Efficacy of lurasidone in the treatment of agitation: A post hoc analysis of five short-term studies in acutely ill patients with schizophrenia.

Abstract

OBJECTIVE:

This post hoc analysis evaluated the effect of lurasidone on agitation in acutely ill patients with schizophrenia.

METHOD:

Patient-level data were pooled from five 6-week, randomized, double-blind, placebo-controlled studies of fixed-dose, once-daily, oral lurasidone (40, 80, 120, or 160 mg/d). Agitation was assessed with the Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) score, utilizing a mixed model for repeated measurement analysis.

RESULTS:

In patients with higher levels of agitation at baseline (PANSS-EC score≥14; n=773), lurasidone was associated with significantly greater improvement in least-squares (LS) mean PANSS-EC scores versus placebo at Day 3/4 (-1.6 vs -1.0; p<0.05), Day 7 (-2.3 vs -1.6; p<0.05), and at Week 6 endpoint (-5.5 vs -3.8; p<0.001; effect size=0.43). In patients with lower agitation at baseline (PANSS-EC score<14; n=754), LS mean PANSS-EC score change was significantly greater for lurasidone compared with placebo at Day 7 (-0.8 vs -0.1; p<0. 01) through Week 6 endpoint (-1.9 vs -0.9; p<0.001; effect size=0.31). Higher doses of lurasidone were notably more effective than lower doses in patients with more severe agitation at study baseline.

CONCLUSION:

In this pooled analysis of 5 short-term studies, lurasidone provided early and sustained reduction in agitation, assessed using the PANSS-EC score, in patients with an acute exacerbation of schizophrenia. Higher doses of lurasidone were particularly effective in patients with more severe agitation at study baseline. Overall, these results suggest that lurasidone may be a useful treatment option for patients exhibiting agitation associated with acute psychotic symptoms of schizophrenia. ClinicalTrials.gov Identifiers: NCT00088634 (Study D1050196); NCT00549718 (Study D1050229), NCT00615433 (Study D1050231); NCT00790192 (Study D1050233). Study D1050006 was completed prior to the requirement to register trials.

• Authors: Michael H Allen, Leslie Citrome, Andrei Pikalov, Jay Hsu, Antony Loebel
• Journal: General hospital psychiatry (Gen Hosp Psychiatry) Vol. 47 Pg. 75-82 (07 2017) ISSN: 1873-7714 [Electronic] United States
• PMID: 28807142 (Publication Type: Journal Article, Randomized Controlled Trial)
• Copyright: Copyright © 2017 Sunovion Pharmaceuticals Inc. Published by Elsevier Inc. All rights reserved.

Chemical References

• Antipsychotic Agents
• Lurasidone Hydrochloride

Topics

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Antipsychotic Agents (administration & dosage, pharmacology)
• Double-Blind Method
• Female
• Humans
• Lurasidone Hydrochloride (administration & dosage, pharmacology)
• Male
• Middle Aged
• Outcome Assessment, Health Care
• Psychomotor Agitation (drug therapy, etiology)
• Schizophrenia (complications, drug therapy)
• Young Adult