The metabolic profile of lumateperone 42 mg appears favorable, according to a post hoc analysis of a trio of studies involving patients with schizophrenia. Researchers shared their findings in a poster at Psych Congress 2020.
“Antipsychotic treatment of schizophrenia is often associated with increased rates of metabolic syndrome, as defined by criteria for waist circumference, triglycerides, high-density lipoprotein cholesterol, blood pressure, and fasting glucose,” researchers wrote.
Pooled data from two short-term studies showed similar baseline rates of metabolic syndrome among patients randomized to lumateperone 42 mg (16%) and those randomized to risperidone 4 mg (19%). At the end of treatment, however, metabolic syndrome rates decreased to 13% in the lumateperone group but increased to 25% in the risperidone group, according to the poster abstract.
Furthermore, more patients in the lumateperone group (46%), compared with the risperidone group (25%), improved from having metabolic syndrome at baseline to no longer having the condition at treatment’s end.
In a year-long, open-label trial that evaluated metabolic syndrome rates in patients who switched from another antipsychotic to lumateperone 42 mg, 36% of participants with metabolic syndrome at baseline no longer met criteria for the condition at the end of treatment.
“Fewer than half that percentage,” researchers wrote, “shifted from not meeting metabolic syndrome criteria to having metabolic syndrome (15%).”
Intra-Cellular Therapies Inc. sponsored the study.
Edward JB, Satlin A, Durgam S, et al. Cardiometabolic safety of lumateperone (ITI-007): post hoc analyses of short-term randomized trials and an open-label long-term study. Poster presented at Psych Congress 2020; September 10-13, 2020; Virtual.