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2011 HSR&D National Meeting Abstract

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2011 National Meeting

1069 — A Clinical Trial of Long-Acting Injectable Risperidone and Oral Antipsychotics

Rosenheck RA (VA CT Healthcare System), Krystal JH (VA CT Healthcare System), Lew R (Massachusetts Veterans Epidemiology and Research Information Center (MAVERIC)), Barnett PG (HERC), Fiore L (MAVERIC), Valley D (MAVERIC), Thwin SS (MAVERIC), Vertrees J (VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center (CSPCRPCC)), Liang V (MAVERIC), CSP 555 Invetigators (VAMCs)

Objectives:
Medication non-adherence is a major reason for poor outcomes in schizophrenia. Long-acting injectable (LAI) risperidone Risperdal ® Consta ®, the first LAI second generation antipsychotic (SGA), may improve adherence and outcomes. We tested Consta (r) in a long-term randomized trial of unstable patients against oral medication.

Methods:
US Veterans Affairs (VA) patients with schizophrenia and schizo-affective disorder, hospitalized within the past 2 years or judged to be at risk of hospitalization from increasing psychiatric service use, were randomly assigned to LAI risperidone bi-weekly (25-50 mg/injection), or to the psychiatrist’s choice of oral antipsychotics, and followed for up to two years. The primary intention-to-treat endpoint was VA or non-VA psychiatric re-hospitalization. Symptoms, quality of life, and global functioning were assessed through blinded video-conference interviews.

Results:
Participants (N = 369) were hospitalized either at randomization (40%) or within the previous two years (55%), or were at current risk of hospitalization (5%). LAI risperidone showed no superiority to oral anti-psychotics on time to first psychiatric hospitalization (p = .39). Mixed models showed no significant superiority for LAI risperidone on psychiatric symptoms, quality of life, or the Personal and Social Performance (PSP) measure of global functioning, all assessed blindly via video interview, or on standardized measures of neurological side effects. However, LAI patients reported more adverse events at the injection site and extrapyramidal symptoms.

Implications:
LAI risperidone showed no superiority to psychiatrist’s choice of oral treatment in patients with schizophrenia and schizoaffective disorder at relatively high risk of hospitalization, but showed more local injection site and extrapyramidal adverse effects.

Impacts:
This study dampens enthusiasm for a costly treatment that is often used in patients who do poorly on oral antipsychotics, but additional cost-effectiveness research is being conducted to give a more complete assessment of this treatment


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