A randomized controlled trial of the effect of sublingual orally disintegrating olanzapine versus oral olanzapine on body mass index: The PLATYPUS Study

Schizophrenia Research

Volumn 113, Issue 1, 2009, Pages 41-48

  Karagianis, J ^a,b   Grossman, L ^a,c   Landry, J ^a   Reed, V A ^d   de Haan, L ^e   Maguire, G A ^f   Hoffmann, V P ^a   Milev, R ^g  

^a ELI LILLY AND COMPANY   (United States)

^b MEMORIAL UNIVERSITY OF NEWFOUNDLAND   (Canada)

^c UNIVERSITY OF TORONTO   (Canada)

^d ELI LILLY AUSTRALIA PTY LTD   (Australia)

^e UNIVERSITY OF AMSTERDAM   (Netherlands)

^f UNIVERSITY OF CALIFORNIA   (United States)

^g QUEEN S UNIVERSITY   (Canada)

Author keywords

Bipolar; Disintegrating olanzapine; Metabolic; Schizophrenia; Weight

Indexed keywords

OLANZAPINE; PLACEBO;

ADULT; AKATHISIA; ANXIETY; APPETITE; ARTHRALGIA; ARTICLE; BIPOLAR DISORDER; BODY MASS; BODY WEIGHT; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DECREASED APPETITE; DEPRESSION; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; DYSPEPSIA; FATIGUE; FEMALE; HUMAN; INCREASED APPETITE; INFLUENZA; INSOMNIA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PATIENT COMPLIANCE; PRIORITY JOURNAL; PSYCHOSIS; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SCHIZOAFFECTIVE PSYCHOSIS; SCHIZOPHRENIA; SIDE EFFECT; SOMNOLENCE; SUICIDE ATTEMPT; TREMOR; WAIST CIRCUMFERENCE; WEIGHT GAIN; XEROSTOMIA;

ADMINISTRATION, ORAL; ADMINISTRATION, SUBLINGUAL; ADOLESCENT; ADULT; AGED; ANTIPSYCHOTIC AGENTS; BENZODIAZEPINES; BLOOD GLUCOSE; BODY MASS INDEX; BODY WEIGHT; CHOLESTEROL; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; MALE; MIDDLE AGED; PATIENT COMPLIANCE; PSYCHOTIC DISORDERS; QUALITY OF LIFE; WAIST CIRCUMFERENCE; YOUNG ADULT;

EID: 67650090764     PISSN: 09209964     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.schres.2009.05.024     Document Type: Article

References (49)

1. Allison D.B., Mentore J.L., Heo M., Chandler L.P., Cappelleri J.C., Infante M.C., and Weiden P.J. Antipsychotic-induced weight gain: a comprehensive research synthesis. Am. J. Psychiatry 156 11 (1999) 1686-1696
2. Standards of medical care in diabetes-2008. Diabetes Care 31 suppl 1 (2008) S12-S54
3. Arranz B., San L., Dueñas R.M., Centeno M., Ramirez N., Salavert J., and Del Moral E. Lower weight gain with the orally disintegrating olanzapine than with standard tablets in first-episode never treated psychotic patients. Hum. Psychopharmacol. Clin. Exp. 22 (2007) 11-15
4. Basson B.R., Kinon B.J., Taylor C.C., Szymanski K.A., Gilmore J.A., and Tollefson G.D. Factors influencing acute weight change in patients with schizophrenia treated with olanzapine, haloperidol, or risperidone. J. Clin. Psychiatry 62 4 (2001) 231-238
5. Bergstrom R.F., Mitchell M., Witcher J., et al. Rapid onset of absorption with olanzapine orally disintegrating tablets. Schizophr. Res. 67 suppl1 (2004) 160
6. Canadian Psychiatric Association; Clinical practice guidelines. 2005. Treatment of schizophrenia. Can. J. Psychiatry 50 13 Suppl 1 (2005) 7S-57S
7. Casey D.E., Carson W.H., Saha A.R., et al. Switching patients to aripiprazole from other antipsychotic agents: a multicenter randomized study. Psychopharmacology 166 (2003) 391-399
8. Centers for Disease Control and Prevention. Overweight and Obesity: Health Consequences (2008). http://www.cdc.gov/nccdphp/dnpa/obesity/consequences.htm http://www.cdc.gov/nccdphp/dnpa/obesity/consequences.htm. Accessed 17 September, 2008
9. Chawla B., and Luxton-Andrew H. Weight change after switching from olanzapine tablets to orally disintegrated tablets in obese patients with schizophrenia. Presented at 19th ECNP, Paris, France, 16-20, September 2006 (2006)
10. Chawla B., and 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. 23 (2008) 211-216
11. Crocq M.A., Guillon M.S., Bailey P.E., and Provost D. Orally disintegrating olanzapine induces less weight gain in adolescents than standard oral tablets. Eur. Psychiatry 22 7 (2007) 453-454
12. De Haan L., van Amelsvoort T., Rosien K., and Linszen D. Weight loss after switching from conventional olanzapine tablets to orally disintegrating olanzapine tablets. Psychopharmacology (Berl) 175 (2004) 389-390
13. Deberdt W., Winokur A., Cavazzoni P.A., Trzaskoma Q.N., Carlson C.D., Bymaster F.P., Wiener K., Floris M., and Breier A. Amantadine for weight gain associated with olanzapine treatment. Eur. Neuropsychopharmacol. 15 1 (2005) 13-21
14. Dobetti L. Fast-melting tablets: developments and technologies. Pharm. Tech. (Suppl) (2001) 44-50
15. 2-like receptor. Am. J. Physiol. 266 (1994) 284-291
16. Evans S., Newton R., and Higgins S. Nutritional intervention to prevent weight gain in patients commenced on olanzapine: a randomized controlled trial. Aust. N. Z. J. Psychiatry 39 6 (2005) 479-486
17. Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. 2001. Executive summary of the third report of the National Cholesterol Education Program (NCEP) expert panel on detection, evaluation, and treatment of high blood cholesterol in adults (Adult Treatment Panel III). JAMA 285 (2001) 2486-2497
18. Faulkner G., and Cohn T.A. Pharmacologic and nonpharmacologic strategies for weight gain and metabolic disturbance in patients treated with antipsychotic medications. Can. J. Psychiatry 51 (2006) 502-511
19. Ford E.S., Giles W.H., and Dietz W.H. Prevalence of the metabolic syndrome among US adults. Findings from the Third National Health and Nutrition Examination Survey. JAMA 287 (2002) 356-359
20. Ganguli R. Behavioral therapy for weight loss in patients with schizophrenia. J. Clin. Psychiatry 68 Suppl 4 (2007) 19-25
21. International Diabetes Federation. IDF clinical guidelines task force: global guideline for type 2 diabetes mellitus (2005), IDF, Brussels. http://www.idf%20org/webdata/docs/IDF%20GGT2D.pdf Available at www.idf org/webdata/docs/IDF%20GGT2D.pdf. Accessed July 2, 2007
22. Kane J.M. Treatment adherence and long-term outcomes. CNS Spectr. 12 10 Suppl 17 (2007) 21-26
23. Karagianis J., Hoffmann V.P., Arranz B., Treuer T., Maguire G.A., de Haan L., and Chawla B. Orally disintegrating olanzapine and potential differences in treatment-emergent weight gain. Hum. Psychopharmacol. 23 4 (2008) 275-281
24. Kinon B.J., Basson B.R., Gilmore J.A., and Tollefson G.D. Long-term olanzapine treatment: weight change and weight-related health factors in schizophrenia. J. Clin. Psychiatry 62 2 (2001) 92-100
25. Kinon B.J., Kaiser C.J., Ahmed S., Rotelli M.D., and Kollack-Walker S. Association between early and rapid weight gain and change in weight over one year of olanzapine therapy in patients with schizophrenia and related disorders. J. Clin. Psychopharmacol. 25 (2005) 255-258
26. Klein D.J., Cottingham E.M., Sorter M., Barton B.A., and Morrison J.A. A randomized, double-blind, placebo-controlled trial of metformin treatment of weight gain associated with initiation of atypical antipsychotic therapy in children and adolescents. Am. J. Psychiatry 163 (2006) 2072-2079
27. Kratz A., Sluss P.M., Januzzi Jr. J.L., and Lewandrowski K.B. Appendices: laboratory values of clinical importance. In: Kasper D.L., Braunwald E., and Fauci A.S. (Eds). Harrison's Principles of Internal Medicine. 16th ed. (2005), McGraw-Hill, New York A-1-A-15
28. Kwon J.S., Choi J.S., Bahk W.M., Yoon Kim.C., Hyung Kim.C., Chul Shin.Y., Park B.J., and Geun O.h.C. Weight management program for treatment-emergent weight gain in olanzapine-treated patients with schizophrenia or schizoaffective disorder: a 12-week randomized controlled clinical trial. J. Clin. Psychiatry 67 4 (2006) 547-553
29. Lieberman J.A., Stroup S., McEvoy J.P., Swartz M.S., Rosenheck R., Davis C., Lebowitz B.D., Severe J.B., and Hsiao J.K. Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. N. Engl. J. Med. 353 12 (2005) 1209-1223
30. Littrell K.H., Hilligoss N.M., Kirshner C.D., Petty R.G., and Johnson C.G. The effects of an educational intervention on antipsychotic-induced weight gain. J. Nurs. Scholarsh. 35 3 (2003) 237-241
31. Markowitz J.S., DeVane C.L., Malcolm R.J., et al. 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. 46 2 (2006) 164-171
32. Mathews D.R., Hosker J.P., Rudenski A.S., Naylor B.A., Treacher D.F., and Turner R.C. Homeostasis model assessment: insulin resistance and β-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia 28 (1985) 412-419
33. Meyer J.M. Strategies for the long-term treatment of schizophrenia: real-world lessons from the CATIE trial. J. Clin. Psychiatry 68 Suppl 1 (2007) 28-33
34. Morken G., Widen J.H., Grawe R.W., Morken G., Widen J.H., and Grawe R.W. Non-adherence to antipsychotic medication, relapse and rehospitalisation in recent-onset schizophrenia. BMC Psychiatry 30 8 (2008) 32
35. Must A., Spadano J., Coakley E.H., Field A.E., Colditz G., and Dietz W.H. The disease burden associated with overweight and obesity. JAMA 282 (1999) 1523-1529
36. National Institutes of Health. Third report of the national cholesterol education program expert panel on detection, evaluation, and treatment of high blood cholesterol in adults [Adult Treatment Panel III] (2001), National Institutes of Health, Bethesda, Md NIH Publication 01-3670
37. Newcomer J.W. Second-generation (atypical) antipsychotics and metabolic effects: a comprehensive literature review. CNS Drugs 19 suppl 1 (2005) 1-93
38. O'Keefe C.D., Noordsy D.L., Liss T.B., and Weiss H. Reversal of antipsychotic-associated weight gain. J. Clin. Psychiatry 64 (2003) 907-912
39. Patel P.B., Chaudhary A., and Gupta G.D. Fast dissolving drug delivery systems: an update-June, 2006 (2006). http://www.pharmainfo.net/exclusive/reviews/fast_dissolving_drug_deliver y_systems:_%20an_update/ Available online, accessed 11 August, 2008 at 12:10 CET. http://www.pharmainfo.net/exclusive/reviews/fast_dissolving_drug_deliver y_systems:_ an_update/
40. Reinstein M.J., Sonnenberg J.G., Mohan S.C., Jones L.E., and Girard S. Difference in weight change and hypersalivation between Faza-Clo ® (Clozapine, USP) orally disintegrating tablets and solid oral Clozapine Tablets. Presented at American Psychiatric Association Annual Meeting, Toronto, Canada, May 2006 (2006)
41. Roose S.P., Nelson J.C., Salzman C., Hollander S.B., and Rodrigues H. Mirtazapine in the nursing home study group: open-label study of mirtazapine orally disintegrating tablets in depressed patients in the nursing home. Curr. Med. Res. Opin. 19 8 (2003) 737-746
42. Sachs G.S., and Guille C. Weight gain associated with use of psychotropic medications. J. Clin. Psychiatry 60 SUPPL. 21 (1999) 16-19
43. San L., Casillas M., Ciudad A., and Gilaberte I. Olanzapine orally disintegrating tablet: a review of efficacy and compliance. CNS Neurosci. Ther. 14 3 (2008) 203-214
44. Schooler N.R. Relapse prevention and recovery in the treatment of schizophrenia. J. Clin. Psychiatry 67 Suppl 5 (2006) 19-23
45. Stip E., Anslemo K., Wolfe M., Lessard C., and Landry P. Long-term treatment with atypical antipsychotics and risk of weight gain. Drug Safety 29 6 (2006) 550-552
46. Weiden P.J., Daniel D.G., Simpson G., and Romano S.J. Improvement in indices of health status in outpatients with schizophrenia switched to ziprasidone. J. Clin. Psychopharmacol. 23 6 (2003) 595-600
47. Weiden P.J., Mackell J.A., and McDonnell D.D. Obesity as a risk factor for antipsychotic noncompliance. Schizophr. Res. 1 (2004) 51-57 66(1)
48. Wu R.R., Zhao J.P., Guo X.F., He Y.Q., Fang M.S., Guo W.B., Chen J.D., and Li L.H. Metformin addition attenuates olanzapine-induced weight gain in drug-naive first-episode schizophrenia patients: a double-blind, placebo-controlled study. Am. J. Psychiatry 165 3 (2008) 352-358
49. Yatham L.N., Kennedy S.H., and O'donovan C. Canadian Network for Mood and Anxiety Treatments (CANMAT) guidelines for the management of patients with bipolar disorder: consensus and controversies. Bipolar. Disord. 7 suppl 3 (2005) 5-69