TITLE:
Long-Term Clinical Outcome of Patients Using Risperidone Long-Acting Injectable: The Romanian e-STAR Database
AUTHORS:
Ioana Micluţia, Mãdãlina Vrabie, Roxana Ciungu
KEYWORDS:
Schizophrenia Registry, Risperidone Long-Acting Injectable, Hospitalizations, Clinical Outcome, Safety
JOURNAL NAME:
Open Journal of Psychiatry,
Vol.5 No.2,
March
10,
2015
ABSTRACT: The objectives of e-STAR
Romania (NCT00283517) were to collect clinical outcome data of Romania
schizophrenia or schizo-affective disorder patients; prospectively to assess
the reasons of treatment initiation, medication usage patterns; to document
(long-term) clinical efficacy; and to collect safety data, as well as recording
2-year corresponding retrospective data. In total, 378 eligible subjects were
enrolled who were initiated either on risperidone long-acting injectable (RLAI)
(290) or on an oral antipsychotic (OA) (88) at baseline as required by the
local Summary of the Product Characteristics. Data were collected from per
patient both retrospectively and prospectively over a 24-month period at
3-month intervals after starting treatment. The results indicated that subjects
suffering from schizophrenia or schizo-affective disorder initiated on RLAI
were less likely to be hospitalized within the first 24 months after the
initiation of treatment. Moreover, subjects treated with RLAI experienced
significant improvements in their illness severity and functioning.
Discontinuation rates for RLAI were low and doses were stable throughout the 24
months following the initiation of treatment. In addition, the necessity for
supplementary concomitant medication was reduced. Adverse events were reported
in 20.3% (RLAI) and 11.4% (OA) of the subjects. In general, patients initiated
on RLAI and OA at baseline both clinically improved on all assessed parameters
but a larger improvement was observed for patients on RLAI. Incidences of
reported AEs during the use of RLAI in a naturalistic setting are comparable
with those described in clinical studies; however, the incidence of
extrapyramidal signs and weight gain was lower than expected.