Objective: Patients with schizophrenia are at increased risk of developing diabetes mellitus and cardiovascular disease. Furthermore, some atypical antipsychotics are associated with metabolic disturbances, which augment the risk for these comorbid conditions. In clinical trials, effects on metabolic parameters with aripiprazole are similar to those with placebo and superior to those with olanzapine, and the Schizophrenia Trial of Aripiprazole (STAR) demonstrated comparable efficacy of aripiprazole versus standard of care (SoC; physicians' selection of quetiapine, olanzapine, or risperidone).
Method: In this post hoc analysis, data from STAR were used to assess the risks of diabetes and coronary heart disease (CHD) in patients with schizophrenia. The Stern (San Antonio Heart Disease Study) and Framingham models, with modifications, were used to predict the risk of diabetes at 7.5 years and CHD at 10 years, respectively.
Results: Aripiprazole-treated patients had more favorable changes in lipids, glucose, and body weight versus SoC. In a subsample of patients who had fasting lipid and glucose test results, the Stern model predicted 23.4 fewer incidences of new-onset diabetes with aripiprazole versus SoC in a hypothetical 1000-patient cohort. The number needed to treat with aripiprazole to avoid 1 adverse outcome expected with SoC was 43. In the same population, the Framingham model predicted 3.9 fewer CHD events, with a number needed to treat with aripiprazole of 256.
Conclusion: Aripiprazole-treated patients had more favorable changes in metabolic parameters compared with SoC, leading to a reduced risk of diabetes and CHD, based on validated models.