Use of lurasidone, an atypical antidepressant, for the short- and long-term treatment of adults and adolescents with bipolar depression is associated with a generally low risk for development of metabolic syndrome, according to study results presented at Psych Congress 2019, held October 3 to 6 in San Diego, California.
To examine the potential metabolic effects of lurasidone in a sample of patients with bipolar I depression, Michael Tocco, PhD, of Sunovion Pharmaceuticals, Inc., and colleagues conducted a post hoc analysis in which they pooled data from 3 double-blind placebo-controlled 6-week studies of lurasidone as monotherapy or adjuvant therapy, an open-label 6-month extension study, and a 28-week adjuvant therapy study (lurasidone vs placebo).
In the short-term monotherapy study, patients (n=330) were administered lurasidone in fixed-flexible doses of 20 to 60 mg or 80 to 120 mg, or placebo (n=168). In the 2 adjunctive studies, patients were administered either placebo (n=334) or lurasidone in flexible doses of 20 to 120 mg combined with therapeutic doses of either lithium or valproate (n=360).
In the long-term analysis, investigators extracted data from an open-label study in which patients who completed one of the aforementioned 6-week studies continued for a 6-month extension with lurasidone in flexible doses of 20 to 120 mg (n=331) or placebo (n=168). They also gathered data from a double-blind maintenance study in which researchers randomly assigned patients to continue lurasidone in flexible doses in combination with lithium or valproate (n=360) or receive placebo (n=334).
Patients included in both studies were aged 18 to 75 years, were experiencing a major depressive episode at the time of the analysis, and met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision criteria. Moreover, white men made up approximately half of the patients included in the study.
Researchers defined metabolic syndrome according to National Cholesterol Education Program Adult Treatment Panel-III criteria. They found that the percentage of patients with new-onset metabolic syndrome was similar whether patients were treated with lurasidone or placebo. Of the short-term group treated with lurasidone monotherapy, 9.9% of patients met metabolic syndrome criteria compared with 11.6% of those receiving placebo. In a similar fashion, of the patients treated with adjunctive therapy, 10.3% developed metabolic syndrome compared with 8.3% of patients receiving placebo. In the 6-month double-blind adjunctive study, 9% of patients treated with lurasidone met metabolic syndrome criteria compared with 10.5% of patients receiving placebo.
The investigators concluded that the use of lurasidone is associated with a low risk for development of metabolic syndrome and that the “findings are consistent with similar results in patients with schizophrenia.”
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The researchers reported a financial relationship with Sunovion Pharmaceuticals, Inc.
Tocco M, Newcomer JW, Mao Y, Pikalov A. Lurasidone and metabolic syndrome: results from short- and long-term clinical studies in patients with bipolar depression. Presented at: Psych Congress 2019; October 3-6, 2019; San Diego, CA. Poster 302.