Patients with schizophrenia are at high risk for diabetes, dyslipidemia, hypertension, and obesity, which can be exacerbated by some atypical antipsychotics.

To evaluate the effect of lurasidone on weight and metabolic parameters.

To establish the cardiometabolic safety of lurasidone.

Short-term data were pooled from seven, double-blind, 6-week studies of subjects with acute exacerbation of schizophrenia treated with lurasidone 20-160 mg/day (N=1508); haloperidol 10 mg/day (N=72); olanzapine 15 mg/day (N=122); risperidone 4 mg/day (N=65); quetiapine XR 600 mg/day (N=119) or placebo (N=708). Long-term data (6-22 months) were pooled from patients treated with lurasidone 40-120 mg/day (flexibly dosed).

Proportions of patients experiencing ≥7% weight gain during short-term treatment were: lurasidone 4.8%, haloperidol 4.2%, olanzapine 34.4%, risperidone 6.2%, quetiapine XR 15.3%, and placebo 3.3%. Median lipid changes were: triglycerides (mg/dL), lurasidone -4.0, haloperidol -3.0, olanzapine +25.0, risperidone +4.0, quetiapine XR +9.5, and placebo -6.0; total cholesterol (mg/dL), lurasidone -5.0, haloperidol -8.0, olanzapine +9.0, risperidone +6.5, quetiapine XR +6.0, and placebo -5.0; trends were similar for LDL. Median changes in glucose (mg/dL) were similar for lurasidone (0.0) and placebo (0.0), and higher for haloperidol (+2.0), olanzapine (+4.0), risperidone (+3.0), and quetiapine XR (+3.0). Minimal-to-no changes in HbA1c were observed. With long-term lurasidone treatment, mean weight change after 12-month exposure was -0.73 kg and median metabolic changes were: -2.0 mg/dL for total cholesterol and -5.0 mg/dL for triglycerides.

Short- and long-term treatment with lurasidone showed minimal changes in weight and decrease in mean total and LDL cholesterol and triglycerides.