Long-term treatment with lurasidone led to few effects on body weight, lipids, glucose, and prolactin, based on data from a 12-month analysis, according to data presented at the American Psychiatric Association (APA) 2017 Annual Meeting, taking place May 20-24, 2017, in San Diego, California.
Christoph U. Correll, MD, professor of psychiatry and molecular medicine at Hofstra Northwell School of Medicine on Long Island, Hempstead, New York, and colleagues conducted an open-label trial on the long-term safety of lurasidone in adolescents with schizophrenia.
“Use of second-generation antipsychotics (SGA) in the treatment of adolescents with schizophrenia has been associated with different safety concerns, including weight gain, increased glucose and lipids, and hyperprolactinemia,” the authors note. “However, few data are available from prospective studies that demonstrate the long-term safety of SGA.”
Dr Correll and colleagues entered a total of 180 patients (57.8% of whom were male; mean age,15.6 years) with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision, diagnosis of schizophrenia into an extension study of the effectiveness and safety of 24 months of open label, flexible-dose treatment with lurasidone (20-80 mg/day). Safety measures included frequency of treatment-emergent adverse events and changes from open-label baseline in mean weight and median metabolic parameters and prolactin.
The mean daily dose of lurasidone during the open-label treatment period was 55.8 mg/day, and the proportion of patients using a modal dose of 20, 40, 60, and 80 mg was 2.3%, 40.4%, 25.1%, and 32.2%, respectively. Discontinuation resulting from adverse events occurred in 11.1% of patients; the 3 most frequent adverse events leading to study discontinuation were schizophrenia (3.9%), suicidal ideation (1.7%), and psychotic disorder (1.1%).
“In the placebo-to-lurasidone treatment group (N=57), the five most frequent adverse events were headache (24.6%), nausea (14.0%), increased weight (14.0%), anxiety (10.5%), and agitation (10.5%), and in the lurasidone-continuation group (N=123), the five most frequent adverse events were headache (16.3%), anxiety (11.4%), agitation (10.6%), schizophrenia (8.9%), and depression (8.1%). Small median changes at 12 months were noted for cholesterol (+0.7mg/dL), triglycerides (+4.1mg/dL), glucose (+0.6mg/dL), and prolactin (males +0.1ng/mL; females +0.5ng/mL). Mean change in weight at 12 months was +5.7kg (versus an expected weight gain of +2.8kg),” the authors noted.
At 12 months, the interim analysis demonstrated few metabolic effects associated with lurasidone in adolescents with a diagnosis of schizophrenia. The safety profile was also consistent with results from previous adult studies with the treatment.
Correll CU, Arango C, Tocco M, et al. Safety of Lurasidone in Adolescents With Schizophrenia: Interim Analysis of a 24-Month, Open-Label Extension Study. Presented at: American Psychiatric Association (APA) 2017 Annual Meeting; May 20-24; San Diego, California. Abstract P5-53.