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Retrospective Analysis of Diabetes Risk in Elderly Patients With Dementia in Olanzapine Clinical Trials

From Sub-acute Services, Beverly Healthcare Northside, Atlanta, GA (JLM), and Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN (VPH, IL, JA, RWB, TAH).

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 200 mg/dL at any time after baseline or one casual glucose value 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/m²) 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 (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 25 (HR = 0.86), 7% weight gain (HR = 2.26), and antipsychotic treatment (HR = 1.36) were not significant.

Conclusion: In elderly patients with dementia enrolled in olanzapine clinical trials, an elevated casual glucose (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.

Key Words: Treatment-emergent diabetes • olazapine • elderly • dementia • diabetes risk