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A 28-week, randomized, double-blind study of olanzapine versus aripiprazole in the treatment of schizophrenia.
J Clin Psychiatry. 2009 Apr; 70(4):572-81.JC

Abstract

OBJECTIVE

To evaluate the effectiveness of olanzapine versus aripiprazole in patients with schizophrenia.

METHOD

Patients aged 18 to 65 years with schizophrenia (diagnosed according to DSM-IV-TR criteria) were randomly assigned to either olanzapine (n = 281) or aripiprazole (n = 285) for 28 weeks of double-blind treatment. The primary outcome was time to all-cause discontinuation. Efficacy was measured by Positive and Negative Syndrome Scale (PANSS) total change from baseline. Time-to-event data were analyzed via the Kaplan-Meier method. The study was conducted from October 2003 to July 2007.

RESULTS

Treatment groups did not differ significantly in time to all-cause discontinuation (p = .067) or all-cause discontinuation rate (olanzapine, 42.7% vs. aripiprazole, 50.2%; p = .053). Olanzapine-treated patients had significantly longer time to efficacy-related discontinuation (p < .001) and a significantly lower efficacy-related discontinuation rate (olanzapine, 8.9% vs. aripiprazole, 16.8%; p = .006). Olanzapine-treated patients had a significantly greater mean decrease (last observation carried forward) in PANSS total score (-30.2) than did aripiprazole-treated patients (-25.9, p = .014). Olanzapine-treated patients had a mean weight change of +3.4 kg (vs. +0.3 kg for aripiprazole-treated patients; p < .001) and a significantly greater incidence of >or= 7% body weight gain at any time (40.3% vs. 16.4%; p < .001). Fasting mean glucose change was +4.87 mg/dL for olanzapine and +0.90 mg/dL for aripiprazole (p = .045). Incidence of baseline glucose < 100 mg/dL and >or= 126 mg/dL at any time was 1.7% for olanzapine and 0.6% for aripiprazole (p = .623). Fasting mean total cholesterol change was +4.09 mg/dL for olanzapine and -9.85 mg/dL for aripiprazole (p < .001). Incidence of baseline total cholesterol < 200 mg/dL and >or= 240 mg/dL at any time was 9.2% for olanzapine and 1.5% for aripiprazole (p = .008). Fasting mean triglycerides change was +25.66 mg/dL for olanzapine and -17.52 mg/dL for aripiprazole (p < .001). Treatment groups did not significantly differ on measures of extrapyramidal symptoms.

CONCLUSION

Treatment groups did not differ significantly on the primary outcome. Olanzapine-treated patients had significantly greater improvement in symptom efficacy at 28 weeks as well as significantly greater mean increases in weight and glucose and significantly greater worsening on lipids parameters.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT00088049.

Authors+Show Affiliations

Department of Psychiatry, The Zucker Hillside Hospital, Glen Oaks, NY 11004-1150, USA. psychiatry@lij.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19323965

Citation

Kane, John M., et al. "A 28-week, Randomized, Double-blind Study of Olanzapine Versus Aripiprazole in the Treatment of Schizophrenia." The Journal of Clinical Psychiatry, vol. 70, no. 4, 2009, pp. 572-81.
Kane JM, Osuntokun O, Kryzhanovskaya LA, et al. A 28-week, randomized, double-blind study of olanzapine versus aripiprazole in the treatment of schizophrenia. J Clin Psychiatry. 2009;70(4):572-81.
Kane, J. M., Osuntokun, O., Kryzhanovskaya, L. A., Xu, W., Stauffer, V. L., Watson, S. B., & Breier, A. (2009). A 28-week, randomized, double-blind study of olanzapine versus aripiprazole in the treatment of schizophrenia. The Journal of Clinical Psychiatry, 70(4), 572-81.
Kane JM, et al. A 28-week, Randomized, Double-blind Study of Olanzapine Versus Aripiprazole in the Treatment of Schizophrenia. J Clin Psychiatry. 2009;70(4):572-81. PubMed PMID: 19323965.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A 28-week, randomized, double-blind study of olanzapine versus aripiprazole in the treatment of schizophrenia. AU - Kane,John M, AU - Osuntokun,Olawale, AU - Kryzhanovskaya,Ludmila A, AU - Xu,Wen, AU - Stauffer,Virginia L, AU - Watson,Susan B, AU - Breier,Alan, Y1 - 2009/03/24/ PY - 2008/05/27/received PY - 2008/11/07/accepted PY - 2009/3/28/entrez PY - 2009/3/28/pubmed PY - 2009/7/1/medline SP - 572 EP - 81 JF - The Journal of clinical psychiatry JO - J Clin Psychiatry VL - 70 IS - 4 N2 - OBJECTIVE: To evaluate the effectiveness of olanzapine versus aripiprazole in patients with schizophrenia. METHOD: Patients aged 18 to 65 years with schizophrenia (diagnosed according to DSM-IV-TR criteria) were randomly assigned to either olanzapine (n = 281) or aripiprazole (n = 285) for 28 weeks of double-blind treatment. The primary outcome was time to all-cause discontinuation. Efficacy was measured by Positive and Negative Syndrome Scale (PANSS) total change from baseline. Time-to-event data were analyzed via the Kaplan-Meier method. The study was conducted from October 2003 to July 2007. RESULTS: Treatment groups did not differ significantly in time to all-cause discontinuation (p = .067) or all-cause discontinuation rate (olanzapine, 42.7% vs. aripiprazole, 50.2%; p = .053). Olanzapine-treated patients had significantly longer time to efficacy-related discontinuation (p < .001) and a significantly lower efficacy-related discontinuation rate (olanzapine, 8.9% vs. aripiprazole, 16.8%; p = .006). Olanzapine-treated patients had a significantly greater mean decrease (last observation carried forward) in PANSS total score (-30.2) than did aripiprazole-treated patients (-25.9, p = .014). Olanzapine-treated patients had a mean weight change of +3.4 kg (vs. +0.3 kg for aripiprazole-treated patients; p < .001) and a significantly greater incidence of >or= 7% body weight gain at any time (40.3% vs. 16.4%; p < .001). Fasting mean glucose change was +4.87 mg/dL for olanzapine and +0.90 mg/dL for aripiprazole (p = .045). Incidence of baseline glucose < 100 mg/dL and >or= 126 mg/dL at any time was 1.7% for olanzapine and 0.6% for aripiprazole (p = .623). Fasting mean total cholesterol change was +4.09 mg/dL for olanzapine and -9.85 mg/dL for aripiprazole (p < .001). Incidence of baseline total cholesterol < 200 mg/dL and >or= 240 mg/dL at any time was 9.2% for olanzapine and 1.5% for aripiprazole (p = .008). Fasting mean triglycerides change was +25.66 mg/dL for olanzapine and -17.52 mg/dL for aripiprazole (p < .001). Treatment groups did not significantly differ on measures of extrapyramidal symptoms. CONCLUSION: Treatment groups did not differ significantly on the primary outcome. Olanzapine-treated patients had significantly greater improvement in symptom efficacy at 28 weeks as well as significantly greater mean increases in weight and glucose and significantly greater worsening on lipids parameters. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00088049. SN - 1555-2101 UR - https://www.unboundmedicine.com/medline/citation/19323965/A_28_week_randomized_double_blind_study_of_olanzapine_versus_aripiprazole_in_the_treatment_of_schizophrenia_ L2 - http://www.psychiatrist.com/jcp/article/pages/2009/v70n04/v70n0414.aspx DB - PRIME DP - Unbound Medicine ER -