers J, et al. Randomized, doubleblind, placebo-controlled study of paliperidone extended-release and quetiapine in inpatients with recently exacerbated schizophrenia. Am J Psychiatry 2009; 166: 691-701.
10. Schreiner A, Korcsog P, Niehaus DJH, et al. A prospective randomized controlled trial of paliperidone ER versus oral olanzapine in patients with schizophrenia. Schizophr Res 2010; 117: 384.
11. Morosini PL, Magliano L, Brambilla L, Ugolini S, Pioli R.Development, reliability and acceptability of a new version of the DSM-IV Social and Occupational Functioning Assessment Scale (SOFAS) to assess routine social functioning. Acta Psychiatr Scand 2000; 101: 323-9. (Pubitemid 30173584)
12. Levine SZ, Rabinowitz J, Engel R, Etschel E, Leucht S.Extrapolation between measures of symptom severity and change: an examination of the PANSS and CGI. Schizophr Res 2008; 98: 318-22. (Pubitemid 350235891)
13. Leucht S, Kane JM, Kissling W, Hamann J, Etschel E, Engel RR. What does the PANSS mean? Schizophr Res 2005; 79: 231-8. (Pubitemid 41457263)
14. Marder SR, Davis JM, 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: 538-46. (Pubitemid 28100274)
15. Meltzer HY, Bobo WM, Nuamah IF, 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 study. J Clin Psychiatry 2008; 69: 817-29. (Pubitemid 351838691)
16. Glick ID, Bossie CA, Alphs L, Canuso CM. Onset and persistence of antipsychotic response in patients with schizophrenia. J Clin Psychopharmacol 2009; 29: 542-7.
17. Ortega I, Perez-Ruixo JJ, Stuykens K, Piotrovsky V, Vermeulen A.Modelling the effectiveness of paliperidone ER and olanzapine in schizophrenia: meta-analysis of 3 randomized, controlled clinical trials. J Clin Psychopharmacol 2010; 50: 293-310.
18. Schreiner A, Dilbaz N, Kotler M, et al. Paliperidone ER in nonacute patients with schizophrenia previously unsuccessfully treated with oral olanzapine. Schizophr Res 2010; 117: 498.
19. Schreiner A, Hoeben D, Lahaye M, et al.A flexible-dose study of paliperidone ER in non-acute patients with schizophrenia previously unsuccessfully treated with other oral antipsychotics. Schizophr Res 2010; 117: 267-8.
20. Schreiner A, Hoeben D, Lahaye M, et al.A flexible-dose study of paliperidone ER in non-acute patients with schizophrenia previously unsuccessfully treated with aripiprazole. Schizophr Res 2010; 117: 499.
21. Schooler N, Gharabawi G, Bossie C, Canuso C, Turkoz I, Lindenmayer JP.A "virtual" comparison of paliperidone ER and risperidone IR in patients with schizophrenia. Schizophr Bull 2007; 33: 459.
22. Turkoz I, Bossie CA, Lindenmayer JP, Schooler N, Canuso CM. Paliperidone ER and oral risperidone in patients with schizophrenia: a comparative database analysis. BMC Psychiatry 2011; 11: 21.
23. Canuso CM, Youssef EA, Bossie CA, Turkoz I, Schreiner A, Simpson GM. Paliperidone extended-release tablets in schizophrenia patients previously treated with risperidone. Int Clin Psychopharmacol 2008; 23: 209-15.
24. Schreiner A, Hoeben D, Lahaye M, et al.A flexible-dose study of paliperidone ER in non-acute patients previously unsuccessfully treated with oral risperidone. Schizophr Res 2010; 117: 384.
25. Canuso CM, 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: 155-64.
26. Canuso CM, Bossie CA, Turkoz I, Alphs L. Paliperidone extended-release for schizophrenia: effects on symptoms and functioning in acutely ill patients with negative symptoms. Schizophr Res 2009; 113: 56-64.
27. Turkoz I, Bossie CA, Dirks B, Canuso CM. Direct and indirect effects of paliperidone extended-release on negative symptoms of schizophrenia. Neuropsychiatr Dis Treat 2008; 4: 949-58.
28. Canuso CM, Turkoz I, Sheehan JJ, Bossie CA.Efficacy and safety of paliperidone extended-release in schizophrenia patients with prominent affective symptoms. J Affect Disord 2010; 120: 193-9.
29. Tzimos A, Samokhvalov V, Kramer M, et al. Safety and tolerability of oral paliperidone extended-release tablets in elderly patients with schizophrenia: a double-blind, placebo-controlled study with six-month open-label extension. Am J Geriatr Psychiatry 2008; 16: 31-43.
30. Emsley R, Berwaerts J, Eerdekens M, et al.Efficacy and safety of paliperidone extended-release in the treatment of acute schizophrenia: pooled data from three 52-week open-label studies. Int Clin Psychopharmacol 2008; 23: 343-56.
31. Canuso CM, Bossie CA, Amatniek J, Turkoz I, Pandina G, Cornblatt B. Paliperidone extended-release tablets in patients with recently diagnosed schizophrenia. Early Interv Psychiatry 2010; 4: 64-78.
32. Janicak PG, Wu JH, Mao L. Hospitalization rates before and after initiation of paliperidone ER in patients with schizophrenia: results from open-label extensions of the US double-blind studies. Curr Med Res Opin 2008; 24: 1807-15. (Pubitemid 351929078)
33. Kramer M, Simpson G, Macilius V, et al. Paliperidone extended-release tablets for prevention of symptom recurrence in patients with schizophrenia. J Clin Psychopharmacol 2007; 27: 6-14.
34. Kramer M, Simpson G, Maciulis V, et al.One-year open-label safety and efficacy study of paliperidone extended-release tablets in patients with schizophrenia. CNS Spectrums 2010; 15: 506-14.
35. Patrick DL, Burns T, Morosini P, Gagnon DD, Rothman M, Adriaenssen I. Measuring social functioning with the Personal and Social Performance scale in patients with acute symptoms of schizophrenia: interpretation of results of a pooled analysis of three phase III trials of paliperidone extended-release tablets. Clin Ther 2010; 32: 275-92.
36. Kozma CM, Dirani RG, Canuso CM, Mao L. Predicting hospital admission and discharge with symptom or function scores in patients with schizophrenia: pooled analysis of a clinical trial extension. Ann Gen Psychiatry 2010; 9: 24.
37. Schreiner A, Hoeben D, Lahaye M, et al. Patient functioning with flexible doses of paliperidone ER.A 6-month prospective study. Schizophr Res 2010; 117: 268.
38. Hough D, Nuamah IF, Lim P, Sampson A, Gagnon DD, Rothman M. Independent effect of paliperidone extended release on social functioning beyond its effect on positive and negative symptoms of schizophrenia. A mediation analysis. J Clin Psychopharmacol 2009; 29: 496-7.
39. Kozma C, Dirani R, Canuso C, Mao L. Change in employment status over 52 weeks in patients with schizophrenia: an observational study. Curr Med Res Opin 2010; 27: 327-33.
40. Canuso CM, Lindenmayer JP, 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: 587-98.
41. Canuso CM, Schooler N, Carothers J, et al. Paliperidone extended-release in schizoaffective disorder. J Clin Psychopharmacol 2010; 30: 487-95.
42. Canuso CM, Turkoz I, Jing Fu D, Bossie CA. Role of paliperidone extended-release in treatment of schizoaffective disorder. Neuropsychiatr Dis Treat 2010; 6: 667-79.
43. thAnnual New Clinical Drug Evaluation Unit Meeting. Hollywood, FL, USA, 29 giugno-2 luglio 2009.
44. Harrington C, English C. Tolerability of paliperidone: a meta-analysis of randomized, controlled trials. Int Clin Psychopharmacol 2010; 25: 334-41.
45. Hough DW, Natarajan J, Vandebosch A, Rossenu S, Kramer M, Eerdekens M. Evaluation of the effect of paliperidone extended release and quetiapine on corrected QT intervals: a randomized, double-blind, placebo-controlled study. Int Clin Psychopharmacol 2011; 26: 25-34.
46. Pani L, Marchese G. Expected clinical benefits of paliperidone extended-release formulation when compared with risperidone immediate-release. Expert Opin Drug Deliv 2009; 6: 319-31.
47. Luthringer R, Staner L, Noel N, et al. A double-blind, placebo-controlled, randomized study evaluating the effect of paliperidone extended-release tablets on sleep architecture in patients with schizophrenia. Int Clin Psychopharmacol 2007; 22: 299-308. (Pubitemid 47237549)
48. Nussbaum AM, Stroup TS. Oral paliperidone for schizophrenia. Cochrane Database of Systematic Reviews 2008, Issue 2. Art. No.: CD006369. DOI: 10.1002/14651858.CD006369.pub2.
49. Agid O, Kapur S, Arenovich T, Zipursky RB. Delayed-onset hypothesis of antipsychotic action. A hypothesis tested and rejected. Arch Gen Psychiatry 2003; 60: 1228-35. (Pubitemid 37494076)
50. Leucht S, Busch R, Hamann J, Kissling W, Kane JM. Early-onset hypothesis of antipsychotic drug action. A hypothesis tested, confirmed and extended. Biol Psychiatry 2005; 57: 1543-9. (Pubitemid 40805384)
51. Kinon BJ, Ascher-Svanum H, Adams DH, Chen L.The temporal relationship between symptom change and treatment discontinuation in a pooled analysis of 4 schizophrenia trials. J Clin Psychopharmacol 2008; 28: 544-9.
52. Derks EM, Fleischhacker WW, Boter H, Peuskens J, Kahn RS for the EUFEST Study Group.Antipsychotic drug treatment in first-episode psychosis. J Clin Psychiatry 2010; 30: 176-80.
53. Emsley R, Rabinowitz J, Medori R.Time course for antipsychotic treatment response in first-episode schizophrenia. Am J Psychiatry 2006; 163: 743-5. (Pubitemid 44464590)
54. Murphy BP, Chung YC, Park TW, McGorry PD. Pharmacological treatment of primary negative symptoms in schizophrenia: a systematic review. Schizophr Res 2006; 88: 5-25. (Pubitemid 44693240)
55. Buckley PF, Stahl SM. Pharmacological treatment of negative symptoms of schizophrenia: therapeutic opportunity or cul-desac? Acta Psychiatr Scand 2007; 115: 93-100. (Pubitemid 46114869)
56. Hor K, Taylor M.Suicide and schizophrenia: a systematic review of rates and risk factors. J Psychopharmacol 2010; 24 (suppl. 4): 81-90.
57. Stahl SM, Buckley PF. Negative symptoms of schizophrenia: a problem that will not go away.Acta Psychiatr Scand 2007; 115: 4-11. (Pubitemid 44973546)
58. International Early Psychosis Association Writing Group. International clinical practice guidelines for early psychosis. Br J Psychiatry 2005; 187 (suppl. 48): 120-4.
59. Crossley NA, Constante M, McGuire P, Power P.Efficacy of atypical antipsychotics in the treatment of early psychosis: meta-analysis. Br J Psychiatry 2010; 196: 434-9.
60. Uchida H, Mamo DC, Mulsant BH, Pollock BG, Kapur S. Increased antipsychotic sensitivity in elderly patients: evidence and mechanisms. J Clin Psychiatry 2009; 70: 397-405.
61. Madhusoodanan S, Zaveri D. Paliperidone use in the elderly. Curr Drug Saf 2010; 5: 149-52.
62. Birnbaum M, Sharif Z. Medication adherence in schizophrenia: patient perspectives and the clinical utility of paliperidone ER. Patient Prefer Adherence 2008; 2: 233-40.
63. Suzuki T, Uchida H, Watanabe K, et al. How effective is it to sequentially switch among olanzapine, quetiapine and risperidone? A randomized, open-label study of algorithm-based antipsychotic treatment to patients with symptomatic schizophrenia in the real-world clinical setting. Psychopharmacol 2007; 195: 285-95. (Pubitemid 350045835)
64. Juckel G, Morosini PL. The new approach: psychosocial functioning as a necessary outcome criterion for therapeutic success in schizophrenia. Curr Opin Psychiatry 2008; 21: 630-9.
65. Schaub D, Brüne M, Jaspen E, Pajonk FG, Bierhoff HW, Juckel G. The illness and everyday living: close interplay of psychopathological syndromes and psychosocial functioning in chronic schizophrenia. Eur Arch Psychiatry Clin Neurosci 2011; 261: 85-93.
66. Burns T, Patrick D. Social functioning as an outcome measure in schizophrenia studies. Acta Psychiatr Scand 2007; 116: 403-18. (Pubitemid 350086150)
67. Kawata AK, Revicki DA. Psychometric properties of the Personal and Social Performance scale (PSP) among individuals with schizophrenia living in the community. Qual Life Res 2008; 17: 1247-56.
68. Vieta E. Developing an individualized treatment plan for patients with schizoaffective disorder: from pharmacotherapy to psychoeducation. J Clin Psychiatry 2010; 71 (suppl. 2): 14-9.
69. Conley R, Gupta SK, Sathyan G. Clinical spectrum of the osmotic-controlled release oral delivery system (OROS), an advanced oral delivery form. Curr Med Res Opin 2006; 22: 1879-92. (Pubitemid 44663390)
70. Spina E, Cavallaro R. The pharmacology and safety of paliperidone extended-release in the treatment of schizophrenia. Expert Opin Drug Saf 2007; 6: 651-66.
71. Vermeir M, Naessens I, Remmerie B, et al. Absorption, metabolism and excretion of paliperidone, a new monoaminergic antagonist, in humans. Drug Metab Dispos 2008; 36: 769-79. (Pubitemid 351468385)
72. Berwaerts J, Cleton A, Herben V, et al. The effects of paroxetine on the pharmacokinetics of paliperidone extended-release tablets. Pharmacopsychiatry 2009; 42: 158-63.
73. Invega. Riassunto delle Caratteristiche del Prodotto. Revisione dicembre 2010.
74. Janicak PG, Winans EA. Paliperidone ER: a review of the clinical trial data. Neuropsychiatr Dis Treat 2007; 3: 869-83.
75. Stöllberger CX, Huber JO, Finsterer J. Antipsychotic drugs and QT prolongation. Int Clin Psychopharmacol 2005; 20: 243-51. (Pubitemid 41192144)
76. Rummel-Kluge C, Komossa K, Schwarz S, et al. Head-to-head comparison of metabolic side effects of second generation antipsychotics in the treatment of schizophrenia: a systematic review and meta-analysis. Schizophr Res 2010; 123: 225-33.
77. De Hert M, Dekker JM, Wood D, Kahl KG, Holt RIG, Möller HJ. Cardiovascular disease and diabetes in people with severe mental illness position statement from the European Psychiatric Association (EPA), supported by the European Association for the Study of Diabetes (EASD) and the European Society of Cardiology (ESC). Eur Psychiatry 2009; 24: 412-24.
78. Berwaerts J, Cleton A, Rossenu S, et al. A comparison of serum prolactin concentrations after administration of paliperidone extended-release and risperidone tablets in patients with schizophrenia. J Psychopharmacol 2009; 24: 1011-8.