Paliperidone palmitate - Review of the efficacy, safety and cost of a new second-generation depot antipsychotic medication

International Journal of Clinical Practice

Volumn 64, Issue 2, 2010, Pages 216-239

  Citrome, L ^a,b  

^a NEW YORK UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b NATHAN S KLINE INSTITUTE FOR PSYCHIATRIC RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALPHA 1 ADRENERGIC RECEPTOR; ALPHA 2 ADRENERGIC RECEPTOR; CARBAMAZEPINE; DOPAMINE 2 RECEPTOR; GENERIC DRUG; HISTAMINE H1 RECEPTOR; MICROSPHERE; PALIPERIDONE; PALMITIC ACID; RISPERIDONE; SEROTONIN RECEPTOR; VALPROATE SEMISODIUM;

ABDOMINAL DISCOMFORT; ABDOMINAL PAIN; AGITATION; AKATHISIA; ANTICHOLINERGIC EFFECT; ANXIETY; AUDITORY HALLUCINATION; BLOOD PRESSURE; CLINICAL TRIAL; COGNITIVE DEFECT; CONSTIPATION; DELTOID MUSCLE; DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL DISORDERS; DIZZINESS; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG COST; DRUG DELIVERY SYSTEM; DRUG DOSE COMPARISON; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG FORMULATION; DRUG HYDROLYSIS; DRUG INDUCED HEADACHE; DRUG INFORMATION; DRUG METABOLISM; DRUG SAFETY; DRUG SOLUBILITY; DRUG WITHDRAWAL; ERECTILE DYSFUNCTION; EXTRAPYRAMIDAL SYMPTOM; GASTROINTESTINAL SYMPTOM; GLUTEUS MAXIMUS MUSCLE; HUMAN; HYPOTENSION; INJECTION SITE INDURATION; INJECTION SITE PAIN; INJECTION SITE REACTION; INSOMNIA; INTERNET; MAINTENANCE DRUG DOSE; MAINTENANCE THERAPY; MYALGIA; NEGATIVE SYNDROME; ORTHOSTATIC HYPOTENSION; PAIN; PARKINSONISM; PATIENT COMPLIANCE; PRIORITY JOURNAL; PROLACTIN BLOOD LEVEL; PSYCHOSIS; PULSE RATE; RECEPTOR BINDING; RECURRENT DISEASE; REVIEW; SCHIZOPHRENIA; SEDATION; SIDE EFFECT; SINUS TACHYCARDIA; SOMNOLENCE; SYNCOPE; SYRINGE; TACHYCARDIA; URINARY TRACT INFECTION; VOMITING; WEIGHT GAIN; XEROSTOMIA;

ADMINISTRATION, ORAL; ANTIPSYCHOTIC AGENTS; COST-BENEFIT ANALYSIS; DELAYED-ACTION PREPARATIONS; DOUBLE-BLIND METHOD; DRUG COSTS; DRUG THERAPY, COMBINATION; HUMANS; ISOXAZOLES; PALMITATES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SCHIZOPHRENIA; TABLETS; TREATMENT OUTCOME;

EID: 72449129531     PISSN: 13685031     EISSN: 17421241     Source Type: Journal    
DOI: 10.1111/j.1742-1241.2009.02240.x     Document Type: Review

References (40)

1. Citrome L. Paliperidone: Quo vadis? Int J Clin Pract 2007 61 : 653 662.
2. Kantrowitz J, Citrome L. Paliperidone - the evidence of its therapeutic value in schizophrenia. Core Evid 2008 2 : 261 271.
3. Lautenschlager M, Heinz A. Paliperidone-ER: first atypical antipsychotic with oral extended release formulation. Expert Rev Neurother 2008 8 : 193 200.
4. Narasimhan M, Srinivasan S, Pae CU, Masand P. Profile of paliperidone extended release: review of efficacy and safety data. Expert Rev Clin Pharmacol 2008 1 : 737 744.
5. Yang LP, Plosker GL. Paliperidone extended release. CNS Drugs 2007 21 : 417 425.
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. Johnson & Johnson. FDA Approves Invega Sustenna for the Acute and Maintenance Treatment of Schizophrenia. 31 July 2009. http://www.jnj.com/ connect/news/all/20090731-153000 (accessed September 2009).
8. 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.
9. Samtani MN, Vermeulen A, Stuyckens K. Population pharmacokinetics of intramuscular paliperidone palmitate in patients with schizophrenia: a novel once-monthly, long-acting formulation of an atypical antipsychotic. Clin Pharmacokinet 2009 48 : 585 600.
10. United States Food and Drug Administration. NDA Approval Letter. 31 July 2009. http://www.accessdata.fda.gov/drugsatfda-docs/appletter/2009/ 022264s000ltr.pdf (accessed September 2009).
11. Johnson & Johnson. A Randomized, Double Blind, Parallel-Group Comparative Study of Flexibly Dosed Paliperidone Palmitate (25, 50, 75, or 100 mg eq.) Administered Every 4 Weeks and Flexibly Dosed Risperdal Consta (25, 37.5, or 50 mg) Administered Every 2 Weeks in Subjects with Schizophrenia. http://download.veritasmedicine.com/PDF/CR004195-CSR.pdf (accessed September 2009).
12. Johnson & Johnson. A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Response Study to Evaluate the Efficacy and Safety of 3 Fixed Doses (50 mg eq., 100 mg eq., and 150 mg eq.) of Paliperidone Palmitate in Subjects with Schizophrenia. http://download.veritasmedicine.com/PDF/CR002353- CSR.pdf (accessed September 2009).
13. Johnson & Johnson. A Randomized, Crossover Study to Evaluate the Overall Safety and Tolerability of Paliperidone Palmitate Injected in the Deltoid or Gluteus Muscle in Subjects with Schizophrenia. http://download. veritasmedicine.com/PDF/CR002350-CSR.pdf (accessed September 2009).
14. Johnson & Johnson. A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating Paliperidone Palmitate in the Prevention of Recurrence in Subjects with Schizophrenia. http://download.veritasmedicine.com/ PDF/CR004198-CSR.pdf (accessed September 2009).
15. Johnson & Johnson. A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Response Study to Evaluate the Efficacy and Safety of 3 Fixed Doses (25 mg eq., 50 mg eq., and 100 mg eq.) of Paliperidone Palmitate in Subjects With Schizophrenia. http://download.veritasmedicine.com/PDF/CR003562- CSR.pdf (accessed September 2009).
16. Johnson & Johnson. A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of 50 and 100 mg eq. of Paliperidone Palmitate in Subjects With Schizophrenia. http://download.veritasmedicine.com/ PDF/CR004357-CSR.pdf (accessed September 2009).
17. Johnson & Johnson. A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Response Study to Evaluate the Efficacy and Safety of 3 Fixed Doses (25 mg eq., 100 mg eq., and 150 mg eq.) of Paliperidone Palmitate in Subjects With Schizophrenia. http://download.veritasmedicine.com/PDF/CR012550- CSR.pdf (accessed September 2009).
18. Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. Invega Sustenna (paliperidone palmitate) Extended-Release Injectable Suspension. http://www.invegasustenna.com/invegasustenna/shared/pi/invegasustenna.pdf (accessed September 2009).
19. Citrome L. Compelling or irrelevant? Using number needed to treat can help decide Acta Psychiatr Scand 2008 117 : 412 419.
20. Citrome L. Quantifying risk: the role of absolute and relative measures in interpreting risk of adverse reactions from product labels of antipsychotic medications. Curr Drug Saf 2009 4 : 229 237.
21. Kraemer HC, Kupfer DJ. Size of treatment effects and their importance to clinical research and practice. Biol Psychiatry 2006 59 : 990 996.
22. Elan Drug Technologies. Technology Focus. http://www. elandrugtechnologies.com/invisibleray/media/images/-client-specific/file/ TechnologyFocus.pdf (accessed September 2009).
23. Shayegan DK, Stahl SM. Atypical antipsychotics: matching receptor profile to individual patient's clinical profile. CNS Spectr 2004 9 (Suppl. 11 6 14.
24. Spina E, Avenoso A, Facciolà G et al. Plasma concentrations of risperidone and 9-hydroxyrisperidone: effect of comedication with carbamazepine or valproate. Ther Drug Monit 2000 22 : 481 485.
25. Berwaerts J, Cleton A, Herben V et al. The effects of paroxetine on the pharmacokinetics of paliperidone extended-release tablets. Pharmacopsychiatry 2009 42 : 158 163.
26. Valenstein M, Ganoczy D, McCarthy JF, Myra Kim H, Lee TA, Blow FC. Antipsychotic adherence over time among patients receiving treatment for schizophrenia: a retrospective review. J Clin Psychiatry 2006 67 : 1542 1550.
27. Byerly MJ, Nakonezny PA, Lescouflair E. Antipsychotic medication adherence in schizophrenia. Psychiatr Clin North Am 2007 30 : 437 452.
28. Perkins DO. Predictors of noncompliance in patients with schizophrenia. J Clin Psychiatry 2002 63 : 1121 1128.
29. Weiden P, Rapkin B, Zygmunt A, Mott T, Goldman D, Frances A. Postdischarge medication compliance of inpatients converted from an oral to a depot neuroleptic regimen. Psychiatr Serv 1995 46 : 1049 1054.
30. Law MR, Soumerai SB, Ross-Degnan D, Adams AS. A longitudinal study of medication nonadherence and hospitalization risk in schizophrenia. J Clin Psychiatry 2008 69 : 47 53.
31. Weiden PJ, Kozma C, Grogg A, Locklear J. Partial compliance and risk of rehospitalization among California Medicaid patients with schizophrenia. Psychiatr Serv 2004 55 : 886 891.
32. Morken G, Widen JH, Grawe RW. Non-adherence to antipsychotic medication, relapse and rehospitalisation in recent-onset schizophrenia. BMC Psychiatry 2008 8 : 32. DOI :.
33. Lindenmayer JP, Liu-Seifert H, Kulkarni PM et al. Medication non-adherence and treatment outcome in patients with schizophrenia or schizoaffective disorder with suboptimal prior response. J Clin Psychiatry 2009 70 : 990 996.
34. Alia-Klein N, O'Rourke TM, Goldstein RZ, Malaspina D. Insight into illness and adherence to psychotropic medications are separately associated with violence severity in a forensic sample. Aggress Behav 2007 33 : 86 96.
35. Herings RM, Erkens JA. Increased suicide attempt rate among patients interrupting use of atypical antipsychotics. Pharmacoepidemiol Drug Saf 2003 12 : 423 424.
36. Ascher-Svanum H, Faries DE, Zhu B, Ernst FR, Swartz MS, Swanson JW. Medication adherence and long-term functional outcomes in the treatment of schizophrenia in usual care. J Clin Psychiatry 2006 67 : 453 460.
37. Möller HJ. Long-acting injectable risperidone for the treatment of schizophrenia: clinical perspectives. Drugs 2007 67 : 1541 1566.
38. Citrome L. Olanzapine pamoate: a stick in time? A review of the efficacy and safety profile of a new depot formulation of a second-generation antipsychotic Int J Clin Pract 2009 63 : 140 150.
39. Quraishi SN, David A, Brasil MA, Alheira FV. Depot haloperidol decanoate for schizophrenia. Cochrane Database Syst Rev 1999, Issue 1. Art. No.: CD001361. DOI :.
40. Leucht S, Corves C, Arbter D, Engel RR, Li C, Davis JM. Second-generation versus first-generation antipsychotic drugs for schizophrenia: a meta-analysis. Lancet 2009 373 : 31 41.