Effects of Lurasidone On Hostility in Patients with an Acute Exacerbation of Schizophrenia: a Pooled Post HOC Analysis of 5 Short-term Studies

Abstract

Introduction

Lurasidone has demonstrated efficacy in the treatment of schizophrenia.

Objective

To evaluate the effect of lurasidone on hostility in patients with an acute exacerbation of schizophrenia.

Aims

To assess the efficacy of lurasidone for reducing hostility.

Methods

Data were pooled from 5 double-blind, placebo-controlled, 6-week studies of lurasidone (40-160 mg/d) in patients with evidence of hostility at study baseline (Positive and Negative Syndrome Scale [PANSS] hostility item score ≥2). Lurasidone was compared with placebo using mixed-model repeated-measures analysis, with and without adjustment for positive symptoms of schizophrenia and somnolence as covariates.

Results

A total of 1148 patients met criteria for hostility at baseline (lurasidone, n=775; placebo, n=373). Lurasidone was significantly superior to placebo in reducing the PANSS hostility item score from Week 1 (P=0.002) through Week 6 (P>0.001). After adjusting for change in positive symptoms, lurasidone significantly decreased hostility compared with placebo from Week 2 (P=0.014) through Week 6 (P>0.05). After adjusting for the presence of somnolence, lurasidone significantly reduced hostility relative to placebo beginning at Week 2 and every assessment thereafter (P>0.05), except for Week 6. Overall, 63.1% of lurasidone-treated patients demonstrated any improvement (≥1 point change) on the PANSS hostility item at study endpoint compared with 55.0% of patients taking placebo (number needed to treat=13; 95% confidence interval, 8-49).

Conclusions

Lurasidone showed a specific antihostility effect in this post hoc analysis; improvement in hostility was significantly greater with lurasidone than placebo and was independent of change in other positive symptoms or somnolence.

Funding

Sunovion Pharmaceuticals Inc.