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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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Treatment-emergent categorical lipid changes.
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Figure 6: Treatment-emergent categorical lipid changes.

Mentions: Categorical changes in lipids are also reported separately based upon protocol-specified fasting collection methods. Fasting and random values were combined across all six studies for total cholesterol and high-density lipoprotein (HDL) cholesterol while fasting only studies are reported for low density lipoprotein (LDL) cholesterol and triglycerides. No statistically significant differences were seen in any fasting values for LDL or triglycerides between patients of either group (See Figure 6). However, significantly more white patients (59/135) had a categorical increase in fasting and random cholesterol levels from borderline (≥200 mg/dl and <240 mg/dl) to high (≥240 mg/dl) compared to black patients (15/64; P = .019). Additionally, significantly more white males (33/87) showed a decrease in HDL cholesterol levels from normal (≥40 mg/dl) to low (<40 mg/dl) compared to black males (24/105; P = .039).


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)

Treatment-emergent categorical lipid changes.
© Copyright Policy - open-access
Related In: Results  -  Collection

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

Figure 6: Treatment-emergent categorical lipid changes.
Mentions: Categorical changes in lipids are also reported separately based upon protocol-specified fasting collection methods. Fasting and random values were combined across all six studies for total cholesterol and high-density lipoprotein (HDL) cholesterol while fasting only studies are reported for low density lipoprotein (LDL) cholesterol and triglycerides. No statistically significant differences were seen in any fasting values for LDL or triglycerides between patients of either group (See Figure 6). However, significantly more white patients (59/135) had a categorical increase in fasting and random cholesterol levels from borderline (≥200 mg/dl and <240 mg/dl) to high (≥240 mg/dl) compared to black patients (15/64; P = .019). Additionally, significantly more white males (33/87) showed a decrease in HDL cholesterol levels from normal (≥40 mg/dl) to low (<40 mg/dl) compared to black males (24/105; P = .039).

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