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Aripiprazole Not Associated With Increased Diabetes Risk: Presented at APA

By Bruce Sylvester

SAN FRANCISCO, CA -- May 26, 2003 -- Unlike other atypical antipsychotics, aripiprazole treatment of schizophrenic patients does not elevate their risk of subsequently developing type 2 diabetes, researchers reported here on May 21^st at the 156^th Annual Meeting of the American Psychiatric Association.

Previous studies reported a link between some of the newer antipsychotics and diabetes (Am J Psychiatry 2002;159:561-566, J Clin Psychiatry 2002;63:758-762), according to the authors.

Atypical antipsychotics, especially clozapine and olanzapine, have also been linked to other metabolic correlates to diabetes -- such as obesity, hyperglycemia, and dyslipidemia.

To determine whether the observed increased risk for diabetes is a class effect or specific to only some of the newer antipsychotics, the researchers evaluated data on 306 subjects who entered a 26-week double-blinded clinical trial of aripiprazole versus placebo for maintenance treatment.

Citing a study by Stern and colleagues in which follow-up data on 1,791 patients was used to develop a logistic regression model to predict the risk of developing type 2 diabetes (Ann Intern Med 2002;136:575-581), the researchers used this same model to predict the risk of developing diabetes over the next 7.5 years using a variety of data gathered at baseline and at week 26.

For the 153 placebo patients, the researchers observed the following changes from baseline at 26 weeks: increased fasting plasma glucose (4.89 mg/dL) and decreased high-density lipoprotein (HDL; -2.41 mg/dL), systolic blood pressure (-3.93 mm Hg), and body mass index (BMI; -0.49 kg/m²).

Observed changes for the 153 patients in the aripiprazole group were increased fasting plasma glucose (0.61 mg/dL) and decreased HDL (-3.51 mg/dL), decreased systolic blood pressure (-5.31 mm Hg), and reduced BMI (-0.54 kg/m²).

The investigators noted that "the change between treatment arms was not statistically significant (MANOVA, P=0.75). Estimated changes in diabetes risk at 7.5 years increased by 6.42% for placebo and decreased by 0.33% for aripiprazole (P=0.10)."

"We used 6 risk factor models to find any added risk of diabetes with aripiprazole use, and we found none," said lead researcher and presenter Peter Weiden, MD, professor of psychiatry at State University of New York Health Science Center in Brooklyn, New York, United States.

"Since the agent does not raise the risk of diabetes, we can finally say that an increased risk of diabetes is not a class effect specific to all atypical antipsychotics, Dr. Weiden said. "This is important and good news for clinicians and for patients, and it could have a profound effect not only on weight gain but on the crucial issue of treatment compliance."

The study was supported by Bristol-Myers Squibb Company and Otsuka Pharmaceutical Company, Ltd.


[Study title: Aripiprazole Is Not Associated With Increased Diabetes Risk: A Long-Term Model. Abstract NR738]

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