Comparison of SGA oral medications and a long-acting injectable SGA: the PROACTIVE study.

Authors

• Peter F Buckley
• Nina R Schooler
• Donald C Goff
• John Hsiao
• Alexander Kopelowicz
• John Lauriello
• Theo Manschreck
• Alan J Mendelowitz
• Del D Miller
• Joanne B Severe
• Daniel R Wilson
• Donna Ames
• Juan Bustillo
• Jim Mintz
• John M Kane

Publication/Presentation Date

3-1-2015

Abstract

Until relatively recently, long-acting injectable (LAI) formulations were only available for first-generation antipsychotics and their utilization decreased as use of oral second-generation antipsychotics (SGA) increased. Although registry-based naturalistic studies show LAIs reduce rehospitalization more than oral medications in clinical practice, this is not seen in recent randomized clinical trials. PROACTIVE (Preventing Relapse Oral Antipsychotics Compared to Injectables Evaluating Efficacy) relapse prevention study incorporated efficacy and effectiveness features. At 8 US academic centers, 305 patients with schizophrenia or schizoaffective disorder were randomly assigned to LAI risperidone (LAI-R) or physician's choice oral SGAs. Patients were evaluated during the 30-month study by masked, centralized assessors using 2-way video, and monitored biweekly by on-site clinicians and assessors who knew treatment assignment. Relapse was evaluated by a masked Relapse Monitoring Board. Differences between LAI-R and oral SGA treatment in time to first relapse and hospitalization were not significant. Psychotic symptoms and Brief Psychiatric Rating Scale total score improved more in the LAI-R group. In contrast, the LAI group had higher Scale for Assessment of Negative Symptoms Alogia scale scores. There were no other between-group differences in symptoms or functional improvement. Despite the advantage for psychotic symptoms, LAI-R did not confer an advantage over oral SGAs for relapse or rehospitalization. Biweekly monitoring, not focusing specifically on patients with demonstrated nonadherence to treatment and greater flexibility in changing medication in the oral treatment arm, may contribute to the inability to detect differences between LAI and oral SGA treatment in clinical trials.

Volume

41

Issue

2

First Page

449

Last Page

459

ISSN

1745-1701

Published In/Presented At

Buckley, P. F., Schooler, N. R., Goff, D. C., Hsiao, J., Kopelowicz, A., Lauriello, J., Manschreck, T., Mendelowitz, A. J., Miller, delD., Severe, J. B., Wilson, D. R., Ames, D., Bustillo, J., Mintz, J., Kane, J. M., & PROACTIVE Study (2015). Comparison of SGA oral medications and a long-acting injectable SGA: the PROACTIVE study. Schizophrenia bulletin, 41(2), 449–459. https://doi.org/10.1093/schbul/sbu067

Disciplines

Business Administration, Management, and Operations | Health and Medical Administration | Management Sciences and Quantitative Methods

PubMedID

24870446

Department(s)

Administration and Leadership

Document Type

Article