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Psych Congress  

Lurasidone and Metabolic Syndrome: Results From Short- and Long-Term Clinical Studies in Patients With Bipolar Depression

Authors  

Michael Tocco, PhD – Sunovion Pharmaceuticals Inc.; John Newcomer, MD – Thriving Mind South Florida, Miami, FL and Washington University School of Medicine, St. Louis, MO; Yongcai Mao, PhD – Sunovion Pharmaceuticals Inc.; Andrei Pikalov, MD, PhD – Sunovion Pharmaceuticals Inc.

Sponsor  
Sunovion Pharmaceuticals Inc.

Background: The elevated prevalence of metabolic syndrome (MetS) in patients with depression has been associated with increased mortality rates. The aim of this post-hoc analysis was to assess the effect of treatment with lurasidone on risk of MetS in patients with bipolar depression.

Method: Lurasidone data (20-120 mg/d) used in the current analyses consisted of 3 double-blind (DB), placebo-controlled, 6-week studies in adults with bipolar I depression (N=1,192), consisting of 1 monotherapy, and 2 adjunctive therapy trials with lithium or valproate. Also analyzed was a 6-month open-label (OL) extension study (monotherapy, N=316; adjunctive therapy, N=491); and a 28-week DB adjunctive therapy study with lurasidone or placebo (N=496). MetS was defined based on NCEP ATP III criteria (2005 revision).

Results: In the short-term monotherapy and adjunctive therapy studies, the proportion of patients at baseline with MetS was 27.6% and 23.6%, respectively, for lurasidone, and 23.8% and 25.1%, respectively, for placebo; and at week 6 (LOCF) was 27.5% and 26.6%, respectively, for lurasidone and 29.9% and 20.2%, respectively, for placebo. The proportion of patients with new onset MetS was similar for lurasidone and placebo in the short-term studies (monotherapy, 9.9% vs. 11.6%; adjunctive therapy, 10.3% vs. 8.3%); and in the 28-week DB adjunctive therapy study (9.0% vs. 10.5%).

Conclusion: This post-hoc analysis found that short- and long-term treatment with lurasidone was associated with a relatively low risk for the development of metabolic syndrome in patients with bipolar I disorder. These findings are consistent with similar analyses in patients with schizophrenia.

This poster was presented at the 32nd annual Psych Congress, held Oct. 3-6, 2019, in San Diego, California.

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