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Psych Congress  

Effect of Lurasidone on Metabolic Indices in Bipolar I Depression: Data From Monotherapy and Adjunctive Therapy Studies

Authors  
Andrei Pikalov MD, PhD
Susan McElroy MD
Josephine Cucchiaro PhD
Jay Hsu PhD
Hans Kroger MPH, MS
Debra Phillips BS
Antony Loebel MD
Sponsor  
Sunovion Pharmaceuticals Inc.

Objectives: To evaluate the effect of short-term treatment with lurasidone on weight and metabolic parameters in patients with bipolar I depression.


Methods: Safety results were analyzed from two 6-week, double-blind, placebo-controlled studies that evaluated the efficacy and safety of lurasidone as monotherapy (20-60 mg/d and 80-120 mg/d) or as adjunctive therapy (20-120 mg/d) with lithium (Li) or valproate (VPA), in patients with bipolar I depression, with or without rapid cycling (DSM-IV-TR). 
Results: In the monotherapy study, the proportion of subjects with a clinically significant (≥7%) increase in weight from baseline to Week 6 was low for lurasidone (2.4%) and placebo (0.7%). Comparable median changes were observed at Week 6 in total cholesterol (-0.5 vs. -3.0 mg/dL), LDL cholesterol (-2.0 vs. -2.0 mg/dL), triglycerides (+1.5 vs. +8.0 mg/dL) and glucose (0.0 vs. +0.5 mg/dL) with lurasidone and placebo, respectively. No dose-related effects on metabolic parameters were observed. In the adjunctive therapy study, the proportion of subjects with a clinically significant increase in weight was low for lurasidone (3.1%) and placebo (0.7%). Comparable median changes were observed at Week 6 in total cholesterol (-4.0 vs. 0.0 mg/dL), LDL cholesterol (-3.0 vs. -3.0 mg/dL), triglycerides (+4.5 vs. -4.0 mg/dL) and glucose (+1.0 vs. +1.0 mg/dL) with lurasidone and placebo, respectively.

 
Conclusions: In these two placebo-controlled studies in subjects with bipolar I depression, short-term treatment with lurasidone, either as monotherapy, or as adjunctive therapy with Li or VPA, was associated with minimal changes in weight, lipid parameters, or measures of glycemic control.

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