Retrospective analysis of diabetes risk in elderly patients with dementia in olanzapine clinical trials.
OBJECTIVE
The objective of this study was to evaluate the association of established risk factors for treatment-emergent diabetes (TED) among patients over 65 years of age with dementia who received treatment with olanzapine.


METHODS
This was a post hoc analysis of data pooled from seven olanzapine clinical trials, which included patients over 65 years of age with dementia. The association of established risk factors for TED was evaluated using categorical and time-to-event analysis. TED was defined as two casual (fasting or nonfasting) glucose values > or =200 mg/dL at any time after baseline or one casual glucose value > or =200 mg/dL at the final visit, initiation of antidiabetic medication, or new clinical diagnosis of diabetes.


RESULTS
Elderly patients subsequently identified with TED (N = 29, 2.1%) had similar baseline body mass indices (24 kg/m(2)) and were similar in age (82 versus 80 years) to those who did not have TED. Cox proportional hazards model identified only elevated casual glucose (> or =140 mg/dL) measure at baseline to be significantly associated with the development of TED (hazard ratio [HR] = 11.2, p <0.0001) in this elderly cohort. Other clinical risk factors, like body mass index > or =25 (HR = 0.86), 7% weight gain (HR = 2.26), and antipsychotic treatment (HR = 1.36) were not significant.


CONCLUSIONS
In elderly patients with dementia enrolled in olanzapine clinical trials, an elevated casual glucose (> or =140 mg/dL) at baseline was the only risk factor significantly associated with subsequent development of TED. Risk of diabetes in these studies was not significantly associated with antipsychotic treatment group assignment.
Micca
Joseph L
JL
Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN 46285, USA.
Hoffmann
Vicki Poole
VP
Lipkovich
Ilya
I
Ahl
Jonna
J
Baker
Robert W
RW
Hardy
Thomas A
TA
D000368:Aged; D000704:Analysis of Variance; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D001569:Benzodiazepines / Q000008:administration & dosage / Q000009:adverse effects; D001786:Blood Glucose / Q000032:analysis; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D015331:Cohort Studies; D003704:Dementia / Q000188:drug therapy*; D003924:Diabetes Mellitus, Type 2 / Q000453:epidemiology*; D005260:Female; D006801:Humans; D008297:Male; D000077152:Olanzapine; D012189:Retrospective Studies; D012307:Risk Factors
D014150:Antipsychotic Agents; D001786:Blood Glucose; D001569:Benzodiazepines; D000077152:Olanzapine