Effect of Lurasidone On Metabolic Parameters in Patients with Bipolar Depression

Abstract

Introduction Patients with bipolar disorder are at a higher risk of metabolic complications and associated mortality than the general population. Objective/Aims To evaluate the extent to which treatment with lurasidone was associated with clinically relevant shifts in key weight and metabolic parameters in patients with bipolar I depression (BPD). Methods Data were from 3 short-term studies in patients with BPD who were randomized to 6 weeks of double-blind, placebo-controlled treatment with lurasidone (18.5-111 mg/d), either as monotherapy (one study, N=499), or adjunctive therapy with lithium or valproate (2 studies, N=694). Patients completing the 6-week trials continued in a 6 month open-label extension study (N=494). The proportion of patients with shifts in metabolic parameters were analyzed at the 6 week and 6 month end-points, and are reported descriptively. Shifts were defined as changes in weight (≥7% change), BMI category, triglycerides (increase ≥50 mg/dL), total cholesterol (increase ≥40 mg/dL), LDL (increase ≥30 mg/dL), and glucose (shift to ≥110 mg/dL). Results At Week 6 in the monotherapy study, a similar proportion of patients treated with lurasidone vs placebo, respectively, had shifts in weight (2.0% vs 0.6%), triglycerides (15.7% vs 10.1%), total cholesterol (5.5% vs 3.4%), LDL (6.4% vs 3.4%), and glucose (11.3% vs 9.5%). Results were similar for lurasidone vs placebo in the adjunctive therapy study. At Month 6 of the extension study, a relatively low proportion of the patients on lurasidone met shift criteria. Conclusions These data add to the substantial and growing body of information regarding the metabolic safety of lurasidone. NCT00868699, NCT01284517, NCT00868452, NCT00868959. Sponsored by Sunovion Pharmaceuticals Inc.