Olanzapine orally disintegrating tablet: A review of efficacy and compliance

CNS Neuroscience and Therapeutics

Volumn 14, Issue 3, 2008, Pages 203-214

  San, Luis ^a   Casillas, Marta ^b   Ciudad, Antonio ^b   Gilaberte, Inmaculada ^b  

^a HOSPITAL CLÍNIC   (Spain)

^b ELI LILLY AND COMPANY   (Spain)

Author keywords

Compliance; Efficacy; Olanzapine orally disintegrating tablet; Schizophrenia

Indexed keywords

ALPRAZOLAM; BENZODIAZEPINE; HALOPERIDOL; OLANZAPINE; RISPERIDONE;

ABNORMAL INVOLUNTARY MOVEMENT SCALE; AGITATION; AKINESIA; ANXIETY DISORDER; AREA UNDER THE CURVE; ASTHENIA; BIOEQUIVALENCE; BIPOLAR DISORDER; BRADYCARDIA; CLINICAL GLOBAL IMPRESSION SCALE; CLINICAL TRIAL; DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL DISORDERS; DRUG DOSAGE FORM COMPARISON; DRUG EFFICACY; DRUG FORMULATION; DRUG PREFERENCE; DRUG SAFETY; DRUG STABILITY; DRUG TOLERABILITY; EXTRAPYRAMIDAL SYMPTOM; HEADACHE; HUMAN; HYPERTRIGLYCERIDEMIA; HYPOTENSION; INSOMNIA; LABORATORY TEST; MAXIMUM PLASMA CONCENTRATION; MENTAL PATIENT; MOTOR DYSFUNCTION; NURSING ASSESSMENT OF MEDICATION ACCEPTANCE; PATIENT COMPLIANCE; PATIENT SATISFACTION; POSITIVE AND NEGATIVE SYNDROME SCALE; PSYCHOLOGICAL RATING SCALE; PSYCHOSIS; RATING SCALE; REVIEW; SCHIZOPHRENIA; SIDE EFFECT; SIMPSON ANGUS SCALE; SOMNOLENCE; TABLET FORMULATION; TIME TO MAXIMUM PLASMA CONCENTRATION; TREMOR; UNSPECIFIED SIDE EFFECT; VITAL SIGN; WEIGHT GAIN; XEROSTOMIA;

ADMINISTRATION, ORAL; ANTIPSYCHOTIC AGENTS; BENZODIAZEPINES; BIOLOGICAL AVAILABILITY; BIPOLAR DISORDER; CHEMISTRY, PHARMACEUTICAL; DRUG DELIVERY SYSTEMS; HUMANS; OUTCOME ASSESSMENT (HEALTH CARE); PATIENT COMPLIANCE; SCHIZOPHRENIA; SOLUBILITY; TABLETS;

EID: 49849089222     PISSN: 17555930     EISSN: 17555949     Source Type: Journal    
DOI: 10.1111/j.1755-5949.2008.00053.x     Document Type: Review

References (64)

1. Bhana N, Foster RH, Olney R, Plosker GL. Olanzapine: An updated review of its use in the management of schizophrenia. Drugs 2001 61 : 111 161.
2. McCormack PL, Wiseman LR. Olanzapine: A review of its use in the management of bipolar I disorder. Drugs 2004 64 : 2709 2726.
3. Wagstaff AJ, Easton J, Scott LJ. Intramuscular olanzapine: A review of its use in the management of acute agitation. CNS Drugs 2005 19 : 147 164.
4. Haynes RB, Sackett DL. Compliance in health care. Baltimore, MD : Johns Hopkins Press. 1979
5. National Institute of Health. Research on adherence to interventions for mental disorders. Available at http://www.grants.nih.gov/grants/guide/pa-files/ PA-03-111.html.
6. Nichols-English G, Poirier S. Optimizing adherence to pharmaceutical care plans. J Am Pharm Assoc 2000 40 : 475 485.
7. Miller NH. Compliance with treatment regimens in chronic asymptomatic diseases. Am J Med 1997 102 : 43 49.
8. Osterberg L, Blaschke T. Adherence to medication. N Engl J Med 2005 353 : 487 497.
9. Oehl M, Hummer M, Fleischhacker WW. Compliance with antipsychotic treatment. Acta Psychiatr Scand Suppl 2000 407 : 83 86.
10. Hogarty GE, Goldberg SC, Schooler NR, Ulrich RF. Drug and sociotherapy in the aftercare of schizophrenic patients II. Two-year relapse rates. Arch Gen Psychiatry 1974 31 : 603 608.
11. Weiden PJ, Olfson M. Cost of relapse in schizophrenia. Schizophr Bull 1995 21 : 419 429.
12. Lindstrom E, Bingefors K. Patient compliance with drug therapy in schizophrenia. Economic and clinical issues. Pharmacoeconomics 2000 18 : 106 124.
13. Gilmer TP, Dolder CR, Lacro JP, Folsom DP, Lindamer L, Garcia P, Jeste DV. Adherence to treatment with antipsychotic medication and health care costs among Medicaid beneficiaries with schizophrenia. Am J Psychiatry 2004 161 : 692 699.
14. Lieberman J, Chakos M, Wu H, Alvir J, Hoffman E, Robinson D, Bider R. Longitudinal study of brain morphology in first episode schizophrenia. Biol Psychiatry 2001 49 : 487 499.
15. Sokal J, Messias E, Dickerson FB, Kreyenbuhl J, Brown CH, Goldberg RW, Dixon LB. Comorbidity of medical illnesses among adults with serious mental illness who are receiving community psychiatric services. J Nerv Ment Dis 2004 192 : 421 427.
16. Regier DA, Farmer ME, Rae DS, Locke BZ, Keith SJ, Judd LL, Goodwin FK. Comorbidity of mental disorders with alcohol and other drug abuse. Results from the Epidemiologic Catchment Area (ECA) Study. JAMA 1990 264 : 2511 2518.
17. Modestin J, Ammann R. Mental disorder and criminality: Male schizophrenia. National Institutes of Health. Research on adherence to interventions for mental disorders. Schizophr Bull 1996 22 : 69 82.
18. Herings RM, Erkens JA. Increased suicide attempt rate among patients interrupting use of atypical antipsychotics. Pharmacoepidemiol Drug Saf 2003 12 : 423 424.
19. Misdrahi D, Llorca PM, Lançon C, Bayle FJ. Compliance in schizophrenia: Predictive factors, therapeutical considerations and research implications. Encephale 2002 28 : 266 272.
20. Olfson M, Mechanic D, Hansell S, Boyer CA, Walkup J, Weiden PJ. Prediction of homelessness within three months of discharge among inpatients with schizophrenia. Psychiatr Serv 1999 50 : 667 673.
21. Schooler NR. Relapse prevention and recovery in the treatment of schizophrenia. J Clin Psychiatry 2006 67 (Suppl 5 19 23.
22. Ascher-Svanum H, Zhu B, Faries D, Lacro JP, Dolder CR. A prospective study of risk factors for nonadherence with antipsychotic medication in the treatment of schizophrenia. J Clin Psychiatry 2006 67 : 1114 1123.
23. Fenton WS, Blyler CR, Heinssen RK. Determinants of medication compliance in schizophrenia: Empirical and clinical findings. Schizophr Bull 1997 23 : 637 651.
24. Fleischhacker WW, Oehl MA, Hummer M. Factors influencing compliance in schizophrenia patients. J Clin Psychiatry 2003 64 (Suppl 16 10 13.
25. Awad AG, Voruganti LN. New antipsychotics, compliance, quality of life, and subjective tolerability-are patients better off? Can J Psychiatry 2004 49 : 297 302.
26. Donohoe G, Owens N, O'Donnell C, Burke T, Moore L, Tobin A, O'Callaghan E. Predictors of compliance with neuroleptic medication among inpatients with schizophrenia: A discriminant function analysis. Eur Psychiatry 2001 16 : 293 298.
27. Godleski LS, Goldsmith LJ, Vieweg WV, Zettwoch NC, Stikovac DM, Lewis SJ. Switching from depot antipsychotic drugs to olanzapine in patients with chronic schizophrenia. J Clin Psychiatry 2003 64 : 119 122.
28. U.S. Food and Drug Administration [online]. Available from URL : http://www.fda.gov/cder/dsm/DRG/drg00201.htm Accessed June 30, 2008 K. Orally disintegrating tablets. Tables & Capsules 2004 7 : 30 35.
29. Brown D. Orally disintegrating tablets: Taste over speed. Drug Deliv Technol 2001 3 : 58 61.
30. Seager H. Drug delivery products and the Zydis fast-dissolving dosage form. J Pharm Pharmacol 1998 50 : 375 382.
31. DeRoche CC. Consumer preference for orally disintegrating tablets over conventional forms of medication: Evolving methodology for medication intake in dysphagia [lecture]. 12th Annual Meeting of the Dysphagia Research Society Oct 2-4 San Francisco, CA. 2003.
32. Danileviciūte V, Adomaitiene V, Sveikata A, Maciulaitis R, Kadusevicius E, Volbekas V. Compliance in psychiatry: results of a survey of depressed patients using orally disintegrating tablet. Medicina (Kaunas) 2006 42 : 1006 1012.
33. Thyssen A, Remmerie B, D'Hoore P, Kushner S, Mannaert E. Rapidly disintegrating risperidone in subjects with schizophrenia or schizoaffective disorder: A summary of ten phase I clinical trials assessing taste, tablet disintegration time, bioequivalence, and tolerability. Clin Ther 2007 29 : 290 304.
34. Bergstrom RF, Mitchell M, Witcher J, Huorston JP, Hill AL, Taylor CC, Liu-Seifert H, Jones B. Rapid onset of absorption with olanzapine orally disintegrating tablets. Schizophr Res 2004 67 (suppl 1 160.
35. Witcher JW, Bergstrom RF, Cerimele BJ, Hatcher BL, Jewell H, Hemingway J, Ratnasingam L Mitchell MI. Pharmacokinetics and bioequivalence of olanzapine rapidly-disintegrating tablets [abstract no. 3431]. American Association of Pharmacists Annual Meeting; 1998 Nov 15-19 San Francisco (CA). 1998 Available at URL : http://www.aapspharmsci.org/abstracts/AM_1998/3431.html Accessed June 30, 2008 JS, DeVane CL, Malcolm RJ, Gefroh HA, Wang JS, Zhu HJ, Donovan JL. Pharmacokinetics of olanzapine after single-dose oral administration of standard tablet versus normal and sublingual administration of an orally disintegrating tablet in normal volunteers. J Clin Pharmacol 2006 46 : 164 171.
36. Chue P, Jones B, Taylor CC, Dickson R. Dissolution profile, tolerability, and acceptability of the orally disintegrating olanzapine tablet in patients with schizophrenia. Can J Psychiatry 2002 47 : 771 774.
37. Zyprexa-EU Summary of Product Characteristics. Available from URL : http://www.emea.europa.eu/humandocs/PDFs/EPAR/Zyprexa/H-115-PI-en.pdf Accessed June 30, 2008 Accessed June 30, 2008 EJ, Flanagan RJ, Taylor DM. The preparation and stability of a liquid olanzapine preparation for oral administration in hospitals. Pharm J 2000 265 : 275 276.
38. Kinon BJ, Hill AL, Liu H, Kollack-Walker S. Olanzapine orally disintegrating tablets in the treatment of acutely ill, non-compliant patients with schizophrenia. Int J Neuropsychopharmacol 2003 6 : 97 102. Erratum in: Int J Neuropsychopharmacol 2003; 6(3):313.
39. Kay SR, Fiszbein A, Opler LA. The Positive and Negative Syndrome Scale (PANSS) for schizophrenia. Schizophr Bull 1987 13 : 261 276.
40. Guy W. Clinical Global Impressions ECDEU Assessment. Manual for Psychopharmacology, Revised (DHEW Publ. No. ADM 76-338). Rockville, MD : National Institute of Mental Health, 1976 218 222.
41. Dardennes R, Chartier F, Heurtebize N, Olivier V, Perrin E. Naturalistic use of the orally disintegrating tablet formulation of olanzapine in acute schizophrenic patients: An observational prospective study. Int J Neuropsychopharmacol 2004 7 (Suppl. 2 P01.389.
42. Belgamwar RB, Fenton M. Olanzapine IM or velotab for acutely disturbed/agitated people with suspected serious mental illnesses. Cochrane Database of Systematic Reviews 2005, Issue 2, Art. No.: CD003729.
43. Simpson JR, Thompson CR, Beckson M. Impact of orally disintegrating olanzapine on use of intramuscular antipsychotics, seclusion, and restraint in an acute inpatient psychiatric setting. J Clin Psychopharmacol 2006 26 : 333 335.
44. Reeves RR, Wallace KD, Rogers-Jones C. Orally disintegrating olanzapine: A possible alternative to injection of antipsychotic drugs. J Psychosoc Nurs Ment Health Serv 2004 42 : 44 48.
45. Pascual JC, Perez V, Martin JL, Safont E, Puigdemont D, Alvarez G. Olanzapine orally-disintegrating tablet in severe psychotic agitation: A naturalistic study. Actas Esp Psiquiatr 2007 35 : 47 51.
46. Czekalla J, Wagner T, Schacht A, Kluge M, Kinon B. Effectiveness and medication acceptance of olanzapine disintegrating tablets compared to standard olanzapine tablets in acutely treated psychiatric patients. Patient Preferences and Adherence 2007 1 : 19 27.
47. Hatta K, Kawabata T, Yoshida K, Hamakawa H, Wakejima T, Furuta K, Nakamura M, Hirata T, Usui C, Nakamura H, Sawa Y. Olanzapine orally disintegrating tablet vs. risperidone oral solution in the treatment of acutely agitated psychotic patients. Gen Hosp Psychiatry 2008 30 : 367 371.
48. Cohen JA, Perel JM. Adolescent weight loss during treatment with olanzapine. J Child Adolesc Psychopharmacol 2004 14 : 617 620.
49. Tiedge UA. Schizophrenia: Advantages by changeover from olanzapine film-coated tablets to disintegrating tablets. Nervenheilkunde 2005 24 : 232.
50. de Haan L, van Amelsvoort T, Rosien K, Linszen D. Weight loss after switching from conventional olanzapine tablets to orally disintegrating olanzapine tablets. Psychopharmacology (Berl) 2004 175 (3 389 390.
51. Stip E, Anselmo K, Wolfe M, Lessard C, Landry P. Long-term treatment with atypical antipsychotics and risk of weight gain. Drug Saf 2006 29 : 550 552 Author reply 552 to: Drug Saf 2006; 29(4): 303-19 K, Braun BT, Simansky KJ. Serotonin contracts the isolated rat pylorus via a 5-HT2-like receptor. Am J Physiol 1994 266 : R284 R291.
52. Templeman LA, Reynolds GP, Arranz B, San L. Polymorphisms of the 5-HT2C receptor and leptin genes are associated with antipsychotic drug-induced weight gain in Caucasian subjects with a first-episode psychosis. Pharmacogenet Genomics 2005 15 : 195 200.
53. Eli Lilly and Company. Psychopharmacologic Drugs Advisory Committee Briefing Document. Zyprexa® Olanzapine Pamoate (OP) Depot (Olanzapine Long-Acting Injection) Schizophrenia. Available at : http://www.fda.gov/ohrms/ dockets/ac/08/briefing/2008-4338b1-03-Lilly.pdf. Accessed 19 January 2008.
54. Arranz B, San L, Dueñas RM, Centeno M, Ramirez N, Salavert J, Del Moral E. Lower weight gain with the orally disintegrating olanzapine than with standard tablets in first-episode never treated psychotic patients. Hum Psychopharmacol 2007 22 : 11 15.
55. Crocq MA, Guillon MS, Bailey PE, Provost D. Orally disintegrating olanzapine induces less weight gain in adolescents than standard oral tablets. Eur Psychiatry 2007 22 : 453 454.
56. Chawla B, Luxton-Andrew H. Long-term weight loss observed with olanzapine orally disintegrating tablets in overweight patients with chronic schizophrenia. A 1 year open-label, prospective trial. Hum Psychopharmacol 2008 23 : 211 216.
57. Karagianis J, Landry J, Milev R, Grossman L, Monga N, de Hann L, Maguire GA, Hoffmann VP, Lee B. A 16-week, randomized, doublet blind, double dummy trial of sublingual orally disintegrating olanzapine vs standard olanzapine tablets in patients who gained weight during olanzapine treatment: The PLATYPUS Study. Schizophr Res 2008 102/1-3 (Suppl 2 238.
58. Weiden P, Rapkin B, Mott T, Zygmunt A, Goldman D, Horvitz-Lennon M, Frances A. Rating of medication influences (ROMI) scale in schizophrenia. Schizophr Bull 1994 20 : 297 310.
59. Weiden PJ, Mott T, Curcio N. Recognition and management of neuroleptic noncompliance. In : Shriqui C, Nasrallah H, eds. Contemporary issues in the treatment of schizophrenia. Washington, DC : American Psychiatric Press, 1995 463 485.
60. Perry PJ, Sanger T, Beasly C. Olanzapine plasma concentrations and clinical response in acutely ill schizophrenic patients. J Clin Psychopharmacol 1997 17 : 472 477.
61. Liu-Seifert H, Houston J, Adams D, Kinon BJ. Association of acute symptoms and compliance attitude in noncompliant patients with schizophrenia. J Clin Psychopharmacol 2007 27 : 392 394.
62. Tornatore FL. Orally disintegrating antipsychotics may promote compliance and adherence in patients with schizophrenia. J Clin Psychiatry 2005 66 : 1493-1494 Author reply to: J Clin Psychiatry 2005; 66(1): 122-133 YC, Lee MY, Lin CC, Chen CH. Orally disintegrating olanzapine for the treatment of a manic patient with esophageal stricture plus chronic pharyngitis. Prog Neuropsychopharmacol Biol Psychiatry 2007 31 : 541 542.
63. Douzenis A, Michopoulos I, Economopoulos T, Lykouras L, Soldatos CR. Sublingual use of olanzapine in combination with alprazolam to treat agitation in a terminally ill patient receiving parenteral nutrition. Eur J Cancer Care 2007 16 : 289 290.
64. Ciorabai EM, Oyffe I, Dilbaz N, Lozano S, Ruschel S, Salburg J, Dyachkova Y, Treuer T. Patients preference of olanzapine orodispersible tablet compared with olanzapine classic oral tablet in a multinational, randomized, crossover study. Eur Psychiatry 2008 23 (Suppl 2 150 151.