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Impact of race on efficacy and safety during treatment with olanzapine in schizophrenia, schizophreniform or schizoaffective disorder.

Stauffer VL, Sniadecki JL, Piezer KW, Gatz J, Kollack-Walker S, Hoffmann VP, Conley R, Durell T - BMC Psychiatry (2010)

Bottom Line: Additionally, a significantly greater percentage of black patients experienced clinically significant weight gain (≥ 7%) at anytime compared to white patients (36.1% vs. 30.4%, P = .021).The findings did not demonstrate overall substantive differences in efficacy or safety between white and black patients diagnosed with schizophrenia or related disorders treated with olanzapine.However, a significantly greater percentage of black patients (36.1%) experienced clinically significant weight gain compared to white patients (30.4%).

View Article: PubMed Central - HTML - PubMed

Affiliation: Lilly USA, LLC, Lilly Corporate Center, Indianapolis, IN 46285, USA. vstauffer@lilly.com

ABSTRACT

Background: To examine potential differences in efficacy and safety of treatment with olanzapine in patients with schizophrenia of white and black descent.

Methods: A post-hoc, pooled analysis of 6 randomized, double-blind trials in the treatment of schizophrenia, schizophreniform disorder, or schizoaffective disorder compared white (N = 605) and black (N = 375) patients treated with olanzapine (5 to 20 mg/day) for 24 to 28 weeks. Efficacy measurements included the Positive and Negative Syndrome Scale (PANSS) total score; and positive, negative, and general psychopathology scores; and the Clinical Global Impression of Severity (CGI-S) scores at 6 months. Safety measures included differences in the frequencies of adverse events along with measures of extrapyramidal symptoms, weight, glucose, and lipid changes over time.

Results: 51% of black patients and 45% of white patients experienced early study discontinuation (P = .133). Of those who discontinued, significantly more white patients experienced psychiatric worsening (P = .002) while significantly more black patients discontinued for reasons other than efficacy or tolerability (P = .014). Discontinuation for intolerability was not different between groups (P = .320). For the estimated change in PANSS total score over 6 months, there was no significant difference in efficacy between white and black patients (P = .928), nor on the estimated PANSS positive (P = .435), negative (P = .756) or general psychopathology (P = .165) scores. Overall, there was no significant difference in the change in CGI-S score between groups from baseline to endpoint (P = .979). Weight change was not significantly different in white and black patients over 6 months (P = .127). However, mean weight change was significantly greater in black versus white patients at Weeks 12 and 20 only (P = .028 and P = .026, respectively). Additionally, a significantly greater percentage of black patients experienced clinically significant weight gain (≥ 7%) at anytime compared to white patients (36.1% vs. 30.4%, P = .021). Changes across metabolic parameters (combined fasting and random lipids and glucose) were also not significantly different between groups, with the exception of a greater categorical change in total cholesterol from borderline to high among white subjects and a categorical change from normal to low in high density lipoprotein (HDL) cholesterol among white males.

Conclusions: The findings did not demonstrate overall substantive differences in efficacy or safety between white and black patients diagnosed with schizophrenia or related disorders treated with olanzapine. However, a significantly greater percentage of black patients (36.1%) experienced clinically significant weight gain compared to white patients (30.4%).

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Estimated change in PANSS total score in olanzapine-treated black and white patients over 24 weeks. Graph based on MMRM Model including fixed terms baseline PANSS total score, treatment week, protocol, investigator, race, and ethnic origin × treatment week. Race P-value = 0.93.
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Figure 2: Estimated change in PANSS total score in olanzapine-treated black and white patients over 24 weeks. Graph based on MMRM Model including fixed terms baseline PANSS total score, treatment week, protocol, investigator, race, and ethnic origin × treatment week. Race P-value = 0.93.

Mentions: The primary efficacy measure was the estimated change from baseline in the PANSS total score over 6 months. At the end of treatment, the estimated mean reduction was 27.0 points (SE = .80) for the white patient group and 26.0 (SE = 1.10) for the black patient group. Overall, the reduction in the PANSS total score was not found to be statistically significantly different between groups (P = .928, Figure 2). Likewise, the overall estimated mean changes from baseline in PANSS positive, PANSS negative, and general psychopathology scores were also not statistically different between groups (P = .435, P = .756, P = .165, respectively).


Impact of race on efficacy and safety during treatment with olanzapine in schizophrenia, schizophreniform or schizoaffective disorder.

Stauffer VL, Sniadecki JL, Piezer KW, Gatz J, Kollack-Walker S, Hoffmann VP, Conley R, Durell T - BMC Psychiatry (2010)

Estimated change in PANSS total score in olanzapine-treated black and white patients over 24 weeks. Graph based on MMRM Model including fixed terms baseline PANSS total score, treatment week, protocol, investigator, race, and ethnic origin × treatment week. Race P-value = 0.93.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3020682&req=5

Figure 2: Estimated change in PANSS total score in olanzapine-treated black and white patients over 24 weeks. Graph based on MMRM Model including fixed terms baseline PANSS total score, treatment week, protocol, investigator, race, and ethnic origin × treatment week. Race P-value = 0.93.
Mentions: The primary efficacy measure was the estimated change from baseline in the PANSS total score over 6 months. At the end of treatment, the estimated mean reduction was 27.0 points (SE = .80) for the white patient group and 26.0 (SE = 1.10) for the black patient group. Overall, the reduction in the PANSS total score was not found to be statistically significantly different between groups (P = .928, Figure 2). Likewise, the overall estimated mean changes from baseline in PANSS positive, PANSS negative, and general psychopathology scores were also not statistically different between groups (P = .435, P = .756, P = .165, respectively).

Bottom Line: Additionally, a significantly greater percentage of black patients experienced clinically significant weight gain (≥ 7%) at anytime compared to white patients (36.1% vs. 30.4%, P = .021).The findings did not demonstrate overall substantive differences in efficacy or safety between white and black patients diagnosed with schizophrenia or related disorders treated with olanzapine.However, a significantly greater percentage of black patients (36.1%) experienced clinically significant weight gain compared to white patients (30.4%).

View Article: PubMed Central - HTML - PubMed

Affiliation: Lilly USA, LLC, Lilly Corporate Center, Indianapolis, IN 46285, USA. vstauffer@lilly.com

ABSTRACT

Background: To examine potential differences in efficacy and safety of treatment with olanzapine in patients with schizophrenia of white and black descent.

Methods: A post-hoc, pooled analysis of 6 randomized, double-blind trials in the treatment of schizophrenia, schizophreniform disorder, or schizoaffective disorder compared white (N = 605) and black (N = 375) patients treated with olanzapine (5 to 20 mg/day) for 24 to 28 weeks. Efficacy measurements included the Positive and Negative Syndrome Scale (PANSS) total score; and positive, negative, and general psychopathology scores; and the Clinical Global Impression of Severity (CGI-S) scores at 6 months. Safety measures included differences in the frequencies of adverse events along with measures of extrapyramidal symptoms, weight, glucose, and lipid changes over time.

Results: 51% of black patients and 45% of white patients experienced early study discontinuation (P = .133). Of those who discontinued, significantly more white patients experienced psychiatric worsening (P = .002) while significantly more black patients discontinued for reasons other than efficacy or tolerability (P = .014). Discontinuation for intolerability was not different between groups (P = .320). For the estimated change in PANSS total score over 6 months, there was no significant difference in efficacy between white and black patients (P = .928), nor on the estimated PANSS positive (P = .435), negative (P = .756) or general psychopathology (P = .165) scores. Overall, there was no significant difference in the change in CGI-S score between groups from baseline to endpoint (P = .979). Weight change was not significantly different in white and black patients over 6 months (P = .127). However, mean weight change was significantly greater in black versus white patients at Weeks 12 and 20 only (P = .028 and P = .026, respectively). Additionally, a significantly greater percentage of black patients experienced clinically significant weight gain (≥ 7%) at anytime compared to white patients (36.1% vs. 30.4%, P = .021). Changes across metabolic parameters (combined fasting and random lipids and glucose) were also not significantly different between groups, with the exception of a greater categorical change in total cholesterol from borderline to high among white subjects and a categorical change from normal to low in high density lipoprotein (HDL) cholesterol among white males.

Conclusions: The findings did not demonstrate overall substantive differences in efficacy or safety between white and black patients diagnosed with schizophrenia or related disorders treated with olanzapine. However, a significantly greater percentage of black patients (36.1%) experienced clinically significant weight gain compared to white patients (30.4%).

Show MeSH
Related in: MedlinePlus